As consumer desire for clean, healthy, and natural foods continues to grow, food companies are increasingly interested in including these types of claims on product labels. The theory is that the more “natural” or “healthy” a food product appears, the more likely consumers are to purchase it. The use of any word or term on a food product label, however, could create significant regulatory or class action risk for food companies.

For this reason, food companies should carefully consider any marketing term that is included on a product label or in product advertising. Although FDA has direct regulatory authority over food labels per se, the agency has interpreted this authority to include food advertising (i.e., ancillary statements made in flyers, in commercial advertisements, or on the internet). In turn, the Federal Trade Commission (FTC) also has direct regulatory authority over food advertising claims and can take its own regulatory enforcement actions against food companies that make claims found to be deceptive or misleading. FTC will find an advertisement deceptive and unlawful if it contains a material representation or omission of fact that is likely to mislead consumers acting reasonably under the circumstances.

The risks associated with using such claims can be significant. This is especially true when both regulators and class action lawyers are constantly scanning store shelves for products using these terms. In this article, we will look closely at the definitions of both “healthy” and “natural” and provide an update on the overall regulatory enforcement approach being adopted, as well as some recent examples of class action lawsuits.

“Healthy” Labels

When using the term “healthy” on a product label or in advertising, food companies should conduct a careful review of FDA’s definition and previous treatment of the term to avoid regulatory action and potential lawsuits. FDA has previously taken formal regulatory action, including issuing formal (and public) warning letters, for the improper use of the term “healthy” on product labels and in advertising. Even without regulatory action, companies may face lawsuits when “healthy” is improperly used on foods, potentially leading to huge defense expenses and possibly a costly settlement.

As defined by FDA, the term “healthy” requires that the food meet certain nutritional requirements; however, after issuing a Warning Letter to KIND for the use of “healthy” on products that the agency argued did not meet these requirements, and later reversing its decision, FDA has started to refine its policy and approach to enforcing the labeling requirements.

Generally, all agree that a product using the term “healthy” must be low fat, low in saturated fat, and low cholesterol. Additionally, for certain product categories, the product must also be a good source of one or more vitamins or minerals. Additional requirements can be found in the regulations. All companies should thus carefully review the requirements of 21 C.F.R. 101.65(d)(2) before making a “healthy” claim on a product.

In addition to the requirements provided in 21 C.F.R. 101.65(d)(2), FDA has issued guidance stating that products that are not low in total fat but have a fat profile of predominately mono- and polyunsaturated fats or are a good source of potassium or vitamin D can use the term “healthy” in labeling and advertising. Although guidance documents are not law, FDA has stated that the agency will use enforcement discretion to avoid taking regulatory action against products labeled “healthy” in accordance with the September 2016 guidance document. The agency also indicated that updates to the Dietary Guidelines supported the additional products that can be labeled “healthy,” and that the latest nutrition science would be considered when finalizing an updated definition for the term.

FDA published an update on its research activities on March 28, 2022, indicating that the agency is continuing to review the definition of “healthy” and is currently investigating the use of an approved icon for “healthy” products. The agency has determined that a standardized symbol for “healthy” foods may help improve dietary patterns within the U.S., and the agency is currently conducting research to develop the image and standards for a voluntary “healthy” icon.

With that said, the use of the term could still be dangerous if all regulatory requirements are strictly followed. Notably, many recent class actions litigating foods claiming to be healthy focus on products with high levels of added sugars and include products that only make an implied claim of healthfulness. In a case litigated in 2020, a consumer sued Welch’s for making claims such as “helps support a healthy heart” on various 100% juice products. In Hanson v. Welch Foods Inc., 470 F. Supp. 3d 1066 (N.D. Cal. 2020), the consumer sought to represent a California-wide class, alleging that the products actually increased the risk of heart disease due to their high sugar content. Welch’s ultimately settled with the consumer, on behalf of a class of consumers, for both monetary relief totaling $1,500,000 and an agreement to remove all claims that suggest the product is healthy.

Similarly, Clif Bar was recently sued for making various claims that suggested certain products were healthy. Among the claims made were “nourishing kids in motion” and “nutritious on-the-go snacks for our kids.” These claims, according to the plaintiff in Milan v. Clif Bar & Co., 489 F. Supp. 3d 1004 (N.D. Cal. 2020), were misleading because of the high levels of added sugar in the Clif Bar products. The consumer sought to represent all New York and California consumers who purchased the various products, and these classes were approved by the court. The case has not yet been litigated nor have the parties settled.

What is clear from the litigation, however, is that these types of claims and lawsuits can be extremely expensive. The costs of attorneys can easily exceed hundreds of thousands, if not millions, of dollars, and the settlements can be equally costly.

“Natural” Labels

Unfortunately, FDA has not yet defined the term “natural.” Although the agency previously requested comments in 2016 from the public on the meaning of the term “natural,” it has not yet issued guidance or a final rule implementing a regulatory definition. FDA has, however, stated that the agency considers “natural” to mean that nothing artificial or synthetic, including all color additives, has been added to the food unless the additive is normally expected to be in that food. USDA similarly has not issued a regulatory definition but has stated that the agency considers “natural” meat and poultry products to be those products that contain no artificial ingredients or color and that are only minimally processed.

Until FDA finalizes a definition of “natural,” companies should use the term “natural” with caution and only when the product contains no artificial or synthetic ingredients. Additionally, products being marketed as “natural” should be minimally processed, meaning that any processing the food undergoes does not fundamentally change the product.

In light of this confusion, over the past several years many lawsuits have sought to challenge “natural” claims, targeting everything from yogurt made with milk from cows fed genetically modified feed to granola bars that had trace amounts of herbicides. Other products routinely targeted included those using the term “natural,” notwithstanding the presence of various ingredients such as citric acid, xanthan gum, and soy lecithin.

More recent class actions continue to focus on the presence of additives or residues that consumers may perceive to be unnatural. McCormick & Co. recently settled a class action lawsuit for use of the claim “all natural” on various seasonings that contained corn starch, white corn flour, and citric acid. The plaintiff alleged that these ingredients were “highly processed, synthetic, and/or genetically modified,” and were, therefore, not natural. In Holve v. McCormick & Co., 334 F. Supp. 3d 535 (W.D.N.Y. 2018), the consumer sought to represent a national class of affected consumers, and the agreement settled the claims on behalf of a national class. The settlement totaled $3,000,000 in monetary penalties and included an agreement by McCormick to modify the labeling of various products.

Similarly, Tropicana continues to litigate a class action lawsuit, Willard v. Tropicana Mfg. Co., No. 20-cv-01501 (N.D. Ill. Dec. 30, 2021), in which the consumers claim that the presence of DL-malic acid in juices labeled as “100% natural” causes the claim to be deceptive and misleading. The plaintiffs, who have targeted numerous Tropicana products in the action, seek to represent a national class of consumers.

With these risks in mind, be sure to scrutinize your labels, claims, and ingredients to avoid becoming a target. Also, remember that, regardless of what FDA’s guidance provides, both of these terms (“natural” and “healthy”) have evolving meaning to consumers. So, even if the terms are being used appropriately in the technical sense, class action lawyers could still attempt to argue that, based upon current consumer perceptions or understanding, consumers are being misled.

What is clear is that a regulator or plaintiff lawyer may begin to salivate when they see these terms. Review your labels now to make sure that they are salivating over the quality of your product, and not the quantity in your pocketbook.

Stevens is a food industry attorney and founder of Food Industry Counsel, LLC and a member of the Food Quality & Safety Editorial Advisory Panel. Reach him at stevens@foodindustrycounsel.com. Presnell is the newest member of Food Industry Counsel and has worked in the food industry for nearly a decade. Reach her at presnell@foodindustrycounsel.com.

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Autoclavable Paddle Blender Bag

Seward has launched the Stomacher 3500 autoclavable paddle blender bag. Its material composition makes the new autoclavable bag the first paddle blender bag that can survive irradiation, stomaching, and the autoclave disposal cycle without losing its integrity. The bag prevents bursting and spillages after autoclaving, ensuring the contents can be disposed of where and when intended, rather than being accidentally dumped onto the floor. The single chamber autoclavable bags are ideal for sample sizes ranging from 400-4,500 mL and irradiated sterile for use in laboratory blenders. They are available in packs of 250 in five sachets of 50 and sterility assured and made from food-grade materials and suitable for all microbiological applications. The bag’s wide range of applications also includes small batch media preparation, which can then be sterilized in an autoclave. Seward, seward.co.uk.

Cutting Tool

IMA Dairy & Food USA has made enhancements to the cutting tools used for its recently introduced ZERO Technology, which helps food brands easily use sustainable monomaterial cup packages. Highlighted by an extractable central cutting unit (CCU) design, the innovation drastically reduces production downtime for change-outs, minimizes spare part costs, and raises the number of punches between sharpenings. Ideally suited to IMA’s Erca, Hassia, and Intecma brands of form-fill-seal (FFS) machines, the technology uses a punch process to provide cutting and pre-cutting of eco-conscious materials such as PET, PP, and PLA. The enhanced cutting tools overcome other longstanding obstacles: production downtime and cost of ownership. By using an interchangeable cutting elements setup that allows individual tools components to be expediently replaced onsite, line stoppage can be reduced to 20 minutes. IMA Dairy & Food, imadairyfood.com.

Checkweigher for Packaged Foods

The Raptor Checkweigher series from Fortress Technology Ltd. is now available for North American food producers. The system helps food manufacturers meet legislative weight requirements and targets operational inefficiencies, including upstream product giveaway, non-conforming food packs and packaging waste. The regular system and its XL version have modular electronics, which allows them to be integrated with a Fortress metal detector and upstream packaging equipment. The series also features an HMI touchscreen panel, which can be pre-programmed to calibrate numerous SKUs. Fortress Technology, Ltd., fortresstechnologies.com.

Wastewater Monitoring System

Food processing plants require large amounts of water for washing, rinsing, cooking, disinfecting, bottling, canning, and packaging, and both incoming and discharged water must be treated to ensure product quality and environmental safety. To help food facility water and wastewater system operators conveniently monitor equipment and environmental conditions, Sensaphone has released the cloud-based Sentinel PRO system with supporting

iPhone/Android applications. The system interfaces with any water or wastewater processing equipment that uses a PLC with Modbus sensors and can read values over 2-wire RS485 or Ethernet/TCP. The system immediately notifies users when sensor readings move outside of preset parameters, which can indicate potential threats to pumps and systems. The system sends alerts via text, email, or phone call. Users can view data values in real time, set alarms, acknowledge alerts, review data, and generate reports from their mobile device, tablet, or computer. Sensaphone, sensaphone.com.

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Roast Level and Brew Temperature Affect the Color of Brewed Coffee

Beverage color significantly affects perceived sensory quality and consumer preference. Although the color of coffee beans is well known to vary strongly with roast level, little work has examined how roast level and brewing conditions affect the color of the final beverage. These authors report that the color of full immersion brewed coffee is significantly affected by both roast level and brewing temperature. Coffees from three different origins were each roasted to three different levels (light, medium, and dark) and then brewed at three different temperatures (4°C, 22°C, and 92°C). Each sample was brewed toward full extraction and then diluted to precisely 2% total dissolved solids so that differences in concentration would not confound color measurements. Absorbance spectra (UV-vis) and color tristimulus values (L*a*b*) were then collected and analyzed. The authors concluded that roast level had the strongest impact on brew color, and that brew temperature had a significant impact on color for light and medium roasts, with less impact on dark roasts. Qualitatively, the cold brewed coffees tended to be redder, while the hot brewed coffees were blacker. The results suggest that there is an opportunity to manipulate and brand brewed coffee color through judicious choices of roast level and brewing temperature. Journal of Food Science. Published online ahead of print March 29, 2022. DOI: 10.11111750-3841.16089

Production of Non-Alcoholic Beer via Cold Contact Fermentation

The use of non-conventional yeasts is increasingly seen as an option for the production of low and alcohol-free beers. In this study, four non-conventional yeasts (Kazachstania servazzii, Kluyevoromyces marxianus, Pichia fermentans, and Torulaspora delbrueckii), originally isolated from sourdough cultures, were assessed by screening their ability to reduce wort aldehydes at a fermentation temperature of 1.0°C ± 0.5°C. Of the evaluated yeasts, T. delbrueckii was found to be most promising, being capable of the removal of wort-derived aldehyde off-flavors, while being sufficiently sensitive to low temperatures to limit the formation of ethanol. Despite the different alcohol by volume (0.07% vs. 0.28%), the beers produced via cold contact fermentation at 10 L scale with T. delbrueckii and a reference lager yeast strain were similar, with no major differences found after sensory analysis. The results suggest that T. delbrueckii could be used in cold contact fermentation to produce non-alcoholic beers with alcohol content at, or close to, 0%. Journal of The Institute of Brewing. 2022;128:28-35.

Sodium Reduction Strategies in Foods

In response to health concerns generated by increased sodium intake, many new approaches have been studied to reduce the sodium content in processed food. It has been suggested that reducing sodium in the food supply may be the most appropriate solution. The aim of this review was to establish what sodium reduction strategies are effective in maintaining acceptable sensory qualities for various food industry applications. Studies that evaluate and report on the effectiveness of a sodium reduction strategy relevant to food and included outcomes detailing how the strategies were received by human participants using sensory data are included, as well as book chapters, literature reviews, and patents focusing on sodium reduction strategies. Only those published in English since 1970 were included, and 277 primary studies, 27 literature reviews, 10 book chapters, and 143 patents were selected for inclusion. Data extracted included details such as analytical methods, broad and specific treatment categories, significant outcomes, and limitations, among other material. Sodium reduction methods were categorized as either salt removal, salt replacement, flavor modification, functional modification, or physical modification. Although salt removal and salt replacement were the focus of most of the studies included, future research would benefit from combining methods from other categories while investigating the impact on sensory characteristics, technological aspects, and consumer perception of the strategy. Comprehensive Reviews in Food Science and Food Safety. 2022;21:1300-1335.

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Even people who know nothing about cannabis know that it can have a strong smell. Cannabis flower is packed with aromatic terpenes, which give the plant its many strong and distinctive odors. The potency of terpenes carries over to the flavor of the plant, making it taste, as Canadian cannabis industry consultant Brandon Wright puts it, “very green.” This “green” flavor can be a challenge for edibles producers looking to add cannabis or cannabinoids to their products. Should they mask cannabis flavor? Should they lean into it? What do consumers want?

Wright opened his first company after the 2015 Supreme Court of Canada decision that the production and distribution of cannabis edibles for medical users was constitutionally protected. At the dawn of Canadian edibles, he says, the two main sources of cannabinoids were cannabutter (butter infused with cannabis) and Rick Simpson Oil (RSO), a high-concentration cannabis oil extract made with solvents such as naptha. “In the early days, a lot of things looked, tasted, and smelled ‘green.’ That’s just not the case anymore,” he adds. Instead, edibles producers now often use tetrahydrocannabinol (THC) distillates or isolates, which eventually took over from RSO as the cheapest and strongest source of cannabinoids for edibles.

Wright also notes that, among regulated markets, THC distillates seem to be the most common cannabinoid additives due to the ease of masking their flavors. “Distillates in particular are a fairly well-refined product,” he says, adding that the distillate process already takes out a lot of what you’d consider that green, “weedy” taste. “What you’re left with isn’t exactly a chemical taste; it would be akin to the alcohol taste in a rum ball. It doesn’t taste like alcohol, but you know alcohol is in it. There’s a sense there’s something there underlying this that is more than just the flavor of the candy. That’s how I know it’s infused.”

For some, the use of distillates has made edibles too easy to create. Christina Wong, a chef who develops cannabis-infused recipes, is tired of distillate in edibles. “My biggest pet peeve is people who have any edible or drink product [can just] add a [THC] distillate or isolate, and say ‘Here we go, I have an edible,’” she says. “I know it’s very hard to be a producer, to get a product to market, finding a co-packer and somebody who can create those products. Adding distillate and isolate is the ‘easy’ button. Anybody can add distillate/isolate to a product and call it an edible, and there are a lot of interesting ones. But personally, I’m on a mission to promote higher quality ingredients and educate the consumer about how they should buy quality.”

While distillates and isolates have little flavor in lower doses, they can also be acrid; skill and practice are needed to incorporate them into a polished final edible product. Wright says that THC distillate between 85% and 95% potency is a plant-synthesized chemical so strong it’s “akin to turpentine.” Wong calls the taste of some distillates and isolates “bitter and horrible” and says that she’d rather work with the full plant and its many flavors instead of orienting her recipes around hiding the chemical taste of added cannabinoids.

Potency also influences distillate and isolate bitterness, which Wright says is one of the limits on the desirability of distillate-based edibles. “In the regulated market, almost exclusively, you’ll see more distillates being used,” he says, “because then people don’t have to think about the problem of masking the greenness. But [as potency increases], some of the bitterness will remain.” He adds that a trained food scientist is an important component of your R&D process.

Trial and Error for Cannabis Flavor

New edible products must meet strict regulatory requirements for cannabinoid content, a concern that must also be addressed during the product development stage. Rachel King, a founding partner and culinary director of edibles company Kaneh Co., agrees that R&D plays an important role in edibles product development. “We have done lots of R&D and have had a ton of trial and error,” she says. “We have the system ironed out now, but we rely heavily on lab results, proper scaling of ingredients, and recipe ratios. Data has been our best friend in this.” Once the potency content has been established, the art of masking the chemical taste becomes paramount.

Wright says the taste of distillate can generally be masked. “It’s easier with savory things that are more complex—things like peanut butter cups,” he says. “Gummies and things made purely out of sugars or basic products are tougher to mask it in.”

At Kaneh Co., King has found chocolate the easiest flavor with which to mask cannabis, followed by coffee. “Fruit flavors don’t always mask the taste,” she says, “but the stronger the fruit flavor the better. Depending on the cannabis material used, fruit flavors or even vanilla can enhance certain notes in the cannabis flavor profile to create a pleasant synergistic effect. The stronger the food flavor, the better it will mask the cannabis flavor.”

Dave Maggio, chief operating officer of multi-state edibles operator Cheeba Chews, says his go-to cannabis masking flavor is mint. He agrees that “fruity” as a flavor isn’t very effective, unless it’s the kind of precise citrus flavor calibrated to the terpene profiles of particular strains. “There’s a lot of R&D, but you can’t just pick a strain and decide you’re going to mix it with strawberry.”

His company initially launched as a line of taffy products, and Maggio says that taffy is a rich medium in which to mask the flavor of pure distillate. “With chocolate and caramel, you can mask the flavor much easier.” In their newer gummy products with more delicate flavors, Maggio hires a double distiller to make the distillate even more pure.

Maggio has little use for chemical flavor fixes such as bitter blockers, which he says don’t work with cannabis. “A lot of it has been trial and error, and we find some of the higher-end flavor extracts are what have helped us, rather than bitter blockers or other chemical-type materials that are made for [masking],” he says. “What we found the most success with was using high-end [cannabis] when it comes to flavoring.”

To Mask or Not to Mask Cannabis Flavor?

One quirk of cannabis is its range of flavors and odors, which can be dominated by notes ranging widely from skunk or pine, to citrusy or lavender, to earth, spice, cheese, or turkey dinner. Wong sees this array of flavor possibility as a gold mine.

For some of his company’s new products, however, Maggio says that masking the flavor is no longer the goal. The company is joining the wave of higher-end edibles makers releasing flavors made with full-flavor rosins and solventless extracts like ice-water hashish. “Instead of masking flavors, we’re trying to bring out a different line of product,” Maggio says. “We have our regular product that’s made with distillate or isolate, and then we also do this line of products for people who want to taste the cannabinoids and the terpenes.”

That’s the sort of thing Wong has been seeing more and more of in California, and she’s overjoyed about it. “I would like to see more edibles made with ice-water hash, solventless rosin, and other high-quality cannabis,” she says. “It’s not about masking. I make cannabutter or infused oils at home, and I like to cook and bake using strain-specific pairings. Certain edibles companies are still using cannabutter and solventless rosin for edibles, and it’s delicious. When you can get the true flavor of a strain paired with ingredients, from a culinary point of view, I love that. It elevates the edible experience.”

Using products like rosin or ice-water hash over distillate can be more expensive, but it also can attract a certain segment of cannabis lovers who want a bit of “green” flavor. “That’s not necessarily a bad thing,” Wright says. “From a marketing perspective, people will tell you [that] when the brain doesn’t get what it’s expecting to get, it’s [confusing]. A lot of people expect that taste now, and if they don’t get it, they wonder whether they’re really getting [the cannabis].”

The emerging consumer demand for cannabis-flavored edibles also means more R&D, says Maggio. “We spent so many years on trying to get the flavor to be better, with less cannabis flavor, and taking that flavor to build on,” he says. “But [using rosin offers] a totally different type of flavor perspective. It’s much more natural and really a full flavoring; it amazes me how the strains make a difference, where with distillate, you could put 300 strains in the mix and a kilo of oil, and it really doesn’t matter. It all comes out the same. Every distillate ends up being the same.”

Consumer Expectations

Maggio says his company, like everyone else’s, is trying to figure out what cannabis consumers will want next in an industry that continues to discover itself. “With a country as large as ours, it makes it hard to jump into every little fad that’s out there,” he says. Yet the calling for unmasked, full-flavor edibles is real. “It’s a little bit higher end, and it’s a little more costly to put this product out. You don’t get as much good, usable product out of it. It’s more of a connoisseur kind of product, so it won’t be for everybody. But is it going to be 10% of the industry? Fifty percent of the industry?”

One thing, however, is clear, according to Maggio: “I think we’re going to see a lot more of it.”

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If fire was humankind’s first flavor enhancer, salt emerged as its second. In fact, salt is one of the most amazing workhorse food ingredients ever discovered, not only in terms of enhancing flavor but also for delivering texture, taste, and appealing mouthfeel. It’s been an important preservative and food protection agent for thousands of years. The question now facing the industry, however, given the undeniable reality that too much salt can also be harmful, is whether the ingredient is functionally irreplaceable.

Consider salt’s provenance: Throughout history, the availability and use of this remarkable mineral was pivotal in the rise of civilizations all around the world. At the same time, medical science has taught us that excess salt is too much of a good thing—so much that it becomes a very bad thing indeed. Too much sodium can cause cardiovascular health problems—hypertension, stroke, and kidney disease, to name a few—and most of the sodium in the typical Western diet comes from high added salt content.

From a taste viewpoint, salt has an impressive track record. It’s one of the main “basic” flavors and improves the taste of many foodstuffs by suppressing bitterness, making food more palatable and also relatively sweeter. Today it’s used liberally to add flavor to a plethora of different manufactured and processed foods and restaurant menu items—too liberally, according to many global health authorities.

In October 2021, FDA issued a final guidance with voluntary targets and recommendations for salt over the next two and a half years. The agency’s goal is to persuade the food industry to voluntarily reduce sodium content from an average of 3,400 mg per person per day to 3,000 mg. While this goal is still well above the generally recommended sodium daily target of 2,300 mg per day, the objective is to foster a gradual reduction in sodium content, such that technical and market constraints around sodium reduction can be overcome over time.

Reducing sodium content is certainly achievable; that bears stating. However, there are limits on stealth reduction using the simplified strategy of just using less salt. In practice, formulators can’t go beyond a 10% to 15% reduction of sodium content without running into significant taste, texture, and shelf-life challenges—changes consumers notice immediately, and not in a positive way. The very large challenge lies in naturally protecting (or enhancing) taste while also preserving food safety at a reduced sodium level.

In this article, we identify ways to successfully achieve these objectives.

Industry Change

Although the FDA sodium guidance is voluntary and a way to signal to industry that mandated sodium reduction may be on the way, the current heightened consumer focus on health and wellness, especially amid the COVID-19 pandemic, already demands that the industry make changes. Voluntary guidance also tends to work its way into federal nutrition policy and food-assistance programs, such as school meal initiatives, and “recommendations” from FDA are often also integrated into state and local policies around food procurement, supplemental assistance, and education.

For the food industry, the reformulation race has already started to find solutions that will replace salt’s role in the protection, preservation, and flavor of food. Although meat sits near the top of the list (meat applications are notoriously difficult in terms of meeting sodium targets), with dairy applications such as processed cheese close behind, plant-based meat substitutes, perhaps counterintuitively, often carry significantly higher salt content than their animal counterparts.

Let’s not forget to mention processed meats, cheeses, plant proteins, sauces, marinades, salty snacks, etc. These are all challenging categories for formulators facing multiple concurrent problems involving taste, texture, and shelf life when seeking to reduce salt content. On the practicality side, reducing sodium can also create shelf-life challenges: Many preservative solutions currently on the market, both clean label and conventional, are sodium based, so they can actually end up contributing more sodium to the final product.

The challenges, taken together, are substantial, so food product developers must consider all variables while simultaneously balancing consumer concerns around taste and food safety when they decide to join the salt-reduction game.

Preserving Quality and Safety

For thousands of years, sodium’s critical role has been to preserve food quality and safety. Today, many preservatives are based on organic acids that also contribute sodium to the final product.

One notable modern sodium application is curing meat with nitrite salts. While sodium tends to be naturally present in very small quantities in meat, nitrite salt preservatives can add substantially more. Pork, for example, generally contains 63 mg of sodium per 100 mg, while bacon has 1,480 mg. Herring contains 67 mg but, in its preserved form (kipper) it has 990 mg.

One way of addressing safety and quality solutions is by using the Leistner hurdle concept, which postulates that pathogens in food products can be eliminated or controlled by enacting a number of “hurdles” as building blocks in the foodstuff protection plan, strategies that ensure a product’s safety and avoid wastage by extending shelf life. Some of these hurdles include high or low temperatures, increased acidity, reduced redox potential, the use of biopreservatives, and reduced water activity through the addition of salt, sodium, drying, curing, or conserving. Each hurdle seeks to at least inhibit unwanted microorganisms, and salt is the oldest and most common of these methods.

Viewed from the hurdle standpoint, what occurs when you simply remove sodium? For one, safety can be compromised as resistance to contamination from threats such as Listeria is diminished. Quality can also be put at risk through diminished resilience to spoilage. Furthermore, a shorter shelf life leads to higher food waste, as well as increased supply chain and transportation costs, given that products must be consumed faster and distributed more frequently.

Reducing salt content presents preservative challenges that can also lead to increased sodium content through the use of added preservatives. Fortunately, there are natural, non-sodium-based preservatives that can protect product quality during the reformulation process.

Protecting Taste and Texture

When sodium is reduced, several things happen as the physiological response to the five basic tastes is disrupted: Saltiness is reduced, sourness increases, bitter or “off” tastes become noticeable, and sweetness and umami lose balance. Overall, reducing sodium throws disequilibrium into the organoleptic harmony of foods, allowing bitterness to stand out more and decreasing sweetness. After just a small reduction in salt content, the consumer begins to notice. Therefore, in taste, it’s vital to consider sodium’s overall contribution in terms of temporal taste perception—be it upfront, in the middle, or in terms of aftertaste—and apply solutions that will close the taste gaps or simply mask the previously disguised off tastes.

To complicate matters, salt has many roles in texture and functionality through water binding, in terms of “slice-ability” (enabling protein denaturation or gelation), or in dough rheology to tighten gluten strands. Processed meat is one key category in which salt contributes to mouthfeel and texture—weighty challenges that occur over and above taste and preservation. Whereas taste can be added back in using natural means, such as stocks and broths, as well as many different spices and seasonings, mouthfeel and flavor require a wide variety of natural solutions. A “tool-box” approach that offers many possible solutions is the best way to harmonize and rebalance sodium-reduced products. Whether the challenge is meat, snacks, meat alternatives, dairy, meals, or sauces, it is vital to break down the challenges across taste, texture, and shelf life.

Replacing salt and sodium in foods requires a systems approach by a knowledgeable ingredient supplier that combines solutions that work together to build back taste, shelf life and texture. Here are some solutions that might work to reduce sodium:

• Given the current industry challenges in securing sodium lactate supplies, buffered vinegar liquid and dry, low- and no-sodium preservation solutions must be considered.
• Using texture in meat applications as an example, you can source highly functional stabilizers, texturants, and brines tailored to perform in reduced-salt applications. These can be combined into a taste and preservation portfolio that delivers a fully integrated solution.
• Other sodium-reduction solutions revolve around accessing science in its many forms: flavor creation, modulation, fermentation, dairy, and smoke, grill, and other preparation processes. For example, it’s possible to develop natural flavor solutions in salty snacks that allow for a sodium reduction of up to 250 mg per serving.
• To rebuild the taste sensation, late-lingering flavor, juiciness, continuity, and succulence provided by salt, manufacturers need to leverage a variety of ingredient and flavor solutions. Umami stock can help build middle impact and the perception of sodium, complete with a natural, pantry-friendly ingredient statement. Natural stocks and broths are also excellent flavor enhancers produced through traditional kitchen cooking methods. Natural barbecue cooking is another key strategy.
• Natural salt replacement solutions are derived from fermentation, extraction, and flavor expertise to deliver on salt and umami taste while reducing the amount of sodium in a given product. Solutions can be applied to prepared meals, soups, sauces, snack seasonings, savory spreads, and vegetarian, white meat, and tomato-based products. These can lower salt content by up to 50% depending on the application, deliver salty and umami taste perception, ensure a balanced taste with a clean aftertaste, provide a natural, clean taste experience not based on potassium chloride, allow for declarations of “natural flavoring” or “yeast extract” on package labels, and optimize frozen, chilled, and ambient applications (pasteurized, sterilized).

Reformulating for Success

Clearly, salt reduction is vastly more complex than just removing salt and sodium. In reformulating, it’s crucial to use a “total concept” approach that involves making improvements to address shelf life, texture, and taste, and using preservation solutions that contribute little or no sodium to the final product. Food manufacturers also need to consider practical implications; items such as packaging inventories (i.e., ingredient declarations and nutrition fact panels will change) are also part of the agenda.

Within the next 18 to 24 months, it is highly likely that consumers will begin to notice shifts in the marketplace based directly on the FDA voluntary guidance; starting early is key. Experience tells us that it takes food manufacturers six months to one year to reformulate and validate consumer safety and taste acceptance of food products. This lengthy process can be hastened through partnering with ingredient suppliers to address changes simultaneously and holistically—a “complete formula” strategy versus just tackling the sodium aspect.

For the food manufacturing industry, the drive to reduce sodium should be viewed as an opportunity to regroup, reimagine, and repackage, not only to reduce sodium but also to build on clean labeling and enhanced preservation/natural flavor innovations. Fortunately, the targeted solutions needed are already available.

Vimalarajah is VP of business development, Americas–Food Protection & Preservation, at Kerry Taste & Nutrition in Beloit, Wisc. Reach him at joy.vimalarajah@kerry.com.

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Americans consume nearly 3,400 mg of sodium per day on average, which is almost 50% more than the recommended 2,300 mg limit set by federal guidelines for people aged 14 and older.

“High sodium, especially when coupled with low intake of potassium due to inadequate intake of fruits and vegetables, in some individuals is associated with increased risk of high blood pressure and heart disease,” Julie Miller Jones, PhD, an emeritus professor of nutrition at St. Catherine University in St. Paul, Minn., and a member of the Grain Foods Foundation’s Scientific Advisory Board, tells Food Quality & Safety.

FDA sees this as a major problem, which is why it has unleashed a new set of guidelines designed to encourage the food industry to gradually reduce sodium in a wide range of foods over the next 2.5 years, with the goal of an overall 12% reduction.

“Americans are consuming too much sodium in their diet, and the majority comes from processed, packaged, and prepared foods, not the salt shaker,” said acting FDA Commissioner Janet Woodcock and Center for Food Safety and Applied Nutrition Director Susan Mayne, in a statement. “To gradually reduce sodium across the food supply, the FDA is taking an iterative approach that includes establishing voluntary sodium targets for industry, monitoring and evaluating progress, and engaging with stakeholders.”

The guidelines have been in the works for years, with the recommendations pending since 2016. A list of 163 categories of food products in which salt can be reduced was offered by FDA; the list ranged from condiments to potato chips and deli meats to store-bought bakery items.

Tia Rains, PhD, vice president of customer engagement and strategic development at Ajinomoto Health and Nutrition North America, Inc., a food and beverage manufacturer headquartered in Itasca, Ill., notes that, for decades, public health institutions have recommended that people lower their sodium intake, and yet there has been no improvement, based on population data. “About 70% of sodium in Americans’ diets comes from sodium that is added to packaged foods and food prepared by restaurants,” she says. “Excessive sodium intake can lead to high blood pressure, a major risk factor for heart disease and stroke, which are among the leading causes of death in the U.S. Based on current scientific evidence, a reduction in sodium intake will help mitigate the risk of these health conditions and help improve general wellness among the U.S. population.”

Making Changes

Even before the new guidelines, processors have been trying to reduce sodium because guidelines over the last 20 years have been concerned about the ingredient. The most common food and beverage industry strategies have been reformulating, developing target goals, and trying to meet front-of-pack labeling goals. The industry has also tried monitoring and consumer education, in addition to menu labeling.

Given FDA’s new guidance, Dr. Rains anticipates growing interest among food processors in materials and ingredients that contribute to lower sodium levels in food applications that are cost effective and don’t impact taste. “A largely unexplored solution for reducing sodium is the use of glutamates, like monosodium glutamate (MSG),” she said. “Even though MSG has ‘sodium’ in its name, it actually has 2/3 less sodium than table salt, and, when used in the place of some salt, it can significantly lower the sodium content of a dish or product—in some cases up to 50% in packaged foods and snacks—without compromising taste.”

MSG also provides umami, a savory taste that allows foods to be delicious with less sodium. The seasoning has even been recognized by the National Academies of Sciences, Engineering, and Medicine as a tool to reduce sodium in the food supply.

Some producers have a strategy of slow sodium reduction over time, to allow consumers to adjust their palates; however, this has had mixed success and has been shown to be product dependent. “Technical advances using different forms of salt crystals and applying salt on the surface has allowed salt reduction without loss of flavor,” Dr. Jones says. “Further advances in this and other technologies are being researched and may be expected in some food products. In soups, stews, vegetables, and main dishes, the addition of more onion, garlic, and herbs and flavor-rich ingredients is a great strategy, but all these ingredients are much more costly than salt and do not give the same flavor roundness.”

Various oleoresins extracted from herbs are being used by processors, while salt mixtures that include some potassium chloride are also being studied. “Sodium reduction is very challenging in many foods because salt is added not just for taste but very often for the inhibition of microbial growth in salted fish, meat, pickles, and the like,” Dr. Jones adds. “Lowering sodium in bread a great deal is problematic as the salt controls the rate of yeast fermentation and decrease keeping quality. It also changes the character of the gluten and the crust color as well as enhancing the flavor.”

Therefore, while manufacturers are trying to maintain sensory qualities so as not to impact sales, some companies have lost significant market share and stopped trying to reduce sodium after initial efforts didn’t succeed.

Arguments Against

While many see sodium limits as a great benefit for public safety, the guidance has drawn concern from many businesses, food vendors, and manufacturing facilities.

For instance, the Competitive Enterprise Institute, a non-profit think tank based in Washington, D.C., argued that a one-size-fits-all approach to sodium fails to take into account the dietary needs and risks of people as individuals. “FDA’s nutrition guidelines need to be based on the best available science, and that is especially true when it will impose billions of dollars in costs and when peer-reviewed scientific articles point out that dietary salt is extremely controversial,” says Devin Watkins, an attorney with the group. “Following the science means listening to independent scientists, many of whom disagree with FDA on this issue. At a minimum, before FDA starts overhauling American diets, its scientific assessment needs to be peer reviewed.”

Salt is a highly addictive taste; the brain and body both enjoy salt because they view it as necessary for survival. Because sodium is added to just about every snack, food companies are now worried about losing their consumer cravings, which would result in a decrease of sales. Another factor that is sometimes overlooked is the preservative-like properties of salt, as the ingredient allows food to have a longer shelf life. In fact, high-sodium snacks have been shown to last twice as long, due to a high salt index.

Highlighting Sodium Reductions

FDA states that companies will need to reformulate products or change label claims if they have lowered the sodium. Some food manufacturers are touting their reduction in sodium on their product labels, but many use a “stealth approach,” announcing the change only in the nutrition facts panel, not on the front panel. “Research shows that labeling foods as lower sodium causes many consumers to perceive them as bland, causing low salt products to gather dust on the shelf and hurting a company’s bottom line,” Dr. Jones says.

Joe O’Neill, VP of sales and business development at A&B Ingredients, a food processor based in Fairfield, N.J., supports FDA’s sodium reduction initiative, and the company would like to see more manufacturers follow these guidelines. “Lowering sodium intake is an ambitious yet important condition of improving the state of public health,” he says. “Manufacturers can reduce sodium in existing formulations and maintain a familiar taste with a clean label ingredient statement. All it takes is replacing conventional salt with a natural, lower sodium option, like a low sodium sea salt.”

Looking Ahead

FDA plans to monitor the sodium content of the food supply and evaluate progress toward achieving the targets in the final guidance. The agency expects to issue revised subsequent targets in the next few years to facilitate a gradual, iterative process to reduce sodium intake. “Looking to the future, it is worth considering alternative messages to convey this message to consumers to share that sodium reduction doesn’t necessarily mean compromising on great flavor,” Dr. Rains says. “It would also be wise for companies to highlight their sodium reduction initiatives through external communications, such as company commitments [and] front-of-pack labeling.”

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Food safety is a global concern and foodborne illness outbreaks remain a significant challenge to public health and pose a huge economic burden worldwide. In the U.S., foodborne pathogens cause an estimated 9.4 million illnesses each year, including 56,000 hospitalizations and 1,400 deaths. Additionally, foodborne pathogens cause a 10% gastroenteritis in Europe annually. While 31 known pathogens cause foodborne illness, Salmonella, Campylobacter, Listeria monocytogenes, and E. coli O57:H7 have been implicated as the cause of many multi-state outbreaks of foodborne illness in recent years. Often the investigations of foodborne illness outbreaks fail to find the source, and the illness outbreak is referred to as caused by “unknown etiology” or by “unspecified agents.” Foodborne illnesses are preventable, yet they remain a significant challenge to the food industry and pose a huge public health and economic burden.

Pathogenic bacteria such as Salmonella, E. coli O157:H7, and L. monocytogenes are recognized as the most significant biological hazards, not only in ingredients, raw materials, and finished foods, but also in the food plant environment. Pathogens in the food plant environment can contaminate food, especially ready-to-eat (RTE) foods post processing and prior to packaging. Thus, the food industry and FDA are increasingly employing sampling food manufacturing facilities to isolate pathogenic organisms and characterize and subtype them to develop a microbiological profile of the processing facility that was sampled in addition to the products from that facility.

Similarly, epidemiological investigations by public health agencies (e.g., the Centers for Disease Control and Prevention (CDC) and state and local departments of public health) also involve pathogen isolation, characterization, and subtyping to identify which pathogen is causing an outbreak or recall and tracing the source involved in the outbreak. Clinical isolates obtained from patients affected by a foodborne illness can be compared with samples collected from foods and food plant environments to potentially identify a source of the pathogen that is causing the foodborne illness. When a match is made between clinical isolates and samples from a food or food plant, the scope and impact of the foodborne illness can be best understood. Product recalls may also be targeted based on the results of these efforts.

Food microbiologists have always been interested in methods of identification and characterization of microbial isolates in food and beverages. Early techniques included staining and microscopy; comparison of physiological, biochemical, and serological characteristics to discriminate species; and strains of microorganisms of interest. These techniques allowed for evaluation of the target organism; however, they did not have sufficient discriminatory power to allow precise identification of and differentiation between related strains of microorganisms. Also, these traditional methods are material and labor intensive, time consuming, and expensive for routine use in the identification, characterization, and subtyping of bacterial strains.

Advances in molecular biology during the last part of the 20th century have resulted in the development of efficient techniques that have made possible the rapid identification and characterization of microbial isolates. Next generation sequencing (NGS) methods have transformed from being solely research tools to being routinely applied in diagnostics, outbreak investigations, antimicrobial resistance, forensics, and food authenticity.

NGS is predominantly used in two ways:

1. Determining the whole-genome sequence (WGS) of a single cultured isolate (e.g., a bacterial colony); and
2. Application to a biological sample generating sequences of multiple (if not all) microorganisms in that sample (i.e., “metagenomics”).

WGS, which is a type of NGS that has a high discriminatory power when compared with traditional molecular typing tools, is increasingly replacing traditional microbial typing and characterization techniques.

WGS can differentiate microbial strains at a high enough resolution and is increasingly used by FDA, CDC, USDA Food Safety and Inspection Service (FSIS), and other public health agencies worldwide for epidemiological investigation of foodborne illnesses, identification of related cases, source attribution, and development of intervention strategies

The main applications of WGS technology include investigating foodborne illness outbreaks, achieving trace back and source tracking the cause of outbreak, and linking isolates obtained from food and the food plant environment to clinical isolates from patients. Genomic technology such as WGS can also be used for developing rapid method and culture-independent tests for monitoring ingredients and raw material, detecting emerging pathogens, assessing the persistence of pathogens in the food plant environment, and determining the effectiveness of preventive and sanitary controls. WGS technology can also be used as a possible indicator of antimicrobial resistance.

FDA, CDC, USDA-FSIS, and public health agencies have adopted WGS from 2013, replacing the Pulsed-Field Gel Electrophoresis (PFGE) as the preferred subtyping method for use in PulseNet. The GenomeTrakr is an open-access genomic reference database that contains archived genome sequences obtained from foodborne outbreaks, contaminated food products, and environmental sources. The database can be used to identify contamination sources and to help develop new rapid methods and culture-independent tests based on the genetic information available.

Perhaps the most basic application of WGS technology in food safety is using it to identify pathogens isolated from food or environmental samples. Other applications of WGS include determining the scope of foodborne illness outbreaks, determining which ingredient in a multi-ingredient food is responsible for an outbreak, differentiating sources of contamination (even within the same outbreak), linking illnesses to a processing facility, linking small numbers of illnesses that otherwise might not have been identified as part of the same outbreak, and identifying unlikely routes of contamination.

Examples of the use of WGS of bacterial isolates for regulatory and outbreak investigations include:

• Identifying the source of an E. coli: O121 outbreak linked to raw flour: An epidemiological investigation showed that patients had contact with raw flour before the onset of illness. Traceback investigations identified a flour producer as the possible source. E. coli O121 was isolated from open packages of flour that were obtained from the residences of sickened people.
• Matching food isolates from a food product produced by one firm to environmental isolates from another facility: An FDA investigation linked a strain of L. monocytogenes detected in ice cream to an ingredient supplier using WGS technology and confirmed that the L. monocytogenes in the ice cream matched L. monocytogenes found within the ingredient supplier’s facility.
• Identifying a resident strain of a pathogen: A Salmonella strain was isolated from environmental samples collected from the same facility during inspections that occurred in 2011, 2012, 2015, and 2016. Other investigations illustrating the use of WGS technology by regulatory agencies are discussed elsewhere in this article.

Identifying Sources of Foodborne Illness Outbreaks

In 1993, the highly publicized Jack in the Box outbreak was responsible for infecting more than 600 consumers with E. coli O157:H7. Four people lost their lives. Most of the victims were children. Before Jack in the Box, there was no system or mechanism in place in the U.S. to track foodborne illness outbreaks in real time. The source of the outbreak was undercooked hamburgers. In the absence of a national outbreak surveillance system in the early 1990s, the outbreak was likely only discovered because the victims who became sick were becoming infected in a relatively limited geographical area. In turn, in many cases, the patients were treated in the same hospitals. In some instances, the case patients were treated by the same medical professionals. Because this enabled the medical community to identify and suspect an emerging or ongoing outbreak, they were able to bring their suspicions to the attention of public health officials and work together to eventually determine the source of the outbreak.

Due to the lessons learned from the Jack in the Box outbreak, the federal government realized that similar large-scale outbreaks were likely occurring throughout the U.S. without any organized means or mechanism to detect them. In a successful effort to enhance the federal government’s ability to detect and respond to outbreaks as they were occurring, the government developed and then implemented a nationwide system of mandatory foodborne illness reporting.

Beginning in the late 1990s, as the new system was put into place, whenever a medical professional in any state discovered that a patient was positive with a pathogen of concern (such as L. monocytogenes, Salmonella, or E. coli O157:H7), they were (and are to this day) required to report that finding to the relevant state health department. Individual states were then able to request copies of the isolates and test them. In the late 1990s and early 2000s, the states used PGFE to isolate the specific genetic DNA fingerprint of the pathogen making the patients sick.

Once the PFGE fingerprint was obtained, the results would then be uploaded into the PulseNet database, where the CDC could identify patterns or clusters of illnesses. When indistinguishable DNA fingerprints were uploaded from multiple victims, this told CDC that a foodborne outbreak was emerging. CDC would then share this information with FDA and USDA, as applicable, along with other federal, state, and local health departments. The public health officials at the federal and state levels would then work collaboratively to determine a common source for the cluster of illnesses.

Eventually, between 2005 and 2010, the states began shifting from PFGE analysis to multiple locus variable-number tandem repeat analysis (MLVA). The reason for the shift to MLVA was that the analysis gave public health officials greater resolution over the specific DNA fingerprint of the organism in question. From a lay perspective, MLVA turned a somewhat blurry image of the DNA fingerprint into a crisper image with more delineation, enabling case patient clusters to be identified and defined with more precision and confidence.

A few years later, CDC began moving from MLVA toward the even higher resolution methodology of WGS, which analyzes the entire genome. In turn, the higher resolution DNA fingerprint is uploaded by CDC into the GenomeTrakr database. By shifting from MLVA to WGS, CDC has been able to achieve higher resolution, making a slightly blurry DNA fingerprint crystal clear. MLVA is the standard by which public health officials, including those working for CDC, USDA, and FDA, now link clusters of indistinguishable clinical (human) isolates to food products of concern.

When PulseNet first came online in the late 1990s, numerous overlapping outbreaks were almost immediately identified. PulseNet proved that, although they were not being detected prior to the mid-1990s, many outbreaks were, in fact, occurring. Over the next 20 years, as the methodologies improved and the surveillance system became more effective and capable, outbreaks were identified at an increasing rate. As the national foodborne illness outbreak surveillance system continued to develop and mature, it also became clear that many of the food products sold in commerce, and many of the ingredients used to produce those food products, were at risk from contamination with pathogens of concern. In many cases, a single contaminated ingredient would be sold by a single supplier to dozens of customers and then used to produce hundreds or even thousands of products that would then be distributed to thousands (or tens of thousands) of retail stores.

PulseNet, MLVA, and WGS have given public health officials and government agencies the ability to effectively identify and subsequently solve foodborne illness outbreaks. We suspect, as the methodologies and data sets continue to grow and improve, that fewer and fewer national foodborne illness outbreaks will evade detection.

Whole-Genome Sequencing Technology: Applications, Benefits, and Barriers

The application of WGS technology for investigating foodborne illness outbreaks, conducting traceback, and source tracking the cause of outbreak and linking isolates obtained from food and the food plant environment to clinical isolates from patients is well known. WGS can also be used for developing rapid methods and culture-independent tests for monitoring ingredients and raw material, detecting emerging pathogens, assessing the persistence of pathogens in the food plant environment, and determining the effectiveness of preventive and sanitary controls within the food plant environment.

WGS technology can also be used as a possible indicator of antimicrobial resistance. To facilitate such applications, FDA is sequencing all pathogens collected from food and food plant environments and uploading the genetic information obtained to the publicly searchable GenomeTrakr database. National Antimicrobial Resistance Monitoring System (NARMS) laboratories are using WGS sequences to determine whether the presence of certain genes in pathogens such as Salmonella and Campylobacter can be used to predict the pathogen’s resistance to antibiotics. Research has shown a high degree of correlation between clinical antibiotic resistance and the presence of known resistance genes. WGS data from NARMS may be useful for understanding the dissemination of antibiotic resistance bacteria and their genes via food.

Benefits and Barriers

WGS technology is extremely powerful and highly capable of providing information on contamination sources as well as aiding in the detection, resolution, and prevention of foodborne outbreaks with great precision and in a cost-effective and timely fashion. WGS can also provide information about pathogenicity and virulence, adaptation, and survival of pathogens, which allows regulators to develop, design, and prioritize intervention procedures that will prevent pathogens from entering the food supply. Additionally, the genomic information obtained through WGS can help develop culture-independent methods for the rapid detection of pathogens from a food without the need for isolating the bacteria.

Several barriers limit the implementation of WGS technology by the food industry. Significant barriers include:

• The cost of necessary equipment and consumable materials;
• Lack of trained personnel;
• Difficulty in multiplexing (analyzing several independent samples in the same run);
• The complexity of analysis, including bioinformatics, ­interpretation, and management of the data produced;
• The requirement of a powerful IT infrastructure for ­storage of genomic data;
• A lack of standardization of methods;
• Time to results: Retrospective results are not useful for ­release of the food product or timely corrective action;
• A lack of uncertainty around legal and regulatory implications;
• A lack of clarity on data ownership;
• Potential regulatory obligations and/or pressure to share WGS data that is collected; and
• The potential risk of the misinterpretation of data generated during internal investigations.

Outlook and Summary

WGS technology is an extremely powerful tool that is useful in epidemiological investigations, in tracing a potential source of contamination, and in the detection of pathogens, thus allowing for a comparison of the genomic information of clinical isolates with that of food and environmental isolates. The technology makes the successful investigation of foodborne illness outbreak events possible. Additionally, knowledge about specific genes associated with virulence, pathogenicity, survival, adaptability, and antimicrobial resistance obtained through NGS technologies will allow for preventive food safety and quality assurance worldwide.

While WGS technology has been readily adopted by regulatory agencies and academic researchers worldwide, adoption and implementation of the technology within the food industry is quite variable. Recognizing the excellent potential of WGS technology, some companies have taken a proactive approach to understanding and adopting the technology for sequencing isolates obtained from microbiological analysis of their ingredients, products, or processing environment and for tracking resident versus transient pathogens that may be present within the processing environment. Also, adopting WGS technology has allowed food companies to discuss genomic-based information with regulators, suppliers, and other food companies. Other companies are in the process of evaluating the cost benefits of sequencing and WGS analysis of bacterial isolates.

Companies that have not yet implemented WGS technology should consider becoming familiar with the technology, evaluating potential risks and benefits of adopting the technology, and developing a plan for accessing and implementing the technologies if necessary.

Stevens is a food industry consultant and attorney and founding member of Food Industry Counsel, LLC. He is also a member of the Food Quality & Safety Editorial Advisory Board. Reach him at stevens@foodindustrycounsel.com. Dr. Vasavada is professor emeritus of food science at the University of Wisconsin-River Falls and co-industry editor of Food Quality & Safety. Reach him at purnendu.c.vasavada@uwrf.edu.

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Today’s winemakers, like other food and beverage producers, are working in unusual and changing times. Paradigms have shifted in the COVID-19 era, where booming online selling channels and the limited availability of raw materials is prompting winemakers to adapt their business models to the realities of fast-changing consumer demands.

In several regions, including North and South America, China, and parts of Eastern Europe, unfavorable weather patterns and natural disasters have either limited grape harvests or changed the characteristics of the grapes, placing increasing importance on the testing of grapes and other raw materials. Further, the pandemic has spurred a major shift in consumer behavior toward online buying channels as restaurants temporarily closed to prevent the spread of the virus. Given large selections online versus what is available in most standard brick-and-mortar establishments, consumers are also exerting more buying power and demanding more transparency and quality.

To remain competitive, many wineries are starting to leverage more advanced analytical testing to supplement traditional sensory evaluations and basic testing, helping to ensure product consistency and reduce losses tied to poor product and raw material quality. They also aim to use the collected data as a competitive advantage. Although testing has played an important role at large wineries for decades, many small to mid-sized wineries, often citing budgetary concerns or gaps in technical proficiency, have not yet embraced the potential that analytical testing offers. Recent advances in Fourier transform infrared (FT-IR) spectroscopy instrumentation can help address these challenges, not only by drastically reducing the complexity of testing procedures, but also by reducing the upfront investment required to purchase instrumentation, making advanced yet easy-to-use testing more attainable to wineries of any size.

FT-IR Spectroscopy for Winemakers

Figure 1. Spectrum of a wine sample generated with PerkinElmer LQA 300 FT-IR instrument.

Credit: Courtesy of PerkinElmer.

FT-IR instrumentation uses spectroscopic imaging to essentially map, or “fingerprint,” a sample by creating an infrared spectrum of the absorption or emission of components in the sample across a number of wavelengths. Spectral images, such as those shown in Figure 1, are then compared to a library of known components to both identify and quantify compounds in the sample. Modern FT-IR instruments can produce results in less than a minute and are small enough to transport in the trunk of a small sedan, allowing for agility and portability throughout the winemaking process.

The benefits of onsite FT-IR testing are numerous and include fast results, ease of use, and a low cost of operation, allowing winemakers to monitor their process by measuring critical parameters throughout vinification, thus enabling more comprehensive process control. This provides a more beneficial approach than conducting single data-point measurement, as it helps to ensure full process and input control and avoids product loss if processes fall out of specification before or after isolated test points. As such, it is recommended that testing occur throughout the winemaking process, including the analysis of grapes at intake, must under fermentation, and the finished product after fermentation.

Grape and Must Testing

Testing grapes throughout the growing process and at harvest using an FT-IR ensures product soundness, optimal grape maturity, and fair pricing. Deciding when to harvest grapes has often been more of an art, with harvesters and wineries relying on decades of experience, skill, and a “gut feel.” Supplementing this human knowledge with actionable data enables an optimal blend of experience and science. Striking the correct balance between phenolic and physiological maturity is key and, taking into account the potential impacts of unfavorable climate changes, the importance of testing grapes to determine harvest dates has become increasingly important.

Figure 2. Conceptual model of acid, pH, and sugar content in grapes during the harvest season.
Credit: Courtesy of PerkinElmer.

Three of the most common factors in the determination of optimal grape ripeness for harvest are sugar content, pH, and acidity. As grapes mature on the vine, sugar content and pH increase, while acidity decreases, as shown in Figure 2. Sugar content is measured to ensure that there is enough sugar in the grape to be converted into alcohol during vinification. Sugar content can be determined by a measurement of fermentable sugars glucose and fructose, or by calculating the total soluble solids (°Brix). Monitoring the pH and acidity of grapes and must provides insights into the potential microbial stability of the ingredients throughout fermentation and allows for the planning of acidity corrections.

Must Under Fermentation Testing

Once grape must enters the fermentation process, yeasts take center stage. Although winemakers may have less control of the process during this stage, testing during fermentation is crucial. Yeasts play a major role in winemaking, as they consume sugars and nitrogen in grape must and juice, subsequently producing ethanol and carbon dioxide.

Like the parameters analyzed at harvest, pH, sugar, and acidity levels should also be tested in must undergoing fermentation to monitor the progress of the yeast. Monitoring sugars during fermentation will provide insights on how much longer the must needs to ferment to achieve the ideal sweetness and alcohol content. Finished wines with an intended sweeter taste will have some residual sugar after initial fermentation, while dry white wines will have few or no sugars remaining after fermentation. Conversely, as sugar content declines, ethanol content will increase.

Closely monitoring pH during fermentation is important, as it correlates with the level of sour taste in wine: The lower the pH, the sourer a wine tastes. Further, pH can affect the appearance and stability of wine, with higher pH wines more susceptible to oxidation. Measuring specific acids, such as malic acid, an organic acid that produces a tart taste in wine, can also aid in monitoring progress toward the desired taste profile of the finished product. During vinification, malolactic fermentation (MLF) converts malic acid to lactic acid, producing a creamy, buttery texture in the wine. Too much acid reduction during MLF can result in a higher pH, leading to the aforementioned chance of oxidation and subsequent spoilage. Using onsite FT-IR testing allows winemakers to monitor pH, total acidity, and individual acids in one analysis, without slowing down the process.

Outside of the winemaking process, this taste profile information can help winemakers who are using online selling channels improve the customer experience. Providing detailed and accurate product descriptions both informs and entices potential buyers and can create a competitive advantage with customers who want more information about the products they buy online.

Testing at Blending and Bottling

Testing at the blending and bottling stage, often one of the most common analysis points, provides valuable insights to ensure the finished product meets quality control guidelines and standards. At bottling, it is important to measure the amount of residual sugar left in the wine, as too much sugar could lead to further, unwanted fermentation. The acidity and pH should be stable, with no malic acid present, as it may lead to spoilage during ageing. Testing at bottling also allows winemakers to ensure that their product offers a consistent taste profile and experience for customers.

Measuring ethanol content is vitally important at bottling to ensure accurate labeling and adherence to government agency regulations, such as those developed by the Alcohol and Tobacco Tax and Trade Bureau (TTB). Outside of regulatory requirements, securing more detailed, data-driven information about a finished product can also help winemakers create a competitive advantage with consumers, such as millennials, who are demanding more information about the products they consume. According to a 2021 State of the U.S. Wine Industry Report, millennial buyers are the largest growing segment of the wine industry, and they demand transparency as it relates to labeling and processes. As such, offering detailed, science-based information in marketing efforts and outreach can help winemakers provide the information many customers consider when comparing products.

An Investment in Quality

Analytical equipment, such as FT-IR instrumentation, that is used to inform decision making throughout vinification is a sound investment for wineries of all sizes. Although the trends influencing the market may change in coming years, the need for data-driven decisions and a focus on quality raw materials and finished products will always be paramount. Making the decision to further invest in a more robust quality and process control program that includes testing at all stages of winemaking will not only safeguard against costly quality lapses but can also lead to improved margins and revenue.

Trudell is global market manager for liquids and contract labs at PerkinElmer, Inc. Reach her at jacqueline.trudell@perkinelmer.com.

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Food safety culture is a topic that has been discussed within the food, beverage, and retail industry for decades. Books have been written, videos created, surveys developed, position papers published; Global Food Safety Initiative (GFSI) benchmarked standards have incorporated requirements into their clauses and, most recently, regulations have been passed. Most notably, the European Union enacted regulations requiring organizations to “establish, maintain, and provide evidence of an appropriate food safety culture” (Regulation EC 852).

Closer to home, organizations throughout the United States will remember the announcement made by FDA in April 2019 that introduced the New Era of Smarter Food Safety initiative and gave shape to the four key areas of focus—an exciting and innovative approach to food safety that leverages technology and other tools, including core element four, which focuses on a culture of food safety. The New Era of Smarter Food Safety makes this important point: “We will not make dramatic improvements in reducing the burden of foodborne disease without doing more to influence the beliefs, attitudes and, most importantly, the behaviors of people and the actions of organizations.” Frank Yiannas, FDA’s deputy commissioner, has been a vocal advocate of food safety culture throughout the industry and has been quoted as saying “you can have the best documented standards in the world, but if they’re not consistently put into practice by people, they’re useless.” This is an important reminder on why a culture of food safety is a prerequisite for organizations throughout the food, beverage, and retail industry.

So, how do you develop a culture of food safety in your organization? First, we need to define food safety culture. Second, we’ll unpack some of the common myths and misunderstandings related to the topic of food safety culture that many organizations struggle with. We’ll start by breaking the topic into the two key areas:

• Food safety: The handling, preparation, and storage of food in ways that prevent foodborne illnesses; and
• Culture: The shared values, beliefs, and norms that an organization has established, throughout the entire organization, which is strengthened through various methods that shape employee perceptions, behaviors, and understanding.

Defining Food Safety Culture

The GFSI Technical Working Group defines food safety culture as the “shared values, beliefs, and norms that affect mind-set and behavior toward food safety in, across, and throughout an organization.” The key point of this definition is “…that affect mind-set and behavior toward food safety,” which many organizations describe as the “why” in their food safety management systems. Many have struggled with the purpose behind the requirements, processes, and procedures of their food safety management system, not understanding why they were being asked to follow a specific rule or requirement. They also often have challenges with empowerment, fear, and communication, which, unfortunately, reflect the organization’s existing culture, rather than the culture they are striving for.

The GFSI benchmarked standards that exist today are very clear in articulating the “what” required from a site with regards to food safety culture. For example, BRCGS Food Safety Standard Issue 8 states: “The site’s senior management shall define and maintain a clear plan for the development and continuing improvement of a food safety and quality culture. This shall include the defined activities involving all sections of the site that have an impact on product safety.” In other words, the site’s senior management must understand food safety and know how to define and maintain clearly delineated plans for the development and continuing improvement of food safety and quality culture.

Common Misconceptions

Despite the need to lean on top management for the planning and development of a food safety culture, many organizations consider that a major challenge; engaging senior management and gaining the support and commitment needed to implement the necessary programs designed to support positive changes to affect their culture of food safety can be challenging.

Another common misconception facing food safety and quality professionals when addressing the topic of food safety culture is that it’s something that an organization needs to “get.” The reality is that if an organization is operating in the food industry, and they have people in their organization, then they already have a culture of food safety. The first step on their pathway to a culture of food safety is to identify what level of maturity they are currently operating to, using tools like the Cultivate’s Food Safety Maturity Chart. I was fortunate enough to speak with industry thought leaders on food safety culture during a recent workshop. They explained that a culture of food safety isn’t something that you buy or get; it’s something that you build, then live and breathe every day, from senior management to front line operators, and throughout the entire organization.

Other misunderstandings regarding food safety culture include the perception that a culture of food safety is something that needs to be in place solely to pass an audit, GFSI benchmark, or otherwise; this isn’t the case. In many cases, organizations have gained additional benefits from implementing a food safety culture program, including helping to improve internal communication and gaining greater engagement from employees who are trusted and empowered and celebrate food safety performance on their lines and in their respective areas. Successfully passing a food safety audit is often seen as confirmation of having an effective and more mature culture of food safety; however, this does not confirm that the organization has bridged the gap between the requirements of the food safety standard and their colleagues’ understanding of the “why” and “how.”

Commitment to Food Safety

One of the more debated and contentious topics related to a culture of food safety is that it isn’t—or shouldn’t be—seen as a competitive advantage. A culture of food safety could be a competitive advantage for organizations, however, as it would help to demonstrate their commitment to their people, reduce staff attrition, improve efficiencies, and reduce the cost of failure. All of these benefits could be positioned as a competitive advantage, used to positively differentiate themselves from other organizations in the industry by demonstrating to new and existing customers how they empower their people to do more to keep food safe.

Organizations who seek to build a culture of food safety, whose staff are appropriately empowered by a culture of trust, openness, and innovation, and they are both motivated and able to assume ownership of and address risks and issues as they arise, will see the benefits from the bottom line to their reputation and brand. If a senior management team could see a graph that showed how a poor culture of food safety costs the organization an average of 20% in the cost of quality in percentage of sales versus a mature culture of food safety, where the average cost of quality in percentage of sales would be around 2.5%, not considering all of the organizational benefits from an effective culture of food safety, the numbers speak for themselves.

Getting it wrong is an expensive exercise, both financially and from a brand integrity perspective, whereas a positive and effective culture of food safety builds an engaged and resilient framework for food industry organizations. The first step on the pathway to a culture of food safety is to understand your maturity today, and then build your food safety culture team—the same approach as if you were going to develop a HACCP plan: You assemble your team first.

Coole is a food safety culture expert and food and retail supply chain director at BSI. He can be reached at neil.coole@bsigroup.com

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For thousands of years, vintners have harnessed a complex system of living organisms and biochemical processes to make wine. While the beverage has evolved over time and styles have diversified, the fundamental process of making a wine has stayed the same: Yeast ferment the sugar in grape juice, transforming it into ethanol, carbon dioxide, and heat.

The art of winemaking lies in knowing how to use different grape varieties, yeast strains, and production steps to create distinctive styles that are recognized for their aroma, taste, and appearance. Those traits, however, result from complex interactions among the growing conditions of grapes, their biochemical makeup at harvest, the reactions that occur during fermentation, and the biochemical development of must, juice, and wine during processing. Any imbalances in these interactions during production—from vine to glass—can alter the outcome and decrease the quality and palatability of a wine.

The wine market is highly competitive, and brand loyalty hinges on creating distinctive and enjoyable experiences again and again. Therefore, a winery’s success comes from deftly orchestrating vinification to preclude imbalances. Ensuring customer satisfaction and building brand equity means making timely decisions that steer winemaking toward the exact experience a vintner aims to create.

Data Enables Time-Critical Decisions in Winemaking

When it comes to creating premium wines, there is no substitute for the experience and knowledge of a vintner. But complementing that expertise with a precise characterization of the biochemical changes occurring in a batch better informs decisions to optimize production, ultimately boosting wine quality and selling price. Analytical testing at all production stages is the key to such data-driven decisions. Sensitive, easy-to-use analyzers allow the vintner to monitor the material composition and conditions of biochemical reactions and identify when and how best to intervene. Imbalances can be anticipated and corrective action can be tailored to reestablish ideal conditions in a timely manner.

Analysis is crucial from the beginning of the winemaking process, even while grapes are still on the vine. A refractometer can be used to measure grape sugar content and thus determine the best harvest time. Sugar and organic acid content should also be measured in grapes brought in from external sources, as these parameters typically vary with growing conditions (e.g., temperature, soil type, rainfall). Different wine types and varietals build on different acid-to-sugar ratios, and a suboptimal biochemical starting point can lead to a stuck fermentation that falls short of reaching the necessary final gravity.

Dedicated electrodes can be used to accurately measure the pH, organic acids, and nitrogen content of must. The results can better guide the use of additives to promote fermentation and control pH, while preventing an imbalance in acidity that can derail the flavor, color, and microbial stability of the wine. Sulfur dioxide, which is used as an antioxidant and inhibitor of microbial activity, can be monitored to prevent an excess that dulls fermentation and lowers wine quality. Finally, hand-held devices can measure liquid turbidity and dissolved oxygen in barrels and bottles to ensure desired clarity and prevent excessive oxidation that discolors and degrades wine flavor.

Analytical needs vary from one winery to another. Therefore, the first step toward establishing a cost-effective analysis infrastructure is to systematically evaluate the type and frequency of testing that best serves production procedures.

Design an Analytical Testing Plan

A range of advanced, easy-to-use, and highly reliable analytical instruments make measuring critical winemaking parameters straightforward. Designed to withstand the wear and tear of a manufacturing floor, these analyzers enable testing of a few to several hundred samples, either in a lab or directly at vines, vats, or barrels. The choice of instrument depends on three factors: the number of bottles produced at a winery, the frequency of measurements needed throughout the production process, and the vicinity of an accredited food analysis and safety lab. The latter point is important; waiting for results to return from an offsite lab can be the difference between a successful batch and one that is downgraded or lost. At a minimum, a wine producer should consider quantifying the parameters listed in Table 1 (see p. TK) on site, because changes usually require quick corrective action.

A good starting point is to design an analytical testing plan that maps the points in manufacturing where data is important to inform next steps. The plan should outline the type and frequency of measurements to be made at each point and actions to be taken based on results. As a whole, the plan dictates the number of samples to be analyzed daily, the variety of analyses needed, and the ideal timing for corrective action. That information helps decide which samples can be shipped to offsite labs and which instruments are needed on site.

Laying out a well-planned testing strategy with guidelines for subsequent actions is the foundation of a cost-effective and smart quality control infrastructure, and it simply makes good business sense.

In-Process Analytical Testing

A robust analytical testing strategy to monitor production is the cornerstone of any good wine business. The core objective of the monitoring is to minimize variability in parameters that impact the traits of a wine, keeping them in the narrow range characteristic of a particular wine style. The benefits of this in-process monitoring, however, go far beyond just “keeping chemistry in check.” End-to-end analytical testing supports compliance with quality and safety standards, maintains a robust and efficient production, and builds brand reputation through consistently high-quality and enjoyable wines (Figure 1).

Figure 1. Monitoring key parameters during winemaking is indispensable to consistently producing memorable, quality wine.

Compliant quality and safety. Global, national, and local regulatory bodies in the wine industry dictate procedures that are and aren’t allowed in vinification. For example, European Union legislation permits the addition of lysozyme for fining, but it must not exceed 500 mg/L. Other regulations stipulate that certain components in wine be published on labels, such as sulfite residues exceeding 10 mg/L and percentage alcohol content. By continuously tracking the biochemistry of a wine under production, a vintner can optimize the use of additives and processing aids and ensure that the final product aligns with regulations. Furthermore, the data collected serve as an audit to trace problems to their origin, a survey of overall production constancy over time, and a tool to predict product quality.

Robust, efficient, scalable production. Commercially viable wines must achieve healthy profit margins in a highly competitive market. Even the best-tasting wine cannot succeed in today’s market without the manufacturing scale and reproducibility to secure supply. Scaling up production to a commercially meaningful volume while preserving the defining qualities of a wine—sweetness, acidity, tannin levels, flavor, and body—is challenging and may require adjustments and rethinking. Critical parameters measured along the way, from vine to glass, are benchmarks for the scale-up process, helping to ensure that buildout of each manufacturing step leaves intact the biochemistry that achieves stylistic and quality goals. With the data collected, every optimization decision begins with a known biochemical profile for the wine. As adjustments are made over time, that profile becomes a unique biochemical signature of the wine, guiding production.

Continuity of brand. The brand of a company is a promise to customers about what they can expect from products and services. In the case of a winery, that promise is kept by delivering on expectations of the aroma, taste, and appearance of its wines. Those precise traits are repeatedly and consistently created through the meticulous control of production processes, so it stands to reason that any investment in facilitating that control—creating an analytical testing strategy and acquiring the necessary equipment—is an investment in brand. Analytical testing renders each production step transparent, and the insights obtained allow a vintner to better craft established and new wines. In short, a unique wine may be an asset to a winery, but a memorable wine that is enjoyed year after year is brand equity.

Table 1. Routine analytical testing throughout winemaking.

Always on Track to Meet Stylistic and Quality Goals

The long-term success of every business centers on giving customers a reason to return. In the wine industry, that means creating memorable and repeatable experiences through exceptional product quality, quality that not only meets food safety, regulatory, and import/export requirements, but also guarantees the flavor, aroma, color, and clarity traits that define a brand.

With a burgeoning global wine market and unprecedented choice for customers, the competition is intense. Successful wineries make every batch count. Successful wineries know in real time how grapes evolve into wine and steer the process to meet stylistic and quality goals for each blend and varietal. Additionally, successful wineries intervene at critical points to prevent that transformation from derailing. With advanced analytical tools to monitor winemaking, quality control becomes the gateway to higher-quality products, delighted customers, and stronger market positioning.

Hartwell is a senior product manager within the water lab products division at Thermo Fisher Scientific. Reach her at wlp.techsupport@thermofisher.com.

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