Industry Awaiting FDA Approval to Sell CBD Dairy Products

Companies need to choose their markets carefully, Jim Watson, senior beverage analyst at market research firm Rabobank, said at the International Dairy Foods Association’s conference. “Fluid milk doesn’t make the most sense if you’re thinking of a product that has a marijuana association,” the Dairy Reporter quoted Watson as saying. Milk is associated with kids, while CBD is tied to marijuana, he said. He said that CBD is more likely to be infused into ice cream or protein-fortified workout beverages. Ice cream could be used by adults who eat it before bed to relax, he said.

The Need for More Data

Hahn says Congress is pressing for an update from FDA to issue a regulation that outlines a safe level of CBD, but adds that more studies are needed before FDA, which he described as “data-driven,” could make such a determination.

On its website, FDA encouraged other experts to submit data on the long-term effects of CBD use and other factors. Stephen M. Hahn, MD, commissioner of food and drugs at FDA, says little is known about the potential effects of sustained and/or cumulative use of CBD and risks to vulnerable populations such as children, pregnant and lactating women, the elderly, and certain animal populations.

“This does not mean that we know CBD is unsafe to these populations or under these circumstances but, given the gaps in our current knowledge and the known risks that have been identified, we also are not at a point where we can conclude that unapproved CBD products are safe for use,” Dr. Hahn says. “We encourage Americans to consult with their health care providers before using CBD products.”

FDA has approved one CBD prescription drug to treat two rare, severe pediatric epilepsy disorders. It hasn’t evaluated or approved any other CBD products, Dr. Hahn says.

He adds that FDA is looking for reliable and high-quality data on the sedative effects of CBD, the impacts of long-term sustained or cumulative exposure to CBD, transdermal penetration and pharmacokinetics of CBD, the effect of different routes of CBD administration (oral, topical, inhaled) on its safety profile, the safety of CBD for use in pets and food-producing animals, and the processes by which “full spectrum” and “broad spectrum” hemp extracts are derived, what the content of such extracts is, and how those products may compare to CBD isolate products.

In addition to legalizing hemp, the farm bill has opened up significant opportunities for research, including new drugs, says Dr. Hahn. As the body of research grows, FDA will have more information for decision making, he adds.

To stimulate research and additional data, FDA is reopening a public comment document established in May 2019 and extending the comment period indefinitely. The docket also will have a way for researchers from academia and industry to share confidential information.
“As data become available that are high quality, reliable, and relevant to our evaluation of CBD products that fall under the FDA’s purview, we will be able to refine—and, perhaps in some cases, revise—our thinking and approaches,” Dr. Hahn adds.