What are FDA's next regulatory steps on CBD and hemp?
- The Food and Drug Administration is considering "potential regulatory pathways" for the interstate commerce of hemp and cannabis compounds in foods and beverages following renewal of the Farm Bill, according to a recent statement from FDA Commissioner Scott Gottlieb. The $867-billion bill, signed by President Donald Trump on Dec. 20, legalized the commercial production of hemp.
- Gottlieb said the agency plans to hold a public meeting "in the near future" to hear from stakeholders about their experiences and challenges with the products, including any safety-related concerns.
- "We’ll use this meeting to gather additional input relevant to the lawful pathways by which products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient," Gottlieb said in the statement. "We’ll also solicit input relevant to our regulatory strategy related to existing products, while we continue to evaluate and take action against products that are being unlawfully marketed and create risks for consumers."
Although the 2018 Farm Bill legalized hemp, it's not a free pass for CBD to be added to foods and beverages. That's because the FDA's regulatory position under the Federal Food, Drug and Cosmetic Act is that CBD can't be legally sold in conventional foods or dietary supplements.
While hemp and marijuana are both members of the cannabis family, hemp extracts contain CBD, a non-psychoactive compound that doesn't produce marijuana's trademark high from tetrahydrocannabinol, or THC. Hemp does contain very low levels of THC, but hemp products legally sold in the U.S. must have no more than 0.3% of the chemical.
The FDA is particularly concerned about drug claims made for products not approved by the agency that may contain CBD or other cannabis-derived compounds, Gottlieb said. Any such products marketed as providing therapeutic benefits must be approved beforehand for their intended use, he added, just like any other human or animal drug.
"Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S.," Gottlieb said.
Meanwhile, food and beverage makers aren't waiting on the sidelines when it comes to introducing these products. Besides being used to infuse beverages such as water, coffee, cocktails and iced tea, CBD is being added to a wide variety of other foods, including ice cream, salads, milk and even children's cereal and pet treats. Other recent innovations containing CBD are California-based SNAAK CBD, which markets itself as optimizing sports performance — but is only available in California and online — and Spring's line of CBD-infused sodas sold in New York, Florida, Nevada and Illinois.
Large food manufacturers seem to be taking a wait-and-see attitude before rushing to add CBD or hemp to their products, so these items have largely come from smaller companies. But as more players enter the industry and new products make their way into retail, that could quickly change.
The market for CBD and hemp-derived products is already significant, and manufacturers and marketers are gearing up to do business nationwide. According to the Capital Press, a New Frontier Data report found that U.S. CBD sales jumped almost 40% in 2017, hitting $367 million. And the total retail value of all U.S. hemp products last year — including food — was estimated at $820 million, according to the Agricultural Marketing Resource Center.
These sales gains will likely continue their upward trajectory. By 2022, hemp-derived CBD is projected to be a $22-billion market, according to a report from the Brightfield Group, which helps to explain why the FDA is anxious to make its regulatory oversight clear to all stakeholders as soon as possible. Also, with the new congressional session getting underway, there could be a move to legalize CBD in all food and drink products nationwide — once a revised oversight and safety framework is in place.
Moving forward, the ongoing federal government shutdown could pose at least a temporary obstacle to the FDA's plans as far as holding a public meeting and then explaining — and perhaps shifting — its regulatory oversight of the interstate commerce of foods and beverages containing CBD and hemp. Still, a sense of urgency could help to overcome that since, as Gottlieb put it, the increasing public interest in the issue "makes it even more important with the passage of this law for the FDA to clarify its regulatory authority over these products."
- U.S. Food and Drug Administration Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds
- NBC Washington FDA Weighs Legalizing Interstate Sales of Cannabis-Based CBD in Food, Drinks