CBD (cannabidiol) gummies for all? Not so fast... at least not in the USA according to Dr. Scott Gottlieb, who spoke at the Brookings Institution today, of the US Food and Drug Administration (FDA).
Vape shops are increasingly carrying CBD products, as many types of retailers are. But in light of the passage of The Agriculture Improvement Act of 2018 (“AIA”), it raises the question as to what products now carry less risk, or no risk, when placed on the retailer’s shelf.
The AIA is significant in that it removed hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law.
Hemp of course, is still defined as cannabis (Cannabis sativa L.), but what has changed with the definition of “hemp” is that with this type of cannabis plant, concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC) have an extremely low level -- less than 0.3 percent on a dry weight basis.
Specifically, ‘hemp’ is defined under the AIA as follows.
“The term ‘hemp’ means the plant Cannabis sativa L. and any part of that plant, including the seeds thereof, and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
In terms of what is actually legal, the answer will depend on several factors, including but not limited to:
1. What the product is,
2. Whether it is for consumption or other use,
3. Who (or what) is consuming it,
4. What part of the plant itself is an ingredient in the product
5. Whether the hemp portions of the product actually derive from hemp grown under the AIA program, and
6. Whether or not the marketing associated with the product purports to mitigate an ailment, or indicates some other health benefit
Notably, the US Food and Drug Administration (FDA) has determined that it considers the following to be Generally Recognized As Safe, or “GRAS,” as the term is commonly used, for human consumption:
· Hulled hemp seeds
· Hemp seed protein
· Hemp seed oil
With the use of these 3 types of products being deemed as safe, they can be legally marketed in human foods for use as food without approval as a “food additive” by the FDA, provided the products comply with all other legal requirements and do not make disease treatment types of claims.
In the agency’s own words, the FDA “requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce.” In other words, FDA uses the same standard as it would hold any product when marketed as a drug for human or animal use where it claims the product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes).
Furthermore, the FDA explained that because both cannabidiol (CBD) and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements, under the Food Drug and Cosmetic Act (FD&C Act), it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements.
Therefore, it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.
Moreover, while some products are legal, most remain illegal and FDA fully intends to take whatever enforcement action that is needed to protect the public health against companies illegally selling cannabis and cannabis-derived products that (1) may put consumers at risk and, (2) are being marketed in violation of the FDA’s authorities.
At this time, FDA is working on a regulatory framework to allow for a pathway for approval for those who seek to lawfully introduce these products into interstate commerce.
It does not, however, already exist.
If you have questions about the AIA and its application, feel free to send me a message using the Contact form on the Home page.