I recently teamed up with my colleagues Hilary Bricken and Griffen Thorne to put on a free webinar answering all of your pressing questions about cannabis legal issues in California. (Check out the replay here.) The response was overwhelmingly positive, and we received a lot of great questions that we weren’t able to get to during the hour-long session. We’ll be offering similar webinars in the future, but in the meantime we thought it would be useful to take some time and answer some of the questions we received that we weren’t able to cover live. In this round of questions, we’ll tackle issues that relate to hemp and CBD.
Q: If my CBD company posts a testimonial on its website that arguably includes a “medical claim” will a disclaimer protect me?
The FDA will treat products as drugs if the labeling or marketing of those products suggests they are “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” Phrases like “combats tumor cells” and “[has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer” clearly suggest that the CDB product can cure, mitigate, treat or prevent cancer, and is thus a drug.
Any suggestion that a product might have a role in treating or diagnosing a disease, or that it is intended to affect the structure or any function of the body of humans or other animals, is a health claim that subjects the product to drug regulations (unless it falls within the narrow confines of the Dietary Supplement Health & Education Act – the FDA has ruled that CBD does not). There are certain requirements for making disclaimers when making structure/function claims on nutritional supplements, but because CBD products cannot be marketed as nutritional supplements, these requirements do not apply and a disclaimer will not protect you if you are making medical claims.
Also keep in mind that the Federal Trade Commission (“FTC”) guidelines for using endorsements or testimonials in advertising make it clear that testimonials and endorsements can’t be false or misleading, and if they are, the advertiser can itself be responsible. The FTC has issued warning letters to companies that advertise their CBD-infused products as treatments or cures for serious medical conditions.
Q: Given that CBD products cannot contain “medical claims” and given that the term “medical claim” is broadly defined, how can I describe the use of my product?
The analysis is nuanced here, but everything stated in the answer to the previous question applies. If you are including wording on your CBD products in your advertising for those products that suggests that your product might have a role in treating or diagnosing a disease, or that it is intended to affect the structure or function of the body, it is a health claim. One of the core functions of the FDA is to ensure that companies aren’t marketing products for the treatment of diseases when those products haven’t been approved by the FDA.
Here are some recommendations we’ve given in previous posts:
- Do not make health claims about the therapeutic value of your products;
- Monitor enforcement actions (i.e., warning letters) and regulations of both the FDA and the FTC to understand enforcement priorities; and
- Develop compliance programs to (i) ensure that your marketing efforts align with federal guidelines and (ii) ensure that your compliance team is familiar with the FDA and the FTC’s regulations.
Q: Are you aware of any existing legal authority that states CBD products are considered “adulterated” food products? Or is this an open legal question?
According to guidance issued by the California Department of Public Health (“CDPH”) in 2018, “CBD is an unapproved food additive and NOT allowed for use in human and animal foods per the FDA, and thus it is not approved in California.”
AB 2827, the successor bill to AB 228 that was introduced on February 20, 2020, seeks to clarify that:
“a food or beverage is not adulterated by the inclusion of industrial hemp products, including cannabidiol derived from industrial hemp, and would prohibit restrictions on the sale of food or beverages that include industrial hemp products or cannabidiol derived from industrial hemp based solely on the inclusion of industrial hemp products or cannabidiol derived from industrial hemp.”
The bill is currently sitting in the Committee on Health.
Q: Is it true that hemp and cannabis cannot be combined?
In California, the Medicinal and Adult-Use Cannabis Regulation and Safety Act (“MAUCRSA”) only governs the regulation of commercial cannabis activity and explicitly excludes “industrial hemp” from the definition of “cannabis:”
- “Cannabis” means all parts of the plant Cannabis sativa Linnaeus, Cannabis indica, or Cannabis ruderalis, whether growing or not; the seeds thereof; the resin, whether crude or purified, extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or resin.
- “Cannabis” also means the separated resin, whether crude or purified, obtained from cannabis.
- “Cannabis” does not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of the mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of the plant which is incapable of germination.
- “Cannabis” does not mean “industrial hemp” as defined by Section 11018.5 of the Health and Safety Code.
The BCC has stated that retailers licensed by the BCC are licensed to sell cannabis goods and may not sell industrial hemp products on the same licensed premises where cannabis goods are sold.
Q: What about hemp products for farm animals in California?
The prohibition on edible hemp-derived CBD products in California extends to animals, as the CDPH’s guidance states:
“[u]ntil the FDA rules that industrial hemp-derived CBD oil and CBD products can be used as a food or California makes a determination that they are safe to use for human and animal consumption, CBD products are not an approved food, food ingredient, food additive, or dietary supplement.”
Industrial hemp is another issue altogether, as the Association of American Feed Control Officials does not recognize hemp as an ingredient in animal feed.
Q: If another state like Washington allows sales of hemp-derived CBD products, could a company in Washington sell those products to a person in California?
No, these products cannot be manufactured or sold in California. It is important that hemp-CBD manufacturers understand not only the regulations of the state in which they are based, but also the regulations of each state to which they ship products. Keeping track of the regulations in all 50 states is a hefty regulatory burden.
Stay tuned for Part 2 of this roundup next Saturday, with the rest of your questions!