California Hashish Webinar Questions – firebird-cbdoil
I recently teamed up with my colleagues Hilary Bricken and Griffen Thorne to host a free webinar that answers all of your urgent legal questions about cannabis in California. (Check out the replay here.) The response was overwhelmingly positive and we received many great questions that we couldn't answer during the one-hour session. We will continue to offer 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 that we received that we could not address live. In this round of questions, we will look at questions related to hemp and CBD.
Q: If my CBD company publishes a testimonial on their website that may contain a “medical claim”, will a disclaimer protect me?
The FDA will treat products as drugs if the labeling or marketing of these products indicates that they are "intended to diagnose, cure, alleviate, treat, or prevent disease." Sentences such as "combats tumor cells" and "[has] antiproliferative properties that inhibit cell division and growth in certain types of cancer" clearly indicate that the CDB product can cure, alleviate, treat or prevent cancer and is therefore a medicament.
Any indication that a product may play a role in the treatment or diagnosis of a disease or that it is said to affect the structure or function of the body of humans or other animals is a health claim that exposes the product to a medicinal product. unless it falls under the narrow limits of the Dietary Supplement Health & Education Act – the FDA has decided that CBD does not). There are certain requirements for creating disclaimers when making structural / functional claims for food supplements. However, since CBD products cannot be marketed as dietary supplements, these requirements do not apply and a disclaimer does not protect you if you provide medical information.
Also note that the Federal Trade Commission ("FTC") guidelines on the use of endorsements or testimonials in advertising make it clear that testimonials and endorsements cannot be false or misleading, and if so, it may be the advertiser's responsibility. The FTC has issued warning letters to companies promoting their CBD-infused products as a treatment or remedy for serious illnesses.
Q: How can I describe the use of my product because CBD products cannot contain "medical information" and the term "medical information" is generally defined?
The analysis is nuanced here, but everything that is stated in the answer to the previous question applies. If you include formulations on your CBD products in your advertisements for those products that indicate that your product may have a role in the treatment or diagnosis of a disease, or is believed to affect the structure or function of the body, it is health Claim. One of the core functions of the FDA is to ensure that companies do not market disease treatment products unless those products have been approved by the FDA.
Here are some recommendations we made in previous posts:
- Do not provide health claims about the therapeutic value of your products;
- Monitor enforcement actions (i.e., warning letters) and regulations from both the FDA and the FTC to understand enforcement priorities; and
- Develop compliance programs to (i) ensure that your marketing efforts comply with federal guidelines and (ii) ensure that your compliance team is familiar with the FDA and FTC regulations.
Q: Do you know of any existing legal authority that states that CBD products are considered "adulterated" food products? Or is it an open legal question?
According to the guidelines of the California Department of Health (“CDPH”) from 2018, “CBD is an unapproved food additive and NOT approved by the FDA for use in human and animal foods and therefore not approved by the FDA California. ”
AB 2827, the successor law to AB 228 introduced on February 20, 2020, is intended to clarify the following:
“A food or drink is not adulterated by the inclusion of industrial hemp products, including cannabidiol from industrial hemp, and would prohibit restrictions on the sale of food or beverages that contain industrial hemp products or cannabidiol made solely from industrial hemp through the intake of industrial hemp products or cannabidiol Industrial hemp "
The bill is currently on the Health Committee.
Q: Is it true that hemp and cannabis cannot be combined?
In California, the Medical and Adult Cannabis Regulation and Safety Act ("MAUCRSA") only regulates 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, regardless of whether they grow or not; the seeds of it; the resin, whether raw or purified, is extracted from any part of the plant; and any compound, manufacture, salt, derivative, mixture or preparation of the plant, its seeds or resins.
- "Cannabis" also means the separated resin, whether raw or purified, that is obtained from cannabis.
- "Cannabis" does not include the ripe stems of the plant, fibers made from the stems, oil or cakes made from the seeds of the plant, other compounds, preparations, salt, derivatives, mixtures or preparations of the ripe Substances stems (with the exception of the resin extracted from them), fiber, oil or cake or the sterilized seeds of the plant that cannot germinate.
- "Cannabis" does not mean "industrial hemp" in the sense of section 11018.5 of the Health and Safety Act.
The BCC has stated that retailers licensed by the BCC are licensed to sell cannabis goods and cannot sell industrial hemp products in the same licensed premises where cannabis goods are sold.
Q: What about hemp products for farm animals in California?
The ban on CBD products from edible hemp in California extends to animals, as stated in the guidelines of the CDPH:
"[u] Until the FDA regulations require that CBD oil and CBD products from industrial hemp can be used as food or California determines that they are safe for human and animal consumption, CBD products are not permitted Food, food ingredients, food additives or food supplements. "
Industrial hemp is another problem overall since the Association of American Feed Control Officials does not recognize hemp as a component of animal feed.
Q: If another state like Washington allows the sale of hemp CBD products, could a Washington company 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 located, but also the regulations of each state to which they ship products. Tracking regulations in all 50 countries is a significant regulatory burden.
Look forward to part 2 of this summary next Saturday with the remaining questions!
The Post You Ask We Answer (Part 1): Questions from the California cannabis webinar first appeared on Harris Bricken.