We’ve written extensively on this blog about industrial hemp-derived CBD products, including CBD comestibles, CBD pet products, CBD in alcohol, and CBD topicals. Of all these categories of goods, the CBD industry seems to have reached a consensus that CBD topical products present the lowest level of risk for businesses, hence companies like CVS, Walgreens, and Sephora opting to offer the products for sale.
But a number of warning letters from the FDA, including one issued on October 10, 2019 to Rooted Apothecary LLC, make it very clear that sellers of CBD topical products do not have an unfettered pass from the FDA to sell these products.
As we’ve analyzed before, cosmetics are treated differently under federal law than food products. Cosmetics are “articles intended to be rubbed poured, sprinkled or sprayed on . . . or otherwise applied to the human body . . . for cleansing, beautifying, promoting attractiveness, or altering appearance,” except for soap which is classified separately. 21 USC 321(i). Cosmetics and ingredients in cosmetics are not subject to pre-market approval, unlike food and drugs. The FDA relies on consumer complaints to monitor the cosmetics industry. However, this does not mean that the FDA does not have regulatory authority over cosmetics and their ingredients. Some ingredients cannot be used in cosmetics (i.e. chloroform), and will lead a product to be deemed “adulterated.” The FDA has been clear that “certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients.
However, the FDA also makes clear that “[i]ngredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way.” And to add another layer of complexity to the analysis, it is possible for topical products to be deemed both a cosmetic and a “drug” by the FDA, and we know that CBD and CBD products cannot be marketed as drugs without having undergone the FDA’s drug approval process.
This takes us back to the October 10th letter that the FDA issued to Rooted Apothecary. In that letter, the FDA laid out its determination that certain products sold by Rooted Apothecary, including a “Hemp Infused Body Butter,” are “unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d).” The FDA also determined that these products were “misbranded drugs” under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1) and that introduction of these products into interstate commerce violates the FD&C Act.
The FDA reiterated its position that CBD products cannot be marketed for therapeutic or medical uses without having been reviewed for safety and effectiveness by the FDA – this requirement applies to all CBD products, including topical and cosmetic products. The FDA also seemed particularly concerned by the medical claims made by Rooted Apothecary because many of its products were being marketed for use in infants and children. Some of the problematic claims made by Rooted Apothecary for its “EARS – Essential Oil + CBD Infusion” topical roller product include the following:
- “No matter what age, ear aches are a terrible, no good way to live each day! Our main priority was safety, effectiveness . . . as we formulated this for the entire family including our precious little ones. When the pain is bad, this roller goes to work for soothing pain, inflammation, and to battle against the bacterial/viral critters to blame.”
- “Lavender . . . Analgesic, Antibacterial, Sedative . . .”
- “Melaleuca . . . Anti-parasitic, Antiviral . . . Decongestant . . ..”
Based on claims like the foregoing, the FDA determined that many of Rooted Apothecary’s products were drugs under section 210(g)(1) of the FD&C Act because they “are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body.”
The letter also scrutinized Rooted Apothecary for selling “misbranded drugs” and making “unsubstantiated advertising claims,” and should serve as a cautionary tale to manufacturers and sellers of CBD topical products. CBD topical products may often be less problematic than edible products as far as the FDA is concerned, but making claims about your products that place them within the definition of a “drug” is certain to land you in the agency’s crosshairs. Thoroughly reviewing packaging, marketing copy, and websites for these types of claims will be crucial for every company offering topical CBD products for sale.