Capitalizing on Americans’ growing interest in cannabidiol (CBD), CVS and Walgreens recently announced plans to carry creams, lotions and other topical products containing the cannabis-derived compound.
CVS specified it wouldn’t be selling food additives or supplements containing CBD, and Walgreens made no mention of the latter product categories in its announcement.
That’s no surprise to attorneys who specialize in FDA regulatory matters. FDA has concluded it’s unlawful to add CBD to a food in interstate commerce or sell CBD products as a dietary supplement.
But no current regulation prohibits or restricts cannabis-derived ingredients in cosmetic products, according to an updated FDA Q&A concerning its regulation of cannabis and cannabis-derived products. Except for most color additives, cosmetic products and ingredients are not subject to premarket FDA approval.
“Ingredients 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,” FDA explained in the Q&A.
Ashish Talati, a partner in Chicago with the law firm Amin Talati Upadhye LLP, focuses his practice on FDA regulatory matters. In a phone interview, he described as “very low” the risk profile of a cosmetic containing CBD—as long as the product is safe for its intended use and otherwise complies with FDA regulations.
Another lawyer who focuses her practice on FDA regulations weighed in on the recent announcements by CVS and Walgreens.
“It makes sense to me that retailers would be open to allowing certain cosmetic products that contain CBD to be sold in their United States stores because, based on agency statements, they can do so with relatively minimal risk if they’re ensuring that the products do not present safety issues and are taking steps to ensure the products are not being promoted with drug claims,” said Raqiyyah Pippins, a partner in Washington with Arnold & Porter Kaye Scholer LLP, in an email.
“By drug claims, I mean both claims that a product cures, prevents, treats or mitigates a disease and claims that the product is going to affect the structure or function of the body.”
In part, federal law defines a cosmetic as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance.”
Mike DeAngelis, a spokesman for CVS Health, said the retailer is selling hemp-derived CBD products at select stores in California, Colorado, Illinois, Indiana, Kentucky, Maryland and Tennessee. The products, he added, include topicals such as creams, roll-ons, lotions, salves and sprays.
“We are not selling any CBD-containing supplements or food additives,” DeAngelis said in an email. “We are working with CBD product manufacturers that are complying with applicable laws and that meet CVS’ high standards for quality.”
In late March, CNBC broke the news that Walgreens planned to sell CBD products. A Walgreens spokesperson said the retailer would offer certain products containing CBD in nearly 1,500 Walgreens stores in Colorado, Kentucky, Illinois, Indiana, New Mexico, South Carolina, Oregon, Tennessee and Vermont.
“The CBD-related items we are planning to carry are non-THC [tetrahydrocannabinol, the psychoactive constituent in marijuana] containing topical creams, patches and sprays,” the spokesperson said in an email. “This product offering is in line with our efforts to provide a wider range of accessible health and well-being products and services to best meet the needs and preferences of our customers.”
Pippins said FDA hasn’t specified a threshold for an acceptable concentration of CBD in cosmetics.
“It’s really important that the industry be proactive in ensuring the safety of cosmetic products containing CBD, including being careful about not using high concentrations absent a scientific basis for concluding that the concentration will not cause an adverse effect or event for a user,” the lawyer said.
Talati also highlighted the importance of refraining from making claims that a CBD-containing product treats a disease. During a recent hearing on Capitol Hill, then-FDA commissioner Scott Gottlieb, M.D., raised some concerns over news that big U.S. retailers planned to carry CBD.
"We expressed concern yesterday, I did, about Walgreens and CVS stepping into this market,” Gottlieb said at a House Appropriations Committee hearing, CNBC reported April 3. “So you now see big-box stores seeking to market CBD products for some uses where the claims seem to be potentially over the line, for the treatment of pain for example.”
Gottlieb, who departed FDA just days ago, previously told lawmakers his agency was using its “enforcement discretion” to target products containing CBD. “I will take enforcement action against CBD products that are on the market if manufacturers are making what I consider ‘over-the-line’ claims,” he said.
For example, Gottlieb said FDA would take action against marketers of CBD that claim to cure cancer or prevent Alzheimer’s disease because those statements “could mislead a patient to forgoing otherwise effective therapy.” FDA and FTC officials recently sent several warning letters to CBD marketers for purportedly making disease claims.
According to FDA, CBD is excluded from the definition of a dietary supplement and it can’t be added to food because, in large part, the compound is an active ingredient in an approved drug and was previously authorized for investigation as a new drug and the subject of substantial clinical trials made public.
But the U.S. marketplace has largely defied FDA. In recent years, legions of CBD-containing products—including dietary supplements—have proliferated online and on retail store shelves. Adding to CBD’s momentum: President Donald Trump’s signing of the 2018 Farm Bill, which removed hemp and its derivatives from the Controlled Substances Act.
Several U.S. lawmakers who supported the Farm Bill want a legal pathway for CBD in foods and supplements, and FDA recently scheduled a public hearing on May 31 to solicit feedback on a potential rulemaking that would accommodate their wishes. FDA also is considering whether a legislative solution is more feasible than a rulemaking, the latter of which could take several years.
Diverse interests, including the pharmaceutical industry, are expected to attend the public hearing at FDA’s White Oak Campus in Silver Spring, Maryland. In June 2018, FDA approved Epidiolex, a CBD drug developed by GW Pharmaceuticals plc to treat seizures associated with severe forms of epilepsy in children.
The hearing, Pippins said, “will be an important opportunity for stakeholders to hear the positions that different industry voices have on what would be the appropriate pathway and to also inform FDA on how they could create a pathway to allow its use in foods while ensuring its safety.”