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CBD Brands Face FDA Scrutiny on Marketing Claims
The agency is warning about the lack of safety information about the uber hyped ingredient.
What can brands selling CBD products actually say about this elusive darling of the beauty and wellness market? Nothing too specific, if the latest warnings by federal public health regulators are any indication.
The U.S. Food and Drug Administration, which has been considering the safety of cannabidiol since its precursor hemp came off the Controlled Substances Act list last December, has now targeted claims about the ingredient's potential health benefits.
In warning letters sent to 15 companies on Nov. 25, the agency took issue with companies that had marketed various CBD oils, gummies and moisturizers along with claims about its ability to address various illnesses or chronic conditions, the kind of health claims companies are generally not allowed to make without FDA approval. The agency also issued a consumer advisory warning that it hasn't seen enough data about CBD's safety and that there is some indication about health risks from the ingredient, especially if it is taken with alcohol or other medications.
“The FDA is concerned that people may mistakenly believe that trying CBD ‘can't hurt,'” the agency said in its statement. “The agency wants to be clear that we have seen only limited data about CBD's safety and these data point to real risks that need to be considered.”
The warnings come months after the agency held a public hearing in May on the safety and marketing practices around cannabis-derived compounds, including CBD. The then-Acting Commissioner of Food and Drugs, Ned Sharpless, acknowledged the “explosion of interest” in CBD products, but said the agency still needed more information.
“The agency is getting pressure from the industry to clear a path to market,” said Kristi Wolff, partner at Kelley Drye & Warren LLP. “The FDA is saying, ‘We've been telling you for months what we need in order to give you this level of certainty and you haven't produced it. We can't, as a public health agency, give this ingredient a pass.'”
CBD's apparently versatile use in edible and topical products can trigger the regulators' concerns about whether the products in question are being properly marketed as a cosmetic, or whether they need to be categorized as supplements, which would draw more scrutiny, or as drugs, which would need the agency's prior approval, attorneys said.
The agency generally views cosmetics as products that are meant to cleanse, moisturize or beautify and which are applied on the skin. The FDA doesn't have to pre-approve ingredients used in cosmetics, with rare exceptions in cases like color additives in hair dyes.
Under this framework, the general standard for cosmetics manufacturers is to confirm that their ingredients are safe, legal experts said. But cosmetics could veer into drug territory if they're being advertised as being able to address specific health conditions.
Based on the agency's safety warnings so far, it's risky to market CBD products as dietary supplements, or to add it to human or animal food or drink products, or to make health-related claims about it, attorneys said.
“It's an interesting category because federal regulatory authority over cosmetics is a complex area,” said Jon Dedon, attorney at Kennyhertz Perry.
Another wrinkle in CBD marketing is that the FDA approved it in 2018 for use in a seizure medication called Epidiolex. Under the Food, Drug and Cosmetic Act, active ingredients approved for use in a prescription drug may be restricted from being marketed as dietary supplements. Unlike medications, dietary supplements generally don't need FDA approval, but if they contain a “new dietary ingredient,” they'll need to show some data on its safety, according to the FDA's web site.
As a fellow consumer protection agency, the Federal Trade Commission may also scrutinize CBD marketing, and potentially view pointed health claims as defective trade practices under the FTC Act, legal experts said.
The FTC and FDA have somewhat different enforcement priorities, with different implications for companies targeted by them.
The FDA tends to focus more on issuing warnings and trying to obtain injunctions to halt the distribution and sale of certain products. The FTC, on the other hand, may bring enforcement actions in federal court, sometimes in sealed complaints asking a federal judge to grant a temporary restraining order against the company, or even an asset freeze.
“When the FTC gets involved, it can be a bad situation,” said Dedon.
Meanwhile, state and local prosecutors are also watching. In July, the Washington, D.C., attorney general Karl Racine teamed with three dozen state attorneys general to raise similar safety concerns, and to signal plans to work with the FDA in policing
“There's a federal component with the FDA and FTC and a state component, and brands have to think through both,” said James Lawrence, partner at Michael Best & Friedrich LLP, who advises clients on FDA issues.