Federal agencies continue to pay attention to the marketing claims by cannabinoid (CBD) product marketers, as evidenced by warning letters sent last week by the Federal Trade Commission (FTC) and the U.S. Food & Drug Administration (FDA) to three CBD companies making health-related claims about their products. The letters specifically target claims made on the companies’ websites and some social media pages that CBD products can treat or cure a range of human diseases and conditions, including cancer, Alzheimer’s, depression, and anxiety disorders, as well as a number of health conditions for dogs. The letters state that these claims may violate both the Federal Food, Drug, & Cosmetics and Federal Trade Commission Acts and order the companies to respond with the specific actions they will take to address the agencies’ concerns.
The agencies’ action sends an important signal to marketers after the recent declassification of Hemp as a Class 1 illegal drug in the 2018 Farm Bill. Companies marketing CBD should expect that the FDA and FTC along with state consumer protection divisions to assert their jurisdiction to protect consumers and review of product marketing claims – even claims only occurring on websites and social media platforms.
In the press release announcing the letters, the FTC notes that the letters are part of its “ongoing efforts to ensure that dietary supplements and other health-related products are advertised truthfully, and that efficacy claims made for such products are supported by competent and reliable scientific evidence.” The FTC’s standard for “competent and reliable scientific evidence” for CBD products making health related claims should be expected to be a relatively high bar. FTC’s definition calls for “tests, analyses, research, studies, or other evidence based upon the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.” Anecdotal evidence from CBD users or newspaper and magazine articles fall short.
The FDA has also released a statement noting its continuing concern over the number of drug claims made about CBD products that have not been approved by the FDA or are being marketed as dietary supplements, and its intention to “advance new steps to better define our public health obligations in this area” and “to closely scrutinize products that could pose risks to consumers.” As evidenced by these most recent letters, CBD companies should note that regulators are looking beyond on-label product claims, and are focusing on company websites and social media sites like Facebook and Twitter. Companies should therefore carefully consider the various channels they use to reach consumers and pay close attention to the messages consumers are receiving about their products.
The regulatory landscape for CBD products is still catching up with the rapid market expansion, and there are ongoing opportunities for companies to participate in discussions with regulatory agencies about how to approach oversight of the sale and marketing of CBD products. The FDA is holding a public hearing on May 31, 2019 that will be webcast, and will open a docket for public comments to be filed online. Vermont CBD companies should also be aware the Vermont Agency of Agriculture Food & Markets is currently working on draft rules that will likely regulate many of the terms commonly associated with CBD and hemp products, which may affect how these terms can be used in product marketing. The draft rules have not yet been officially posted for public comment, but a copy of the current draft is available here.
While the regulatory waters may seem a bit murky at present, CBD marketers should not be completely discouraged. With carefully curated and substantiated marketing claims used on labels, websites, and social media platforms brands are establishing themselves today. Indeed CVS Pharmacy recently announced it would place CBD products on its shelves in selected states, including California, Colorado, Illinois, Indiana, Kentucky, Maryland and Tennessee. For more information about CBD product marketing regulation, contact Brian Dunkiel or Vic Westgate.