FDA CBD enforcement continues under Biden
In the first few months of the Biden Administration, the Food and Drug Administration has continued to actively pursue companies marketing and selling CBD products in violation of the Federal Food, Drug and Cosmetic Act (the “FD&C Act”), picking up where the Trump administration left off. FDA’s recent efforts target products marketed as unapproved drugs for pain relief.
FDA previously issued rounds of warning letters to companies marketing CBD dietary supplements as effective for treating serious diseases such as cancers, or because CBD was added to human and animal foods, all in violation of the FD&C Act.
In the latest round of letters, FDA targeted two companies for marketing CBD products for pain relief, marking a shift in priority from consumables to topicals. FDA alleges that one company marketed CBD products for pain relief in roll-on and pump forms, and the other in the form of gels, sprays, creams, and one liquid supplement.
Under the FD&C Act, any product intended to diagnose, cure, mitigate, treat or prevent a disease is a drug. According to FDA, over the counter drugs must be approved by the FDA, or, meet the requirements for marketing without an approved new drug application under federal law—including drug products containing CBD.
Although each company’s marketing included claims beyond pain relief, we believe the pain relief claims were the primary driver for FDA scrutiny. One company’s products claimed to provide pain relief and other beneficial effects (e.g., anti-inflammatory, anxiety, and depression treatment). The other company’s products make stand-alone pain relief claims, but also other therapeutic claims in a company FAQ, which FDA highlighted. The FAQ stated:
What are the Health Benefits of CBD? . . . Benefits of activating the CB1 receptors may include: relieving depression, lowering anxiety, lowering blood pressure, lowering intestinal inflammation and more.”
There are no outward signs that the agency will revise its enforcement policies, and it is unclear when or if FDA will issue long-expected regulatory guidance clarifying appropriate CBD marketing practices. FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D stressed in a March statement that “unapproved, CBD products may have dangerous health impacts and side effects,” and that FDA will “continue to monitor and take action, as needed, against companies that unlawfully market their products.”
The Federal Trade Commission is also actively enforcing, announcing settlements with six different CBD companies involving fines ranging from $20,000-$85,000, in addition to notifications to consumers.