FDA Warning Letters Are Pearls Of Wisdom
FDA Warning Letters Are Pearls Of Wisdom
While the pandemic may seem like a thing of the past, warning letters from the Food and Drug Administration (FDA) are not.
Last week, the FDA issued a new round of letters to no less than seven CBD companies that used research studies to claim or misleadingly imply that their CBD products can cure, mitigate, treat or prevent COVID-19. You can read these letters by clicking on the following links:
Heaven’s Organics LLC
Functional Remedies, LLC D/B/A Synchronicity Hemp Oil
Greenway Herbal Products LLC
The issuance of these letters is not surprising. For the past two years, the agency has consistently explained that it is concerned with the fact that these deceptive and misleading product claims could cause people to delay or stop appropriate medical treatment for COVID-19, leading to serious and life-threatening harm.
These letters also coincide with two recent major development: First, the publication of scientific studies showing that cannabidiol (CBD), cannabinoid acids, and synthetic cannabis-derived compounds may prevent or treat COVID infections. Second, the FDA’s request that Congress amend the Dietary Supplement Health and Education Act of 1994 (DSHEA) to “clarify FDA’s authorities over products marketed as dietary supplements to facilitate enforcement against unlawfully marketed products.”
Although the industry is well aware of the legal risk associated with making medical claims regarding CBD, few companies seem to understand what constitutes over-the-line medical claims that put them at risk of FDA enforcement actions.
Medical claims are explicit or implicit statements that a product can be used to diagnose, cure, mitigate, treat, or prevent a disease, or affects the bodily structure or function of the end-use consumer. Generally, medical claims can only be made in association with approved drug under the Food, Drug and Cosmetic Act (FDCA).
Drugs are the most strictly regulated category of products in the United States. Federal law mandates that all new drugs manufactured and sold in the U.S. be shown to be safe and effective for their intended use before being marketed. In 2018, the FDA approved CBD as the active ingredient in Epidiolex. However, the approval of CBD in Epidiolex did not result in the approval of CBD in other drugs nor other product categories, such as foods, dietary supplements, or cosmetics.
In the past couple of years, the FDA has sent a total of 71 warning letters to manufacturers and distributors of CBD that made various medical claims about their CBD products. In these letters, the FDA consistently took the position that these statements rendered the subject CBD products unapproved drugs that violated the FDCA.
Warning letters are a valuable tool for any CBD company because they reveal the types of statements that make the FDA tick and can help them adjust their marketing practices to reduce the risk of enforcement actions.
In addition, not falling under the scrutiny of the FDA may also help CBD companies shield themselves from more-significant headaches, including potential product seizures, criminal charges, litigation, major fines, and penalties as well as state law consumer protection claims and personal injury claims.
Every CBD company that operates on the U.S. market should keep up with FDA enforcement trends and read – or have their marketing team or consultants read – warning letters. They contain pearls of wisdom that can help the industry better navigate this very strenuous regulatory landscape.
Nathalie Bougenies chairs Harris Bricken‘s hemp CBD practice group and focuses her practice on health and wellness, in addition to corporate transactions and regulatory compliance. For the past three years, Nathalie has helped clients navigate the complex regulatory landscape of hemp products intended for human consumption and advises domestic and international clients on the sale, distribution, marketing, labeling, and importation of these products. Nathalie frequently speaks on these issues and has made national media appearances, including on NPR’s “Marketplace.” She also authors a weekly column for “Above the Law” that features content on cannabis policy and regulation and is a regular contributor to her firm’s “Canna Law Blog.” For three consecutive years, Nathalie has been named Rising Star by Super Lawyers.