With the enactment of the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill), hemp-derived CBD appeared to be on the table for marketing all across the country. However, the U.S. Food and Drug Administration's (FDA) press release issued that same day put a hold on the jubilation, stating that FDA considered any and all cannabis-containing or cannabis-derived products as drug products and not food or dietary supplements, regardless of whether the CBD was hemp-derived.
On April 2, 2019, departing FDA Commissioner Scott Gottlieb issued a statement about FDA's next steps to advance a regulatory pathway for cannabis-containing and cannabis-derived products. At the same time FDA updated its cannabis-containing products and cannabis-derived products Q&A. It is clear that, at this point, FDA has not changed its position. It is unlawful to introduce food or beverages containing CBD or THC into interstate commerce or market these products as dietary supplements. This is due, in part, to FDA's opinion that CBD and THC were active ingredients in approved drugs (or drugs being studied pursuant to an Investigative New Drug application) before they were legally marketed as food under federal law. According to FDA, the result of this is that CBD or THC can only be added to foods or beverages or marketed as dietary supplements if FDA issues a regulation through notice-and-comment rulemaking, a time-intensive exercise. In addition, FDA may consider some delivery forms of CBD to be "drugs."
Because the Food Drug and Cosmetic Act does not require premarket clearance for cosmetics, FDA has taken a more nuanced position on cosmetics containing CBD.
FDA has also now clarified that its priority with respect to enforcement at this time is for CBD products that are marketed with "over-the-line" health claims, such as those described below. That being said, it has set forth the steps it is taking to move the ball forward on regulation of cannabis products.
First, FDA scheduled a public hearing for May 31, 2019, to allow stakeholders to share their experiences and any foreseeable challenges with these products. FDA will also provide stakeholders with an opportunity to provide written public comments. Of particular interest to FDA is information, data and views on the safety of CBD-containing and cannabis-derived products. For example, FDA is seeking information and data about what levels of cannabis and cannabis-derived compounds cause safety concerns; how the mode of delivery (e.g., ingestion, absorption, inhalation) affects the safety of, and exposure to, these compounds; how cannabis and cannabis-derived compounds interact with other substances such as drug ingredients; and the like. The goal of this hearing is to obtain input from stakeholders on possible strategies that will allow for lawful marketing of CBD-containing and cannabis-derived products in a predictable and efficient manner, while still providing incentives for drug development with CBD and cannabis-derived compounds.
Second, FDA has formed a high-level internal agency working group, co-chaired by Principal Deputy Commissioner Amy Abernethy and Principal Associate Commissioner for Policy Lowell Schiller, to explore pathways for CBD as a dietary supplement and/or as conventional food or food additives. This group will consider both legislative and regulatory changes that may be required with an eye toward the impact of marketing CBD products on public health. The working group plans to begin sharing information and findings with the public as soon as this summer.
Third, FDA requires that cannabis products, including those derived from hemp, that are marketed with a claim of therapeutic benefit to be approved for its intended use. Therefore, FDA issued multiple warning letters to companies marketing CBD products with "egregious and unfounded claims that are aimed at vulnerable populations," including those making unproven claims to treat serious or life-threatening diseases. FDA is concerned about products sold online and, therefore, available all over the country, such as oil drops, capsules, syrups, teas, and topical lotions and creams. In collaboration with the Federal Trade Commission, FDA issued three waning letters yesterday on dozens of products based on review of webpages, online stores and social medial websites. Examples of inappropriate and deceptive claims include:
- "CBD successfully stopped cancer cells in multiple different cervical cancer varieties."
- "CBD also decreased human glioma cell growth and invasion, thus suggesting a possible role of CBD as an antitumor agent."
- "For Alzheimer's patients, CBD is one treatment option that is slowing the progression of that disease."
- "Fibromyalgia is conceived as a central sensitization state with secondary hyperalgesia. CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders."
- "Cannabidiol May be Effective for Treating Substance Use Disorders."
- "CBD reduced the rewarding effects of morphine and reduced drug seeking of heroin."
- "CBD may be used to avoid or reduce withdrawal symptoms."
Finally, FDA has updated its answers to its frequently asked questions to align with the views in its previous statements, press releases and warning letters. FDA further notes that it "continues to believe that the drug approval process represents the best way to help ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy." This is, in part, because clinical trials of cannabis and cannabis-derived compounds are needed to assess their safety and effectiveness.
With respect to food and dietary supplements, FDA states that ingredients derived from THC- and CBD-free parts of the cannabis plant (such as certain hemp seed ingredients) may be able to be marketed as dietary supplements or food additives, assuming they conform to the laws and regulations concerning dietary supplement products or are found to be generally recognized as safe (GRAS), respectively. Three hemp products have been found to be GRAS: hulled hemp seed, hemp seed protein powder and hemp seed oil. However, FDA caveats that the finding of these three products as GRAS does "not affect the FDA's position on the addition of CBD or THC to food."
With respect to cosmetics, FDA states that cannabis and cannabis-derived ingredients are not currently prohibited or restricted by regulation from being cosmetic ingredients. However, any cosmetic product containing these ingredients must comply with all cosmetic regulations, including those concerning adulteration and misbranding. For example, a cosmetic is adulterated if it has any poisonous or deleterious substance that is injurious to users under the conditions of use in the labeling or under customary use. A cosmetic is quickly considered a drug by FDA if it makes any suggestion that it affects the structure or function of the body or is used to diagnosed, cure, mitigate, treat or prevent disease.
Based on the FDA's updated position and the complex nature of the regulatory scheme, we urge entities interested in marketing products containing CBD to consult with attorneys familiar with the regulatory landscape.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.