|Footnotes for this article are available at the end of this page.
On May 15, 2020, the Food and Drug Administration (FDA or “Agency”) announced a voluntary recall of a CBD containing product that tested positive for lead.1 According to information shared by FDA, the recalling firm is inspected and licensed under the Florida Department of Food and Agriculture and Consumer Services (FDFACS) to produce products containing CBD. A random sample of one of the company’s products was tested by FDACS and was found to contain lead levels at 4.7 ppm. Following the findings by FDFACS the company also had a sample of the product tested at an ISO-accredited lab. The results listed the lead content at 0.5ppm, putting it within the legal limits in Florida. However, the company initiated a voluntary recall of the implicated batch of product.
The fact that FDA is assisting in a voluntary recall because a FDA regulated product tests positive for lead, a clear risk to the public health, is nothing new. As the former Deputy Director of FDA’s Office of Dietary Supplement Programs, I played a role in recalls and seizures that were required because products marketed as dietary supplements were found to contain lead.2 What makes this situation noteworthy is that the FDA is assisting in a voluntary recall of a product that contains CBD. CBD is short for cannabidiol, one of the main components in the cannabis plant. The 2018 Farm Bill established that cannabis plants that contain less than 0.3% THC are considered industrial hemp and that such plants, and components extracted from them, including CBD, do not violate the Controlled Substances Act (CSA).3 However, regardless of CBD’s status relative to the CSA, the Farm Bill did nothing to change the FDA’s position that CBD is a violative ingredient under the Food Drug and Cosmetic Act (the Act) when it is added to a product labeled as a conventional food or dietary supplement.4
In an announcement dated December 20, 2018, the same day the Farm Bill was signed into law, FDA clarified its regulatory authority over CBD, and stated that it would, while taking enforcement action against products containing CBD that fall under its jurisdiction, continue to take steps to make the pathways for the lawful marketing of CBD containing products more efficient.5 Since then FDA has almost exclusively limited its enforcement actions to sending Warning Letters to firms that make disease claims about CBD-containing products. Although FDA held a public hearing about cannabis-derived compounds in May 2019, the Agency has not made public any proposals for pathways for the legal marketing of CBD.6
Now, nearly a year and a half after the signing of the Farm Bill and a year since FDA’s public hearing, it appears that the Agency is willing to work with a company to protect the public health while looking the other way when it comes to the fact that the product contains CBD as an ingredient. Should this be taken as a signal to regulated industry that FDA is willing to work them to bring a wholesome, CBD-containing product to market? Could this indicate that the Agency is close to taking a new position relative to CBD and did not want to seem heavy-handed by taking enforcement action just before doing so? Or should we be on the lookout for this firm to receive a warning letter following the completion of the recall?
Companies that are or plan to sell a FDA regulated product that contains CBD should conduct a risk/reward analysis. This analysis should include the following suggestions:
- If you are selling a product that violates the Act, don’t give the Agency any other reason to come after you;
- Be proactive and diligent in ensuring you’re putting a wholesome product into commerce and that current good manufacturing practices are being followed;
- Take the time to determine and establishing strict specifications for your raw ingredients and components and test to ensure that possible contaminants, such as heavy metals or excessive THC levels, are not present;
- Ensure Certificate of Analysis (CoAs) that accompany ingredients reflect your specifications and then confirm the CoAs for accuracy;
- Establish and maintain a solid Supplier Qualification Program, work to have a relationship with your suppliers but have provisions in your contracts or purchase agreements that describe who bears what responsibility for components that are out of specifications;
- Ensure that claims made about the product do not include disease claims and that the claims are substantiated by competent and reliable scientific evidence;
- When in doubt, seek legal and regulatory advice from someone knowledgeable in these matters.
Companies with legal questions regarding marketing CBD or other hemp and hemp-derived products can contact Kevin M. Bell, Robert Durkin, or Richard J. Oparil.
 For more information concerning FDA’s position on CBD go to FDA’s website at: https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd