FDA Notifies Public About Voluntary Recall for Hemp CBD

On May 20, 2020, Marijuana Moment reported on a new development on the Food and Drug Administration’s (FDA) position on hemp-derived cannabidiol (Hemp CBD). The article centers on the following tweet from the FDA:

The FDA is essentially warning the public about a voluntary recall by Summit Labs’ CBD oil due to test results showing that the product is high in lead.

The FDA regularly posts voluntary updates as a public service. After all, the FDA’s purpose is to protect the public from unsafe goods. What is interesting about this May 15th notification is that it relates to CBD. The FDA’s position is that CBD cannot be sold as a food or dietary supplement so it is rare to see the FDA take any action relating to a CBD company outside of a warning letter or updating its FAQs on CBD.

Here the FDA is essentially helping Summit Labs with its voluntary recall, as indicated from the following passage from the FDA’s notice of recall (linked in the tweet above):

Summitt Labs is voluntarily recalling Batch#730 Lot#K018 of KORE ORGANIC Watermelon CBD Oil Tincture, 30 ml bottle, 15mg 450x to the consumer level. The Florida Department of Agriculture and Consumer Services tested a random sample and found the product to contain lead levels at 4.7 ppm. When informed of this, Summitt Labs issued an immediate voluntary recall and started an internal investigation. As part of this investigation Summitt Labs had a sample from Batch #730 Lot #K018 tested at an ISO/IEC accredited lab. Lead results were 500 ppb (.5ppm), which is within the legal limits as defined by the State of Florida. However, based on the test from the Florida Department of Agriculture and Consumer Services, Summitt Labs initiated, and will complete, a full recall of Batch #730 Lot #K018 in full cooperation with the FDA and Florida Department of Agriculture and Consumer Services.

Summitt Labs is an inspected and licensed facility under the Florida Department of Food and Agriculture and Consumer Services to produce products containing CBD but the Federal Food and Drug Administration does not consider CBD to be a legal drug or dietary supplement.

The FDA’s statements here are telling, as it acknowledges that Summit Labs is licensed with the state of Florida. Currently, the FDA is working on regulations for the fast-growing Hemp CBD industry and has also indicated that it may release enforcement priorities in the interim.

Over the last two years the FDA has only really focused on warning the public about Hemp CBD products generally. It hasn’t distinguished standard operators from Hemp CBD companies that sell products containing harmful additives, or companies that falsely claim Hemp CBD is contained in a product when it has none. In other words, FDA doesn’t distinguish between good and bad actors in Hemp CBD. The FDA’s warning letters appear only to be triggered based on whether the distributors of those products make medical claims about Hemp CBD.

Now it appears that the FDA is willing to work with a Hemp CBD company who is trying to protect the public through a voluntary recall. This could be a preview of things to come where the FDA works with Hemp CBD companies to protect the public.

I also think it’s relevant that the FDA mentioned the Florida Department of Agriculture and Consumer Services because Florida has some of the most robust regulations on Hemp CBD products. Florida, unlike the FDA, does allow for the sale of ingestible Hemp CBD products so long as done in compliance with its regulations and laws. The FDA’s opposition to Hemp CBD, combined with the wide availability of these products, has forced states to step into the FDA’s shoes in regulating these goods. The FDA is likely to work with and learn from these states as it develops its own regulations and policies on Hemp CBD.

If you’d like to learn more about Hemp CBD regulations at the state level, feel free to reach out to our hemp attorneys. We prepare a monthly risk matrix tracking how each of the fifty states treats Hemp CBD products, including ingestible (food and dietary supplements), smokable (vapor products and hemp flower) and cosmetic products.

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