Dr Ned SharplessNed Sharpless, MD
The FDA has issued a warning letter to Rooted Apothecary LLC, of Naples, Florida, for the illegal sale of unapproved products containing cannabidiol (CBD) online with unproven claims to treat a number of conditions, among them Parkinson disease and Alzheimer disease.1

The joint letter was issued alongside the Federal Trade Commission and expressed particular concern with the marketing of products to pediatric patient populations. The letter noted that “with the exception of Dronabinol, Epidiolex, Marinol, and Syndros, no product containing cannabis or cannabis-derived compounds (either plant-based or synthetic) has been approved as safe and effective for use in any patient population.”2

Some examples of the unsubstantiated claims the online store made included assertions that the CBD products could offer neuroprotective effects against neurodegenerative disorders like Alzheimer disease and Parkinson disease. The FDA and FTC have requested a response from Rooted Apothecary within 15 business days with plans to correct the violations.

“Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance,” said acting FDA Commissioner Ned Sharpless, MD, in a statement. “We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions. This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children.”

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The agency noted that failure to make corrections may result in actions such as product seizure and injunction, as well as an order to require customer backpay for products sold.

The FDA reiterated its ongoing concern with products claiming to contain CBD and marketed for therapeutic and medical purposes. As of now, only one CBD product has been approved for medical use in the US, the aforementioned Epidiolex, manufactured by GW Pharmaceuticals for the treatment of Lennox-Gastaut and Dravet syndromes, 2 rare forms of epilepsy with limited treatment options. Even so, CBD remains a Schedule I substance under the Controlled Substances Act, though Epidiolex itself was rescheduled after its approval to Schedule V.

“We’ve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements,” Sharpless continued in his statement. “As we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains our top priority. We appreciate the FTC joining us on these and other actions to protect consumers from fraudulent CBD products.”

In 2019 alone, the FDA has issued 6 other letters to companies in 5 states for the marketing of unapproved new drugs that allegedly contain CBD. As part of these actions, the FDA tested the chemical content of CBD compounds in some of these products, and most were found to not contain the levels of CBD which they claimed. Since 2017, the FDA has sent more than 10 such letters.3

“The FDA is working quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies,” Amy Abernethy, MD, PhD, principal deputy commissioner, FDA, said in a statement. “We recognize that there is a significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety, and quality of many of these products.”

“We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence,” Abernathy added.
REFERENCES
1. FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease [press release]. Silver Spring, MD: FDA; Published October 22, 2019. fda.gov/news-events/press-announcements/fda-ftc-warn-company-marketing-unapproved-cannabidiol-products-unsubstantiated-claims-treat-teething. Accessed October 22, 2019.
2. FDA. Warning Letter: Rooted Apothecary. Issued October 10, 2019. Updated October 22, 2019. fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rooted-apothecary-llc-585312-10102019. Accessed October 22, 2019.
3. FDA. Warning Letters and Test Results for Cannabidiol-Related Products. FDA website. Updated October 9, 2019. fda.gov/news-events/public-health-focus/warning-letters-and-test-results-cannabidiol-related-products. Accessed October 22, 2019.