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December 13, 2023 By: Asa Waldstein

Seven-Year-Old Facebook Post Leads To Warning Letter

Takeaway -

Review old social posts for regulatory “landmines”

This company received a warning letter for claims made on its website and old social media posts. The oldest post cited in this letter is from 2016, which shows that even old and potentially “forgotten” social posts are active marketing in the eyes of the authorities. Many companies now have “clean” marketing, but they may have inadvertently overlooked the regulatory landmines in their old socials. Now is the time to review and update these old posts (and old blogs).

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Some very high-risk language on Facebook is cited in the letter.

From warning letter: ” In a July 29, 2017 post: “Can Plaquex® help prevent cancer?…When I linked the facts of these three independent information sources, the thought came to me, that Plaquex® – Phosphatidylcholine – may be able to prevent cancer.”

Following the “breadcrumbs” in warning letters is always fun. For example, in this letter, FDA notes that the Facebook page links to a website (book-selling site) that links to another website where customers can order supplements. FDA rarely references anything over “two clicks,” which is what makes this so interesting. FYI, the two-click rule is an urban legend and, as demonstrated in this letter, does not protect from disease claim enforcement. This “commercial bridge” is important, as it’s often cited in warning letters.

Unfortunately, this warning letter has not stopped the company from continuing to make very high-risk claims, such as statements about ingredients being antidepressant and antiarthritic.

Read the full letter here.

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.

Written by

Asa Waldstein
Asa Waldstein
Asa Waldstein is a 24-year veteran of the dietary supplement industry, with experience spanning manufacturing, marketing, and regulatory compliance. He is the principal of Apex Compliance, a software company dedicated to streamlining regulatory marketing compliance for the dietary supplement and natural products sectors. Asa also leads Supplement Advisory Group, a boutique consultancy focused on marketing risk analysis, labeling, and practical compliance strategies for websites and social media. Asa has helped oversee three FDA GMP inspections with no 483s and was honored with the 2023 AHPA Herbal Hero Award and the 2024 What's Up Supps Policy and Change Agent Award. He currently serves as Chair of the American Herbal Products Association’s (AHPA) Cannabis Committee, helping shape policy and industry best practices