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June 19, 2024 By: Asa Waldstein

Company Cited For Selling Tianeptine Products

Takeaway -

Email newsletters are marketing

This company received a warning letter for selling tianeptine—a substance deemed dangerous and inappropriate for dietary supplements according to FDA. Read more about FDA’s position here.

In January FDA inspected this company and determined they sell tianeptine products, but I am unsure why it took until June to issue this letter. There may be a piece of the puzzle missing but this seems like a long time to take this action. I ask, what can we do to support FDA to remove drug-spiked products from the marketplace swiftly? 

It seems this same company (or its subsidiary) had about $1.3 million in kratom products seized by US Marshals on FDA’s request back in 2021. Read more about this here

Here is a Warning Letter Wednesday post about kratom and opioid claims

Here’s an interesting part of the warning letter. FDA cites claims made in an email newsletter. I’ve heard of companies being cited for claims made on labels, websites, socials, catalogs, or brochures but not for email-only newsletters. This shows that all marketing is labeling and is open to scrutiny.

From warning letter: “Examples of claims from your email blast promotional material, which links back to your website … that provide evidence of the intended use of these products as drugs.” 

FYI, at the time of writing, the company’s website was taken down. 

Read the full warning 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) Technology & AI Innovation Committee.