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Company Cited For Selling Tianeptine Products

Email newsletters are marketing

Company Cited For Selling Tianeptine Products

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.

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