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Tianeptine Rings Latest Unapproved Drug Alarm, Followed By Echo About Lack Of FDA Regulation

 
• By Malcolm Spicer

Tianeptine isn’t approved as drug in US nor allowed for use as dietary ingredient or food additive. FDA has warned multiple firms selling tianeptine-containing products and federal prosecutors recently announced guilty plea from man who sold the drug to consumers.

• Source: Shutterstock

The latest alarm about drug ingredients found in products marketed as dietary supplements in the US also is the latest example of an incorrect view that the Food and Drug Administration doesn’t regulate ingredients used in food and supplements.

The FDA on 21 November published a warning to consumers about a product branded Neptune’s Fix Tianeptine Elixir, or any product containing the drug tianeptine, after receiving reports of severe adverse events linked to use of the products, including deaths,

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More from Policy & Regulation

Third-Party ‘Testing, Inspection and Certification’ Cleaning Up Amazon Supplement Market

 
• By Malcolm Spicer

Three FDA warnings related to supplement manufacturing, labeling or marketing submitted to Amazon or companies selling vitamin, mineral or supplement products on its e-commerce platform since April 2024.

Digital Services Deliver Hemp, States Deliver Regulation With Congress Yet To Act

 
• By Malcolm Spicer

Four months into session, no bills have been introduced in Congress to authorize FDA to establish a regulatory pathway for the lawful use of hemp ingredients in products other than drugs or propose some other solution to the federal conundrum present since lawmakers in 2018 de-scheduled hemp.

Little Industry Opposition To FDA Plan To Remove Synthetic Dyes, Or Agreement They’re Unsafe

 
• By Malcolm Spicer

Dyes and colors which FDA says industries agree should no longer be used aren’t unsafe and are currently used only with the agency’s approval, industry stakeholders say. Center for Science in the Public Interest says the dyes are used “in tens of thousands of foods and beverages that are commonly consumed here in the United States.”