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Opioid Treatment Claims Linked To Depression Drug Found In Supplements

 
• By Malcolm Spicer

FDA warns MA Labs and Jack B Goods about online claims that their tianeptine-containing products treat opioid use disorder, pain and anxiety and other violative and unproven claims. CDC reports a jump in poison control center reports on tianeptine, which is approved outside the US to treat depression.

A drug ingredient approved in other countries to treat depression, tianeptine, is the latest substance FDA has found in products marketed as dietary supplements in the US with claims to treat withdrawal from opioid abuse.

FDA on Nov. 20 published warning letters from the Office of Compliance in its Center for Food Safety and Applied Nutrition to two firms that agency officials determined have sold tianeptine-containing products online. Both firms, MA Labs LLC of Henderson, Nev., and Jack B Goods Outlet Store in Ridgeland, Miss

More from Regulation

More from Policy & Regulation

Accelerating Natural Options Among US FDA’s Steps For Removing Petroleum-Based Food Dyes

 
• By Malcolm Spicer

HHS Secretary Kennedy commends food companies for cooperating, but also says, “We have them on the run now and we are going to win this battle. And four years from now, we're going to have most of these products off the market.”

US Plans End To Petroleum-Based Dyes In Food

 
• By Malcolm Spicer

HHS Secretary Robet F. Kennedy Jr. and FDA Commissioner Marty Makary to announce planned changes as “a major step forward” as part of Kennedy’s “Make America Healthy Again” campaign President Trump has adopted for his administration.

Deleting Self-Affirmed GRAS Option Could Stretch FDA’s Already Thin Food Safety Resources

 
• By Malcolm Spicer

FDA introduced the option because it didn’t have sufficient staff to handle the volume of GRAS submission reviews requested by food and other firms for ingredients. Requiring submissions for all GRAS determinations “would just be an unworkable situation for the food industry if somehow submitting notice, submitting notices for FDA review and concurrence, was required,” says food and drug attorney Federick Stearns.