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“Last month, the Food and Drug Administration (FDA) issued a warning to consumers not to purchase or use products marketed as dietary supplements that include tianeptine. Tianeptine can be found in retail outlets, and can create ‘opioid-like effects.’ It is not approved for use in the United States, but that has not deterred some unscrupulous companies from including it in their products and marketing them as dietary supplements that can treat substance use disorder. Such claims and marketing are illegal actions under the Federal Food, Drug, and Cosmetic Act. It also is cruel to those Americans who experience substance use disorder and need real support—not a cheap, unsubstantiated ‘fix.’ However, recent reporting indicates that tianeptine is reaching and harming consumers now more than ever before.
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Now, FDA estimates that there are more than 95,000 of these products on the market. But, the agency does not know the true number—let alone what ingredients are included in those products. The Dietary Supplement Listing Act would have given FDA much-needed insight into the market and improved its abilities to initiate enforcement action against the companies that market dangerous or illegal ingredients, such as tianeptine, in their supplement products.
I will reintroduce the Dietary Supplement Listing Act this year. In the face of mounting public health threats, I urge the [Dietary Supplement Trade Association] to help support legislative efforts such as this that would ensure the FDA can protect consumers effectively. I also request that the [Dietary Supplement Trade Association] provide my office with a written plan to work with responsible supplement manufacturers to remove tianeptine and other dangerous or illegal ingredients from the supplement market. Let me be clear: we must take substantive action to ensure that other mothers, fathers, siblings, and friends do not experience the same pain and suffering that Karen faces now.”
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