The Food and Drug Administration (FDA) has issued multiple warnings telling consumers not to use or purchase products from the supplement brand Neptune's Fix or any other products containing the ingredient tianeptine. Neptune Resources LLC, the maker of Neptune’s Fix products, agreed to a voluntary nationwide recall of all Neptune’s Fix products last month in response to the warnings. Tianeptine, an ingredient in the recalled products, is not approved for any medical use in the United States.
The Agency has warned that any tianeptine product is associated with serious health risks and is investigating Neptune’s Fix in conjunction with state and local partners. Several lawmakers have asked the FDA whether it is working with the Drug Enforcement Administration (DEA) to possibly add tianeptine to a drug schedule under the Controlled Substances Act.
As of March 2024, eleven states have designated tianeptine as a controlled substance (i.e., Schedule I or Schedule II): Alabama, Florida, Georgia, Indiana, Kentucky, Michigan, Minnesota, Mississippi, Ohio, Oklahoma, and Tennessee.
Retailers and consumers should report adverse events or side effects related to the use of Neptune’s Fix and similar products to FDA's MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting the report online at MedWatch Online Voluntary Reporting Form.
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