FDA Slaps Supplement Maker With Warning Letter for Unapproved, Misbranded Drugs

Dietary supplement maker TJM Resale’s Synaptik Supplements & Ligand Solutions was slapped with an FDA warning letter over the sale of unapproved and misbranded drugs.

The St. Paul, Minn.-based company’s claims about its Anhydrous Caffeine Bulk Powder would make it a drug, according to the letter. For example, the company claims the powder can be used to burn fat and speed up a user’s metabolism, as well as serve as an appetite suppressant.

The product’s composition also is not generally recognized as safe and effective for use under the conditions suggested in the labeling, and therefore requires FDA approval, according to the letter, which follows an agency review of the powder’s label and the company’s website.