FDA Sends Warning Letters

FDA Sends Warning Letters

NEW ORLEANS--The Food and Drug Administration (FDA), in two December warning letters, addressed mislabeling issues associated with certain dietary supplements. The first letter, from FDA's New Orleans District, was sent to Jackson, Miss.-based Forever Young Products Inc. for failing to meet FDA's Current Good Manufacturing Practices for finished pharmaceuticals. According to the agency, the products in question had label claims that made the products fall into the drug category. Some of those categories included topical acne drug products, topical antifungal drug products and anorectal drug products. According to FDA, the company verbally committed to correct "these observed deficiencies."

The second letter, from FDA's Dallas District, warned Bloomfield Hills, Mich.-based Pollard & Albertson that its dietary supplement, Nexcite, was labeled as a misbranded food. Nexcite, formally known as Niagara (the sexually stimulating drink marketed to women), did not include all dietary ingredients (i.e., caffeine, flavoring) in its supplement facts or ingredient panels.