FDA WARNING_LETTER - Supplementality LLC - January 31, 2013

On January 2013, the FDA and FTC reviewed www.supplementality.com and found the company offering unapproved and uncleared products, labeled as dietary supplements, intended to diagnose, mitigate, prevent, treat, or cure the Flu Virus. These products include Resveratrol (40mg and 250mg), Garlic 90 (500mg), Echinacea, Elderberry, Ashwagandha (500mg), and Astragalus Immune System Support (500mg).

The FDA cited website claims such as "Help fight off influenza and other viruses and their symptoms naturally" and specific claims for each product, like Resveratrol being an "antiviral, inhibiting...certain flu and respiratory viruses," and Echinacea reducing "symptoms of colds and flu." These claims render the products "new drugs" under 21 U.S.C. § 321(p), requiring FDA approval, which they lack. Furthermore, the products are misbranded under 21 U.S.C. § 352(f)(1) because they address conditions not amenable to self-diagnosis, thus lacking adequate directions for layperson use.

The FDA demanded immediate cessation of marketing these unapproved products and a response within 15 days via email (FDAFLUTASKFORCECFSAN@fda.hhs.gov) detailing corrective actions. Failure to comply could result in enforcement actions like seizure, injunction