Nutrition Strength Ltd. – FDA Warning Letter, Nov 12, 2024

The FDA issued a Warning Letter to Nutrition Strength on November 12, 2024 (Ref: 696350) regarding the marketing of unapproved new animal drugs, specifically "Dog Seizure and Epilepsy Supplement" and "Blood Support for Dogs." An FDA review of www.nutritionstrength.com from October to November 2024 found these products promoted and sold in the U.S. via Amazon hyperlinks.

The FDA determined these products are "drugs" under FD&C Act section 201(g)(1) due to claims on the website, labeling, and Amazon pages indicating intent for disease treatment or affecting animal body structure/function. Examples for "Dog Seizure and Epilepsy Supplement" include claims of protecting against, controlling, and managing epileptic attacks and promoting nervous system balance. For "Blood Support for Dogs," claims include aiding anemic dogs, furnishing folic acids, and increasing hemoglobin.

These products are also deemed "new animal drugs" under section 201(v) because they are not generally recognized as safe and effective. They lack an approved new animal drug application, conditionally approved application, or index listing, rendering them unsafe (section 512(a)) and adulterated (section 501(a)(5)). The introduction of adulterated drugs into interstate commerce is prohibited (section 301(a)).

Nutrition Strength must respond within fifteen working days, detailing corrective actions,