FDA WARNING_LETTER - Sportron International, Inc. - March 27, 2019

The FDA conducted an inspection of Sportron International's facility in Whitewright, TX, from March 22-27, 2019, and reviewed their website, www.sportroninternational.com, in August 2019. The inspection and website review revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

The products Sportron Omegatone, Sportron Joint Formula/A-Tron, Sportron B-Plex, and Sportron D-Plex-5000 are deemed unapproved new drugs and misbranded drugs. Website claims, such as "Reduces Inflammatory Pain" for Omegatone and "Anemia Support" for B-Plex, establish their intent for disease treatment, cure, mitigation, or prevention, making them "new drugs" under 21 U.S.C. § 321(p). These products lack FDA approval for safety and effectiveness, violating 21 U.S.C. § 355(a) and § 331(d). Furthermore, Sportron Omegatone and Sportron B-Plex are misbranded under 21 U.S.C. § 352(f)(1) because they lack adequate directions for layperson use, as their intended uses require professional supervision.

The facility also exhibited serious Current Good Manufacturing Practice (CGMP) violations for dietary