Princess Lifestyles, LLC – FDA Warning Letter, Mar 26, 2021

The FDA issued a Warning Letter to Princess Lifestyles, LLC, following a March 2021 inspection and a February 2022 website review. The company's products, including TMAXX and PS Brain, are deemed unapproved new drugs and misbranded drugs due to therapeutic claims on their website, violating sections 201(g)(1)(B), 201(p), 301(d), 505(a), 502(f)(1), and 301(a) of the Act. PS Brain is also misbranded as it requires professional supervision.

Additionally, all dietary supplement products are adulterated under 402(g)(1) due to significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111). Deficiencies include: 1. Failure to establish and follow written quality control procedures (21 CFR 111.103, 111.140(b)(2)). 2. Failure to establish component specifications, including identity specifications (21 CFR 111.70). 3. Failure to establish and follow written procedures for holding and distribution operations (21 CFR 111.453, 111.455). 4. Failure to establish and follow written procedures for returned dietary supplements, including material review and disposition