What happened
Original notice title
Princess Lifestyles, LLC MARCS-CMS 614384, February 23, 2022
From the archived source record
Based on inspectional findings and a review of your website, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs/Misbranded Drug FDA reviewed your website at the Internet addresses www.princesslife.com, in February 2022 and has determined that you take orders there for your various products, including your TMAXX and PS Brain products. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, your PS Brain product fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Dietary Supplement CGMP Violations Your dietary supplement products that you manufacture, package, label, and/or hold are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because the products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements in 21 CFR Part 111. Additionally, even if the product labeling for your TMAXX and PS Brain products did not have therapeutic claims that make these products unapproved new drugs and misbranded drugs, these products would still be adulterated dietary supplements within section 402(g)(1) of the Act because these products have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. Although a firm may contract out certain dietary supplement manufacturing operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 04abb9db27ba
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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