Princess Lifestyles, LLC
FDA issued a warning letter to Princess Lifestyles, LLC (San Gabriel, CA) following a March 2021 facility inspection and February 2022 website review, finding that multiple dietary supplement products — including TMAXX and PS Brain — bore disease-treatment claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The agency also cited extensive CGMP violations (no written QC procedures, missing component specifications, inadequate complaint and returns handling), an adulterated product containing ephedrine alkaloids (Stomaisu), and widespread labeling deficiencies across 13 product lines. FDA warned that failure to promptly correct violations may result in seizure or injunction.
Flagged claims (2)
Regain control of your body's metabolism by balancing the…regulation of…cholesterol with Tmaxx.
Although studies [of PS, an ingredient in your product] in humans with Alzheimer's disease were less dramatic, they still produced significant improvements in cognitive function. In patients with mild dementia, significant cognitive and behavioral enhancing effects were observed. Most studies have used a standardized PS that provides an elemental level of 100 mg taken twice per day.
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure or injunction.
Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure or injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most nutrition / supplements sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker