FormPour
FDA issued a warning letter to FormPour (Shuja Arshad, Canton, MI) regarding the sale of 'SMGT-GLT-1 Nano Microneedle Patch' on eBay, which FDA determined is an unapproved new drug under section 505(a) of the FD&C Act. The product's labeling made explicit disease-treatment claims for Type 2 Diabetes, weight loss, and cardiovascular protection, establishing its intended use as a drug. Because no approved NDA is in effect for this product, its interstate sale violates sections 301(d) and 505(a) of the FD&C Act. FDA demanded written corrective action within fifteen working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (3)
For: Type 2 Diabetes Treatment Weight Loss Cardiovascular Protection
The patch contains a blend of fat-burning ingredients (such as caffeine, green tea extract, or other thermogenic compounds) that work to help stimulate fat metabolism, reduce cellulite, and promote a smoother, slimmer appearance.
Global User Survey Results 98.6% Type 2 Diabetes Treatment Weight Loss Aid 97.5% 98.1% Cardiovascular Protection
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations.
Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.
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