FDA WARNING_LETTER - FormPour - December 01, 2025

On March 31, 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to FormPour, specifically addressed to Shuja Arshad, following a December 2025 review of the company"s eBay store. The investigation revealed that FormPour was marketing and selling the "SMGT-GLT-1 Nano Microneedle Patch" in the United States with claims that classify it as a drug. Specifically, the product"s labeling suggested it could be used for the treatment of Type 2 Diabetes, weight loss, and cardiovascular protection.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), products intended for the diagnosis, cure, or prevention of disease are categorized as drugs. Because this microneedle patch is not generally recognized as safe and effective for its claimed uses and lacks an approved application from the FDA, it is considered an unapproved new drug. The distribution of this product violates federal law, specifically sections 301(d) and 505(a) of the FD&C Act, which prohibit the introduction of unapproved new drugs into interstate commerce.

The FDA has directed FormPour to take immediate action to address these violations. The company must respond in writing within 15 working days, detailing the specific steps taken to correct the issues and prevent their recurrence. Failure to comply with these requirements may result in further regulatory or legal actions, such as product seizures or injunctions.