FormPour(RE: 722215)

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

WARNING LETTER

March 31, 2026

RE: 722215

Shuja Arshad:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your eBay store at https://www.ebay.com/str/formpour in December 2025. The FDA has observed that your eBay store offers “SMGT-GLT-1 Nano Microneedle Patch” for sale in the United States. Based on our review, this product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Based on a review of your eBay store, your “SMGT-GLT-1 Nano Microneedle Patch” product is a drug as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body.

Examples from your product labeling, including on your eBay store, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:

SMGT-GLT-1 Nano Microneedle Patch
On the webpage https://www.ebay.com/itm/376775334757?_skw=smgt-glp-1+nano+microneedle+patch&itmmeta=01KCKN9J0DKBD2MW9SRESK76%E2%80%A6:

• “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.”

• “For:
  Type 2 Diabetes Treatment
  Weight Loss
  Cardiovascular Protection”

• “Global User Survey Results
  98.6% Type 2 Diabetes Treatment
  Weight Loss Aid 97.5%
  98.1% Cardiovascular Protection”

Your “SMGT-GLT-1 Nano Microneedle Patch” product is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in the labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). 

Conclusion 

The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.

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. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “722215” in the subject line of the email.

Sincerely,
/S/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

cc: 

Mike Carson
Regulatory Policy Group eBay, Inc.
2025 Hamilton Avenue
San Jose, California 95125