FDA WARNING_LETTER - Nomida.biz - September 24, 2024

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Record Details

On September 12, 2024, the FDA issued a Warning Letter to www.nomida.biz for unlawfully selling unapproved and misbranded new drugs, specifically semaglutide and tirzepatide products, to U.S. consumers over the internet. The FDA's review of the website revealed violations of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The identified violations include the introduction of unapproved new drugs into interstate commerce. Nomida.biz offers semaglutide products (e.g., "SEMAGLUTIDE (10MG)", "SEMAGLUTIDE 10/4 mg/ml (GLP-1)") and tirzepatide products (e.g., "TIRZEPATIDE (10MG & 60MG)", "TIRZEPATIDE 10/1 mg/ml (GLP-1+GIP)") for weight management. These products lack FDA approval, unlike their prescription-only, FDA-approved counterparts (Ozempic, Wegovy, Rybelsus for semaglutide; Mounjaro, Zepbound for tirzepatide), which carry boxed warnings for serious risks like thyroid C-cell tumors.

Furthermore, the

Company: Nomida.biz
Inspection Date: September 24, 2024
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Leigh Verbois (Director)

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ID · b5964a71-355a-40c1-a95f-00c1e9f78a5d

Violation Codes10

21 U.S.C. 321(g)21 U.S.C. 331(d)21 U.S.C. 331(k)21 U.S.C. 353(b)21.U.S.C. 355(a)21 U.S.C. 321(p)21 U.S.C. 352(f)(1)21 CFR 201.521 CFR 201.115(a)21 U.S.C. 331(a)

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