Usapeptidecom: FDA Warning Letter (February 26, 2025)

Summary

Company

Usapeptidecom

Letter number

#696885

Issue date

February 26, 2025

Subject

Not listed by FDA for this letter

This letter is one of a run to online sellers of research-use peptides: FDA warning letters to peptide sellers, 2023 to 2026.

FDA’s letter of April 23, 2025 to Www24Hreupbiz also cites its recipient for selling products FDA calls unapproved new drugs.

Word for word, from the letter of February 26, 2025

This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.usapeptide.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)].

As discussed below, FDA has observed that www.usapeptide.com introduces into interstate commerce unapproved and misbranded semaglutide and tirzepatide drug products. There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that www.usapeptide.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to protect the public from harm.

Despite statements on your product labeling and website such as “research use only,” “not for human consumption,” “lab purposes only,” and “not intended to diagnose, cure, mitigate, treat or prevent disease,” evidence obtained from your website establishes that certain products offered for sale by www.usapeptide.com are drugs intended for human use.

Examples of claims from the products’ labeling, including on your website listed above, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs for human use includes the following:

“Semaglutide, also marketed under the brand names Ozempic, Rybelsus and Wegovy, is an FDA-approved injectable for weight loss…” “Semaglutide is a potent once-weekly GLP-1 RA, significantly reducing HbA1c, body weight and systolic blood pressure.”

5mg Tirzepatide (Mounjaro) 5mg and 10mg Tirzepatide (Mounjaro) 10mg: “… recently approved in the US to help type 2 diabetes patients better manage blood sugar.” “Tirzepatide is a compound that has been shown to help with weight loss…” “… stimulates the release of hormones that signal the brain to reduce food intake and increase feelings of fullness.”

These products are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.

On www.usapeptide.com, you offer semaglutide marketed as “Semaglutide (GLP-1 Analogue) 5mg” and “Semaglutide (GLP-1 Analogue) 10mg.” While there are FDA-approved versions of semaglutide on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Semaglutide (GLP-1 Analogue) 5mg” and “Semaglutide (GLP-1 Analogue) 10mg” offered by www.usapeptide.com. Currently there are three semaglutide products that are FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. FDA-approved semaglutide injection marketed under the brand name Ozempic is indicated as an adjunct to diet and exercise to improve glycemic control in individuals with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. FDA-approved semaglutide injection marketed under the brand name Wegovy is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in certain adult and pediatric patients. FDA-approved semaglutide tablets marketed under the brand name Rybelsus are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. FDA-approved semaglutide products bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of thyroid C-cell tumors.

Quoted word for word from the U.S. Food and Drug Administration. We assert nothing beyond what the agency published, and the full letter is at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/usapeptidecom-696885-02262025

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