WARNING LETTER
Swisschems
MARCS-CMS 695663 —
December 10, 2024
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Swisschems
42 Broadway FL 12th
New York
,
NY
10004
United States
support@swisschems.is
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
Secondary Issuing Offices
United States
WARNING LETTER
December 10, 2024
Dear Swisschems:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://swisschems.is/ in October 2024 and has observed that your website offers “Semaglutide” and “Retatrutide” products for sale in the United States. We have also reviewed your Facebook social media website at https://www.facebook.com/swisschems.is/ and your Instagram social media website at https://www.instagram.com/swisschemsupgraded where you direct consumers to your websites at https://swisschems.is/ to purchase your products. As described below, your “Semaglutide” and “Retatrutide” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).
Despite statements on your product labeling marketing your products as “research chemicals only,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because they are intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body. Examples of claims observed on your website that establish the intended use of your products as drugs intended for human use include, but may not be limited to, the following:
Semaglutide
On the product webpage for “Semaglutide,” https://swisschems.is/product/semaglutide-3mg-1-vial/:
• “Peer-Reviewed Studies . . . Once-weekly semaglutide in adults with overweight or obesity. . .. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes.”
On a September 18, 2024, post from your Facebook social media website, https://www.facebook.com/swisschems.is/ and your Instagram social media website, https://www.instagram.com/swisschemsupgraded:
• “Ready to elevate your research? Semaglutide, a key player in metabolic and weight regulation is now available! Don’t miss this chance to explore its role in glucose regulation, energy balance, and more. . .. Special Offer: Buy 3 or more and get 10% OFF your order! Stock up now for your next breakthrough. #Semaglutide #MetabolicStudies . . . #GlucoseRegulation”
Retatrutide
On the product webpage “Retatrutide,” https://swisschems.is/product/retatrutide-5mg/:
• “Retatrutide (LY-3437943) is a promising anti-obesity agent. It is designed to be a triple hormone receptor agonist, meaning it activates three important receptors in the body: GLP-1 (glucagon-like peptide-1), GIP (glucose-dependent insulinotropic polypeptide), and GCGR (glucagon receptor). These receptors play crucial roles in regulating glucose levels and metabolic functions in the body.”
• “Peer-Reviewed Studies . . . Triple-Hormone-Receptor Agonist Retatrutide for Obesity – A Phase 2 Trial . . . Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA”
Your “Semaglutide” and “Retatrutide” products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Conclusion
This letter is 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 result in 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 these 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.
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
Content current as of:
12/17/2024
Regulated Product(s)
Drugs