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  5. Synthetix Inc. DBA Helix Chemical Supply - 668918 - 02/07/2024
  1. Warning Letters

WARNING LETTER

Synthetix Inc. DBA Helix Chemical Supply MARCS-CMS 668918 —

Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Matthew Lucks
Synthetix Inc. DBA Helix Chemical Supply

558 Grand Concourse Suite 279
Bronx, NY 10451
United States

info@helixchem.co
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

Secondary Issuing Offices

United States

WARNING LETTER

February 7, 2024

RE: 668918

Dear Matthew Lucks:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.helixchem.com in October 2023 and has observed that your website offers “Semaglutide” and “Tirzepatide” products for sale in the United States. As described below, your “Semaglutide” and “Tirzepatide” 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 301(d). Furthermore, your “Semaglutide” and “Tirzepatide” products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352, introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Despite statements on your product labeling marketing your products for “research use only” and “not for human consumption,” 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 from the products’ labeling, including as 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:

From your website www.helixchem.com:

Semaglutide

“Dose Amounts
Each vial contains:
Weeks 1-4 – 8 doses (reconstituted vial expires after 8 weeks.)
Weeks 5-8 – 8 doses (reconstituted vial expires after 8 weeks.) . . .
Semaglutide is a derivative of the naturally occurring GLP-1, a peptide known to lower blood sugar levels and enhance insulin secretion. Research shows that Semaglutide may also improve heart, liver, and lung function while helping to slow or prevent the effects of Alzheimer’s disease.”

Tirzepatide
“Dose Amounts
Each vial contains:
Weeks 1-4 – 4 doses
Weeks 5-8 – 2 doses. . .
Tirzepatide is a synthetic derivative of gastric inhibitory polypeptide (GIP) that has simultaneous glucagon-like peptide-1 (GLP-1) functionality.”

From the “Standard Dose Protocol for Tirzepatide Research” document accompanying Tirzepatide:

“If additional glycemic control is needed. . . This is the standard schedule for the medication, Mounjaro.”

Unapproved New Drugs

Your “Semaglutide” and “Tirzepatide” 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).

Misbranded Drugs

Your “Semaglutide” and “Tirzepatide” products are also misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for their intended use(s). “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended, 21 C.F.R. 201.5. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1), include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Your “Semaglutide” product is indicated for a condition that is not amenable to self-diagnosis and treatment by a layperson, therefore adequate directions cannot be written such that a layperson can use the product safely for its intended use. In addition, your “Semaglutide” and “Tirzepatide” products are also prescription drugs as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), in light of their toxicity or potential for harmful effects, methods of use, or collateral measures necessary for their use. For these reasons, your “Semaglutide” and “Tirzepatide” products are misbranded under section 502(f)(1) of the FD&C Act.

The introduction, delivery for introduction, or causing the introduction or delivery for introduction into interstate commerce of these misbranded drugs is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(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 15 working days of receipt of this letter, of the specific steps you have taken to address 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 cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. 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.

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/

CAPT Tina Smith
Director
Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

 
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