FDA 就网站销售未获批司美格鲁肽注射剂向 Online Generic Medicine 发出警告信（MARCS-CMS 737806）

Delivery Method:

VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED

Product:

Drugs

Recipient:

Online Generic Medicine/www.onlinegenericmedicine.com

United States

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

September 23, 2026

[email protected]

WARNING LETTER
Reference Number: MARCS-CMS 737806

To Online Generic Medicine:

This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your website www.onlinegenericmedicine.com. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that you comply with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.

As discussed below, FDA has observed that www.onlinegenericmedicine.com introduces into interstate commerce unapproved and misbranded injectable semaglutide drug products. There are inherent risks to consumers who purchase unapproved and misbranded drug products. 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. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis.

Accordingly, FDA requests that www.onlinegenericmedicine.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.

FDA Review

Violations were identified and documented during a review of your website www.onlinegenericmedicine.com, FDA Establishment Identifier (FEI) 3048678145, on August 26, 2026, and September 2, 2026.

Violations of the Federal Food, Drug, and Cosmetic Act

On your website at internet address www.onlinegenericmedicine.com, you introduce into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 331(a), 331(d), 331(k), 352(f)(1), 353(b)(1), and 355(a)).

The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.

Unapproved New Drug Violations

Certain products offered for sale by www.onlinegenericmedicine.com 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.

You failed to obtain approved applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355) for these products that you have introduced into interstate commerce. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act.

An example of an unapproved semaglutide drug product you offer for sale on www.onlinegenericmedicine.com is semaglutide marketed as "Semanat Injection (Semaglutide)." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 Code of Federal Regulations (CFR) 201.128) includes the claim "Semanat Injection, [sic] is a potent glucagon-like peptide-1 (GLP-1) receptor agonist wich [sic] is designed to help manage blood sugar levels in type 2 diabetes and support weight management."

While there are FDA-approved versions of semaglutide drug products on the market in the United States, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for "Semanat Injection (Semaglutide)” offered by www.onlinegenericmedicine.com. Currently there are several semaglutide products 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 adults with type 2 diabetes mellitus; to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes mellitus and established CV disease; and to reduce the risk of sustained eGFR decline, end-stage kidney disease, and CV death in adults with type 2 diabetes mellitus and chronic kidney 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 to reduce the risk of major adverse CV events in adults with established CV disease and either obesity or overweight, to reduce excess body weight and maintain weight reduction long term in certain adult and pediatric patients, and for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis in adults.

Furthermore, 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.

Misbranded Drug Violations

A drug is misbranded under section 502(f)(1) of the FD&C Act if its labeling fails to bear adequate directions for use. "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (see 21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act 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. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. 353(b)(1)(A)), can be used safely only at the direction, and under the supervision, of a licensed practitioner.

You failed to bear adequate directions for use on the labeling for this drug product that you have introduced into interstate commerce. Because the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the product safely for their intended use. Consequently, the labeling for this drug product fails to bear adequate directions for use, causing it to be misbranded under section 502(f)(1) of the FD&C Act. Because this drug is not approved in the United States, it is also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering this drug for sale to U.S. consumers, www.onlinegenericmedicine.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act.

Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a health care practitioner licensed by law to administer prescription drugs. By offering the aforementioned drug product without requiring a prescription, www.onlinegenericmedicine.com jeopardizes patient safety and misbrands the drug product under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act.

Conclusion

As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.

Send your written response to [email protected] within 15 business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your written response with reference number “MARCS-CMS 737806” in the subject line of the email.

If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.

If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.

Please note FDA posts warning letters on www.fda.gov.

Sincerely,
/S/
Sangeeta Vaswani Chatterjee, PharmD
Director
Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration