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  5. Nomida.biz - 687590 - 09/12/2024
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WARNING LETTER

Nomida.biz MARCS-CMS 687590 —

Product:
Drugs
Recipient:
Nomida.biz

United States

Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

TO: www.nomida.biz

FROM: The United States Food and Drug Administration

RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

DATE: September 12, 2024

WARNING LETTER

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.nomida.biz 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.nomida.biz 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.nomida.biz cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to protect the public from harm.

Unapproved New Drugs:

Certain products offered for sale by www.nomida.biz 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.nomida.biz you state that “Nomida is at the Forefront of Weight Loss Innovation,” you “specialize in Semaglutide and Tirzepatide, offering powerful solutions for weight management,” you help “Find easy, effective methods to manage your weight,” and your “products are the next big thing in Weight Loss. They’re Safe, Effective, and Designed for Results.” On www.nomida.biz in the “Weight Loss” section of your website, you offer semaglutide marketed as “SEMAGLUTIDE (10MG),” “SEMAGLUTIDE 10/4 mg/ml (GLP-1),” “SEMAGLUTIDE (5MG),” and “SEMAGLUTIDE 5/2 mg/ml (GLP-1).” You also offer a “SEMAGULTIDE KIT” which includes the aforementioned semaglutide products. 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 (10MG),” “SEMAGLUTIDE 10/4 mg/ml (GLP-1),” “SEMAGLUTIDE (5MG),” and “SEMAGLUTIDE 5/2 mg/ml (GLP-1)” offered by www.nomida.biz. 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.

In addition, on www.nomida.biz you offer tirzepatide marketed as “TIRZEPATIDE (10MG & 60MG)” and “TIRZEPATIDE 10/1 mg/ml (GLP-1+GIP).” You also offer a “TIRZEPATIDE KIT” which includes the aforementioned tirzepatide products. While there are FDA-approved tirzepatide products 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 “TIRZEPATIDE (10MG & 60MG)” and “TIRZEPATIDE 10/1 mg/ml (GLP-1+GIP)” offered by www.nomida.biz. Currently there are two tirzepatide 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 tirzepatide injection marketed under the brand name Mounjaro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. FDA-approved tirzepatide injection marketed under the brand name Zepbound is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in certain adult patients. FDA-approved tirzepatide also bears a boxed warning addressing the risk of thyroid C-Cell tumors.

Misbranded Drugs:

A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] 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 [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. Prescription drugs, as defined in section 503(b)(1) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner.

Because the aforementioned drugs are prescription drugs 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 products safely for their intended use. Consequently, the labeling for these drugs fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because the drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering these drugs for sale to U.S. consumers, www.nomida.biz is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

Additionally, “SEMAGLUTIDE (10MG),” “SEMAGLUTIDE 10/4 mg/ml (GLP-1),” “SEMAGLUTIDE (5MG),” “SEMAGLUTIDE 5/2 mg/ml (GLP-1),” “TIRZEPATIDE (10MG & 60MG),” and “TIRZEPATIDE 10/1 mg/ml (GLP-1+GIP)” offered by www.nomida.biz are intended for injection, which heightens the public health concern associated with these products and may further contribute to the potential for patient harm. You state that “Semaglutide 5mg ships in a Lyophilized Powder form (>99% purity) in 2ml vial” and “To Reconstitute, you need a solvent such as BAC Water (Sold Here)”. On www.nomida.biz you offer a “SEMAGLUTIDE KIT” and a “TIRZEPATIDE KIT,” which includes semaglutide or tirzepatide products, “Bacteriostatic Water,” “Pack of 10 insulin Syringes,” “One 3ml draw syringe and Vial,” “Dosing Chart/Instructions,” and “Alcohol Wipes.” 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.

Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drugs without requiring a prescription, www.nomida.biz jeopardizes patient safety and misbrands the drugs 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 [21 U.S.C. § 331(k)].

FDA is sending this warning letter to www.nomida.biz because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drugs noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded products in violation of the FD&C Act.

Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. 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 within 15 working days.

If you are not located in the U.S., 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 U.S.

Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.

Sincerely,
/S/
S. Leigh Verbois, Ph.D.
Director, Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research

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