WARNING LETTER
www.buynetmeds.com
MARCS-CMS 706335 —
June 12, 2025
Product:
Drugs
Recipient:
www.buynetmeds.com
India
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
TO: www.buynetmeds.com
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: June 12, 2025
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.buynetmeds.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)].
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.
FDA has observed that www.buynetmeds.com introduces into interstate commerce unapproved and misbranded opioid drug products. Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers. FDA has also observed that www.buynetmeds.com introduces into interstate commerce unapproved and misbranded semaglutide drug products, including injectable versions. 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.buynetmeds.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.
Unapproved New Drugs:
Certain products offered for sale by www.buynetmeds.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 [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.buynetmeds.com you offer for sale tapentadol, an opioid, marketed as:
Asmanol 100mg
Asmanol 100
Aspadol 50mg | TapentadoI
Aspadol® 50
Aspadol 75mg
Aspadol® 75
Aspadol 100mg
Aspadol® Tab
Etadol 100mg
ETADOL 100
Noosanta 100mg
Noosanta 100
Rin Tapenta 50mg
Rin-Tapenta™-50
Tapaday 50MG | Tapentadol
TAPADAY 50
Tapaday 100mg | Tapentadol
TAPADAY 100
Tapaday O 100mg
Tapaday-O-100
Tapal 100mg Tablets | Tapentadol
Tapal 100
Tapal-ER 100mg
Tapedac 100mg
Tapenax ER 50 Tablet
Tapfree ER™ 100
TAPFREE ER 100MG
Tapidol 50mg | Tapentadol
Tapidol-50mg
TAPIDOL 100MG
Tapidol-100
Tapsmart 100 mg
Tapsmart-100
Topcynta 50mg
TOPCYNTA 50
Topcynta 100MG
TOPCYNTA 100
Tprexadol 100mg | Tapentadol
Tprexadol™-100
Tydol 50mg | Tapentadol
Tydol™ 50
Tydol 100mg
Tydol™ 100
Typendol 100mg
Yenta 100mg
Yenta-100
Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes claims from each product’s description. Examples are listed below:
“Asmanol 100mg (Tapentadol) is an opioid analgesic class medicine that is used to treat moderate to severe acute postoperative pain.”
“Aspadol 50mg (Tapentadol) pill helps to relieve moderate to severe pain such as toothache, headache, or in conditions that affect joints and muscles.”
“Etadol 100mg is a brand name for Tapentadol, a centrally acting analgesic that relieves pain in the brain and spinal cord.”
“Noosanta 100 mg Tablet is an adult pain reliever intended to treat moderate to severe acute pain.”
“Rin Tapenta 50mg Tablet is used to treat moderate to severe acute pain.”
“Tapaday 100 mg tablet is a powerful medication that can provide relief for short-term acute pain…”
“Tapal-ER 100mg is a prescription medication used to treat moderate to severe pain in adults.”
“Tapedac 100mg Tablets are an adult-only prescription medicine used to treat moderate to severe acute pain.”
“Tapenax ER 50 Tablet’s key advantage is that it gives good pain relief for moderate to severe pain.”
“The prescription medication Tapfree ER 100mg is used to treat moderate to severe acute pain in adults.”
“Adults who are experiencing moderate to severe acute pain may be prescribed a drug called Tapidol 100mg.”
“Tapsmart 100 mg is treat [sic] for the management of moderate to severe pain in adults.”
“Tapentadol hydrochloride is the active component of the pharmaceutical drug Topcynta 50mg.”
“Tprexadol 100mg is prescribed to adults to relieve moderate to severe acute pain.”
“Tydol 50mg is prescribed to adults to treat moderate to severe acute pain.”
“Adults use Typendol 100mg to relieve moderate to severe acute pain.”
“An adult painkiller called Yenta 100 mg Tablet is intended to treat moderate to severe acute pain.”
While there are FDA-approved versions of tapentadol 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 drug products, listed above, offered by www.buynetmeds.com. Currently, there are two tapentadol 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 tapentadol marketed under the brand name NUCYNTA is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. FDA-approved tapentadol marketed under the brand name NUCYNTA ER is indicated for the management of severe and persistent pain, including neuropathic pain associated with diabetic peripheral neuropathy, that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. FDA-approved tapentadol 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 risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby). In addition, when tapentadol is taken in conjunction with other central nervous system depressants, including alcohol and benzodiazepines, use may result in coma or death.
On www.buynetmeds.com you offer for sale semaglutide, including injectable versions, marketed as:
Rybelsus 3mg Tablet
Semaglutide Tablets Rybelsus® 3mg 1 blister card of 10 tablets
Rybelsus 7mg
Rybelsus® 7mg Semaglutida Tabletas
Rybelsus 14mg
Semaglutide Tablets Rybelsus® 14mg 1 blister card of 10 tablets
Semaglutide 0.25 mg Injection
Fitaro™ 0.25
Semaglutide 0.5 mg Injection
Fitaro™ 0.5
Semaglutide 1 mg Injection
Fitaro™ 1
Semaglutide 1.7 mg Injection
Fitaro™ 1.7
Semaglutide 2.4 mg Injection
Fitaro™ 2.4
Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes but is not limited to the following claims:
“Rybelsus 3mg (semaglutide) is a type 2 diabetes medicine that acts as a glucagon-like peptide-1 (GLP-1) receptor agonist.”
“Rybelsus 7mg (Semaglutide) Tablet is a type 2 diabetic medicine authorized by the FDA.”
“Rybelsus 14mg (Semaglutide) Pills is a type 2 diabetic medicine authorized by the FDA.”
“Semaglutide 0.5 mg injection is widely administered to people with type 2 diabetes who cannot maintain optimal glycemic control by diet and exercise alone or in combination with other antidiabetic drugs. It lowers blood sugar levels by boosting insulin secretion while lowering glucagon release.”
“In addition to its function in diabetes management, semaglutide has been researched for its ability to promote weight reduction.”
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 drug products, listed above, offered by www.buynetmeds.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 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 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 products also bear a boxed warning, which again, 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 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, and/or the method of their use, and/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, 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 fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because these 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.buynetmeds.com 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, FDA has observed that www.buynetmeds.com offers prescription drugs for sale without a prescription. 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.buynetmeds.com 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.buynetmeds.com 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 and unapproved drug 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/
Sangeeta Vaswani Chatterjee, Pharm.D.
Acting Director, Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
07/01/2025
Regulated Product(s)
Drugs