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TO: www.buyprosoma.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 10, 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.buyprosoma.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)].

As discussed below, FDA has observed that www.buyprosoma.com introduces into interstate commerce unapproved and misbranded opioids. 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.buyprosoma.com introduces into interstate commerce unapproved and misbranded benzodiazepines. Benzodiazepines are drug products with an acknowledged potential for abuse, and it is important to address the public health impact of their nonmedical use. Benzodiazepine nonmedical use is widespread, and individuals frequently co-use benzodiazepines with alcohol, prescription opioids, and illicit drugs. Associated harms of benzodiazepine nonmedical use are substantial but occur primarily when people use benzodiazepines in combination with other drugs. Further, in cases where benzodiazepines were co-used with other substances, medical outcomes are typically more severe than in cases involving benzodiazepines alone. Polysubstance overdose deaths account for the vast majority of overdose deaths documenting involvement of benzodiazepines. The easy availability of benzodiazepines via the Internet poses additional significant risks to U.S. consumers.

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.buyprosoma.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.buyprosoma.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.

For example, on www.buyprosoma.com you offer for sale tapentadol, marketed as “Tapentadol 100 MG (Aspadol)” and “Aspadol® Tab.” 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 “Tapentadol 100 MG (Aspadol)” and “Aspadol® Tab” offered by www.buyprosoma.com. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Tapentadol 100 MG (Aspadol) is an improved medicine which is used to treat moderate and severe pain.” Currently, there are two tapentadol products that are FDA-approved for the U.S. market. 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.

As another example, on www.buyprosoma.com you offer for sale tramadol, marketed as “Topdol 50 MG (Tramadol)” “TOP DOL 50,” “Tramadol 50 MG (Capsules),” “Tramadol 50mg Online,” “Buy Best Tramadol 100MG (Top Dol 100MG),” “Tramadol 100 mg Tabletas,” “Tramadol 225 MG,” and “TRAMADOL-225.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “Topdol 50 MG (Tramadol) is used to relieve moderate to moderately severe pain, including pain after surgery,” “Tramadol 50 mg Online is also a painkiller and helps control secondary neurological in nature,” “Tramadol capsules work by sending the signals to the brain to change how your body feels and responds to pain,” and “Tramadol is a narcotic-like pain reliever.” While there are FDA-approved versions of tramadol 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 “Topdol 50 MG (Tramadol)” “TOP DOL 50,” “Tramadol 50 MG (Capsules),” “Tramadol 50mg Online,” “Buy Best Tramadol 100MG (Top Dol 100MG),” “Tramadol 100 mg Tabletas,” “Tramadol 225 MG,” and “TRAMADOL-225” offered by www.buyprosoma.com. FDA-approved tramadol is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

FDA-approved tapentadol and tramadol are opioid drug products only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved tapentadol and tramadol 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 and tramadol products are taken in conjunction with other central nervous system (CNS) depressants, including alcohol and benzodiazepines, use may result in coma or death.

On www.buyprosoma.com you also offer for sale alprazolam, marketed as “Buy Xanax 1MG Online,” “Xanax® (Alprazolam) 1 mg,” “Xanax 2MG,” and “XANAX (ALPRAZOLAM) TABLETS, USP 2 mg.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “Alprazolam is a generic form of Xanax that is used to treat anxiety and panic disorders” and “Xanax is often recommended for: ANXIETY DISORDERS: It poops off symptoms of anxiety and unease, including high alertness or chronic stress (more than most).” While there are FDA-approved versions of alprazolam 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 “Buy Xanax 1MG Online,” “Xanax® (Alprazolam) 1 mg,” “Xanax 2MG,” and “XANAX (ALPRAZOLAM) TABLETS, USP 2 mg” offered by www.buyprosoma.com. FDA-approved alprazolam, including the brand name XANAX, is a benzodiazepine indicated for the acute treatment of generalized anxiety disorder and panic disorder with or without agoraphobia.

Additional examples of benzodiazepines you offer for sale on www.buyprosoma.com include:

Clonazepam marketed as “Klonopin 2MG (Clonazepam)” and “Rivotril® 2 mg Tabletten Clonazepam.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “Clonazepam is used in the prevention and management of various types of seizures,” “of panic attacks and related episodes of anxiety,” and “the treatment of a specific sleep disorder called REM sleep behavior disorder.” While there are FDA-approved versions of clonazepam 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 “Klonopin 2MG (Clonazepam)” and “Rivotril® 2 mg Tabletten Clonazepam” offered by www.buyprosoma.com. FDA-approved clonazepam, including the brand name KLONOPIN, is indicated for the treatment of certain seizures and of panic disorder, with or without agoraphobia, as defined in DSM-V.

Diazepam marketed as “Valium 10MG (Diazepam)” and “Valium® 10 mg tabletten / comprimés / Tabletten.” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claims “Valium 10mg is prescribed by the doctors to the patients who are undergoing Alcohol Withdrawal symptoms,” “for seizure ailments or disorders,” and “If you are suffering from an anxiety disorder, have trouble sleeping, feel continuous sweating in your hands and feet.” While there are FDA-approved versions of diazepam 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 “Valium 10MG (Diazepam)” and “Valium® 10 mg tabletten / comprimés / Tabletten” offered by www.buyprosoma.com. FDA-approved diazepam, including the brand name VALIUM, is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety and acute alcohol withdrawal.

Lorazepam marketed as “Ativan 1MG (Lorazepam).” Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Ativan (lorazepam)As [sic] a powerful benzodiazepine, Ativan is frequently prescribed for anxiety disorders and insomnia.” While there are FDA-approved versions of lorazepam 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 “Ativan 1MG (Lorazepam)” offered by www.buyprosoma.com. FDA-approved lorazepam, including the brand name ATIVAN, is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.

FDA-approved alprazolam, clonazepam, diazepam, and lorazepam are benzodiazepine drug products only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved alprazolam, clonazepam, diazepam, and lorazepam bear a boxed warning, addressing risks including abuse, misuse, addiction, and physical dependence. In addition, the concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

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.buyprosoma.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.buyprosoma.com offers prescription drugs for sale without a prescription. In addition to the aforementioned drugs, on www.buyprosoma.com you offer for sale hydrocodone, marketed as “Hydrocodone 10/325 MG” and “Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg / 325 mg” and oxycodone marketed as “Oxycodone 30MG (Hydrochloride)” and “Oxycodone Hydrochloride Tablets, USP 30 mg.” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claims “Hydrocodone 10/325 mg helps in curing pain” and “Oxycodone 30 MG is a prescription opioid medication used to treat moderate to severe pain.” FDA-approved hydrocodone and oxycodone are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Furthermore, FDA-approved hydrocodone and oxycodone bear a boxed warning, addressing risks including addiction, abuse, misuse, life-threatening respiratory depression, neonatal opioid withdrawal syndrome, and accidental exposure resulting in death. In addition, when hydrocodone and oxycodone are taken in conjunction with other CNS depressants, including alcohol and benzodiazepines, use may result in coma or death.

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.buyprosoma.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.buyprosoma.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