WARNING LETTER
www.soma4ever.com
MARCS-CMS 706082 —
June 13, 2025
Product:
Drugs
Recipient:
www.soma4ever.com
Singapore
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
TO: www.soma4ever.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 13, 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.soma4ever.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.soma4ever.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.soma4ever.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 are 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.
Finally, FDA has observed that www.soma4ever.com introduces into interstate commerce unapproved and misbranded Schedule II stimulants. Schedule II stimulants have an acknowledged high potential for abuse, and it is important to address the public health impact of their diversion and nonmedical use. Diversion is the primary source of prescription stimulants for nonmedical use, and nonmedical use is most frequent among young adults and college students. Polysubstance use is common among those who use prescription stimulants nonmedically, with individuals frequently co-using illicit drugs and/or prescription opioids. These concerns come against a backdrop of rising mortality from psychostimulant-involved overdoses, which involve illicit stimulants the vast majority of the time, but sometimes involve prescription stimulants. The easy availability of benzodiazepines and Schedule II stimulants 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.soma4ever.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.soma4ever.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.
Evidence obtained from your website www.soma4ever.com establishing that the products you offer for sale are drugs intended for human use (as defined in 21 CFR 201.128) includes the claims “The medicines sold on our website are 100% genuine and safe to use. We only sell FDA-approved medications that will make you feel better. Our website sells anxiety medications, including Xanax, Ativan, Valium, and Klonopin; insomnia medications, including Ambien; and ADHD medications, including Adderall and Rivotril,” and “We also deal in different kinds of pain medications, both opioids, and non-opioids.”
One example of an unapproved opioid you offer for sale on www.soma4ever.com is tapentadol, marketed as “Tapentadol 100mg” 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 100mg” and “Aspadol® Tab” offered by www.soma4ever.com. 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.
Additional examples of unapproved opioids you offer for sale on www.soma4ever.com are oxycodone, marketed as “Percocet 10mg/325mg,” and tramadol, marketed as “Tramadol 50mg” “Tramadol 50 mg Tabletas,” “Tramadol 100mg,” “Trakem-100,” “Tramadol 100mg (Citra),” “Citra Tabletas,” “Oltram 100mg,” “OL-TRAM® TABLETS 100mg,” “Tramadol 225mg Royal,” and “Royal - 225.” While there are FDA-approved versions of oxycodone and 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 “Buy Percocet 10mg online,” “Tramadol 50mg” “Tramadol 50 mg Tabletas,” “Tramadol 100mg,” “Trakem-100,” “Tramadol 100mg (Citra),” “Citra Tabletas,” “Oltram 100mg,” “OL-TRAM® TABLETS 100mg,” “Tramadol 225mg Royal,” and “Royal - 225” offered by www.soma4ever.com. FDA-approved oxycodone, including the brand name PERCOCET, and tramadol are each indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
FDA-approved tapentadol, oxycodone, PERCOCET, and tramadol are opioid drug products only available pursuant to a prescription from a licensed practitioner. Furthermore, FDA-approved tapentadol, oxycodone, PERCOCET, 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, oxycodone, PERCOCET, 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.
An example of an unapproved benzodiazepine you offer for sale on www.soma4ever.com is alprazolam, marketed as “Xanax 1mg,” “Xanax 2mg,” “Ksalol 1mg,” and “Ksalol® 1mg 30 tableta oralna upotreba.” 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 “Xanax 1mg,” “Xanax 2mg,” “Ksalol 1mg,” and “Ksalol® 1mg 30 tableta oralna upotreba” offered by www.soma4ever.com. FDA-approved alprazolam, including the brand name XANAX, is indicated for the acute treatment of generalized anxiety disorder and panic disorder with or without agoraphobia.
Additional examples of unapproved benzodiazepines you offer for sale on www.soma4ever.com include:
Clonazepam marketed as “Klonopin 2mg,” “NOZIM-2,” “Rivotril 2mg” and “Rivotril® Clonazepam 2 mg 60 comprimidos birranurados.” 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,” “NOZIM-2,” “Rivotril 2mg” and “Rivotril® Clonazepam 2 mg 60 comprimidos birranurados” offered by www.soma4ever.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 5mg,” “Valium 10mg,” and “ELIPAM-10.” 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 5mg,” “Valium 10mg,” and “ELIPAM-10” offered by www.soma4ever.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,” “Ativan 2mg,” and “LOR-2.” 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,” “Ativan 2mg,” and “LOR-2” offered by www.soma4ever.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.
An example of an unapproved Schedule II stimulant you offer for sale on www.soma4ever.com is amphetamine, marketed as “Adderall 30mg.” While there are FDA-approved versions of amphetamine 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 “Adderall 30mg” offered by www.soma4ever.com. ADDERALL is the brand name for FDA-approved drug indicated for the treatment of attention deficit hyperactivity disorder and narcolepsy. It is only available pursuant to a prescription from a licensed practitioner. Using the brand name of the drug product ADDERALL indicates that this product is intended to treat attention deficit hyperactivity disorder and narcolepsy. Furthermore, FDA-approved ADDERALL bears a boxed warning, addressing risks including abuse, misuse, and addiction. In addition, ADDERALL can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including ADDERALL, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration.
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.soma4ever.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.soma4ever.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.soma4ever.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.soma4ever.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 V. 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:
06/24/2025
Regulated Product(s)
Drugs