WARNING LETTER
onlineotcmeds.com
MARCS-CMS 717697 —
October 15, 2025
Product:
Drugs
Recipient:
onlineotcmeds.com
United States
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
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: October 15, 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 onlineotcmeds.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 onlineotcmeds.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 onlineotcmeds.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.
Additionally, FDA has observed that onlineotcmeds.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 onlineotcmeds.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 onlineotcmeds.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.
An example of an unapproved opioid you offer for sale on onlineotcmeds.com is fentanyl marketed as “Buy Fentanyl Patches Online” and “NDC 0591-3213-54 Fentanyl Transdermal System.” 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 “Fentanyl is a prescription opioid drug.” While there are FDA-approved versions of fentanyl on the market in the U.S., including for the transdermal route of administration, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Buy Fentanyl Patches Online” and “NDC 0591-3213-54 Fentanyl Transdermal System” offered by onlineotcmeds.com. FDA-approved fentanyl transdermal system is indicated for the management of severe and persistent pain in opioid-tolerant patients that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.
Another example of an unapproved opioid you offer for sale on onlineotcmeds.com is hydromorphone HCl marketed as “Buy Dilaudid online” and “Dilaudid® (Hydromorphone Hydrochloride).” 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 “Hydromorphone belongs to a class of drugs known as opioid (narcotic) analgesics” and “Dilaudid is used to treat moderate to severe pain.” While there are FDA-approved versions of hydromorphone HCl 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 Dilaudid online” and “Dilaudid® (Hydromorphone Hydrochloride)” offered by onlineotcmeds.com. FDA-approved hydromorphone HCl (brand name DILAUDID) is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
An additional example of an unapproved opioid you offer for sale on onlineotcmeds.com is oxymorphone HCl marketed as “Buy Opana online” and “OPANA® ER (Oxymorphone Hydrochloride).” 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 “Opana is used to help relieve moderate to severe pain. It belongs to a class of drugs known as opioid (narcotic) analgesics. It works in the brain to change how your body feels and responds to pain.” While there are FDA-approved versions of oxymorphone HCl 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 Opana online” and “OPANA® ER (Oxymorphone Hydrochloride)” offered by onlineotcmeds.com. FDA-approved oxymorphone HCl (brand name OPANA discontinued) is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. FDA-approved oxymorphone HCl extended release (brand name OPANA ER discontinued) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
FDA-approved fentanyl, hydromorphone HCl (brand name DILAUDID), and oxymorphone HCl are only available pursuant to a prescription from a licensed practitioner. Furthermore, these drug products each 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. This boxed warning addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby), and accidental exposure resulting in death. In addition, when these drug 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 onlineotcmeds.com is brotizolam marketed as “Buy Brotizolam Online,” “BROTIZOLAM,” and “Brotizolam.” 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 “Brotizolam is a triazole-benzodiazepine derivative with sedative, hypnotic, anxiolytic and anticonvulsant activities. Brotizolam binds to the benzodiazepine binding site on the gamma-aminobutyric acid (GABA)-A receptor in the central nervous system (CNS).” There are no FDA-approved versions of brotizolam on the market in the U.S., and there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for brotizolam offered by onlineotcmeds.com.
Another example of an unapproved benzodiazepine you offer for sale on onlineotcmeds.com is diazepam marketed as “Buy Diazepam online,” “Valium (Diazepam),” and “Valium® 10 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 “Diazepam is a benzodiazepine. It affects chemicals in the brain that may be unbalanced in people with anxiety. Diazepam is used to treat anxiety disorders, alcohol withdrawal symptoms, or muscle spasms.” 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 “Buy Diazepam online,” “Valium (Diazepam),” and “Valium® 10 mg” offered by onlineotcmeds.com. FDA-approved diazepam (brand name VALIUM) is indicated for the management of anxiety disorders, acute alcohol withdrawal symptoms, relief of skeletal muscle spasm and spasticity, and as adjunctive therapy in convulsive disorders.
An additional example of an unapproved benzodiazepine you offer for sale on onlineotcmeds.com is lorazepam marketed as “Buy Lorazepam Online,” “Ativan®,” “Ativan® (Lorazepam), Lorcam-1.” 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 “Lorazepam belongs to a class of drugs known as Benzodiazepines which is used to treat anxiety disorders in children and adults. This medicine produces a calming effect on the brain and nerves and enhances the effects of a certain natural chemical in the body.” 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 “Buy Lorazepam Online,” “Ativan®,” “Ativan® (Lorazepam), Lorcam-1” offered by onlineotcmeds.com. FDA-approved lorazepam (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 diazepam (brand name VALIUM) and lorazepam (brand name ATIVAN) are only available pursuant to a prescription from a licensed practitioner. Furthermore, these drug products each 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 onlineotcmeds.com is amphetamine (MAS) marketed as “Buy Adderall online” and “54092-391-01 ADDERALL No-Rx”. 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 “Adderall is the brand name of prescription medicine for treating Attention Deficit Hyper Activity Disorder (ADHD) in children and adults” and “To treat narcolepsy doctors also prescribe Adderall (but not Adderall XR).” While there are FDA-approved versions of amphetamine (MAS) 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 Adderall online” and “54092-391-01 ADDERALL No-Rx” offered by onlineotcmeds.com. FDA-approved amphetamine (MAS) (brand name ADDERALL) is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy. Using the brand name of the drug product ADDERALL indicates that this product is intended to treat ADHD and narcolepsy. FDA-approved amphetamine (MAS extended release) (brand name ADDERALL XR) is indicated for the treatment of ADHD in adults and pediatric patients 6 years and older.
Another example of an unapproved Schedule II stimulant you offer for sale on onlineotcmeds.com is methylphenidate HCl marketed as “Buy Ritalin Online,” “Ritalin (methylphenidate HCl) extended-release capsules,” and “Ritalin® 10 mg tablety.” 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 “It works by changing the amounts of certain natural substances in the brain” and “Ritalin can help increase your ability to pay attention, stay focused on an activity, and control behavior problems.” While there are FDA-approved versions of methylphenidate HCl 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 Ritalin Online,” “Ritalin (methylphenidate HCl) extended-release capsules,” and “Ritalin® 10 mg tablety” offered by onlineotcmeds.com. FDA-approved methylphenidate HCl tablet (brand name RITALIN) is indicated for the treatment of ADHD in pediatric patients 6 years and older and adults, and narcolepsy. Using the brand name of the drug product RITALIN indicates that this product is intended to treat ADHD and narcolepsy. FDA-approved methylphenidate HCl extended-release capsule (brand name RITALIN LA) is indicated for the treatment of ADHD, in pediatric patients 6 to 12 years of age. FDA-approved methylphenidate HCl extended-release tablet (brand name CONCERTA) is indicated for the treatment of ADHD in children 6 years of age and older, adolescents, and adults up to the age of 65.
FDA-approved amphetamine (MAS) (brand names ADDERALL and ADDERALL XR) and methylphenidate HCl (brand names RITALIN, RITALIN LA, and CONCERTA) are only available pursuant to a prescription from a licensed practitioner. Furthermore, these drug products each bear a boxed warning addressing risks including abuse, misuse, and addiction. In addition, these drug products can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including these drug products, 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, onlineotcmeds.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)].
FDA has also observed that onlineotcmeds.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, onlineotcmeds.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 onlineotcmeds.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:
11/04/2025
Regulated Product(s)
Drugs