WARNING LETTER
www.buycodeine.us
MARCS-CMS 702527 —
May 05, 2025
Product:
Drugs
Recipient:
www.buycodeine.us
United States
Issuing Office:
Center for Drug Evaluation and Research (CDER)
United States
TO: www.buycodeine.us
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: May 5, 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.buycodeine.us 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.buycodeine.us 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.buycodeine.us introduces into interstate commerce 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 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.buycodeine.us 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:
Evidence obtained from your website establishes that certain products offered for sale by www.buycodeine.us are drugs intended for human use. Examples of claims that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs for human use include the following:
Toseina: “The active ingredient, codeine, is a narcotic that works by reducing the activity in the part of the brain that triggers coughing. This makes Toseina highly effective for individuals suffering from respiratory conditions like colds, bronchitis, and flu, where dry, unproductive coughing is a major symptom.”
Ritalina: “It is a prescription medication commonly use [sic] to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy. As a central nervous system stimulant, Ritalin works by affecting chemicals in the brain that contribute to hyperactivity and impulse control.”
These products 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.buycodeine.us, you offer codeine phosphate hemihydrate oral solution marketed as “Toseina.” While there are FDA-approved drug products containing codeine phosphate on the market in the U.S., there are no FDA-approved versions of codeine phosphate hemihydrate oral solution. Furthermore, www.buycodeine.us markets “Toseina” under the “PROMETHAZINE CODEINE” category. While there are FDA-approved versions of promethazine hydrochloride (HCl) and codeine phosphate oral solution 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 “Toseina” offered by www.buycodeine.us. FDA-approved promethazine HCl and codeine phosphate oral solution is a combination of codeine, an opioid agonist; and promethazine, a phenothiazine, indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. It is only available pursuant to a prescription from a licensed practitioner. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, promethazine HCl and codeine phosphate oral solution is reserved for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks associated with use of promethazine HCl and codeine phosphate oral solution, and in whom an adequate assessment of the etiology of the cough has been made. FDA-approved promethazine HCl and codeine phosphate oral solution bears 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), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby). In addition, when promethazine HCl and codeine phosphate oral solution is taken in conjunction with other central nervous system (CNS) depressants, including alcohol and benzodiazepines, use may result in coma or death.
As another example, on www.buycodeine.us, you offer methylphenidate hydrochloride tablets marketed as “Ritalina.” While there are FDA-approved versions of methylphenidate hydrochloride tablets 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 “Ritalina” offered by www.buycodeine.us. FDA-approved Ritalin is a CNS stimulant indicated for the treatment of attention deficit hyperactivity disorders (ADHD) and narcolepsy. It is only available pursuant to a prescription from a licensed practitioner. The use of Ritalin exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Ritalin can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including Ritalin, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration. FDA-approved Ritalin also bears a boxed warning 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, overdose, 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 uses. 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.buycodeine.us 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 the www.buycodeine.us 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.buycodeine.us 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.buycodeine.us 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/
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:
06/17/2025
Regulated Product(s)
Drugs