www.thesafepills.org - 702942 - 03/27/2025

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TO: www.thesafepills.org

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: March 27, 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.thesafepills.org 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.thesafepills.org 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.

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.thesafepills.org 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.thesafepills.org 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:

Your description of tapentadol marketed as “Aspadol 100mg (Tapentadol),” “Aspadol® Tab,” “TAPENTADOL TABLET 100 MG,” and “Generic Nucynta” includes:

“Aspadol 100mg is an opioid painkiller that helps to ease moderate to serious pain.”
“Aspadol 100mg contains an active ingredient called Tapentadol that acts directly on opioid receptors in your central nervous system. It further decreases severity by inhibiting how nerve cells transfer pain between your brain and the body.”

Your description of tapentadol marketed as “Typendol 100mg (Tapentadol),” “Typendol 100 mg,”

“TAPENTADOL TABLET BP 100 MG,” and “Generic Nucynta” includes:

“Tapentadol 100 mg is a medication that is an analgesic, which is prescribed in cases of acute pain that encompasses moderate to severe pain conditions. It works by changing the way the body responds to pain.”

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, www.thesafepills.org offers tapentadol, an opioid, marketed as “Aspadol 100mg (Tapentadol),” “Aspadol® Tab,” “TAPENTADOL TABLET 100 MG,” “Typendol 100mg (Tapentadol),” “Typendol 100 mg,” “TAPENTADOL TABLET BP 100 MG,” and “Generic Nucynta.” 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 “Aspadol 100mg (Tapentadol),” “Aspadol® Tab,” “TAPENTADOL TABLET 100 MG,” “Typendol 100mg (Tapentadol),” “Typendol 100 mg,” “TAPENTADOL TABLET BP 100 MG,” and “Generic Nucynta” offered by www.thesafepills.org. 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 hydrochloride 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 hydrochloride 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.

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.thesafepills.org 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.thesafepills.org 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.thesafepills.org 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.thesafepills.org 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/
S. Leigh Verbois, Ph.D.
Director, Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research