Celmade

This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of your websites www.celmade.co and celmade.net. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that you comply with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.

As discussed below, FDA has observed that www.celmade.co and celmade.net introduce into interstate commerce unapproved and misbranded injectable botulinum toxin drug products. FDA has identified significant risks associated with unapproved botulinum toxin products, especially in the absence of appropriate medical supervision. Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body's natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis.

There are also 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.celmade.co and celmade.net cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.

Violations were identified and documented during a review of your websites www.celmade.co on August 4, 2026, and celmade.net on September 1, 2026 (FDA Establishment Identifier (FEI) 3038674250).

On your websites at internet address www.celmade.co and celmade.net, you introduce into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 331(a), 331(d), 352(f)(1), 353(b)(1), and 355(a)).

The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.

Unapproved New Drug Violations

Certain products offered for sale by www.celmade.co and celmade.net 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.

You failed to obtain approved applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355) for these products that you have introduced into interstate commerce. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act.

An example of an unapproved botulinum toxin drug product you offer for sale on www.celmade.co is botulinum toxin type A marketed as "Wonder tox 100." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 Code of Federal Regulations (CFR) 201.128) includes the claim "Wonder Tox 100 works by relaxing targeted facial muscles responsible for expression lines, making it suitable for treating areas such as the forehead, crow's feet, frown lines, and neck bands. It can also be applied to the jawline to slim the face by relaxing the masseter muscles, offering versatility for facial contouring."

An example of an unapproved botulinum toxin drug product you offer for sale on www.celmade.net is botulinum toxin type A marketed as "Wondertox 100 Unit." Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21CFR 201.128) includes the claim "Hyperhidrosis: For individuals experiencing excessive sweating, Wondertox offers relief for areas like the underarms and palms."

While there are FDA-approved versions of botulinum toxin drug products on the market in the United States, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for "Wonder tox 100” offered by www.celmade.co and “Wondertox 100 Unit” offered by celmade.net. Currently there are several botulinum toxin products FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. Examples of FDA-approved botulinum toxin products with a summary of their indications are: BOTOX (onabotulinumtoxinA), indicated for the treatment of overactive bladder, neurogenic detrusor overactivity, chronic migraine, spasticity, cervical dystonia, severe primary axillary hyperhidrosis, strabismus, and blepharospasm and prophylaxis of headaches in adults with chronic migraines; DAXXIFY (daxibotulinumtoxinA-lanm), indicated for the temporary improvement in the appearance of glabellar lines and the treatment of cervical dystonia; and MYOBLOC (rimabotulinumtoxinB), indicated for the treatment of cervical dystonia and chronic sialorrhea.

Furthermore, FDA-approved botulinum toxin drug 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 the risk of distant spread of toxin effect to produce symptoms consistent with botulinum toxin effects. In addition, swallowing and breathing difficulties can be life threatening and there have been reports of death.

Misbranded Drug Violations

A drug is misbranded under section 502(f)(1) of the FD&C Act 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 include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, 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 (21 U.S.C. 353(b)(1)(A)), can be used safely only at the direction, and under the supervision, of a licensed practitioner.

You failed to bear adequate directions for use on the labeling for these drug products that you have introduced into interstate commerce. 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 these products safely for their intended use. Consequently, the labeling for these drugs products fail to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. Because these drugs are not approved in the United States, 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.celmade.co and celmade.net are causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act.

As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.

Send your written response to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov within 15 business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your written response with reference number “MARCS-CMS 735876” in the subject line of the email.

If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.

If you are not located in the United States, 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 United States.

Please note FDA posts warning letters on www.fda.gov.