In another significant enforcement action, on November 5, 2025, FDA issued 18 warning letters to websites illegally marketing botulinum toxin products. In its press release, FDA made clear that it was taking such action due to adverse events associated with the unapproved and misbranded use of such products, including botulism symptoms. FDA stated that it had no choice but to act because, “[t]here 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.”
Factual Background:
After surveying AceCosm’s website, FDA found that the company offered for sale botulinum toxin type A marketed as “[SET] NABOTA 200U + SALINE 20ML” and “Nabota 200U Botulinum Toxin Type A.” AceCosm’s website also included the claims “Prevention of chronic migraine in adults,” “Treatment of urinary incontinence due to neurogenic detrusor overactivity, resulting from conditions such as spinal cord injury or multiple sclerosis,” and “Management of focal armpit hyperhidrosis.” FDA further stated that there are no approved drug applications in effect for “[SET] NABOTA 200U + SALINE 20ML” and “Nabota 200U Botulinum Toxin Type A” offered by www.acecosm.com.
Statutory Basis for Enforcement Action:
In the case of AceCosm, FDA stated that the firm was in violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (the “Act”). Below is a brief overview of these provisions to clarify the nature of the alleged violations.
Section 301(a) prohibits the introduction or delivery for introduction into “interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.” Section 201(b) defines “interstate commerce” as “commerce between any State or Territory and any place outside thereof, and… commerce within the District of Columbia or within any other Territory not organized with a legislative body.” In other words, once a product is transferred between states, it has entered interstate commerce and falls under FDA jurisdiction. Section 301(a) then makes it illegal to introduce an adulterated or misbranded product into interstate commerce.
FDA also cited Section 301(d), which prohibits the introduction or delivery for introduction into interstate commerce of any article in violation of Section 505. Under Section 505(a), “[n]o person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.” Put simply, marketing a drug product without FDA approval is prohibited. As noted above, there are no approved applications for the products AceCosm was selling; therefore, the firm appears to be offering unapproved drug products directly to consumers.
Under Section 503(b)(1) of the Act, drugs that, due to their toxicity or potential harmful effects, are not safe for use except under the supervision of a licensed practitioner must be dispensed only upon a prescription. Botulinum toxin, which carries a Black Box warning, is such a product and clearly can be administered only by a qualified physician. As FDA highlighted in its warning letter, AceCosm was selling a potentially dangerous prescription-only product directly to consumers, without a physician’s prescription.
Additionally, under the Act, a drug is misbranded if its labeling fails to bear adequate directions for use. According to 21 CFR 201.5, “Adequate directions for use” means directions under which a layperson can use a drug safely for its intended purposes. FDA emphasized that, as a prescription product, botulinum toxin cannot be supplied with directions that would mitigate its substantial risks.
In sum, FDA’s Warning Letter asserts that AceCosm violated the Act by selling (i.e., introducing into interstate commerce) a misbranded product that (1) lacks FDA approval, (2) is being dispensed without a prescription, and (3) cannot bear adequate directions for safe use.
Conclusion:
FDA’s 18 warning letters issued earlier this month are consistent with its recent enforcement posture. Despite hiring constraints, 2025 has seen increased enforcement by FDA against pharmaceutical manufacturers for a wide range of violations of the Act. Under FDA Commissioner Marty Makary’s leadership, pharmaceutical companies have been put on notice and should ensure they are fully compliant as FDA’s enforcement activity continues to expand.