Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1An example of an unapproved botulinum toxin drug product you offer for sale on www.cosmenic.net is botulinum toxin type A marketed as “NABOTA® (JEUVEAU®) 100u”.
Passage 2Evidence 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 “Botulinum toxin type A (Nabota) is indicated for the prevention of headaches in adults with chronic migraine.”
Passage 3No 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.
Passage 4Because the aforementioned drug is a prescription drug 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.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.128
- 21 CFR 201.5
- 21 CFR 201.115(a)