Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your Amazon associate products are offered to mitigate, prevent, treat, diagnose, or cure mpox, which is a condition that is not amenable to self-diagnosis and treatment without the supervision of a licensed practitioner.
Passage 2your Amazon associate products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the FD&C Act.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.5