Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this product. Accordingly, this product is an unapproved new drug.
Passage 2The labeling for "La Crema De Rebeca" does not declare that it contains mercury.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.128