Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Based on our review, "Vajraang Phimosis Mini Combo," "Penile Heal Cream," and "Beilloso Balanitis Relief Cream" are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).
Passage 2Examples of claims observed on the labeling that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:
Passage 3"Beilloso Balanitis Relief Cream" does not conform to M005 or any other final administrative order, thus there is no basis under section 505G of the FD&C Act under which this product could be legally marketed without an approved application.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.128