Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Based on the above labeling evidence “Silver Bullet elite douche” and “Silver D elite douche” are over-the-counter (OTC) colloidal silver-containing drug products intended for use in the treatment of vaginal infections.
Passage 2No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products. Thus, “Silver Bullet elite douche” and “Silver D elite douche” are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a).
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.128
- 21 CFR 310.548(b)