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Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

“Prostatitis Remission Cream” is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Passage 2

“Prostatitis Remission Cream” is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the product label and/or website include statements that misleadingly suggest that the drug product is approved or endorsed by FDA in some way. For example, the website for “Prostatitis Remission Cream” includes an image of FDA officials standing with the FDA logo copied from FDA communications.***1*** Further, the product website includes the statement, “FDA certification means that the product has undergone comprehensive testing and meets the highest safety and effectiveness standards.” These assertions misleadingly suggest that “Prostatitis Remission Cream” is approved or endorsed by FDA in some way. “Prostatitis Remission Cream” is not the subject of an FDA-approved application nor is it endorsed by FDA. Therefore, this product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because its labeling is false or misleading. The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).