Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your “Elily Veronvy” and “Elily Veronvy 40+” products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Passage 2Your “Elily Veronvy” and “Elily Veronvy 40+” products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the product labels and/or websites include statements that misleadingly suggest that the drug products are approved or endorsed by FDA in some way. For example: the webpage for “Elily Veronvy” and “Elily Veronvy 40+” includes the image of a blue circle with the claim, “FDA APPROVED” along with the statement, “Veronvy Metabolic Boost Drops . . . was approved by the Food and Drug Administration last year.” As previously noted, there are no FDA-approved applications in effect for your “Elily Veronvy” and “Elily Veronvy 40+” products. Therefore, these products are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because their labeling is false or misleading.