HIS Enterprise Inc dba Adam’s Secret USA, LLC

Selected passages from the FDA letter

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

Passage 1

FDA confirmed through laboratory analysis that samples of your Adam’s Secret and “Dr. Slim Sense” products contain undeclared pharmaceutical ingredients.***1*** Specifically, samples of your “Adam’s Secret Extra Strength 3000 Platinum,” “Adam’s Secret Extra Strength Blue,” and “Adam's Secret Extra Strength Amazing Black,” products contain tadalafil, a phosphodiesterase type-5 (PDE-5) inhibitor. In addition, samples of your “Adam’s Secret Extra Strength Purple” and “Adam’s Secret Extra Strength 2000” products contain tadalafil and sildenafil.

Passage 2

However, under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i), a dietary supplement may not include an article that is approved as a new drug under section 505 of the FD&C Act unless that article was marketed as a dietary supplement or food before its approval as a drug.

Passage 3

Your Adam’s Secret and “Dr. Reade Slim Sense” products are not generally recognized as safe and effective for their above referenced uses and, therefore, they are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).

Passage 4

Your Adam’s Secret and “Dr. Reade Slim Sense” products are also misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fail to bear adequate directions for use.

Passage 5

The labeling for your Adam’s Secret and “Dr. Reade Slim Sense” products do not declare that the products contain a PDE-5 inhibitor or lorcacerin.

Passage 6

The undeclared active pharmaceutical ingredients in your products also cause these products to be misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because their labeling lacks adequate warnings for the protection of users.