FDA WARNING_LETTER - his enterprise inc - January 17, 2023

The FDA issued a Warning Letter to the recipient regarding their "Adam's Secret" and "Dr. Reade Slim Sense" products, sold via www.adamssecret.com and social media. FDA laboratory analysis confirmed that "Adam’s Secret Extra Strength 3000 Platinum," "Adam’s Secret Extra Strength Blue," and "Adam's Secret Extra Strength Amazing Black" contain tadalafil. "Adam’s Secret Extra Strength Purple" and "Adam’s Secret Extra Strength 2000" contain tadalafil and sildenafil. "Dr. Reade Slim Sense" contains lorcaserin.

These undeclared pharmaceutical ingredients classify the products as unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, as they are not generally recognized as safe and effective for their intended uses. Tadalafil and sildenafil are active ingredients in FDA-approved ED drugs (Cialis, Viagra), and lorcaserin was the active ingredient in the withdrawn weight management drug Belviq. These ingredients were not marketed as dietary supplements before their drug approval or investigation, thus excluding the products from the dietary supplement definition.

Furthermore, the products are misbranded drugs under section 502 of the FD&C Act and sold in violation of section 301(a). They lack adequate directions for use (502(f)(1)) because they are prescription