What happened
Original notice title
HIS Enterprise Inc dba Adam’s Secret USA, LLC MARCS-CMS 646494, January 10, 2023
From the archived source record
As described below, these products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Reade Slim Sense” products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352 and sold in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a). 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. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Further, this hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events. Unapproved New Drugs Your Adam’s Secret and your “Dr. From your website www.adamssecret.com/pages/about: “Adams Secret is a holistic alternative to big pharma and is comparable to popular prescription drugs.” Under “Adams Secret 100% Natural Ingredients” o “Native to the Peruvian Andes mountain range, Maca is known to help enhance libido, increase sperm count, plus improve mood and energy.” o “Ginkgo biloba is a tree native to China. 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. Your Adam’s Secret products, which contain undeclared sildenafil and/or tadalafil, and your “Dr. Reade Slim Sense” product, which contains undeclared lorcaserin, are prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), in light of their toxicity or potential for harmful effects, methods of use, or collateral measures necessary for their use.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 14b01e55209e
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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