FDA WARNING_LETTER - Supercore Products Group, Inc. - October 01, 2024

On September 26, 2024, the FDA issued a Warning Letter to Christopher Ingram regarding products sold on hardsteelusa.com, which redirects to supercoreintl.com. The FDA's review from May to September 2024, including product samples and labeling, identified "Hard Steel" and "Gold Hard Steel Plus" as unapproved new drugs and misbranded drugs.

Laboratory analysis confirmed "Hard Steel" contains undeclared sildenafil (a PDE-5 inhibitor) and acetaminophen, while "Gold Hard Steel Plus" contains undeclared sildenafil. Sildenafil is the active ingredient in Viagra, and its undeclared presence poses risks, especially for individuals taking nitrates, potentially causing dangerous blood pressure drops. Undeclared acetaminophen in "Hard Steel" risks liver damage and serious skin reactions, particularly with other acetaminophen-containing products.

These products are marketed as dietary supplements but are excluded from that definition because sildenafil was approved as a new drug (Viagra, 1998) before being marketed as a supplement or food. The products are considered drugs under FD&C Act 201(g)(1) due to their intended use for disease treatment or affecting body function, as evidenced by website and labeling claims.

As "new drugs" under FD&C Act 201(p), they require prior FDA approval, which they lack, violating sections 505(a) and 30