Supercore Products Group, Inc.
FDA issued a warning letter to Supercore Products Group, Inc. (Atlanta, GA) regarding its 'Hard Steel' and 'Gold Hard Steel Plus' products, which were marketed as dietary supplements but found via laboratory analysis to contain undeclared pharmaceutical ingredients sildenafil and acetaminophen. The products were cited as unapproved new drugs and misbranded drugs under the FD&C Act due to erectile dysfunction treatment claims and failure to disclose active drug ingredients that pose serious health risks. The company had already issued a voluntary recall in July 2024, but FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure and/or injunction.
Flagged claims (9)
Best Possible Treatment of Erectile Dysfunction, Extra Strength
Amazing Increase in Thickness
Maximize Length, Width and Stamina
Hard Steel male enhancement is the most powerful all-natural treatment to combat erectile dysfunction.
Experience Rock Hard Erections
Best Possible Treatment of Erectile Dysfunction
NO MORE Premature Ejaculation
Better Ejaculation Control, NO limits
Hard Steel wins against erectile dysfunction
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction.
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