Steel Supplements Inc
FDA issued a warning letter to Steel Supplements Inc. of Sarasota, FL regarding six dietary supplement products (Shredded-AF, Charged-AF, Alpha-AF, 3-EPI-Andro, Focused-AF, and Amped-AF) found to be adulterated under the FD&C Act. The products were found to contain ingredients — hordenine HCl, higenamine HCl, and 5-alpha-hydroxy-laxogenin — that either do not qualify as dietary ingredients and lack GRAS status, or are new dietary ingredients for which required premarket notifications were never submitted. FDA warned that continued interstate commerce of these adulterated products is prohibited and that failure to address the violations may result in seizure or injunction.
Flagged claims (5)
hordenine as a dietary ingredient
5-alpha-hydroxy-laxogenin as a dietary ingredient
higenamine HCl as a dietary ingredient
hordenine HCl as a dietary ingredient
higenamine as a dietary ingredient
Required actions (2)
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address these matters. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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