Exclusive Nutrition Products, LLC
FDA issued a warning letter to Exclusive Nutrition Products, LLC (operating as Black Dragon Labs) regarding two dietary supplement products, Thermo Burn and 5-Alpha. The agency found both products adulterated under the FD&C Act because they contain higenamine HCl and 5-alpha-hydroxy-laxogenin, respectively, which do not qualify as dietary ingredients and are not GRAS, making them unsafe food additives. FDA warned that continued interstate commerce of these adulterated products is a prohibited act and that failure to address the violations may result in seizure or injunction. The company was given 15 working days to respond with corrective steps.
Flagged claims (1)
Laxogenin - short for 5-Alpha-Hydroxy-Laxogenin.
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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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