Complete Nutrition
FDA's Center for Food Safety and Applied Nutrition issued a warning letter to Complete Nutrition (Omaha, NE) regarding their dietary supplement product 'DR1,' which contains 5-alpha-hydroxy-laxogenin. The FDA determined that 5-alpha-hydroxy-laxogenin does not qualify as a dietary ingredient under the FD&C Act and is not GRAS, making it an unsafe food additive that renders DR1 an adulterated dietary supplement. Introducing or delivering the product into interstate commerce constitutes a prohibited act under section 301(a) of the FD&C Act. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.
Flagged claims (1)
DR1
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 any violations. 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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