Nutritional Sales and Customer Service, LLC
FDA's Center for Food Safety and Applied Nutrition issued a warning letter to Nutritional Sales and Customer Service, LLC (metabolicnutrition.com) regarding their dietary supplement product Synedrex. The product was found to be adulterated because it contains three new dietary ingredients — octopamine, hordenine, and higenamine — for which no required premarket new dietary ingredient (NDI) notifications were submitted to FDA. Additionally, FDA determined that hordenine and higenamine lack adequate safety evidence and present a significant or unreasonable risk of illness or injury, making the product adulterated under the FD&C Act regardless of notification status. 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)
octopamine, hordenine, and higenamine as dietary ingredients
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.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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