Max Muscle
FDA issued a warning letter to Max Muscle (Sioux Falls, SD) regarding two dietary supplement products, Lipo Red and StimoVEX XT, finding both adulterated under the FD&C Act. StimoVEX XT was found to contain hordenine HCl, which is not a dietary ingredient and is an unapproved food additive, rendering the product adulterated under section 402(a)(2)(C)(i). Lipo Red was found to contain octopamine, a new dietary ingredient for which no required premarket notification was submitted to FDA, making it adulterated under sections 402(f) and 413(a). FDA warned that failure to address these violations could result in seizure and injunction.
Flagged claims (2)
The label of your Lipo Red product declares octopamine as a dietary ingredient.
The label of your product StimoVEX XT declares hordenine HCl 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 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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