Gluten Free Remedies LLC
FDA issued a warning letter to Gluten Free Remedies LLC (CEO Alex Shikhman, San Diego, CA) regarding its product 'Sulbutiamine Plus Brain Support,' labeled as a dietary supplement. The agency found that sulbutiamine — declared on the label as a dietary ingredient — does not qualify as a dietary ingredient under section 201(ff)(1) of the Act, making the product misbranded under section 403(a)(1). FDA warned that failure to address the violation could result in seizure or injunction, and required a written response within 15 working days.
Flagged claims (1)
sulbutiamine as a dietary ingredient
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, 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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