BergaMet North America LLC
FDA issued a warning letter to BergaMet North America LLC in November 2022 regarding its 'Cholesterol Command' dietary supplement, finding that claims on its website, Facebook page, and Walmart product listing established the product as an unapproved new drug intended to treat or mitigate diseases such as high cholesterol, type 2 diabetes, inflammation, and heart disease. The agency cited both direct marketing claims and endorsed customer testimonials as evidence of drug-intended use. The product was also deemed misbranded under section 502(f)(1) for lacking adequate directions for use. FDA demanded corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (8)
Magnesium [an ingredient in Cholesterol Command] . . . Deficiency is related to . . . T2D [type 2 diabetes], chronic inflammation, heart disease and high blood pressure.
Zinc [an ingredient in Cholesterol Command] . . . This key mineral has specific properties that may address inflammatory or immune system conditions.
Reduces cholesterol
Anti-Inflammatory Citrus Bergamot [an ingredient in your Cholesterol Command product] has been clinically shown to reduce inflammation.
BergaMet products follow the correct dosage and extract concentrations used and recommended in recent clinical studies as a bergamot supplement for high cholesterol . . . and help improve blood vessel function
BergaMet Cholesterol Command is clinically proven to improve cholesterol levels. It reduces LDL
WHEN YOU ORDER BERGAMET . . . Take our supplements with confidence knowing that if they do not improve your LDL levels. You get 100% of your money back down to the penny.
Anti-inflammatory
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. 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 these matters may result in legal action including, without limitation, seizure and injunction.
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