Mr. Bryce Alderson/Ms. Melisa Vong
Orphic Nutrition
2443 Fillmore Street Suite # 380-7475
San Francisco , CA 94115-1814
United StatesIssued Apr 13, 2021Office of Human and Animal Food Operations –West Division 5
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations1
Issue DateApr 13, 2021
Product TypeDrugs
StatusClosed
Closeout LetterOct 24, 2022
Letter Details
Firm
Orphic Nutrition
Location
Mr. Bryce Alderson/Ms. Melisa Vong
Orphic Nutrition
2443 Fillmore Street Suite # 380-7475
San Francisco , CA 94115-1814
United States
FEI Number
N/A
Country
United States
Issue Date
April 13, 2021
Issuing Office
Office of Human and Animal Food Operations –West Division 5
Product Type
Drugs
Status
Closed
Closeout Letter
October 24, 2022
Summary
Orphic Nutrition was cited for marketing seven dietary supplement products (Apple Cider Vinegar Capsules, Ashwagandha Capsules, Garcinia Cambogia Capsules, Premium Collagen Peptides Capsules, Elderberry Gummies, Omega 3 Fish Oil Softgels, and Turmeric Curcumin with Bioperin Capsules) as unapproved drugs through their website and Amazon storefront. The company made disease claims that violated the Federal Food, Drug, and Cosmetic Act, including representations that products could improve blood sugar control, lower cholesterol and triglycerides, reduce blood pressure, treat constipation and diarrhea, and prevent common cold and acne. These claims established the products as drugs intended for the cure, mitigation, treatment, or prevention of disease, requiring FDA approval before marketing.
Orphic Nutrition FDA Warning Letter, April 13, 2021