Orphic Nutrition – FDA Warning Letter, Mar 31, 2021

The FDA issued a Warning Letter to Orphic Nutrition (Mr. Alderson and Ms. Vong) after reviewing their website (www.orphicnutrition.com) and Amazon storefront in March 2021. The FDA determined that Orphic Nutrition's products, including 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, are marketed with claims that establish them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)].

The violations stem from numerous therapeutic claims made on their websites and Amazon listings, suggesting the products are intended for the cure, mitigation, treatment, or prevention of diseases. Examples of such claims include "Improve Blood Sugar Control," "Removes unwanted bacteria and other harmful toxins," "Reduces Inflammation," "Helps reduce the symptoms of depression," "A Folk Remedy For Cancer," "Joint Diseases," "Reduce the severity of viral infections," and "Helps prevent heart disease, arthritis."

Because these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under section 201(p) of the Act [21 U.