Proper Nutrition Inc. – FDA Warning Letter, Apr 27, 2021

The FDA issued a Warning Letter to Proper Nutrition, Inc. on April 20, 2021, following a review of their website, propernutrition.com, in April 2021. The FDA determined that the company sells products, specifically Colostrum 70/40, Intestive, Seacure (blister pack and bottle), and SeaVive for Immune Support, with claims establishing them as unapproved new drugs.

The claims on the website, such as those found on "The Science" page under "Relief for Digestive Disorders" and "Overview," indicate the products are intended for the cure, mitigation, treatment, or prevention of diseases like Irritable Bowel Syndrome, Colitis, and Leaky Gut Syndrome. These claims cause the products to be considered 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)].

Since these products are not generally recognized as safe and effective for their claimed uses, they are deemed "new drugs" under section 201(p) of the Act [21 U.S.C. 321(p)]. Introducing or delivering these new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act [2