FDA WARNING_LETTER - North American Hirudin Biotech Products Inc. - April 21, 2021

The FDA issued a Warning Letter to Mr. An of 2531 Broadway, Suite A, Everett, WA 98201, United States, on April 21, 2021 (CMS 613103). The letter states that FDA reviewed the websites http://ushirudin.com/, http://www.naturalhirudin.com/, and http://buyred65.com/ in February and April 2021, determining that products "Hirudin" and "Red 65" are sold there.

The FDA determined that claims on these websites establish "Hirudin" and "Red 65" as 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)] because they are intended for the cure, mitigation, treatment, or prevention of disease. Examples of claims cited include "Blood-thinning," "dissolve the . . . cholesterol," "strengthens your body’s defense capability against common viruses and bacteria," and treatment for conditions like "unstable angina" and "deep vein thrombosis."

The products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are