Supplement companies that link to articles or published literature from their website product pages take note: FDA views disease discussions in those articles to cause the products to be considered drugs. This warning letter to Europharma sets forth in detail how FDA looks at websites for disease claims. This is important reading for all companies linking to disease-discussion articles in their websites.
Food and Drug Administration
April 24, 2013
Warning Letter: EuroPharma Co. Inc.
This is to advise you that the Food and Drug Administration (FDA) reviewed your web site at the Internet address www.europharmausa.com in February 2013 and has determined that the products Calm Kids, CholestCaps, CuraMed 375 mg, CuraMed 750 mg, Curamin, Mental Advantage, Tri-Iodine, and Viragen products are promoted for conditions that cause the products to be 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 therapeutic claims on your web site establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. You may find the Act and our regulations through links on FDA's home page at http://www.fda.gov.
Examples of some of the claims observed on your website www.europharmausa.com include:
Claims found in article titled "Help Children with Attention Deficit-Hyperactivity Disorder (ADD OR ADHD)," which is found by following a link from the Calm Kids page on your www.europharmausa.com web site:
"For ADD/ADHD focus look for a formula with these ingredients: [an ingredient list that is identical in both ingredients and amounts to what is provided on the Calm Kids page on your www.europharmausa.com web site]."