Details have emerged about last year’s FDA visit to Formulife, Inc. – which included putting them on notice that the “halodrol” and “superdrol” designer steroid compounds in their Halovar and Reign products aren’t actually considered dietary supplements.
Formulife, Inc.Purus Labs, Inc.d.b.a. Dark Cyde Supplements
January 18, 2012
Dear Mr. Smith:
From April 26 through May 19, 2011, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement facility located at 11370 Pagemill Rd., Dallas, Texas.
In addition to a number of adulteration violations, unapproved new drug violations, and misbranding violations of the Federal Food, Drug, and Cosmetic Act, they add:
We also have the following comments:
1. Your firm markets the product REIGN as a dietary supplement; however, this product does not meet the definition of a dietary supplement in section 201(ff) of the Act [21 U.S.C. § 321(ff)]. To be a dietary supplement, a product must, among other things, “bear[ ] or contain[ ] one or more . . dietary ingredients” as defined in Section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)]. Section 201(ff)(1) of the Act defines “dietary ingredient” as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories. The only substances listed as dietary ingredients on the REIGN label are 4-chloro-17a-methyl-androst-1, 4-dien 3-17b-diol and 2a,17a dimethyl-etiocholan-3-one, 17b-ol. These compounds are steroids and are not vitamins, minerals, amino acids, herbs or other botanicals, or dietary substances for use by man to supplement the diet by increasing the total dietary intake. Further, they are not concentrates, metabolites, constituents, extracts or combination of any such dietary ingredients. Therefore, these substances are not dietary ingredients as defined in section 201(ff)(1) of the Act. Thus, because REIGN does not contain a dietary ingredient as defined in section 201(ff)(1) of the Act, this product does not qualify as a dietary supplement.
It is unclear why a letter issued in January, relating to a visit this time last year, has taken until now to be published on the FDA website, or indeed what penalties will be imposed for these violations.