KEYWORDS: Dietary supplement; DSHEA; good manufacturing practice; cGMP; FDA; safety; dietary ingredient; toxicity
ABSTRACT: Sales and use of dietary supplements in the United States is ever growing , as consumers are supplementing the diet with products that benefit health and performance. The US Congress enacted DSHEA in 1994 to better regulate the safety of dietary supplements. Dietary ingredients that had not been consumed prior to October 15, 1994 must be notified to FDA that the manufacturer or distributer has concluded that the dietary ingredient is reasonably expected to be safe when consumed as recommended in the dietary supplement. Along with the safety of the ingredient, any claims to the benefits of the dietary ingredient (or the supplement as a whole) must be submitted to the FDA and, substantiation of the truthfulness of the claim must be readily available to the FDA or the FTC. The manufacture of dietary supplements is subject to FDA scrutiny and must be conducted according to current good manufacturing practice.
Dietary supplements in the US are a fast-growing industry segment, with the supplement category’s US dollar sales growing by 31.7% in 2012, with a compound annual growth rate of 7.1% between 2008 and 2012 (1). Today’s consumers are demanding safe products that provide beneficial effects on a person’s ability to maintain and/or improve health to attain their best health capacity. The growing US interest in dietary supplements is also a significant potential in worldwide industry growth in ingredient manufacturing and sales. But how are dietary supplements regulated and, how do manufacturers obtain “approval” of ingredients that go into dietary supplements? To that matter, are ingredients that go into dietary supplements “approved”? Are dietary supplements even regulated? Are dietary supplements evaluated for safety? Do the supplements provide what they claim? An overview of the regulatory process for dietary supplements and the ingredients that are added to dietary supplements is necessary to understand the legal requirements for dietary supplements and the ingredients that go into dietary supplements (i.e., dietary ingredients).
UNITED STATES DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT (DSHEA) OF 1994
The United States Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994 (2), following public debate concerning the importance of dietary supplements in leading a healthy life, the need for consumers to have current and accurate information about supplements, and controversy over the Food and Drug Administration's (FDA) regulatory approach to dietary supplements.
A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. A dietary supplement was defined by Congress as a product (other than tobacco) that contains one or more of the following dietary ingredients: (a) a vitamin; (b) a mineral; (c) an herb or other botanical; (d) an amino acid; (e) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (f) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in (a) – (e) above. A dietary supplement is to be labeled as a dietary...