title: A false sense of security? The U.S. Food and Drug Administration's framework for evaluating new supplement ingredients.
abstract: The evidence sufficient to establish the expectation of safety for new ingredients in dietary supplements is an area of considerable controversy. Recently, the U.S. Food and Drug Administration (FDA) proposed a sound scientific framework for evaluating the safety of new ingredients. The level of evidence the FDA requires (i.e., in vitro, animal or human testing) hinges on three key factors: (1) documented history of use; (2) the dose and formulation of the new ingredient compared with the historically used ingredient; and (3) the supplement's recommended use (i.e., daily or as needed). Despite its strengths, the framework requires four key modifications to ensure the expectation of safety: (1) historical use should rarely, if ever, be sufficient to replace experimental data; (2) entirely novel ingredients should undergo, at a minimum, a 90-day human testing; (3) manufacturers should be required to submit to the FDA all available data regarding new ingredients, both favorable and unfavorable; and (4) before assuming that consumers follow instructions on supplement labels, this assumption should be empirically confirmed. In the absence of significant modifications, the FDA's guidance may have the effect of providing a false sense of security to consumers seeking safe dietary supplements.
authors: Harvard Medical School, Boston, Massachusetts, USA. pcohen@challiance.org
authors: Pieter A
authors: PA
authors: Cohen
mesh_terms: D000818:Animals; D019587:Dietary Supplements / Q000009:adverse effects / Q000145:classification / Q000592:standards*; D059022:Food Safety; D006801:Humans; D007881:Legislation, Food; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*