FDA Regulation of Dietary Supplements and Requirements Regarding Adverse Event Reporting

Abstract

In 1994, the Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food, Drug, and Cosmetic Act (FDC Act) to set up a distinct regulatory framework for what we now call dietary supplements. The DSHEA was passed with the intent of striking a balance between providing consumers access to safe dietary supplements to help maintain or improve their health and giving the US Food and Drug Administration (FDA) authority to regulate and take action against manufacturers of supplements or supplement ingredients that present safety problems, are presented with false or misleading claims, or are adulterated or misbranded. This article will present FDA's recent experience in collecting and evaluating dietary supplement adverse event data for the purpose of assuring the public that the dietary supplements they purchase are safe.

Heavy metal and pesticide content in commonly prescribed individual raw Chinese Herbal Medicines

“…Most CHMs in the United States are typically covered under the Dietary Supplements Health and Education Act (DSHEA) of 1994 (Frankos et al, 2010), and as such, lack official limits for regulation of heavy metals or pesticides. Some guidelines for maximum levels of heavy metals and pesticides in raw CHMs have been published at the international (e.g., WHO, 1998) or national level (e.g., CPC, 2005), but considerable variation exists in the proposed standards (Zhao et al, 2007), and in most cases regulated limits apply to only a small subset of contaminants or CHMs.…”

The coenzyme Q10 content of food supplements

“…Moreover, it would make sense to enforce additional requirements such as that good manufacturing practices (GMPs) are followed when food supplements are produced. Such a regulation was already accepted in the USA in 2008 and requires that proper controls are in place so that supplements are processed in a consistent manner and meet quality standards including consistent identity, purity, strength and composition (Frankos et al 2010).…”

Skin discolouration with acute onset parkinsonism secondary to systemic zirconium intoxication

“…Although the Food and Drug Administration has issued a warning to consumers about the risk of developing argyria when taking silver-containing dietary supplements, 12 the ingestion of colloidal silver appears to be increasing among patients using alternative medicine. This patient also believed that the colloidal silver (in fact, zirconium) was a 'cure-all' and drank what she thought as silver liquids whenever she was tired.…”