Overview of regulation of dietary supplements in the USA and issues of adulteration with phenethylamines (PEAs).
The multi-billion dollar dietary supplement industry is global in reach. The industry has been criticized for problems related to poor quality control, safety, misbranding, and adulteration. In this review, we describe how the US Food and Drug Administration (FDA) regulates dietary supplements within the framework of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Dietary Supplement Health and Education Act of 1994 (DSHEA), which amended the FD&C Act, gave the FDA the authority to promulgate Good Manufacturing Practices for dietary supplements and required that manufacturers provide the FDA information supporting a conclusion that the ingredients are reasonably expected to be safe if the dietary ingredients were not marketed in the USA before 15 October 1994. Recent amendments to the FD&C Act require that serious dietary-supplement-related adverse events be reported to the FDA and provide the agency with mandatory recall authority. We discuss the presence of naturally occurring (e.g. Ephedra, Citrus aurantium, Acacia) and synthetic (e.g. β-methylphenethylamines, methylsynephrine, α-ethyl-phenethylamine) biologically active phenethylamines (PEAs) in dietary supplements and of PEA drugs (e.g. clenbuterol, fenfluramine, sibutramine, lorcaserin) in weight-loss products. Regulatory actions against manufacturers of products labelled as dietary supplements that contain the aliphatic amines 1,3-dimethylamine and 1,3-dimethylbutylamine, and PEAs such as β-methylphenethylamine, aegeline, and Dendrobium illustrate the FDA's use of its authority under the FD&C Act to promote dietary supplement safety. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.
Office of Regulatory Science, Center for Food Safety Applied Nutrition, College Park, MD, 20740, USA.
Rahul S
RS
Pawar
Office of Regulatory Science, Center for Food Safety Applied Nutrition, College Park, MD, 20740, USA.
Erich
E
Grundel
D019440:Anti-Obesity Agents / Q000009:adverse effects / Q000032:analysis; D019587:Dietary Supplements / Q000009:adverse effects* / Q000032:analysis*; D004340:Drug Contamination; D004335:Drug and Narcotic Control; D006801:Humans; D010627:Phenethylamines / Q000009:adverse effects / Q000032:analysis; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration
D019440:Anti-Obesity Agents; D010627:Phenethylamines
DSHEA; adulteration; dietary supplements; new dietary ingredient; phenethylamine