The Food and Drug Administration (FDA) regulates dietary supplements products and ingredients. FDA’s jurisdiction is granted by the Dietary Supplement and Health Education Act (1994). Manufacturers and distributors of dietary supplements are responsible for evaluating the safety of their products and ensuring that the labeling is compliant with the Federal Food, Drug & Cosmetic Act and FDA’s implementing regulations. FDA is authorized to take enforcement actions for adulterated or misbranded dietary supplements.
Recently, it was reported that a yearlong federal investigation into the dietary supplement industry has resulted in a widespread crackdown on the sale of tainted or misleading products. The Justice Department (working in conjunction with FDA) said on Tuesday that it filed criminal and civil enforcement actions against 117 companies and individuals. A Dallas based company, USPlabs, was identified as selling the best-selling workout supplements Jack3d and OxyElite Pro, which contains the amphetamine-like stimulant dimethylamylamine (DMAA). Federal prosecutors have secured a criminal indictment against USPlabs and six of its executives for misleading retailers and wholesalers that the products used natural plant extracts when, in fact, it uses a synthetic stimulant made in a Chinese chemical factory.
Manufacturers of dietary supplements must conform their practices to comply with FDA regulations. Consumers seeking holistic alternatives to pharmaceutical grade products should be diligent in their evaluation of dietary supplements, ingredients and manufacturers.