Dietary Supplement Regulations – Part 1

Overview – American Regulations

The United States of America introduced the Dietary Supplement and Health Education Act (DSHEA) in 1994, which allowed considerable flexibility between foods and medicines found in other parts of the world. Under DSHEA a dietary supplement may contain ‘a herb or other botanical’ or ‘a concentrate, metabolite, constituent, extract or combination of any ingredient from the other categories.’

The American food safety regulatory system is far more centralized than the European system. The issue of adulteration became a national issue in 1848 when Congress passed the Drug Importation Act, requiring inspection by the US Customs Service to prevent the entry of adulterated drugs from abroad. In 1862, in order to address the issue of adulterated food, the chemical division of the United States Department of Agriculture (USDA) was established and then renamed the Bureau of Chemistry (now FDA).

The genesis of US food legislation goes back to 1906 when a major piece of legislation was passed. The Food and Drugs Act was enacted in June 1906 and prohibited interstate commerce of misbranded and adulterated foods, drinks, and drugs. In 1938, the Federal Food, Drug, and Cosmetic Act (FDCA) pre-empted the Food and Drugs Act. This Act focuses on food misbranding and adulteration and serves as the basic framework for food regulation by the FDA and the USDA. This legislation created food standards, mandated inspections of factories, and provided for the issuance of court injunctions in addition to the already existing seizure and prosecution remedies. Since 1938, the FDCA has been amended a number of times and additional supporting laws have been enacted relating to food safety, security threats, and nutrition. Additionally, state laws supplement this federal framework.

The USDA and the FDA are the main authorities in food regulation in the United States. These two federal agencies encompass all phases of the food regulatory system: They evaluate, investigate, regulate, inspect, and sanction. However, even in a centralized system like the United States, some argue that the USDA and the FDA should consolidate into one single food agency. FDA regulates both finished dietary supplement products and dietary ingredients under a different set of regulations than those covering “conventional” foods and drug products.

Under the DSHEA, the dietary supplement or dietary ingredient manufacturer is responsible for ensuring that a dietary supplement or ingredient is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. All domestic and foreign companies that manufacture, package, label or hold dietary supplement, including those involved with testing, quality control, and dietary supplement distribution in the US, must comply with the Dietary Supplement Current Good Manufacturing Practices (cGMPS) for quality control.

In addition, the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is required to submit to FDA all serious adverse event reports. Further, FDA’s other responsibilities include product information, such as labelling, claims, package inserts, and accompanying literature.

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