Nutraceuticals, also known as dietary supplements, are regulated by the FDA. FDA regulates both finished nutraceutical products as well as dietary ingredients. However, unlike food, drugs, and medical devices, FDA regulates nutraceuticals under the Dietary Supplement Health and Education Act of 1994 (known as “DSHEA”). DSHEA essentially provides that any company in the channel of commerce, from manufacturers and distributors to retailers of nutraceuticals, or their ingredients, are prohibited from marketing products that are “adulterated” or “misbranded.” FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.
Nutraceuticals are considered adulterated when the nutraceutical or dietary supplement differs from the standard of strength, quality, or purity of the name recognized in the United States Pharmacopoeia or National Formulary under which it is sold. Nutraceuticals are considered misbranded when sold under false or misleading labeling. Under FDA regulations at 21 CFR part 111, 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 U.S., must comply with the Dietary Supplement Current Good Manufacturing Practices (CGMPs) for quality control.
That means that any company selling nutraceuticals, from the manufacturer to the retailer, is responsible for ensuring the validity of the safety and labeling of their products in order to comply with the requirements of DSHEA and other DA regulations. Thus, nutraceutical companies, including food companies including dietary supplements into their products, must work with a contract CGMP analytical chemistry laboratory capable of providing these companies with information about strength, quality, and purity of their ingredients.
Global Pharma Analytics has a long history of working with some of the leading suppliers of nutraceuticals across the nation. For nutraceutical companies seeking to partner with a high-quality contract CGMP analytical chemistry laboratory at affordable prices, Global Pharma Analytics is the right choice. Unlike most testing laboratories offering testing for the nutraceutical market, Global Pharma Analytics operates our laboratory under a quality system that is pharmaceutical-grade, the most stringent of the CGMP requirements. For this reason, Global Pharma Analytics is the top choice for nutraceutical and dietary supplement testing needs.
More information about nutraceuticals / dietary supplement regulation: http://www.fda.gov/Food/DietarySupplements/default.htm