By guest-blogger Paul Van Ness. Read part 1 here.
To help ensure the of quality dietary supplements, certification programs have been created by the National Nutritional Foods Association (now the Natural Products Association), United States Pharmacopeia (USP) and NSF International (NSF). These programs are designed to help empower consumers to select supplement products with confidence, knowing that certified manufacturers and products have undergone some degree of testing and analysis for safety and quality.
The National Nutritional Foods Association (now known as the Natural Products Association) created a GMP Certification Program designed to verify that supplement suppliers comply to a standard of good manufacturing practiceiv. These standards govern the practices of dietary supplement ingredient suppliers in the areas of “Personnel, Plant and Grounds, Sanitation, Equipment, Quality Operations, Production and Process Controls, and Warehouse, Distribution, and Post-Distribution Practices.”v Suppliers who meet the minimum requirements may apply for certification and use the Natural Products Association GMP certification mark in their advertising.
United States Pharmacopeia has developed a series of dietary supplement verification requirements for supplement manufacturers, including an audit to ensure good manufacturing practice, testing of products and ingredients, and a review of manufacturing documentationvi. The verification process also includes tests of marketplace samples of verified products and reviews of supplement labels to ensure authenticity, potency, and that required warnings are properly displayed.vii
Similarly, NSF International, a not-for-profit organization, has created a certification plan that includes testing, good manufacturing process inspections and ongoing quality monitoring.viii Manufacturers who meet NSF’s guidelines for finished products may display the NSF Certification Mark on the product label.
FDA’s cGMP Guidelines
In 1994, the “Dietary Supplement Health and Education Act” was signed into law by Bill Clinton. This law changed the way dietary supplements are classified and regulated.ix DSHEA eliminated confusion about the classification of dietary supplements by defining them as foods rather than drugs.x DSHEA also gave the U.S. Food and Drug Administration (FDA) the authority to regulate supplements, but their regulatory power is limited to removing unsafe, illegal or improperly labeled supplements from the market; it is supplement manufacturers themselves who are responsible for the quality of their products.
In response to calls from the dietary supplement industry, in 2007 the FDA issued a set of current good manufacturing practices (cGMPs), requiring that manufacturing firms consistently produce high-quality dietary supplements. The cGMPs apply to companies that “manufacture, package, label, or hold dietary supplements,”xi but dietary ingredient suppliers are exempt from these standards. Also absent is any requirement of testing for any chemical or biological contaminants in ingredients or in finished products. Therefore, to be certain that the supplements you purchase are of the highest-possible quality, it is necessary to select a manufacturer you can trust.
iv Natural Products Association. “Good Manufacturing Practices (GMP) Program. http://www.naturalproductsassoc.org/site/PageServer?pagename=ic_gmp
vi United States Pharmacopeia. “USP Verified.” http://www.usp.org/USPVerified/
vii United States Pharmacopeia. “How USP Verifies Dietary Supplements.” http://www.usp.org/USPVerified/dietarySupplements/process.html
viii NSF International. “Dietary Supplements / Functional Food and Beverages.” http://www.nsf.org/business/dietary_supplements/index.asp?program=DietarySups
ix U.S. Food and Drug Administration / Center for Food Safety and Applied Nutrition. “Overview of Dietary Supplements.” http://www.cfsan.fda.gov/~dms/ds-oview.html
x Dietary Supplement Information Bureau. “Dietary Supplements.” http://supplementinfo.org/index.php?submenu=About&src=gendocs&ref=DietarySupplements&category=About
xi U.S. Food and Drug Administration. “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.” http://www.fda.gov/OHRMS/DOCKETS/98fr/cf0441.pdf
This is the second of three articles about supplement quality. Part 3 will cover questions to ask your supplement company and the CNCA difference.