NPA Submits Comments to FDA on Economic Adulteration
WASHINGTON – The Natural Products Association (NPA) today urged the Food and Drug Administration (FDA) to do more to stop fraudulent products from entering the U.S., including issuing import alerts for nutritional supplements that fail to comply with New Dietary Ingredient (NDI) regulations. NPA submitted its comments to the FDA regarding “Food Standards; General Principles and Food Standards Modernization.”
NPA’s full comments can be viewed here.
NPA expressed its concerns about disreputable firms replacing expensive ingredients with less safe and less costly ingredients. The practice, known as “economic adulteration,” puts consumers at risk when firms replace ingredients in products for purely economic reasons. The Agency has not taken any actions against supplement manufacturers for economic adulteration in the last five years.
NPA also expressed concern that the FDA is falling behind on the Food Safety Modernization Act (FSMA) inspectional cycle. NPA has asked the FDA issue an import alert for dietary supplements or ingredients that fail to comply with new dietary ingredient regulations. In fiscal year 2019, there were less than 50 notifications submitted to the FDA to establish the safety of new dietary ingredients in supplements.
“Fly-by-night companies that cut corners on safety and quality shouldn’t be allowed to send their products into our country. The vast majority of dietary supplement products are safe and produced by reputable supplement manufacturers. But As long as the FDA continues to downplay the seriousness of adulterated products coming into this country, consumers are going to be at risk,” said Daniel Fabricant, Ph.D., President and CEO of NPA. “The FDA has neglected a series of its enforcement obligations over the past several years, meaning unsafe and untested dietary supplement ingredients are being imported to the U.S. and reaching store shelves.”
The Natural Products Association has proposed a two-pronged approach to protecting consumers:
Step I: FDA Import Alert for Supplements.
NPA’s first recommendation is for FDA to issue an import alert for supplements. The import alert requires no additional resources but would be an effective measure that would provide important information to the Agency to facilitate their enforcement of current dietary supplement regulations. An import alert places the responsibility back on the importer to ensure that the products being imported into the United States are in compliance with the FDA’s laws and regulations. The agency last used this authority in 2014 in response to safety concerns related to the importation of Kratom. NPA has requested a meeting with FDA officials to explain the benefits of this approach.
Step II: Expand Participation in the SSCI Initiative.
NPA’s second recommendation is to expand the number of companies who agree to meet industry specific quality assurance standards in NPA’s Supplement Safety and Compliance Initiative (SSCI). SSCI is an industry-driven initiative led by the nation’s leading retailers to provide a harmonized benchmark to recognize various safety standards throughout the entire dietary supplement supply chain. SSCI is a bold step forward in providing quality assurance from harvest to retailer shelf. Dietary supplements must meet or exceed the SSCI benchmark to be accepted in major retailers, all with the goal of providing quality products and increasing consumer confidence. Visit: http://www.ssciglobal.org/
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Natural Products Association
The Natural Products Association (NPA) is the trade association representing the entire natural products industry. We advocate for our members who supply, manufacture and sell natural ingredients or products for consumers. The Natural Products Association promotes good manufacturing practices as part of the growth and success of the industry. Founded in 1936, NPA represents over 700 members accounting for more than 10,000 locations of retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids. Visit www.npanational.org.