One of NPA's concerns: “economic adulteration"—firms replacing ingredients in products for purely economic reasons. Disreputable companies put consumers at risk by replacing expensive ingredients with less safe and less costly ingredients, NPA explained, adding that the FDA has not taken action against supplement manufacturers for economic adulteration in the last five years.
Another concern: FDA is falling behind on the Food Safety Modernization Act (FSMA) inspectional cycle, NPA said, noting that in fiscal year 2019, there were less than 50 notifications submitted to the FDA to establish the safety of new dietary ingredients in supplements. NPA asked the FDA to issue an import alert for dietary supplements or ingredients that fail to comply with New Dietary Ingredient (NDI) regulations.
“Fly-by-night companies that cut corners on safety and quality shouldn’t be allowed to send their products into our country," said Daniel Fabricant, Ph.D., President and CEO of NPA, in a press release. "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. 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 two-pronged approach NPA proposed to help protect consumers:
- FDA to issue an import alert for supplements. NPA contends that the import alert requires no additional resources but would be an effective measure that would provide the FDA with important information to facilitate 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," NPA explained.
- Expand the number of companies who agree to meet 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," NPA said. Dietary supplements must meet or exceed the SSCI benchmark to be accepted in major retailers. The goal: to provide quality products and increase consumer confidence.