The Natural Products Association (NPA) urged the U.S. Food and Drug Administration (FDA) to issue import alerts for nutritional supplements that fail to comply with New Dietary Ingredient (NDI) regulations. NPA submitted comments for the record to the Senate Finance Committee’s hearing “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process.” The hearing will take place on June 2, 2020 at 2:30 p.m. EST.

NPA expressed its 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.

“The COVID-19 health crisis is not an excuse for the FDA to stop doing its job,” said Daniel Fabricant, PhD, president and CEO, NPA. Unfortunately, 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. Adulterated ingredients that have not completed the New Dietary Ingredient notification process are entering our country at an alarming rate and it’s been roughly six years since the FDA provided dietary supplement import alerts to prevent this. This puts American consumers at risk and compliant U.S. supplement-makers at a terrible disadvantage.”

The Natural Products Association has proposed a two-pronged approach to protecting consumers while the FDA is unable to conduct facility inspections during the COVID-19 health crisis.

Step I:  FDA Import Alert for Adulterated Ingredients used in Dietary Supplements

NPA’s first recommendation is for FDA to issue an import alert for adulterated dietary ingredients.  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. 

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, according to NPA. 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.  For more information, http://www.ssciglobal.org/.