Washington, D.C.—The Natural Products Association (NPA) has urged FDA to issue import alerts for supplements that fail to comply with NDI regulations, according to a press release. 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 pm EST.
In the comments, NPA expressed its concern that FDA is falling behind on the Food Safety Modernization Act (FSMA) inspectional cycle, according to a press release. NPA has asked FDA to issue an import alert for supplements or ingredients that fail to comply with NDI regulations. In fiscal year 2019, there were fewer than 50 notifications submitted to FDA to establish the safety of new dietary ingredients.
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NPA has proposed the following two-step approach to protect consumers while FDA is unable to conduct facility inspections during the COVID-19 pandemic:
- Issue an import alert for adulterated ingredients. An import alert places the responsibility back on the importer to ensure that the products being imported into the U.S. are in compliance with FDA regulations. The import alert requires no additional resources, the release explains, but would provide important information to the Agency to facilitate their enforcement of current dietary supplement regulations. This authority was last used in 2014 in response to safety concerns related to the import of kratom.
- Expand participation in SSCI. The Supplement Safety and Compliance Initiative is an industry-driven program led by leading retailers to provide a harmonized benchmark to recognize various safety standards throughout the entire dietary supplement supply chain. Dietary supplements must meet or exceed the SSCI benchmark to be accepted in major retailers. NPA’s second recommendation is therefore to expand the number of companies who agree to meet these industry-specific quality assurance standards.
“The COVID-19 health crisis is not an excuse for the FDA to stop doing its job,” said Daniel Fabricant, Ph.D., President and CEO of 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.”