FDA Slacking In NDI Notification Enforcement; COVID-19 'Is Not An Excuse’ – NPA
In a statement submitted to the Senate Finance Committee, Natural Products Association CEO Dan Fabricant suggests two ways of improving compliance with new dietary ingredient notification requirements at negligible expense to the US FDA.
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Exceptions will be made for inspections of facilities manufacturing medically necessary products, such as products to treat and prevent Covid-19, the disease caused by the virus, and breakthrough products such as cancer treatments.
Both Senate and House reports on FDA FY 2020 appropriation include requests for agency’s research, policy evaluation, market surveillance, issuance of an enforcement discretion policy and appropriate regulatory activities related to regulated products that contain hemp-derived CBD. House report, though, expresses stronger concern about exploding sales of potentially unsafe CBD supplements.
FDA’s GMP final rule set uniform standards to ensure quality throughout manufacturing, packaging, labeling and holding of supplements, but Supplement Safety and Compliance Initiative says manufacturing practices continue to vary widely across the industry and the agency cannot inspect every facility. “FDA can’t solve all our problems. I don’t know if FDA knows the number of facilities it needs to inspect to ensure consumer confidence," says Daniel Fabricant, president of SSCI member NPA.