Medical Association's Diagnosis Of US Supplement Market Has Industry Asking For Second Opinion
AMA decides “to call for more stringent federal regulation of supplements—including increased oversight of manufacturing, marketing, product labeling, and adverse event reporting.” But NPA CEO Daniel Fabricant says supplements account for a fraction of the problems linked to drugs approved for sale in the US. "We don’t have a vitamin C crisis in America, we do have an opioid crisis."
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FDA’s pause in facility inspections could prompt draft legislation for mandatory supplement product registration. It told industry groups it’s working on language for legislation to give it a better handle on products in the market and facilities with problems, says CRN head Steve Mister.
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.
"You begin to see FDA telegraphing that this is important. That was lacking in the past two budgets," said Mike Greene, Council for Responsible Nutrition's chief congressional liaison. White House's budget request recommends $67m increase from FY 2019 to $1.4bn for FDA's food industry programs in CFSAN, which includes the Office of Dietary Supplement Programs, and for the Office of Regulatory Affairs' related field activities.