US Process Modeled On OTC Review Could Improve Supplement Health Claim Requests’ Chances
Claims supplements could be stronger, says a veteran food and supplement industry attorney, if FDA would give appropriate credit to the scientific evidence that firms are providing with their requests to use unqualified health claims.
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FDA intends to exercise enforcement discretion regarding QHCs about the association between reduced risk of recurrent UTI and use of supplements with at least 500 mg cranberry fruit powder and of cranberry juice beverages containing at least 27% cranberry juice.
In decision on Ocean Spray’s citizen petition, FDA says qualified health claims for cranberry to reduce the risk of recurrent urinary tract infections it will allow, under enforcement discretion, for use with supplements must specify a dose of at least 500 mg.
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.