Regulatory News In Brief
This article was originally published in The Tan Sheet
Executive Summary
FTC/Garden of Life case continues; FDA deems ForMor in violation of GMPs; Kanebo faulted for pharmaceutical GMP failures; CytoSport settles litigation over Muscle Milk labeling; USPlabs’ carb claim canned in NAD review; FDA extends comment time on FSMA tracking pilots.
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FTC Leaves Supplement Industry Still Waiting For Shift Away From RCT Standard For Claims
FTC's "standard is the same. There's not any per se lower standard for substantiation just because you position your product as a supplement," says agency attorney Michelle Rusk. Supplement industry stakeholders, though, argue that FTC has no basis to require RCTs for structure/function claims.
FTC Stretched Standards In Enforcement Against Bayer Probiotic Claim
Judge Jose Linares states in his opinion that FTC’s requirement for “competent and reliable scientific evidence” to substantiate ad claims for consumer health care products aligns with FDA’s regulation of supplement claims under DSHEA, and Bayer complied with both agencies’ regs.
FTC Stretched Standards In Enforcement Against Bayer Probiotic Claim
Judge Jose Linares states in his opinion that FTC’s requirement for “competent and reliable scientific evidence” to substantiate ad claims for consumer health care products aligns with FDA’s regulation of supplement claims under DSHEA, and Bayer complied with both agencies’ regs.