Trade Groups Remain Skeptical Of Consumer Reports Supplement Analysis
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Congress should consider legislation authorizing agency to conduct enforcement more directly, says Associate Commissioner Schiller. In FDLI conference keynote, he discussed compliance with FDA regulations across markets it regulates, but made specific example of saying FDA is comparatively hamstrung in regulating businesses marketing products labeled as supplements.
Agency announces plan in statement by two deputy commissioners warning consumers about safety concerns regarding the semi-synthetic derivative of vincamine, "specifically concerns about the use of this ingredient by women of childbearing age." Recent findings by NIH National Toxicology Program's study with rats and rabbits indicate "vinpocetine may cause a miscarriage or harm fetal development," FDA says.
Commissioner Scott Gottlieb announces FDA's plan for policy changes to implement "one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years." Plan includes steps to ensure its regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, particularly finalizing NDI notifications guidance and fostering submissions of the notifications.