Free speech or safety

FDA is asking the public to comment on whether or not its regulations and policies on product labeling and advertising are constitutional in light of recent court decisions that generally supported First Amendment rights for “commercial speech.” The agency noted that there “may be tension between some aspects of FDA’s authority and judicial developments.” The case law, FDA said, “may threaten to diminish the overall legal credibility necessary for FDA to sustain its authority to accomplish its important public health duties.” The public was asked to comment on nine specific questions related to the regulation of advertising and labeling.

Questions ranged from whether drugs and food should be regulated similarly to dietary supplements to whether or not speech-related regulations advance the public health.

Advocates of FDA regulation worried that the agency’s action may signal a loosening of its oversight of food and drugs. Comments are due by July 30, 2002, with an agency response due by Sept. 13, 2002.

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