Case Detail

In re FDA Regulation of Modified Risk Tobacco Products
(Regulatory Proceeding)
On September 29, 2009, WLF filed formal comments with the Food and Drug Administration, asserting that several aspects of the recently enacted federal Tobacco Control Act specifically, provisions regulating all health-related statements regarding tobacco products raise grave First Amendment concerns. WLF noted that the Act prohibits such statements when they are completely truthful. WLF argued that FDA, as the agency charged with administering the Act, can lessen some of the First Amendment concerns by adopting regulations that permit manufacturers to make health-related statements for which they have substantiation, unless FDA makes a determination that the statements are false or misleading. WLF argued that the First Amendment does not permit FDA to ban health-related statements for years on end (as contemplated by the Act) based solely on an assertion that it has not yet had an opportunity to determine whether the claims are truthful.
Case Status:
Awaiting FDA release of proposed implementing regulations.
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