Case Detail

In re FDA Policy on Modified Risk Tobacco Products
On June 4, 2012, WLF filed formal comments with the Food and Drug Administration (FDA), urging it to substantially modify its Draft Guidance on submitting applications for Modified Risk Tobacco Products (MRTPs). The guidance imposes severe restrictions on the rights of tobacco manufacturers to make truthful statements regarding the relative risks of their products. WLF argued that FDA should permit manufacturers to make health-related statements for which they have substantiation, unless FDA makes a determination that the statements are false or misleading. By prohibiting manufacturers from making any such statements unless they can surmount daunting requirements imposed by FDA, the guidance violates the First Amendment, WLF charged. WLF argued that the First Amendment does not permit FDA to ban health-related statements for years on end (as contemplated by the draft guidance) based solely on an assertion that FDA has not yet had a chance to determine whether the claims are truthful.
Case Status:
Awaiting FDA action.
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