FDA First Amendment Application Guidelines Urged By CTFA

FDA should develop guidelines laying out a First Amendment analysis that would be applied prior to any curtailment of marketing "speech" and followed "consistently throughout the agency," the Cosmetic, Toiletry and Fragrance Association asserts in Oct. 28 comments.

Public opinion urging FDA to reevaluate the way it restricts speech for regulated products shows "an overwhelming consensus" supporting the development of guidelines, CTFA says. "It is also important that the agency conclude this process by publishing those guidelines for public comment," the trade association recommends.

CTFA's remarks were submitted in response to third-party comments filed earlier in the year at FDA request. In May, FDA invited public input on the constitutionality of its regulation of marketing and advertising for cosmetics, drugs and other products (¹ (Also see "FDA Commercial Speech Regs Constitutionality Debate Opened By Agency" - HBW Insight, 20 May, 2002.), p. 7).

The call for input was sparked by recent case law, primarily Thompson v. Western States Medical Center, in which the Supreme Court overturned FDA's restrictions on the advertising of compounded drugs.

Third-party comments on the First Amendment "indicate broad support for the need to reevaluate the manner in which FDA restricts speech about regulated products and to ensure that the agency's analysis of proposed regulations affecting commercial speech follows that required in Thompson v. Western States Medical Center," CTFA says.

The association also addresses comments suggesting a review of FDA's First Amendment compliance could result in less protection of the public health by arguing "that is by no means the case."

"A better informed consumer armed with more - not less - truthful information is much more likely to use FDA-regulated products in a way that insures both safety and the maximum possible benefit from the product," CTFA contends.

In comments previously filed by the association Sept. 13, CTFA urged FDA to develop a general policy statement on how it determines whether labeling claims for cosmetics and cosmetic-drugs are "inherently misleading" (² (Also see "Cosmetic Claims “Misleading” Standard Should Be Articulated By FDA – CTFA" - HBW Insight, 23 Sep, 2002.), p. 8).

Actions recommended by CTFA in its earlier submission "are designed to achieve appropriate consideration of both the consumer's right to have truthful and relevant information about the cosmetic and OTC drug products they purchase and protection of the public health and safety," the association reiterates in its latest submission.

Specific examples of FDA decisions that do not comply with the First Amendment's free speech provisions include the ban on high SPF claims for sunscreens and certain requirements in the OTC drug labeling final rule, CTFA says.

CTFA already has argued for extending the First Amendment implications of the Pearson v. Shalala dietary supplement ruling to the OTC realm in comments to the agency last year (³ (Also see "Sunscreen, OTC Labeling Reg First Amendment Intrusions Cited By CTFA" - HBW Insight, 16 Apr, 2001.), p. 3).

"It is essential under the law that FDA conduct its business in compliance with the constitution and the law," CTFA Legal and Regulatory Affairs VP Thomas Donegan said during the CTFA Science meeting in Atlantic City Oct. 23-25.

Banning SPF claims over 30 "cuts off important information about important products that are legal to make," Donegan maintained. "FDA has not made it illegal to make sunscreens over 30, you're just not allowed to talk about it," he added.

Rather than banning the products outright, FDA should consider alternative ways to communicate safety concerns to consumers, Donegan stated. One example could be a label disclosure advising consumers not to prolong their time in the sun, he suggested.

Office of Cosmetics & Colors Director Linda Katz, MD, said the First Amendment issue is pushing the agency to "look at certain things differently."

"The First Amendment has impacted some of the initiatives that have been worked on," Katz said, noting the cosmetics office has had to go back to reassess some policies with regard to the First Amendment.

The Consumer Healthcare Products Association also filed comments with the agency Oct. 28. In its submission, CHPA endorsed the Pharmaceutical Research & Manufacturers of America's stance that FDA's restriction of the use of trademarks and trade names already approved by the U.S. Office of Patents & Trademarks violates the First Amendment.