Labeling Regulations May Challenge First Amendment, says CHPA

Erik Swain

Some of FDA's regulations on the labeling of over-the-counter (OTC) drugs and dietary supplements may come in conflict with the First Amendment, especially in light of a recent U.S. Supreme Court decision concerning "commercial speech," a trade association has stated in a letter to the agency.

In its letter dated September 13, 2002, the Consumer Healthcare Products Association (CHPA; Washington, DC) questioned whether the agency's requirements for mandatory language to be used in OTC drug labeling and dietary supplements are "more extensive than necessary" to serve the government's interest.

The case, Thompson v. Western States Medical Center, decided in early 2002, held that in most cases "commercial speech" should be held in check by the government only when it "concerns unlawful activity or . . . is misleading" and clarified its criteria established in a 1980 case. In the older case, the court decreed that if the speech concerns lawful activity and is not misleading, the government would have to demonstrate that it has a substantial interest in regulating it, that the regulation directly advances that interest, and that the regulation is not more extensive than necessary to serve that interest.

It is the latter contingency that prompted CHPA's letter. First, it questioned why industry may not deviate from the terminology and phraseology employed in FDA's official OTC drug monographs for all sections of the label except indications. "Why, if . . . FDA concedes that this less-rigid approach [for indications] can achieve its desired ends, is the more restrictive exclusivity policy still necessary to achieve the governmental interest for statements of identity, for example?" CHPA asked.

Second, citing the Dietary Supplement Health & Education Act (DSHEA), which requires dietary supplements to be treated as foods for regulatory purposes, CHPA questioned why a conventional food fortified with a particular nutrient needs no disclaimer, but a dietary supplement with the same nutrient must state on its label that its claims "have not been evaluated by the Food & Drug Administration," calling the disparity "inherently suspect."

Third, CHPA stated that while the "Drug Facts" format fills the statutory mandate that OTC drug labeling be "prominent and conspicuous," and while there is a substantial medical interest in having readable medication labels, "nothing in the regulatory record nor the statute itself suggests that the 'prominent and conspicuous' standard can be satisfied only by imposition of a single, inflexible type size, much less the additional requirements for type style, shape, and color of bullets, barlines, hairlines, and column separators."

The letter was prompted by a call from the agency on May 16, 2002, likely made in response to the Western States decision, for industry input on its policies, practices, regulations, and guidances in light of the First Amendment. CHPA asked for the agency to respond with a statement published in the Federal Register articulating its position on First Amendment rights.

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