5.5 AUTHORITATIVE STATEMENTS – FDA MODERNIZATION ACT
Before the Food and Drug Administration Modernization Act of 1997 (FDAMA), companies could not use a health claim or nutrient content claim in food labeling unless the FDA published a regulation authorizing such a claim. Two new provisions of FDAMA28 permitted distributors and manufacturers to use claims if based on current, published, authoritative statements from certain federal scientific bodies. The National Academies of Sciences (NAS), the National Institutes of Health (NIH), and the Centers for Disease Control and Prevention (CDC) are federal government agencies specifically identified as scientific bodies by the FDAMA.
FDAMA’s provisions were intended to expedite the process by which health claims can be established and used. FDA interpreted “authoritative statements” so that they must reflect a consensus within the identified scientific body and be based on a deliberative review by the scientific body of the scientific evidence. In theory, the authoritative‐statement standard is slightly less stringent than FDA’s prior requirement for “significant scientific agreement.” Particularly, FDAMA allows companies to notify FDA of their intent to use a new health claim based on an authoritative statement of only one federal scientific body, rather than show scientific agreement. However, in application, the standards show little difference.
From a process standpoint, FDAMA does require that FDA expedite review. FDAMA gives FDA 120 days to respond to new health claim proposals based on authoritative statements. If the agency does not act to prohibit or modify the claim within that time, the claim can be used.
Nevertheless, FDAMA’s provisions to expedite approval did not meet the desires of everyone in the food industry. FDAMA sped up FDA’s review, but review often resulted in denial. Two years after FDAMA, two food marketers sued over such a denial. The result was the landmark case, Pearson v. Shalala, which is discussed later in this chapter.
FDA has prepared a guide on how a firm can make use of authoritative statement‐based health claims.29 FDAMA does not include dietary supplements in the provisions for health claims based on authoritative statements. Consequently, this method of oversight for health claims cannot be used for dietary supplements at this time.
As this was written, three health claims based on authoritative statements were approved30:
Whole Grain Foods and Risk of Heart Disease and Certain Cancers
Potassium and the Risk of High Blood Pressure and Stroke
Whole Grain Foods with moderate fat content and heart disease31
5.6 QUALIFIED CLAIMS
“Qualified” health claims are a category of claims demarcated by FDA based on First Amendment concerns. This category of claim is based on the FDA’s acceptance of a petition for a health claim with less than significant scientific agreement when the claim is qualified with an explanation of the degree of scientific support. More on the specific requirements and claims follows below; however, first, the following cases are essential to understanding this category.
5.6.1 Restricting Commercial Speech
Before 1976, commercial speech, such as advertising, found no protection under the First Amendment of the U.S. Constitution. Today, commercial speech is deemed to be under a level of First Amendment protection (but remains a lower level of protection than political speech). The Central Hudson case delineates a four‐part analysis of commercial speech. Commercial communication (1) must be determined to be neither false, misleading, nor related to unlawful activity, (2) the government interest must be substantial, (3) the restriction must directly advance that interest, and (4) the restriction cannot be more extensive than necessary to advance the government interest.
Note that Central Hudson provides two prongs of protection. However, there are broad exceptions to the First Amendment protections. Commercial speech that is false is not protected, and commercial speech that is more likely to deceive the public than to inform it may be banned. In addition, commercial speech related to illegal activity may also be prohibited.
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Central Hudson Gas & Electric v. Public Service Commission of New York
447 U.S. 557 (1980)
Mr. Justice POWELL delivered the opinion of the Court.
This case presents the question whether a regulation of the Public Service Commission of the State of New York violates the First and Fourteenth Amendments because it completely bans promotional advertising by an electrical utility….
Central Hudson Gas & Electric Corp., the appellant in this case, opposed the ban on First Amendment grounds….
The Commission’s order restricts only commercial speech, that is, expression related solely to the economic interests of the speaker and its audience. The First Amendment, as applied to the States through the Fourteenth Amendment, protects commercial speech from unwarranted governmental regulation. Commercial expression not only serves the economic interest of the speaker, but also assists consumers and furthers the societal interest in the fullest possible dissemination of information. In applying the First Amendment to this area, we have rejected the “highly paternalistic” view that government has complete power to suppress or regulate commercial speech. “[P]eople will perceive their own best interests if only they are well enough informed, and … the best means to that end is to open the channels of communication rather than to close them… .” Even when advertising communicates only an incomplete version of the relevant facts, the First Amendment presumes that some accurate information is better than no information at all.
Nevertheless, our decisions have recognized “the ‘commonsense’ distinction between speech proposing a commercial transaction, which occurs in an area traditionally subject to government regulation, and other varieties of speech.” The Constitution therefore accords a lesser protection to commercial speech than to other constitutionally guaranteed expression. The protection available for particular commercial expression turns on the nature both of the expression and of the governmental interests served by its regulation.
The First Amendment’s concern for commercial speech is based on the informational function of advertising. Consequently, there can be no constitutional objection to the suppression of commercial messages that do not accurately inform the public about lawful activity. The government may ban forms of communication more likely to deceive the public than to inform it, or commercial speech related to illegal activity.
If the communication is neither misleading nor related to unlawful activity, the government’s power is more circumscribed. The State must assert a substantial interest to be achieved by restrictions on commercial speech. Moreover, the regulatory technique must be in proportion to that interest. The limitation on expression must be designed carefully to achieve the State’s goal. Compliance with this requirement may be measured by two criteria. First, the restriction must directly advance the state interest involved; the regulation may not be sustained if it provides only ineffective or remote support for the government’s purpose. Second, if the governmental interest could be served as well by a more limited restriction on commercial speech, the excessive restrictions cannot survive….
In commercial speech cases, then, a four‐part analysis has developed. At the outset, we must determine