On regularity and regulation, health claims and hype.
Subject: Food industry (Laws, regulations and rules)
Food industry (Marketing)
Food labeling (Laws, regulations and rules)
False advertising (Laws, regulations and rules)
Natural foods (Marketing)
Author: Marks, Jonathan H.
Pub Date: 07/01/2011
Publication: Name: The Hastings Center Report Publisher: Hastings Center Audience: Academic; Professional Format: Magazine/Journal Subject: Biological sciences; Health Copyright: COPYRIGHT 2011 Hastings Center ISSN: 0093-0334
Issue: Date: July-August, 2011 Source Volume: 41 Source Issue: 4
Topic: Event Code: 930 Government regulation; 940 Government regulation (cont); 980 Legal issues & crime; 240 Marketing procedures Advertising Code: 94 Legal/Government Regulation Canadian Subject Form: Food labelling Computer Subject: Food and beverage production/distribution software; Government regulation; Company marketing practices
Product: Product Code: 2001000 Health Foods NAICS Code: 311 Food Manufacturing
Organization: Government Agency: United States. Food and Drug Administration; United States. Food and Drug Administration
Geographic: Geographic Scope: United States Geographic Code: 1USA United States
Accession Number: 268403457
Full Text: There is "a broad trend in the food industry--using nutrition-related claims to market products when the scientific substantiation that consumers will actually benefit is weak or non-existent.... Going after them one-by-one with the legal and resource constraints [that the Food and Drug Administration] work[s] under is a little like playing Whac-a-Mole, with one hand tied behind your back." (1)

These are not the words of a harsh critic of the Food and Drug Administration. They were penned by the agency's deputy commissioner for food. That this is an insider's view makes it all the more troubling.

Recent studies suggest that roughly half the products on supermarket shelves proclaim their purported health benefits. (2) But a trip to the supermarket suggests that this is a conservative estimate. The FDA is not powerless to regulate these claims, but it operates in a regulatory framework that is the product of piecemeal reform and compromise, not intelligent design. And its limited staff resources and budget further constrain what it can do.

The food industry is required to seek prior approval from the FDA only for a small subset of labeling claims regarding the purported health benefits of foods or ingredients. These claims, formally known as "health claims," describe the relationship between a food or food component and a disease or health-related condition. (3) One example from the cereal aisle: "Diets low in saturated fat and cholesterol that include soluble fiber from whole oats may reduce the risk of heart disease."

For several years, the FDA approved a health claim only when it concluded that there was "significant scientific agreement" among qualified experts to support it. However, after this approach was held to be inconsistent with the First Amendment, (4) the FDA began to permit "qualified health claims" in the absence of significant scientific agreement if the claim's potential to mislead could be negated by qualifying language that, for example, describes research as "supportive but not conclusive" or "very limited and preliminary."

Health claims--and qualified health claims, in particular--are increasingly less attractive to industry. The approval process confers no intellectual property rights, so if a company can martial the evidence needed to petition the FDA successfully, its competitors can ordinarily use the approved claim, too. Consumers may also find reading about heart disease and cancer on a food label disconcerting, even if it suggests ways to reduce their risks. And qualifications add verbiage to the claim, rightly making it sound somewhat unconvincing.

Far more attractive to industry are claims that purport to describe a nutrient or ingredient's impact on a structure or function of the body. A familiar example of these "structure/function claims" is the claim that calcium "helps build strong bones." But Dannon made perhaps the most high-profile recent claim--that its Activia yogurt "relieves temporary irregularity" and helps with "slow intestinal transit time." This claim was illustrated on the label by a downward arrow over a slender abdomen. One of the related commercials so captured the nation's attention that it elicited a Saturday Night Live parody.

Structure/function claims on food labeling do not need to be submitted in advance for approval by the FDA. Once the product hits the shelves, the agency can call on the manufacturer to remove the claim, pursuant to the general statutory requirement that food labeling must not be "false or misleading in any particular," but the FDA has the burden of showing that the claim is false or misleading, and it has no subpoena powers; it cannot demand that a manufacturer provide evidence to support the claim. Although the FDA issued seventeen warning letters to various food manufacturers between December 2009 and February 2010, none addressed structure/function claims. And according to a recent report by the General Accountability Office, FDA officials were able to identify only two warning letters in the last decade that expressed concern about such claims. (5) An open letter from the commissioner of the FDA to the food industry in March 2010 complains that--despite an earlier letter lamenting "the number and variety of label claims that may not help consumers distinguish healthy food choices from less healthy ones and, indeed, may be false or misleading"--the FDA "continue[s] to see products marketed with labeling that violates established labeling standards." (6) However, the food industry might argue that the FDA has never given any formal guidance about the evidence necessary to substantiate structure/function claims.

Labeling and Advertisements

In recent months, some informal guidance has emerged as a result of vigorous enforcement from another agency, the Federal Trade Commission. Since 1954, the FDA and the FTC have operated under a Memorandum of Understanding that gives the FDA primary responsibility for regulating food labeling and the FTC primary responsibility for food advertising. In 2010, the FTC issued a complaint against Dannon in relation to Activia and another product, charging that its ads were deceptive because the company could not substantiate several claims, including the one that Activia would improve regularity. (7) The FTC took action pursuant to its power to regulate "unfair or deceptive acts or practices" and "any false advertisement" of food that is "misleading in a material respect." Unlike the FDA, the FTC can call on a food company to turn over the evidence it has to substantiate its claims. In assessing this evidence, the FTC applies a "competent and reliable scientific evidence" standard.

When the FTC reviewed the relevant evidence for Activia, it concluded that eating one serving was "not clinically proven to relieve temporary irregularity and help with slow intestinal transit time," as the manufacturer had claimed. Dannon agreed to pay the FTC $21 million for this and related violations. The company also signed a consent order in which it agreed that--absent further evidence to support the single-serving claim--it would convey to consumers that three yogurts a day were necessary to obtain the purported regularity benefit.

The order covers the use of claims in labeling as well as in advertising. It is also remarkable for the detailed description of the evidence necessary to satisfy the FTC. To make good on the single-serving claim, Dannon must have two randomized, double-blind, placebo-controlled human clinical studies of Activia yogurt or an essentially equivalent product, conducted by different researchers independently of each other, "whose results, when considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate" the claim.

Although the order is not binding on other industry actors, it does offer some informal guidance as to the kind of evidence the FTC might require from them. In the FTC's version of Whac-a-Mole, it is possible that fewer whacks will be required given this guidance--and the substantial fines imposed. But manufacturers may be at risk only if they accompany their labeling claims with high-profile advertising campaigns.

Reform: European Lessons

The GAO recently recommended that Congress give the FDA the power to obtain access to a food company's evidence in support of structure/ function claims (and other potentially false or misleading claims on labeling), and it has asked the FDA to issue guidance to food companies regarding the type and strength of evidence necessary to support such claims. As Congress and the FDA consider how to respond to these recommendations, they should look at recent developments under the European Union's new regime governing health and nutrition claims in both labeling and advertising. (8)

The "health claims" category is broader in the European Union, and it encompasses claims that in the United States are considered structure/function claims. As a result, food companies must submit evidence and obtain approval for them in advance. European regulators recently informed the GAO that more than 85 percent of these claims have been rejected. First amendment jurisprudence might not permit Congress or the FDA to adopt a similarly strict approach. But it should be permissible for the FDA to review and approve structure/function claims in advance and, where appropriate, insist on qualifying language that circumscribes the claim or explains the limited nature of the supporting evidence. Congress would, of course, need to give the FDA the power and resources to discharge this task.

Poorly regulated claims regarding the health benefits of foods may seldom present acute health risks. But they can mislead consumers, who are generally not in a position to differentiate between the different types of claims and recognize which of them have been approved by the FDA. Moreover, claims about health benefits can lead to substantial dietary changes that may cause harm in the medium or long term. For instance, consuming three yogurts a day would add hundreds of calories to a diet and could cause significant weight gain. There may be other adverse effects, too, although there are no incentives for researchers to explore them.

The U.S. government issues new dietary guidance every five years, but the food industry tells us what to eat every day. So long as food companies purport to advise us on nutrition and health, we will need regulators--including a stronger and better-resourced FDA--to protect us from the hype.

Acknowledgments

The Rock Ethics Institute at Penn State and the Edmond J. Safra Center for Ethics at Harvard University provided generous support for this research. I am also grateful to Donald B. Thompson and Stephanie Woods for their invaluable scholarly contributions.

(1.) M. Taylor, "How the FDA Is Picking Its Food Label Battles," The Atlantic, July 19, 2010, http://www.theatlantic.com/life/ archive/2010/07/how-the-fda-is-picking-itsfood-label-battles/59927/.

(2.) S.E. Colby et al., "Nutrition Marketing on Food Labels," Journal of Nutrition Education and Behavior 42, no. 2 (2010): 92-98.

(3.) Food and Drug Administration, "Claims That Can Be Made for Conventional Foods and Dietary Supplements," 2003, http://www. fda.gov/food/labelingnutrition/labelclaims/ ucm111447.htm.

(4.) Pearson v. Shalak, 164 F.3d. 650 (D.C. Cir. 1999).

(5.) General Accountability Office, GAO-11102, "Food Labeling: FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims," January 2011, http://www.gao.gov/new.items/d11102.pdf.

(6.) M. Hamburg, Open Letter to Industry, March 3, 2010, at http://www.fda.gov/food/ labelingnutrition/ucm202733.htm.

(7) Federal Trade Commission, File No. 0823158, "In the Matter of The Dannon Company, Inc.," http://www.ftc.gov/os/caselist/0823158/index.shtm.

(8.) Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on Nutrition and Health Claims Made on Foods, http://eur-lex.europa. eu/LexUriServ/LexUriServ.do?uri=CONSLE G:2006R1924:20100302:EN:PDF.
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