FTC EVALUATING FDA FOOD REGS TO PROVIDE GUIDANCE TO CONSUMERS AND INDUSTRY

FTC EVALUATING FDA FOOD REGS TO PROVIDE GUIDANCE TO CONSUMERS AND INDUSTRY on how the two agencies are "harmonizing" enforcement activities, Federal Trade Commission Chairperson Janet Steiger informed the House Energy and Commerce/transportation and hazardous materials subcommittee. At a May 26 hearing on FTC reauthorization legislation, Steiger reported that FTC staff "is in the process of reviewing the FDA and USDA regulations to determine the most appropriate manner of providing guidance to consumers and industry regarding harmonization of its food advertising enforcement." Steiger explained that FTC "believes there should be a consistent and coordinated approach among the federal agencies responsible for the regulation of food advertising and labeling." She noted that FDA promulgation of food labeling regulations implementing the Nutrition Labeling & Education Act "presents the commission with the task of harmonizing its food advertising enforcement policy with the FDA regulations for labeling." The U.S. Department of Agriculture has issued separate food labeling regs relating primarily to meat and poultry. FTC has submitted comments to FDA on the NLEA regulations. Steiger emphasized to the subcommittee that "a principal focus" of FTC's advertising enforcement program is on "health and nutritional claims for foods." The FTC official pointed out that the commission has "challenged allegedly deceptive claims for various weight loss pills products and plans." Those challenges led to consent agreements with Abbott Labs, United Weight Control Corp. and Health Management Resources in March. The consent orders stipulate that the firms can no longer represent their low calorie (less than 800 per day) weight loss programs "as either unqualifiedly free of health risks or safe" or as "successful, long-term treatments for obesity." Another recent case brought by FTC was an April consent agreement with Nature's Cleanser preventing the company from making unsubstantiated weight loss claims for herbal tablets ("The Tan Sheet" April 26, p. 9). FTC also "seeks to ensure that taxpayer-funded programs do not face anticompetitive activities that may increase prices to consumers," Steiger reported. A recent example of this, she said, was the complaint filed against infant formula manufacturers Mead Johnson, Abbott Labs and American Home Products in July 1992. "An area of great concern" to FTC also is the "proliferation of advertisements touting the environmental benefits of products," because surveys have illustrated that "green claims" are material to consumers' purchasing decisions, Steiger said. FTC issued a guide for use of environmental marketing claims in July 1992 to help reduce consumer confusion and prevent deception in use of environmental terms including "recyclable," "degradable," and "environmentally friendly" in advertising and labeling. At a May 26 session of the HBA '93 Global Expo in New York City, FTC attorney Sue Cohn reiterated that "the prevention of deceptive environmental claims continues to be a priority at the Federal Trade Commission, and I think you will continue to see the commission challenging ads that misrepresent the environmentally beneficial qualities of products." In a recent report, the Environmental Protection Agency observed that environmental marketing claims for OTCs and other H&BAs declined in the first half of 1992, perhaps due to confusion generated by lawsuits, state regs and a lack of federal guidelines ("The Tan Sheet" April 26, p. 17). Steiger wrapped up her testimony by supporting the basic provisions of the FTC reauthorization bill, HR 2243, introduced by Rep. Al Swift (D-Wash.). Reauthorization would "confirm that Congress believes in our mission," Steiger maintained, and would ensure that FTC has the "resources it needs to fulfill that mission." Among its provisions, HR 2243 would allow FTC orders to become effective 60 days after the order is served regardless of any petition for review, and authorize FTC to use civil investigative demands to supplement its subpoena authority in antitrust investigations. Steiger urged for the inclusion of three additional provisions not contained in the bill. They would include: "broadening the venue for district court actions brought" by FTC; "expanding the commission's civil investigative demand authority to permit it to compel production of physical evidence"; and authorizing FTC "to prosecute criminal contempt actions against defendants who violate court orders resulting from actions filed by the commission." Highlighting the work of FTC, Steiger told the subcommittee that in fiscal year 1992, FTC approved 54 consumer protection administrative consent agreements and filed 29 complaints in federal district courts that were still pending at the end of the year. From October 1992 through March 1993, FTC accepted 41 administrative consumer protection consent agreements, issued one administrative complaint, filed 11 district court actions that are still pending, obtained 15 civil penalty judgments totaling over $ 673,000 and obtained consumer redress or disgorgement judgments totaling over $ 9.2 mil. in 12 cases. FTC continues to collaborate with FDA on a study to examine consumer understanding of terminology used in labeling and advertising for over-the-counter drugs. Speaking at a May 24 meeting of the Drug Information Association in Philadelphia, FDA Office of Health Affairs Medical Staff Director Peter Rheinstein, MD, said that the "research protocol of this study is separated into a labeling component and an advertising component." The labeling effort will "examine in- depth consumers' understanding and interpretation of selected phrases and terms used in existing OTC drug labels," Rheinstein said, such as "take as directed," "strongest dose available without a prescription," "see your health professional," "decongestant," and "cough suppressant." The labeling component also will attempt to gauge whether consumers with certain medical conditions such as high blood pressure, pregnancy or aspirin sensitivity "understand and usually comply with warning statements on OTC drug labels that may apply specifically to them," Rheinstein told the DIA audience. He added that an advisory group "has been assembled to provide advice about the subject to FDA and FTC." Members of the advisory panel include reps from the Association of American Advertising Agencies and the American Association of Retired Persons, as well as congressional staffers and academics in pharmacy and marketing, Rheinstein said. FDA is funding most of the study, which will be conducted by Washington, D.C.-based research firm Market Facts.