FDA Warns Food and Beverage Companies Their Products May Be Seized If Labeling Claims Continue to Violate the Law
Taking aim at companies that make (i) nutrient content claims on foods and beverages intended for children younger than age 2, (ii) 0 gram trans fat claims on products high in saturated fats, and (iii) health-related claims, such as the treatment or mitigation of disease, the Food and Drug Administration (FDA) has issued warning letters to 17 companies and an open letter to industry indicating that it will crack down on false or misleading labeling and marketing claims.
Among the targeted companies are Dreyer’s Ice Cream, Inc. (ice cream—no trans fat), Beech-Nut Nutrition Corp. (baby food—nutrient claims for children younger than age 2), Nestle (Juicy Juice products—implied 100 percent juice for juice blends with added flavors), Pompeian, Inc. (olive oil—treat, prevent and cure diseases), Redco Foods (green tea—antioxidants effective in the prevention of cardiovascular disease), and Diamond Food, Inc. (shelled walnuts—omega-3 claims about treating, preventing or curing diseases). Some of the companies are currently defending litigation filed by plaintiffs who allege they are making misleading labeling claims.
According to FDA Commissioner Margaret Hamburg, the companies have been notified that “their labels are in violation of the law and subject to legal proceedings to remove misbranded products from the marketplace,” including seizure or injunction. The action is part of Hamburg’s goal to improve “the scientific accuracy and usefulness of food labeling.” She notes that the examples provided by the targeted companies “are not indicative of the labeling practices of the food industry as a whole,” which, she senses, has a “strong desire . . . for a level playing field and a commitment to producing safe, healthy products.” The warning letters, sent at the end of February 2010 and made public on March 3, were intended to “give food manufacturers further clarification about what is expected of them as they review their current labeling.” Hamburg indicates that the agency will “soon issue new draft guidance relating to front-of-pack calorie and nutrient labeling.”
The Center for Science in the Public Interest (CSPI) called the agency’s action “a loud and clear signal to industry that time is running out on misleading health-related claims on labels.” While the consumer watchdog welcomed the initiative, it warned, “unless the FDA uses its authority to issue new, industry-wide regulations to prevent such abuses, the agency will forever be playing a game of Whack-A-Mole with companies that use deceptive labeling.”
According to news sources, several of the targeted companies have indicated they will change their labels and websites promptly, while at least one company, POM Wonderful, contended that all of its product claims “are true and supported by unprecedented scientific research. Once FDA reviews and better understands the substantial science, we are confident that the agency will agree with our position.” See FDA Press Release, CSPI Statement, The New York Times, March 3, 2010; The Washington Post, March 4, 2010.
In a potentially related development, The Wall Street Journal reports that FDA plans to increase prosecutions of food industry executives in an effort to revamp its criminal division. The article cites a Government Accountability Office (GAO) report that calls for the agency to strengthen oversight of its Office of Criminal Investigations (OCI) to improve its effectiveness as an enforcement tool. Also quoted is an FDA letter to Senator Chuck Grassley (R-Iowa) stating that an internal committee has recommended that FDA and its investigations arm “increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool.”
According to GAO’s “Food and Drug Administration: Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal and Misconduct Investigations,” FDA funding and staffing of OCI has increased significantly since 1999, with a corresponding increase in investigations and workload, but communications between the investigations arm and senior-level agency officials is not ideal and has led to a lack of accountability. FDA has agreed with GAO’s recommendations to (i) “regularly monitor OCI” and (ii) “establish performance measures for OCI to assess whether OCI is achieving its desired results.” FDA’s letter to Senator Grassley reportedly said that the agency is looking for the OCI to share information with FDA leaders on a regular basis and to pick better cases
The WSJ article notes that a federal appeals court judge “slammed the government” in 2009 for its investigation and prosecution of a salad-dressing wholesaler who changed the labels on 1.6 million bottles of salad dressing to extend their “best when purchased by” date. A lower court had convicted the wholesaler for misbranding, but the appeals court reversed, finding no applicable regulations, as well as “improper,” “inadmissible” and “incoherent” testimony on the part of an FDA employee. Additional information about the case appears in issue 296 of this Update. See The Wall Street Journal, March 4, 2010.