FDA Commissioner Margaret Hamburg, MD made good on her promise that nutrition labeling would be a top priority for the Food and Drug Administration (FDA), when, on March 3, 2010, the agency issued Warning Letters to 17 food manufacturers for violations of the Food, Drug, and Cosmetic Act's labeling requirements. Importantly, Dr. Hamburg noted in a letter to the industry that the Warning Letters address some, but not all, of the agency's concerns about labels that may be false and misleading.

Immediate Impact on Industry

FDA's actions are significant in that the violations cited in the Warning Letters do not involve flagrantly egregious claims, nor do the alleged violations pose any immediate consumer safety risks. Rather, for the most part the agency is objecting to dietary descriptors which it believes mislead consumers with respect to their dietary choices. FDA enforcement against these types of violations has not been seen on a wide scale for many years, and it is likely that many other food manufacturers currently use labeling claims that could likewise draw objection from FDA. Thus, it is imperative that food companies undertake prompt and comprehensive compliance assessments of their product labeling to avoid being caught up in future FDA enforcement roundups.

The Details

FDA sent Warning Letters to Dreyers Grand Ice Cream, Inc., Gorton's, Inc., Schwan's Consumer Brands, Spectrum Organic Products, Inc., Beech-but, PBM Products, Nestle, Nestle Nutrition, Redco Foods, Sunsweet Growers, Fleminger Inc., POM Wonderful, Ken's Foods, Inc., Pompeian, Inc., Diamond Food, Inc., First Juice, Inc., Want Want Foods and Nature's Path Foods, Inc.

The agency cited, among others, the following violations of the Food, Drug, and Cosmetic Act:

  • Product labels claiming "no trans fat" do not include the required disclosure that the product has high levels of saturated or total fat;  
  • Product labels on food for children under two include impermissible nutrient content claims that have only been approved for use on food for adults;  
  • Product labels claim products contain 100% juice when, in fact, they are juice blends with flavors added;  
  • Product labels claims the food treats or mitigates disease despite not being approved as a drug; and  
  • Product labels claiming that foods are "healthy" or otherwise nutritious and beneficial to health without meeting the legal requirements for these claims.  

Recipients of Warning Letters have 15 days to respond to FDA identifying the corrective action they intend to take.

Future Impact

FDA's press release indicated that the agency will issue guidance in the near future, as part of its "front-of-package" labeling initiative, directing nutrient and calorie labeling to be placed on the front of food packages. In addition, in her letter to the industry, Dr. Hamburg indicated that the agency will also be issuing a draft guidance for nutritional criteria that should be included on labeling that makes "dietary guidance" statements.

Clearly, this issue is a high priority for the agency, and it intends to make substantial changes to food package labeling requirements as they currently exist.