On March 3, 2010, the US Food and Drug Administration (FDA) published 17 Warning Letters the agency recently issued to various food companies, including, in part, Nestle, Gorton’s, Beechnut, Ken’s Foods, and Redco, for making unauthorized health claims and nutrient content claims on the labeling of several of their various food products. The publication of these enforcement actions is intended to underscore FDA’s continued commitment to food labeling compliance, particularly with respect to nutritional claims.

On March 3rd, FDA Commissioner Margaret Hamburg also published an open letter to the food industry, which stated that “access to reliable information about the calorie and nutrient content of food is important, given the prevalence of obesity and dietary related diseases in the US.” Noting that the use of nutritional symbols and nutritional claims on the principal display panel of food products (aka, “front-of–pack” labeling) had grown rapidly in recent years, Commissioner Hamburg announced that FDA plans to issue draft guidance in the near future relating to front-of-pack calorie and nutrient content labeling. FDA also plans to issue a second draft guidance that would recommend nutritional criteria for foods that make “dietary guidance” statements (e.g., “eat two cups of fruit a day for good health”). A link to Commissioner Hamburg’s letter to industry may be read by clicking http://www.fda.gov/Food/LabelingNutrition/ucm202733.htm

Several of the common violations FDA cited in the 17 Warning Letters published yesterday include the following:

  • The use of a nutrient content claim on the front panel that a product contains no “trans fats”, is misleading when the claim is not accompanied by a statement (eg., “See nutrition information for fat content”) disclosing that the product contains high levels of either “saturated fat,” “total fat,” or “sodium.”
  • Misleading “healthy” claims that appear on foods that do not meet the well-established definition for use of that term.
  • Nutrient content claims, such as “no added refined sugar” and “added vitamins and minerals”, appearing on products intended for children under 2 years of age. Such claims are not permitted because appropriate dietary levels have not been established for children in this age range.
  • The product makes claims such as “full of nutritious antioxidants” but does not meet the requirements for making the claim – (i) an RDI must be established for each nutrient that is the subject of the claim; and (ii) the level of each subject nutrient in the product must be sufficient to justify the claim (e.g., to make the claim “high in antioxidant vitamin c,” the product must contain 20 percent or more of the RDI for vitamin c).

In light of Commissioner Hamburg’s continuing interest in promoting nutritional labeling compliance, we expect FDA compliance officers will continue to closely monitor food labeling and issue Warning Letters to companies when food labeling violations are uncovered.