WASHINGTON — The Food and Drug Administration cautioned food manufacturers their use of "sugar-free" claims must conform to long-established regulations or they will risk penalties that could include seizure of products or even injunctions requiring offenders cease operation.
The Sept. 4 guidance took the form of a "Dear Manufacturer" letter from Dr. Barbara O. Schneeman, director, Office of Nutritional Products, Labeling and Dietary Supplements in the Center for Food Safety and Applied Nutrition at the F.D.A. It reminded manufacturers that food products bearing "sugar-free" claims are required to bear additional calorie statements or else advise consumers that the food is "not a low-calorie food," "not a reduced-calorie food," or "not for weight control."
The F.D.A. letter was issued because the agency has seen an increase in the use of sugar-free claims on the labels of foods that do not meet the requirements for providing additional information about the caloric content of the food, an F.D.A. spokesman told Food Business News.
"As part of our continuing effort to reduce the incidence of obesity in the U.S., the F.D.A. wants to ensure consumers are provided with the label information they need to make informed choices for maintaining a healthy diet," Dr. Schneeman said in her letter. "We are highlighting accurate claims about the absence of sugar as a regulatory priority. The agency intends to take appropriate action against products we encounter that bear a claim about the absence of sugar (i.e. ‘sugar free’) but that fail to meet each of the requirements of the regulation that defines ‘sugar free.’ We intend to pay particular attention to those foods that are required to bear a disclaimer statement under the regulation that defines ‘sugar free,’ but that fail to do so or otherwise fail to comply with the regulation."
"Sugar free" is defined in F.D.A. regulations as a nutrient claim that may be used on a food that contains less than 0.5 grams of sugars per reference amount customarily consumed per labeled serving. For a food that meets the definition of a "meal," the food also must contain less than 0.5 grams of sugars per labeled serving.
Also, foods bearing a "sugar-free" claim may not contain any ingredient that is a sugar or that is generally understood by consumers to contain sugars, unless the listing of the ingredient in the ingredient statement is followed by an asterisk that refers the consumer to an explanation appearing below the list of ingredients. The explanation must indicate the ingredient "adds a trivial amount of sugar," "adds a negligible amount of sugar," or "adds a ‘dietarily’ insignificant amount of sugar."
"F.D.A. has historically taken the position that consumers may associate claims regarding absence of sugar with weight control and with foods that are low calorie or that have been altered to reduce calories significantly," Dr. Schneeman said. "Therefore, the definition of ‘sugar free’ includes the requirement that any food that is not low or reduced in calorie disclose that fact. Without such information, some consumers might think the food was offered for weight control."
To avoid such confusion, the definition of "sugar free" includes the requirement that the food either be labeled with the claim "low calorie" or "reduced calorie," or if the food does not qualify for those claims, its "sugar-free" claim must be immediately accompanied, each time it is used, by one of the following disclaimer statements: "not a reduced-calorie food," "not a low-calorie food," or "not for weight control." The disclaimer statement must be conspicuously displayed and in no case may the letters be less than one-sixteenth inch in height.
A "warning letter" the F.D.A. sent to a New York bakery on Aug. 29 regarding its cookie assortment provided an example of how the agency will proceed when it discovers a violation. The New York baker was advised its use of the "sugar-free" claim for its cookie assortment product constituted "misbranding."
"The product label declares ‘sugar free’ on the principal display panel, but fails to label the required disclaimer statement ‘not a low-calorie food,’ ‘not a reduced-calorie food,’ or ‘not for weight control,’" the F.D.A. told the baker. "The disclaimer statement is required because your product does not meet the requirements to bear a ‘low-calorie’ claim and your product does not bear a ‘reduced-calorie’ claim or other relative claim of special dietary usefulness."
The F.D.A. told the bakery it had 15 working days to advise the agency on how the violations would be corrected. The agency warned, "We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating."
This article can also be found in the digital edition of Food Business News, September 18, 2007, starting on Page 30. Click