The Food and Drug Administration (FDA) appears ready to release a proposal to define “low carb.” In an August speech to the National Press Club, Acting FDA Commissioner Lester Crawford stated, “Later this fall, we are going to take another important step forward by helping to demystify carbohydrates. Consumers are confused when they see the terms low carb and net carb, so FDA will be publishing a proposed rule and providing guidance regarding claims on the carbohydrate content of foods.”
What is the agency considering in its drafting of the proposal? In a July speech to the food industry, Crawford stated, “We’re evaluating petitions from food manufacturers that want to label nutrient content claims for the carbohydrate content of foods. We plan to define such terms as net, low and impact that would provide consumers with more accurate information when shopping for food.”
Claims about the level of carbohydrates in food and dietary supplements are currently not permitted because FDA has not defined them. FDA has defined “low” claims for calories, total fat, saturated fat, cholesterol, sodium and sugars. Without an FDA recognized definition, any company currently marketing a product with such a carbohydrate content claim is using its own definition of what the claim means. There is no standardization and consumers cannot rely on label claims without carefully examining the entire product label.
In the Warning Letter to Peak Performance Foods, FDA did not object to the claim, in and of itself, as it had in previous Warning Letters, but rather objected to the fact that the company was claiming that its products were low carb when in fact, an FDA comparison revealed the products contained the same or similar amounts of carbohydrates as competing products. Thus, the company’s products were not “lower” in carbohydrates then other comparable products. The company’s products contained 7.5 g and 9.6 g of carbohydrates while competitors’ products contained carbohydrates in a range of from 0 g to 13.5 g. The letter did not address what level of carbs should actually be the limit for a low carb claim.
This type of Warning Letter serves almost as an acknowledgment by the agency that low carb claims convey important consumer information and that they are here to stay.
In terms of other agencies, there is an ongoing low carb beer war. On April 8, 2004, the Alcohol and Tobacco Tax and Trade Bureau, issued an interim ruling (TTB Ruling 2004-1) to provide guidance to the alcoholic beverage industry for advertising and labeling claims relating to caloric and carbohydrate claims. Under the interim ruling, which could be set higher or lower after actual rulemaking is completed, the term “low carbohydrate” has been set at no more than 7 g of carbohydrate per serving (12 fl. oz. for malt beverages, 5 fl. oz. for wine, and 1.5 fl. oz. for distilled spirits). Products that contain more than 7 g of carbohydrate per serving, but that are lower in carbs than regular versions of comparable products made by that alcohol producer, may use such statements as “reduced carbohydrate” or “lower carbohydrate,” provided the claim contains specific and accurate comparison information such as, “Reduced Carbohydrate: 10 grams of carbohydrates per 12 fl. oz serving—40 percent fewer than in our [Brand name] malt beverage.” Abbreviations such as “96 calories and 2.4 carbs per 12 fl. oz serving” will also be permitted.
The Food Safety and Inspection Service (FSIS) issued a Statement of Interim Policy on Carbohydrate Labeling Statements in December 2003. FSIS regulates labels and labeling for meat and poultry products. According to FSIS, “Because there are no existing regulations permitting the use of carbohydrate claims on foods governed by the FSIS, labeling of meat and poultry products bearing expressed carbohydrate claims, including, but not limited to, ‘Low Carbohydrate,’ ‘Lower Carbohydrate’ and ‘Carb Free,’ cannot be approved.” The agency will prohibit labeling for meat and poultry products bearing claims that imply the level of carbohydrate in a product is low or place significance on a specific level of carbohydrates (i.e., “Just X grams carbs”).
FSIS will, however, permit for the use of certain limited claims such as “Carb Conscious” or “Carb Wise” that do not expressly state or imply a specific level of carbohydrates. FSIS will also not object to terms such as “Net Carbs,” “Effective Carbs” and “Net Impact Carbs” when used in a manner that is truthful and not misleading, as long as such terms are accompanied by specific information concerning the meaning of the term and providing the calculation necessary to determine the number of carbohydrates included by the term. Finally, “Terms such as ‘Low Carbohydrate’ may be used in ad copy on labeling in conjunction with terms used to describe a diet or lifestyle (not a particular food or product), provided they are used in a manner that is truthful and not misleading.”
Unlike the food labels and labeling regulated by FDA, FSIS approves all meat and poultry labels prior to their use. Thus, all labels bearing carbohydrate references would need to be sent to the FSIS’s Labeling and Consumer Protection Staff for evaluation and approval before use.
Turning back to the question of what form FDA’s proposed carbohydrate regulations might take, FDA is considering industry submissions in the drafting of its proposal.
In very simple terms, petitions submitted to the agency by industry generally agree a food with less than 0.5g of carbohydrates would qualify as “carbohydrate free.” Petitions by Kraft Foods and ConAgra would set the upper limit for “low carbohydrate” claims at 6 g, while the Grocery Manufacturers of America (GMA) request a 9 g limit. There may also be a limitation on the amount of calories that could be derived from carbohydrates (50 percent is proposed).
At the other end of the scale, “high in” claims requested by the petitions would generally mean a minimum of 10 percent of the Daily Value (DV) or 30 g of carbohydrates. A “good source” claim would mean a minimum of 5 percent of DV or 15 g of carbohydrates—both claims possibly with some limitation on the amount of the carbohydrates that could be from sugars. The petitions also address such things as claims for meals and “main” dish products, as well as definitions when the serving size of a food is small.
On June 22, 2004, the American Bakers Association (ABA) filed comments with FDA in part to voice its concern that the “establishment of nutrient content claims for free, low and reduced carbohydrate claims could be misleading to consumers, making them wrongly think that carbohydrates are not healthy.” Overall, ABA agreed with the other proposals for “low” claims. ABA was concerned with the definition of “high in” carbs, arguing such claims should require at least 40 g per reference amount and “good source” should require at least 20 g per reference amount. It was noted that while most other “high in” claims require the presence of 20 percent of the DV of the nutrient, there exists no food where carbohydrates would be present at 20 percent of the DV per serving (60 g). As to a net carbohydrate statement, ABA suggested such a statement include calorie information, unless the food meets the FDA definition for low calorie.
FDA is considering these petitions as it drafts proposals for carbohydrate content claims. The FDA can grant or deny any part of the petitions, address them collectively, or propose a regulation of its own with entirely different numbers.
In any event, FDA will issue a proposal for nutrient content carbohydrate definitions in the very near future. The proposal will be published in the Federal Register and industry, as well as the general public, will have the opportunity to comment before final regulations are issued and become effective.
Steven Shapiro is a partner in the New York-based law firm Ullman, Shapiro & Ullman LLP (www.usulaw.com). He has 16 years of experience in food and drug regulatory matters and regularly counsels clients in all areas of food and drug law relating to the manufacture and marketing of foods, dietary supplements, drugs, cosmetics and medical devices.