Todd Harrison06.01.04
Navigating The Low-Carb Market From A Claims Perspective
Low-carb mania is sweeping across America, bringing with it a tremendous amount of uncertainty when it comes to claims.
By Todd Harrison
The low-carb craze is in full swing and everyone wants to make claim regardless of the level of carbohydrates in their products. However, FDA has yet to address the scope of these claims in any coherent policy guide. Of course, the agency is keenly aware of the proliferation of such claims and has indicated its intention to initiate rulemaking proceedings for nutrient content claims for carbohydrates by the end of the year. In the meantime, it does not appear that FDA will engage in any enforcement action against companies anytime soon, especially if the claims appear to be truthful and not misleading.
Regulatory Status of Carbohydrate Nutrient Content Claims
FDA recently acknowledged the importance of providing consumers with accurate and helpful information regarding carbohydrate content claims. As such, it has been working closely with the USDA’s Food Safety and Inspection Service (FSIS) regarding the use of carbohydrate-related claims on the label, as well as the labeling of food products that contain meat or poultry. While FDA has not publicly acknowledged its agreement with the policy developed by FSIS, it is likely that FSIS would not have issued the document without FDA’s tacit concurrence.
Earlier this year, FDA’s Working Group on Obesity (WGO) issued, as part of its report on obesity, recommendations that address the issue of carbohydrate content claims. The WGO noted that carbohydrate nutrient content claims are becoming commonplace in the market. However, the WGO also recognized that these claims varied greatly and that FDA needed to clarify the regulatory status of these claims. The WGO recommended that FDA file three recently submitted petitions related to nutrient content claims and that it also publish a proposed rule during the summer of 2004 to provide for nutrient content claims for carbohydrates. The WGO also recommended that FDA provide guidance on the use of the term “net” with respect to carbohydrate content.
FSIS’s Carbohydrate Guidance Document
FSIS has determined that some carbohydrate content claims may be used on product labels that do not characterize the level of carbohydrates in a meat or poultry product. These claims include:
•Statements not expressing or implying a specific level of carbohydrates, e.g., “carb conscious” or “carb wise”;
•Carbohydrate content calculations on meat and poultry product labeling, provided the calculations are explained adequately on the labeling, e.g., X grams of carbs;
•Terms including “net carbs,” “effective carbs” and “net impact carbs”, so long as they are truthful and not misleading, and the label defines the meaning of “net carbs”; and
•“Low Carb” claims at this time are not permitted.
Grocery Manufacturers of America’s (GMA) Petition
GMA requested that FDA establish the following definitions:
GMA proposes that “carbohydrate free” be defined as less than 0.5 g per serving and per reference amount customarily consumed (RACC).
GMA petition would define “low carbohydrate” as being 3% or less of the daily reference value (“DRV”).
ConAgra Foods’ (ConAgra) Petition
The proposed definition of “carbohydrate free” is the same in the ConAgra petition as it is in the GMA petition (individual foods - less than 0.5 g per serving and per RACC).
“Low carbohydrate” is defined as 6 g or less (2% of the daily value (DV)) per labeled serving and per RACC, and not more than 50% calories deriving from carbohydrates.
ConAgra proposes that FDA require the use of a disclaimer (“not a low calorie food”) and a rationale (the calculation that was used to derive the “net” value and the rationale for choosing this method of calculation) with all “net carb”-type claims.
Kraft Foods’ (Kraft) Petition
Kraft proposed that “carbohydrate free” (and its equivalents “free of carbohydrate,” “no carbohydrate,” “without carbohydrate,” “trivial source of carbohydrate,” “negligible source of carbohydrate” and “dietarily insignificant source of carbohydrate”) may be used on food labeling, provided that, in the case of individual foods, it contains less than 0.5 g carbohydrate per RACC and per labeled serving.
For such phrases as “low carbohydrate,” “few carbohydrates,” “contains a small amount of carbohydrate,” “low source of carbohydrate,” and “low in carbohydrate,” Kraft proposed that the carbohydrate level not exceed 6 g.
Where does a Company Go from Here?
It is clear that more and more companies intend to make “low carb” claims regardless of the regulatory status of such claims with FDA. Indeed, many companies are already using the phrase “low carb” and other similar phrases on their labeling and in advertising. However, there are no clear rules in place at the moment regarding the regulatory status of such claims and FDA’s enforcement action can be described, at best, as spotty. In fact, the number of warning letters issued does not appear, at this time, to represent extensive FDA enforcement action in this area.
The following provides recommendations as to how to avoid any FDA or FTC issues over carbohydrate nutrient content claims:
Instead of using the phrase “low carb”, consider using “compatible with carb-controlled diets” or “suitable for carb-controlled diets” or “carb-conscious or carb-wise”.
Alternatively, simply state that the product contains ___ grams of carbs, followed by the fiber content. Limit the claims to product labels that have a net carb content of 10 grams or less. In calculating the net carb content, include all ingredients that contain carbohydrates. If more aggressive claims are desirable, consider making them in advertising rather than labeling.NW