This sample letter is part of the "Calories Count" Documents.
March 12, 2004
Dear Food Manufacturer:
As you are aware, the Food and Drug Administration (FDA) is involved in an initiative to give consumers helpful information that will enable them to make more informed choices about their diets and lifestyle in an effort to reduce the incidence of overweight and obesity in the United States A key component in providing nutrient information to consumers is the "Nutrition Facts" panel on food packages. In order for this nutrition information to be useful to consumers, it must be accurate and based on a meaningful amount of food. After the Nutrition Labeling and Education Act was enacted, thereby mandating nutrition labeling, FDA promulgated regulations that specify how serving size must be derived from an appropriate reference amount for the food commodity in question. We recognize that these regulations are very technical. However, FDA has determined that as part of the Obesity Initiative the agency will highlight accurate serving size declarations on food products as a priority. As a result, FDA intends to take appropriate action against violative products, especially when we encounter products that declare a serving size on its label that is substantially different than what it should be by regulation. Therefore, we are taking this opportunity to remind the food industry about the rules for determining an appropriate serving size.
Manufacturers must use the information provided in Title 21 of the Code of Federal Regulations (CFR) sections 101.9(b) and 101.12 to determine a specific serving size for their products. The process for determining an accurate serving size generally consists of the following steps:
- Locate the appropriate food category and reference amount for your product in the two tables in section 101.12(b) of the food labeling regulations. FDA established Reference Amounts Customarily Consumed (reference amounts or RACC) for many food product categories, and these values represent the amount of food customarily consumed at one eating occasion. Most of the reference amounts are for foods in a ready-to-eat form, (i.e., "as prepared"). If your product, in the form in which it is sold, does not have a reference amount in 21 CFR 101.12, then you must establish an appropriate reference amount for your product. 21 CFR 101.12(c) provides the rules for generating a reference amount for products that require further preparation, such as cooking, or the addition of water or other ingredients; 21CFR 101.12(d) provides the rules for imitation or substitute foods; 21 CFR 101.12(e) provides the rules for aerated foods; and 21 CFR 101.12(f) provides the rules for products that represent two or more foods packaged and presented to be consumed together.
- Determine if your product is packaged as a single serving. Most products packaged and sold in units that contain less than 200 percent of the reference amount are required to be labeled as a single-serving. The specifications for these products, and exemptions to this rule, are described in 21 CFR 101.9(b)(6). If your product is a single serving, it must be labeled in accordance with the labeling requirements for single-serving containers in 21 CFR 101.9(b)(6).
- Determine the serving size for products containing multiple servings using the reference amount for the product and 21 CFR 101.9(b)(2), (3) and (4). The serving size is expressed as a common household measure followed by the equivalent metric quantity in parenthesis (e.g., "1/2 cup (112 g)"). Acceptable household measures are listed in order of appropriate use in 21 CFR 101.9(b)(5). Rounding rules for metric quantities and a few additional format options are included in 21 CFR 101.9(b)(7).
- Determine the number of servings and the appropriate rounding rules for the number of servings using the information in 21 CFR 101.9(b)(8).
FDA also recognizes that there is a growing trend in the marketplace for jumbo or super-sized servings. When such products are intended to be consumed by one individual in one eating occasion, the nutrition information should be based on the entire contents of food in the container. We recognize that the current serving size regulations allow for such products to be sold as either one, or more than one, serving even if they are usually consumed at one time. FDA intends to re-evaluate this aspect of the serving size regulations. In the meantime, we encourage manufacturers to provide the most accurate and useful nutrition information to consumers by taking advantage of the flexibility in current regulations on serving sizes and label food packages as containing a single-serving if the entire contents of the package can reasonably be consumed at a single-eating occasion.
FDA encourages the food industry to review their nutrition information and assure that the serving size declared is appropriate for the commodity in question. FDA also encourages manufacturers to refer to our guidance documents at www.cfsan.fda.gov for additional information on serving sizes. FDA intends to make accurate serving size declarations one of our priorities and we will advise manufacturers when we encounter apparent errors in declared serving sizes.
Laura M. Tarantino, Ph.D.
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition
Food and Drug Administration