Special Focus

Nutritional Labeling of Dietary Supplements

Apr 2004
Keller and Heckman LLP's Packaging Practice Group

With the increasing attention in recent years to obesity, nutrition, health, and exercise, the business of dietary supplements has seen astounding growth.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the Federal Food, Drug & Cosmetic Act (FD&C Act) to provide a comprehensive scheme for the regulation of dietary supplements. To be eligible for marketing as a dietary supplement, a product must be intended to supplement the diet through ingestion,¹ must contain one or more dietary ingredients, and must not be represented for use as a conventional food or meal replacement.² Under DSHEA, products classified as dietary supplements are deemed "foods." unless the products are represented as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" (i.e., representations that FDA deems to be drug claims).³

As food products, dietary supplements are required to bear nutrition labeling unless a specific exemption is applicable. The nutrition labeling for dietary supplements is required to appear in a box captioned "SUPPLEMENT FACTS." While the nutrition labeling requirements for foods and dietary supplements are similar in some respects, they differ greatly. For instance, the nutrition labeling for conventional food provides information only regarding specific nutrients for which recommended daily intakes (RDIs) and daily reference values (DRVs) are established, while the nutrition labeling for dietary supplements provides this information as well as information regarding nutrients or dietary ingredients that do not have an established RDI or DRV. Indeed, one of the more important differences between nutrition labeling for conventional foods and dietary supplements is that dietary ingredients, such as amino acids, herbs, etc., are declared in the supplement's nutrition labeling, rather than in the list of ingredients.

Mandatory and Voluntary Nutrition Declaration

Nutrient content declarations on dietary supplements are mandatory for certain nutrients and voluntary for others. More specifically, the following categories exist:

 

• Mandatory, except where the nutrients are present below a minimum level; and
• Voluntary, except where a nutrient content claim is made for a product.

Special rules govern the declaration of nearly all the nutrients/food components. Among the important features are: (1) definitions for certain nutrients; (2) rules regarding correct increments for reporting amounts per serving; and (3) rules regarding permissible rounding to zero.

1. Mandatory, except where the nutrients are present below a minimum levels

Caloric content: Must be expressed to the nearest 5-calorie increment up to and including 50 calories, and to the nearest 10-calorie increment above 50 calories. Metric equivalent (i.e., kilojoules) declaration is permitted on a voluntary basis. Amounts less than 5 calories may be expressed as zero.

Calories from fat: This declaration is mandatory, except when the product contains less than 0.5 grams of fat. If not required and not declared, the statement "Not a significant source of calories from fat" must be placed at the bottom of the Nutrition Facts box under the declarations for vitamins and minerals.

If declared, amounts must be expressed to the nearest 5-calorie increment up to and including 50 calories, and to the nearest 10-calorie increment above 50 calories. Amounts less than 5 calories may be expressed as zero.

Total fat: "Total fat" is defined as "total lipid fatty acids" expressed as triglycerides. Amounts must be expressed to the nearest 0.5-gram increment for amounts below 5 grams, and to the nearest 1-gram increment for amounts greater than 5 grams. Amounts less than 0.5 grams must be expressed as zero.

Saturated fat: "Saturated fat" is defined as "the sum of all fatty acids containing no double bonds." This nutrient declaration is mandatory, except where the product contains less than 0.5 grams of total fat in a serving, no claims are made about fat or cholesterol content, and "calories from saturated fat" is not declared. If not required and not declared, the statement "Not a significant source of saturated fat" must appear under the declarations for vitamins and minerals. The rules for declaring increments and zero amounts are the same as those for total fat.

Cholesterol: This declaration is mandatory, except for products that contain less than 2 milligrams of cholesterol in a serving and make no claim about fat, fatty acids, or cholesterol content. If not required and not declared, the statement "Not a significant source of cholesterol" must be placed under the declarations for vitamins and minerals.

Amounts must be expressed to the nearest 5-milligram increment. If a food contains between 2-5 milligrams, the content may be stated as "less than 5 milligrams." Amounts less than 2 milligrams may be expressed as zero.

Sodium: Must be expressed to the nearest 5-milligram increment for amounts between 5 and 140 milligrams, and to the nearest 10-milligram increment for amounts exceeding 140 milligrams. Amounts less than 5 milligrams may be expressed as zero.

Total carbohydrates: Total carbohydrate content is calculated by subtracting the sum of the crude protein, total fat, moisture, and ash from the total weight of the food. If a serving contains less than 1 gram of total carbohydrates, the statement "Contains less than 1 gram" may be used. Otherwise, the amount per serving must be expressed to the nearest gram increment. Amounts less than 0.5 g may be reported as zero.

Dietary fiber: This declaration is mandatory, except if a serving of food contains less than 1 gram of total dietary fiber. If not required and not declared, the statement "Not a significant source of dietary fiber" must appear at the bottom of the table of nutrient values. The rules for declaring amounts less than 1 gram, increments, and zero amounts are the same as those for total carbohydrates.

Sugars: This declaration is mandatory, except where a product contains less than one gram of sugar per serving and no claims are made about sugars, sweeteners, or sugar alcohols. If not required and not declared, the statement "Not a significant source of sugars" must be placed at the bottom of the nutrition panel.) "Sugars" is defined as "the sum of all free mono- and disaccharides." The rules for declaring amounts less than 1 gram, increments, and zero amounts are the same as those for total carbohydrates.

Protein: If a serving contains less than 1 gram of protein, the statement "Contains less than 1 gram" may be used. Otherwise, the amount per serving must be expressed to the nearest gram increment. Amounts less than 0.5 g may be reported as zero. However, protein may not be declared on the label of dietary supplements that only contain individual amino acids.

Vitamin A, Vitamin C, Calcium, and Iron: Must provide the quantitative amount by weight of vitamin A, vitamin C, calcium, or iron. The Daily Value shall appear to the nearest 1 percent increment. The percent of beta-carotene may be declared in parentheses next to the vitamin A declaration, e.g., "Vitamin A (50% as beta carotene)." No declaration is required for products containing less than 2% of the Daily Value for vitamin A, vitamin C, calcium, or iron.

2. Voluntary, except where a nutrient content claim is made for a product

Calories from saturated fat: The rules for declaring increments and zero amounts are the same as those for total calories. That is to say, amounts must be expressed to the nearest 5-calorie increment up to and including 50 calories, and to the nearest 10-calorie increment above 50 calories. Metric equivalent (i.e., kilojoules) declaration is permitted on a voluntary basis. Amounts less than 5 calories may be expressed as zero.

Calories from polyunsaturated fat: This declaration is voluntary, unless (i) a nutrition claim is made about fatty acids (other than "fat free") or cholesterol; or (ii) monounsaturated fat content is declared. The term is defined as "cis, cis-methylene-interrupted polyunsaturated fatty acids." The rules for declaring increments and zero amounts are the same as those for total fat.

Monounsaturated fat: This declaration is voluntary, except where (i) a nutrition claim is made about fatty acids (other than "fat free") or cholesterol; or (ii) polyunsaturated fats are declared. The term again is limited to cis isomers, as detailed above. The rules for declaring increments and zero amounts are the same as those for total fat.

Soluble fiber: A declaration is necessary where a nutrient content claim is made for soluble fiber. If a serving contains less than 1 gram of soluble fiber, the statement "Contains less than 1 gram" may be used. Otherwise, the amount per serving must be expressed to the nearest gram increment. Amounts less than 0.5 g may be reported as zero.

Insoluble fiber: A declaration is necessary where a nutrient content claim is made for insoluble fiber. If a serving contains less than 1 gram of insoluble fiber, the statement "Contains less than 1 gram" may be used. Otherwise, the amount per serving must be expressed to the nearest gram increment. Amounts less than 0.5 g may be reported as zero.

Sugar alcohol: The term is defined as "the sum of saccharide derivatives in which a hydroxyl group replaces a ketone or aldehyde group and whose use in the food is listed by FDA or is generally recognized as safe." If only one sugar alcohol is present in a product, the specific name of the substance (e.g., sorbitol, xylitol, etc.) may be used on the nutrition panel in lieu of the term "sugar alcohol." The rules for declaring amounts less than 1 gram, increments, and zero amounts are the same as those for total carbohydrates.

Other carbohydrates: The term is defined as "the difference between total carbohydrates and the sum of dietary fiber, sugars, and sugar alcohol, except that if sugar alcohol is not declared (even if present), it shall be defined as the difference between total carbohydrate and the sum of dietary fiber and sugars." The rules for declaring amounts less than 1 gram, increments, and zero amounts are the same as those for total carbohydrates.

Other vitamins and minerals: Declared where a nutrient content claim is made for additional vitamins and minerals. The rules for declaring are identical to the rules governing vitamin A, vitamin C, calcium, and iron. The order of declaration for vitamin and minerals in dietary supplements is as follows: vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin, pantothenic acid, calcium, iron, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium; molybdenum, chloride, sodium, and potassium.

No nutrients other than those specified above may be declared within the Supplement Facts box. This requirement differs from conventional food, where the Nutrition Facts box may bear only specified nutrients but where declarations regarding other nutrients may appear outside the Nutrition Facts box, elsewhere on the label.⁴ However, such an approach would not be permitted for dietary supplements because information about the levels of other nutrients and dietary ingredients in dietary supplements is required to appear in the Supplement Facts box if their purpose is to supplement the diet.

FOOTNOTES

¹ For example, a U.S. district court held that a product containing a vitamin B12 gel intended to be applied inside the nose was a "drug." The court found that this product failed to meet DSHEA's definition of "dietary supplement" because it was not "intended for ingestion." United States v. Ten Cartons, More or Less, of an Article of Drug - Ener. B Nasal Gel, 888 F. Supp. 381 (E.D.N.Y. 1995).

²FD&C Act § 201(ff).

³ See FD&C Act § 201(g).

⁴58 Fed. Reg. 44063, 44073. Such declarations are limited, however, to simple quantitative statements (e.g., "Contains x g of omega-3 fatty acids per serving" or "Provides x g of omega-3 fatty acids per serving"). If the food on which such declaration appears contains fat, saturated fat, sodium, or cholesterol at levels exceeding thresholds established by FDA, the declarations must be accompanied by a disclosure statement (e.g., "See nutrition information for sodium content"), since they are considered express nutrient content claims.