06-7306. Nutrition Labeling of Dietary Supplements; Technical Amendment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending its nutrition labeling of dietary supplements regulations. This action is being taken to ensure the accuracy of FDA's regulations.

DATES:

This rule is effective August 31, 2006.

FOR FURTHER INFORMATION CONTACT:

Susan Thompson, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1784, FAX: [phone], or e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

In the Federal Register of July 11, 2003 (68 FR 41434), FDA published a final rule entitled “Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims” (the trans fat rule). Among other things, the final rule amended § 101.36(b)(2)(i) (21 CFR 101.36(b)(2)(i)) by incorporating “trans fat” as a dietary ingredient that must be declared in the nutrition label of a dietary supplement when it is present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods in accordance with § 101.9(c) (21 CFR 101.9(c)). Other than the addition of “trans fat” to the list of dietary ingredients subject to the requirements in § 101.36(b)(2)(i) (21 CFR 101.36(b)(2)(i)), no other changes to that section were proposed or finalized.

However, in making this revision, requirements for dietary ingredients set forth in § 101.36(b)(2)(i) that were not affected by the addition of the term “trans fat” in that section were inadvertently deleted. The text of the requirements that were inadvertently removed from this section was “Calories from saturated fat and polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, sugar alcohol, and other carbohydrate may be declared, but they shall be declared when a claim is made about them. Any other vitamins or minerals listed in § 101.9(c)(8)(iv) or (c)(9) may be declared, but they shall be declared when they are added to the product for purposes of supplementation, or when a claim is made about them. Any (b)(2)-dietary ingredients that are not present, or that are present in amounts that can be declared as zero in § 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals). Protein shall not be declared on labels of products that, other than ingredients added solely for technological reasons, contain only individual amino acids.” Accordingly, because this regulation is not currently accurate, FDA is publishing this amendment to § 101.36(b)(2)(i) to ensure that it complete and accurate by restoring to the regulation the text of the requirements that were inadvertently deleted as a consequence of the revision introduced by the trans fat rule.

List of Subjects in 21 CFR Part 101

• Food labeling
• Nutrition
• Reporting and recordkeeping requirements

PART 101—FOOD LABELING

1. The authority citation for 21 CFR part 101 continues to read as follows:

Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271.

2. In § 101.36, revise paragraph (b)(2)(i) to read as follows:

§ 101.36

Nutrition labeling of dietary supplements.

* * * * *

(b) * * *

(2) * * *

(i) The (b)(2)-dietary ingredients to be declared, that is, total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron, shall be declared when they are present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods in accordance with § 101.9(c). Calories from saturated fat and polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, sugar alcohol, and other carbohydrate may be declared, but they shall be declared when a claim is made about them. Any other vitamins or minerals listed in § 101.9(c)(8)(iv) or (c)(9) may be declared, but they shall be declared when they are added to the product for purposes of supplementation, or when a claim is made about them. Any (b)(2)-dietary ingredients that are not present, or that are present in amounts that can be declared as zero in § 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals). Protein shall not be declared on labels of products that, other than ingredients added solely for technological reasons, contain only individual amino acids.

* * * * *

Dated: August 25, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.