[Federal Register Volume 71, Number 169 (Thursday, August 31, 2006)]
[Rules and Regulations]
[Pages 51726-51727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-7306]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 1994P-0036] (Formerly 94P-0036)


Nutrition Labeling of Dietary Supplements; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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: 301-436-
2639, or e-mail: <a href="/cdn-cgi/l/email-protection#792a0c0a1817572d111614090a1617391f1d185711110a571e160f"><span class="__cf_email__" data-cfemail="54072127353a7a003c3b3924273b3a143230357a3c3c277a333b22">[email protected]</span></a>.

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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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

0
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.

0
2. In Sec.  101.36, revise paragraph (b)(2)(i) to read as follows:


Sec.  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 Sec.  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

[[Page 51727]]

shall be declared when a claim is made about them. Any other vitamins 
or minerals listed in Sec.  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 Sec.  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.
[FR Doc. 06-7306 Filed 8-30-06; 8:45 am]
BILLING CODE 4160-01-S


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