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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2013]
[CITE: 21CFR172.867]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

Subpart I--Multipurpose Additives

Sec. 172.867 Olestra.

Olestra, as identified in this section, may be safely used in accordance with the following conditions:

(a) Olestra is a mixture of octa-, hepta-, and hexa-esters of sucrose with fatty acids derived from edible fats and oils or fatty acid sources that are generally recognized as safe or approved for use as food ingredients. The chain lengths of the fatty acids are no less than 12 carbon atoms.

(b) Olestra meets the specifications of theFood Chemicals Codex, 4th edition, 1st supplement (1997), pp. 33-35, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418 (Internet addresshttp://www.nap.edu ). Copies may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(c) Olestra may be used in place of fats and oils in prepackaged ready-to-eat savory (i.e., salty or piquant but not sweet) snacks and prepackaged, unpopped popcorn kernels that are ready-to-heat. In such foods, the additive may be used in place of fats and oils for frying or baking, in dough conditioners, in sprays, in filling ingredients, or in flavors.

(d) To compensate for any interference with absorption of fat soluble vitamins, the following vitamins shall be added to foods containing olestra: 1.9 milligrams alpha-tocopherol equivalents per gram olestra; 51 retinol equivalents per gram olestra (as retinyl acetate or retinyl palmitate); 12 IU vitamin D per gram olestra; and 8 [micro]g vitamin K1per gram olestra.

(e)(1) Vitamins A, D, E, and K present in foods as a result of the requirement in paragraph (d) of this section shall be declared in the listing of ingredients. Such vitamins shall not be considered in determining nutrient content for the nutritional label or for any nutrient claims, express or implied.

(i) An asterisk shall follow vitamins A, D, E, and K in the listing of ingredients;

(ii) The asterisk shall appear as a superscript following each vitamin;

(iii) Immediately following the ingredient list an asterisk and statement, "Dietarily insignificant" shall appear prominently and conspicuously as specified in 101.2(c) of this chapter;

(2) Olestra shall not be considered as a source of fat or calories for purposes of 101.9 and 101.13 of this chapter.

[61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, 1996, as amended at 68 FR 46402, Aug. 5, 2003; 69 FR 29432, May 24, 2004]

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