Code of Federal Regulations Title 21. Food and Drugs § 21.172.867 Olestra

(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 the Food Chemicals Codex, 7th ed. (2010), pp. 744–746, 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 United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, 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/cfr/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 μg vitamin K₁ per gram olestra.