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CFSAN/Office of Food Additive Safety
October 9, 2008
Donald L. Wilke, Ph.D.
The Procter & Gamble Company
Ivorydale Technical Center
5299 Spring Grove Avenue
Cincinnati, OH 45217
Re: GRAS Notice No. GRN 000227
Dear Dr. Wilke:
The Food and Drug Administration (FDA) is responding to the notice, dated June 15, 2007, that you submitted in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received the notice on June 19, 2007, filed it on June 27, 2007, and designated it as GRAS Notice No. GRN 000227.
The subject of the notice is olestra. The notice informs FDA of the view of The Procter & Gamble Company (P&G) that olestra is GRAS, through scientific procedures, for use as a total replacement for fats and oils in pre-packaged ready-to-eat cookies. FDA previously approved food additive petitions for olestra as a fat substitute in savory snacks and in ready-to-heat popcorn (21 CFR 172.867; 61 FR 3118, January 30, 1996, and 69 FR 29428, May 24, 2004). Olestra is not considered a source of fat or calories for the purposes of nutrition labeling or for any nutrient content claims.
As part of its notice, P&G includes the report of a panel of individuals (P&G's GRAS panel) who evaluated the data and information that are the basis for P&G's GRAS determination. P&G considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. P&G's GRAS Panel evaluated publicly available scientific information and data about olestra pertaining to the method of manufacture and product specifications, analytical data, intended use levels in specified food products, consumption estimates, multiple safety studies (including in vitro and in vivo genotoxicity studies, metabolic studies, chronic and 2-generation feeding studies in animals), and potential nutritional issues. In addition, P&G's GRAS panel reviewed the results of human studies and post-marketing surveillance studies.(1) Based on this review, P&G's GRAS panel concluded that olestra containing the added vitamins A, D, E, and K that meets its established food grade specifications is GRAS under the conditions of its intended use.
Specifications for olestra are published in the FCC (Fourth Edition). There are specifications for free fatty acids, lead, methanol, peroxide value, residue on ignition, stiffness, and water. The physical state of the olestra mixture is determined by several of the specification parameters including the ester distribution and the length and degree of saturation of the fatty acids. By altering these factors, olestra formulations of varying stiffness can be formulated for different purposes.
P&G estimates the intake of olestra based on the current and intended food-uses and use-levels with food consumption data included in the United States Department of Agriculture's (USDA) 1994-1996 Continuing Survey of Food Intakes by Individuals (CSFII 1994-1996) and the 1998 Supplemental Children's Survey (CSFII 1998). For the purpose of their calculation, proposed food-uses were represented by reduced-fat, low-fat and fat-free cookies, and current food-uses included pre-packaged ready-to-eat savory snacks and pre-packaged ready-to-heat unpopped popcorn. For eaters of these foods, the mean and 90th percentile estimated daily intake (EDI) from the intended use and current use combined were 3.1 and 7.7 grams per day (g/d), respectively, compared to an EDI of 2.6 and 7.0 g/d, respectively, for current uses only. P&G stated that the intake of olestra from the intended use in pre-packaged ready-to-eat cookies will marginally increase the overall exposure to olestra.
P&G summarizes the results of published safety studies for olestra. Metabolic studies in rats and weanling pigs demonstrate that greater than 99% of olestra was unabsorbed. P&G concludes that subchronic toxicological studies in rats, chronic toxicological studies in mice, dogs, and monkeys, and a reproductive and developmental study in rats showed no treatment related effects.
P&G evaluates nutritional issues including a review of published studies on gastrointestinal (GI) physiology and function, olestra's interaction in the digestive tract with lipophilic compounds, as well as effects on appetite regulation and the absorption of nutrients. On the basis of these data, P&G concludes that olestra does not adversely impact GI physiology and function.
P&G states that because olestra is highly lipophilic and resistant to digestion, it interferes with the absorption of fat-soluble vitamins and carotenoids by sequestering them. To compensate for any interference of olestra with the fat-soluble vitamins, vitamins A, D, E and K are required to be added to foods containing olestra (21CFR 172.867(d)). P&G discusses several published studies in relation to the fact that the added fat-soluble vitamins effectively offset any possible absorptive effects of olestra on fat-soluble vitamins. P&G also discusses the fact that, although carotenoid absorption can be affected, dietary consumption patterns of olestra-containing products mitigate this issue. P&G notes that several published studies support the fact that no nutritional imbalances were observed by individuals consuming olestra-containing products long-term.
P&G discusses the published results of several human studies that the firm conducted to investigate potential GI effects of consuming products made with olestra.(2) P&G points out in published reports that there were no statistical differences in reported adverse GI events between those eating olestra-containing chips and those eating regular triglyceride-containing chips.
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to, among other things, add section 301(ll). Section 301(ll) of the FFDCA prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FFDCA, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. In its review of P&G's notice that olestra is GRAS for use as a total replacement for fats and oils in pre-packaged ready-to-eat cookies, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing olestra. Accordingly, this response should not be construed to be a statement that foods that contain olestra, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by P&G, as well as other information available to FDA, the agency has no questions at this time regarding P&G's conclusion that olestra is GRAS for use as a total replacement for fats and oils in pre-packaged ready-to-eat cookies provided that olestra conforms to the conditions listed in 21 CFR 172.867 (a), (b), (d), and (e). The agency has not, however, made its own determination regarding the GRAS status of the subject use of olestra. As always, it is the continuing responsibility of P&G to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000227, as well as a copy of the information in this notice that conforms to the information in the proposed GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying on the homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).
Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
(1) P&G conducted these studies after olestra was approved as a food additive for use in savory snacks (21 CFR 172.867(c)). These studies and other information were discussed at a Food Advisory Committee meeting held by FDA June 15-17, 1998.