Agency Response Letter GRAS Notice No. GRN 000140 - Additional Correspondence
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See also Generally Recognized as Safe (GRAS).
CFSAN/Office of Food Additive Safety
July 29, 2016
Elizabeth Nelson, Esq.
Kemin Foods, L.C.
2100 Maury Street
Des Moines, IA 50317
Re: GRAS Notice No. GRN 000140
Dear Ms. Nelson:
The Food and Drug Administration (FDA) is responding to the supplement, dated December 16, 2015, that you submitted regarding an increase in the intended use level in milk-based meal replacements in GRN 000140. Kemin Foods, L.C. (Kemin) submitted GRN 000140 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). Additional clarifying information regarding the supplement was received on June 9, 2016. The notice informed FDA of the view of Kemin that crystalline lutein is GRAS, through scientific procedures, for use as an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, egg products, fats and oils, frozen dairy desserts and mixes, gravies and sauces, hard candy, infant and toddler foods (other than infant formula), milk products, processed fruits and fruit juices, soft candy, soups and soup mixes, and in medical foods intended as the sole item of the diet at levels ranging from 0.3 to 3 milligrams (mg) per eating occasion (serving). In a letter dated June 14, 2004, FDA informed Kemin that the agency had no questions at that time regarding Kemin’s conclusion that crystalline lutein is GRAS under the intended conditions of use.
In the supplement dated December 16, 2015, Kemin informs FDA of its view that crystalline lutein is GRAS, through scientific procedures, for use as an ingredient in milk-based meal replacements at 6 mg per serving, which is a doubling of the previous level in the milk-based meal replacements.
Kemin provides estimates of dietary exposure to crystalline lutein based on the intended increase in the use level in milk-based meal replacements, and reports that the estimated 90th percentile cumulative dietary exposure to crystalline lutein from all uses to be 21.9 mg per person per day or 0.41 mg per kilogram body weight per day (mg/kg bw/d). Kemin notes that this estimate of exposure is less than the acceptable daily intake set by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2006; JECFA set an acceptable daily intake of 0 to 2 mg/kg bw/d. Kemin concludes that no safety concerns are expected with the increased use level in milk-based meal replacement.
Kemin monitors the published literature on a monthly basis, and states that there has been no published information on lutein safety that would impact or alter the original safety evaluation and all the current information still supports the conclusion in the notice.
Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act, 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 Kemin’s supplement that crystalline lutein is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing crystalline lutein. Accordingly, this response should not be construed to be a statement that foods that contain crystalline lutein, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by Kemin in GRN 000140, the supplement dated December 16, 2015, and the clarifying information received on June 9, 2016, as well as other information available to FDA, the agency has no questions at this time regarding Kemin’s conclusion that crystalline lutein is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of crystalline lutein. As always, it is the continuing responsibility of Kemin 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 the supplement to GRN 000140, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying at www.fda.gov/grasnoticeinventory.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
For clarity, in this additional correspondence letter FDA uses the term "crystalline lutein" to denote the mixture of the carotenoids lutein and zeaxanthin that is the subject of the notice and the term “lutein” to denote the principal component of this mixture. Our use of “crystalline lutein” in this additional correspondence letter should not be considered an endorsement or recommendation of that term as an appropriate common or usual name for the purpose of declaring the substance in the ingredient statement of foods that contain that ingredient. 21 CFR 101.4 states that all ingredients must be declared by their common or usual name. In addition, 21 CFR 102.5 outlines general principles to use when establishing common or usual names for nonstandardized foods. Issues associated with labeling and the appropriate common or usual name of a food are the responsibility of the Office of Nutrition and Food Labeling.