Agency Response Letter GRAS Notice No. GRN 000596
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See also Generally Recognized as Safe (GRAS).
CFSAN/Office of Food Additive Safety
February 21, 2016
Susan J. Murch, Ph.D.
Chemistry Department, Room 350 Fipke Centre
3247 University Way
Kelowna, British Columbia, V1V 1V7
Re: GRAS Notice No. GRN 000596
Dear Dr. Murch:
The Food and Drug Administration (FDA) is responding to the notice, dated August 9, 2015, 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 August 18, 2015, filed it on September 10, 2015, and designated it as GRAS Notice No. GRN 000596.
The subject of the notice is breadfruit flour (Artocarpus altilis and hybrids of A. altilis x A. mariannensis). The notice informs FDA of the view of PlantSMART Labs (PlantSMART) that breadfruit flour is GRAS, through scientific procedures , intended for use as an ingredient in food in general, excluding infant formula and products under the United States Department of Agriculture’s jurisdiction, at a level not to exceed current good manufacturing practices (cGMP).
Our use of “breadfruit flour” or “breadfruit flour (Artocarpus altilis and hybrids of A. altilis x A. mariannensis)” in this 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. Title 21 CFR 101.4 states that each ingredient must be declared by its 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 (ONFL) in the Center for Food Safety and Applied Nutrition (CFSAN).
The subject of the notice is breadfruit flour, produced from the flesh of breadfruit. Breadfruit flour is described as a yellow to off-white powder without any characteristic taste or odor. PlantSMART notes that the common name ‘breadfruit’ refers to the species Artocarpus altilis (Parkinson) Fosberg, and that some cultivated varieties of breadfruit are hybrids of A. altilis and A. mariannensis Trécul. PlantSMART discusses published reports on the composition and nutritional profile of breadfruit flour made from cultivars of A. altilis and hybrids of A. altilis and A. mariannensis. PlantSMART reports that breadfruit flour contains 79–97.5% dry matter, 50–88% carbohydrate, 0.5–11.8% lipids, 1.9–18.7% protein, 0.2–11.4% soluble fiber, and 7.5–62.3% insoluble fiber. PlantSMART provides additional information in their notice on the composition of breadfruit flours made from different cultivars, including starch and sugars, carotenoids, vitamins, minerals, amino acid profiles, and anti-nutrients. PlantSMART states that after breadfruit flour is produced, it is analyzed for residual moisture, microbial contaminants, and heavy metal content.
PlantSMART notes that commercial scale facilities for the production of breadfruit flour do not yet exist in the United States, and describes the small-scale manufacturing process for breadfruit flour. First, breadfruits are collected several days before the fruit is ripe. Second, the breadfruits are cut and the latex is allowed to drain from the fruit. Third, the fruits are peeled, the core removed and the breadfruits are sliced and then dehydrated. Finally, the dried breadfruits are milled into flour.
PlantSMART intends to use breadfruit flour as an ingredient in all food categories where standards of identity allow, and notes that it may be used as an alternative to wheat flour. PlantSMART reports that the daily average consumption of refined grains by persons aged two years and older in the United States is 5.78 ounces per person (p) per day (d) (163.9 grams (g/p/d)) (USDA, 2015). Based on an assumption of total replacement of refined grains with breadfruit flour, PlantSMART concludes that the approximate mean and 90th percentile exposure to breadfruit flour is 6 and 12 ounces/p/d (160 and 330 g/p/d), respectively.
PlantSMART discusses the safety of breadfruit, which has been a dietary staple in the Pacific Islands for over 3000 years.
PlantSMART compiled published information on nutritional data of the breadfruit and its flour, the composition of macronutrients, micronutrients, including minerals, carotenoids, vitamins, and anti-nutritional factors demonstrating that breadfruit flour is similar to other commonly consumed flours. The anti-nutrients examined include trypsin and α-amylase inhibitors, phenolic compounds (e.g., tannins), oxalate, phytate, lignin, saponins, and lectins. PlantSMART concludes that these anti-nutrients are either not detected or are present at levels that are similar or less than those present in other commonly consumed cereal grains, legumes, or nuts and are below the level that will have any adverse effects on consumers.
PlantSMART provided published data regarding the protein content and the amino acid profile of the breadfruit flour. PlantSMART reported that in comparison to other highly consumed tropical crops, breadfruit contains an average of 3.9% protein on a dry weight basis, which is 1.15% higher than cassava, 1.1% higher than banana, and 0.3% higher than sweet potato. PlantSMART also reported that breadfruit protein contains all of the essential amino acids and no unusual amino acids were detected. The cultivar Ma’afala had higher total essential amino acid content (568 mg/g protein) than other varieties of cultivars or wheat flour (336 mg/g protein). PlantSMART discussed the in vitro protein digestibility tests that involved a multi-stage enzyme digestion model that closely mimics the entire digestion process in humans. The results indicated that breadfruit flour protein was more easily digested (10–25%) than wheat protein.
Based on the totality of the scientific evidence, PlantSMART concludes that breadfruit flour is GRAS under the conditions of its intended use.
Standards of Identity
In the notice, PlantSMART states its intention to use breadfruit flour in several food categories, including foods for which standards of identity exist, located in Title 21 of the Code of Federal Regulations. We note that an ingredient that is lawfully added to food products may be used in a standardized food only if it is permitted by the applicable standard of identity.
Potential Labeling Issues
In describing the intended use of breadfruit flour and in describing the information that PlantSMART relies on to conclude that breadfruit flour is GRAS under the conditions of its intended use, PlantSMART raises a potential issue under the labeling provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This issue derives from studies cited by the notifier regarding the glycemic index of breadfruit after human consumption. Under section 403(a) of the FD&C Act, a food is misbranded if its labeling is false or misleading in any particular. Section 403(r) of the FD&C Act lays out the statutory framework for the use of labeling claims that characterize the level of a nutrient in a food or that characterize the relationship of a nutrient to a disease or health-related condition. If products that contain breadfruit flour bear any claims on the label or in labeling, such claims are the purview of ONFL in CFSAN. The Office of Food Additive Safety neither consulted with ONFL on this labeling issue nor evaluated the information in your notice to determine whether it would support any claims made about breadfruit flour on the label or in labeling.
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 PlantSMART’s notice that breadfruit flour is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing breadfruit flour. Accordingly, this response should not be construed to be a statement that foods that contain breadfruit flour, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by PlantSMART, as well as other information available to FDA, the agency has no questions at this time regarding PlantSMART’s conclusion that breadfruit flour is GRAS under the intended conditions of use, provided that cGMPs are followed. The agency has not, however, made its own determination regarding the GRAS status of the subject use of breadfruit flour. As always, it is the continuing responsibility of PlantSMART 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 000596, 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 .
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition