Agency Response Letter GRAS Notice No. GRN 000608
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See also Generally Recognized as Safe (GRAS).
CFSAN/Office of Food Additive Safety
May 27, 2016
Mahdu Soni, Ph.D.
Soni & Associates, Inc.
749 46th Square
Vero Beach, FL 32968
Re: GRAS Notice No. GRN 000608
Dear Dr. Soni:
The Food and Drug Administration (FDA) is responding to the notice, dated November 11, 2015, that you submitted on behalf of Axiom Foods, Inc. and SPRIM Strategy and Intelligent Innovation (Axiom and SPRIM) 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 November 16, 2015, filed it on December 7, 2015, and designated it as GRAS Notice No. GRN 000608.
The subject of the notice is pea protein concentrate (PPC). The notice informs FDA of the view of Axiom and SPRIM that PPC is GRAS, through scientific procedures, for use as an ingredient, formulation aid, and texturizer in foods such as baked goods and baking mixes, beverages and beverage bases, breakfast cereals, dairy product analogs, fats and oils, grain products and pastas, milk products, plant protein products, processed fruits and fruit juices, processed vegetables and vegetable juices, soups and soup mixes at levels up to 34.3%. Axiom and SPRIM also intend to use PPC as a source of protein in sports and meal replacement beverages at a level of 15 to 25 grams (g) per serving. Axiom and SPRIM do not intend to use PPC in infant formula or in meat and poultry products that come under jurisdiction of the United States Department of Agriculture.
As part of their notice, Axiom and SPRIM include the report of a panel of individuals (Axiom and SPRIM’s GRAS panel) that evaluated the data and information that are the basis for Axiom and SPRIM’s GRAS determination. Axiom and SPRIM consider the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. Axiom and SPRIM’s GRAS panel evaluated information describing the identity and composition, specifications, manufacturing process, and estimated dietary exposure, as well as published studies supporting the safety of PPC. Based on this review, Axiom and SPRIM’s GRAS panel concluded that PPC that meets its established food grade specifications is GRAS under the conditions of its intended use.
Axiom and SPRIM provide information about the identity, composition and specifications of PPC. PPC is described as light beige, free-flowing powder that is isolated from yellow peas (Pisum sativum L). Axiom and SPRIM describe the typical composition and specifications for PPC. PPC consists of protein (≥80%), fat (≤8%), carbohydrates (≤10%), ash (≤6%), and moisture (≤10%). Axiom and SPRIM specify limits for lead (< 0.5 milligrams per kilogram (mg/kg)), arsenic (< 0.25 mg/kg), cadmium (< 0.85 mg/kg), mercury (< 0.1 mg/kg), mycotoxins (< 5 micrograms (µg)/kg), and limits for microbial contaminants. Axiom and SPRIM provide the results of five batch analyses to demonstrate that PPC meets specifications.
Axiom and SPRIM describe the method of manufacture for PPC. Axiom and SPRIM state that raw yellow peas are sifted, dehulled, and milled. The milled peas are then mixed with water and centrifuged to separate the protein and starch fractions. The protein fraction is concentrated by additional centrifugation. The protein concentrate is then washed and dried to obtain the final product.
Axiom and SPRIM discuss the dietary exposure to PPC based on intended uses and food consumption data from the National Health and Nutrition Examination Surveys. Axiom and SPRIM estimate the mean and 90th percentile dietary exposures for the U.S. population (users-only) at 10.3 g per person per day (g/p/d) (181 mg/kg body weight (bw)/d) and 17.3 g/p/d (388 mg/kg bw/d), respectively. Axiom and SPRIM estimate the dietary exposure to individuals consuming sports or meal replacement beverage containing PPC to be 30.0 g/p/d. For comparison, Axiom and SPRIM estimate the mean and 90th percentile dietary intake of protein from the consumption of peas to be 20.9 and 41.7 g/p/d, respectively.
Axiom and SPRIM address the safety of PPC by discussing the consumption of pea in human and animal diets, as well as various studies conducted with pea protein. Axiom and SPRIM cite a published genotoxicity study that demonstrated a pea protein isolate with similar composition to PPC, was nonmutagenic and nongenotoxic. Axiom and SPRIM also cite a published toxicity study in which rats were fed pea protein isolate in the diet for 90 days. No compound-related adverse effects were reported at up to 100,000 ppm (equivalent to 8726 mg/kg bw/d for male rats and 9965 mg/kg bw/d for female rats). Axiom and SPRIM additionally discuss published studies where pea protein concentrate, isolate, or hydrolysate was fed to animals and humans to assess possible health effects. No adverse effects are reported in these studies.
Axiom and SPRIM state that allergenicity to pea along with cross-reactivity to other allergens have been reported, these reactions are rare, and PPC does not contain any of the eight allergens that are considered to be major food allergens under the United States Food Allergen Labelling and Consumer Protection Act of 2004 (FALCPA).
Based on the totality of the data and information described above, Axiom and SPRIM conclude that PPC is GRAS under the intended conditions of use.
Standards of Identity
In the notice, Axiom and SPRIM state their intention to use PPC 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.
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 Axiom and SPRIM’s notice that PPC is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing PPC. Accordingly, this response should not be construed to be a statement that foods that contain PPC, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by Axiom and SPRIM, as well as other information available to FDA, the agency has no questions at this time regarding Axiom and SPRIM’s conclusion that PPC 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 PPC. As always, it is the continuing responsibility of Axiom and SPRIM to ensure that food ingredients that the firms market 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 000608, 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