Agency Response Letter GRAS Notice No. GRN 000581
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See also Generally Recognized as Safe (GRAS).
CFSAN/Office of Food Additive Safety
March 20, 2016
Marc C. Sanchez
FDA Atty Contact In-House Counsel & Consultants, LLC
3623 South Downs Trail
Charlotte, NC 28215
Re: GRAS Notice No. GRN 000581
Dear Mr. Sanchez:
This letter corrects our letter in response to GRAS Notice No. GRN 000581, dated January 25, 2016. The purpose of this letter is to correct the name of the subject of the notice, the discussion of the method of manufacture, the value listed for the cadmium specification, and the identities of the subjects of the studies discussed in the notice.
The Food and Drug Administration (FDA) is responding to the notice, dated May 18, 2015, that you submitted on behalf of World Food Processing, LLC (WFP) 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 May 21, 2015, filed it on June 18, 2015, and designated it as GRAS Notice No. GRN 000581.
The subject of the notice is un-hydrolyzed and hydrolyzed pea protein, hereafter referred to as pea protein. The notice informs FDA of the view of WFP that pea protein is GRAS, through scientific procedures, for use as a source of protein in foods such as bakery products, cereals, snack foods, smoothies, beverages, soups, imitation dairy products, dry instant milk shake mixes and protein drinks, instant powdered nutritional beverages, whole muscle and comminuted meat and poultry products, ready to eat (RTE) meat and poultry products, vegetarian products/meat analogues, and meal replacement bars at levels up to 90%.
Our use of pea protein 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).
WFP describes pea protein as a partially water soluble powder that is cream to off-white in color and has a neutral bland taste. WFP describes the method of manufacture for pea protein, which starts with flour made from dried peas (Pisum sativum L.). The pea flour is reconstituted with water and the pH is adjusted with food grade buffers to solubilize proteins. The resulting slurry is centrifuged to separate the soluble and insoluble fractions. The soluble material is subjected to isoelectric precipitation of proteins by pH adjustment. The coagulated proteins are then washed, buffered to neutral pH, and may then be treated with food grade proteases that result in lower molecular weight peptides of shorter chain length and amino acids. WFP states that heat treatment is used to prevent microbial growth and to inactivate the enzymes if used. The resulting product is spray dried to produce the final pea protein powder.
WFP describes the typical composition and specifications for pea protein. Pea protein contains a minimum of 80% protein and on average, 8% fat, 6% carbohydrates, and 5% ash (1.0-1.1% sodium, 1.1% phosphorous, 0.55-1.0% potassium, 0.4% calcium, and 0.01% iron). WFP specifies limits for lead (< 0.01 milligrams per kilogram (mg/kg)), arsenic (< 0.01 mg/kg), cadmium (< 0.05 mg/kg), mercury (< 0.01 mg/kg), total aflatoxins (< 0.7 micrograms per kg), and microbial contaminants.
WFP discusses the dietary exposure to pea protein from its intended use. Based on a use level of 1 gram (g)/serving and food consumption data for representative food categories from the USDA Continuing Survey of Food Intake by Individuals, WFP estimates the mean and 90th percentile dietary exposures to pea protein to be 5.78 and 10.76 g per person per day, respectively. WFP states that consumption of foods containing pea protein is not likely to increase the total daily protein intake.
WFP discusses the safety of pea protein by discussing the consumption of peas by humans and animals, as well as published studies conducted with pea protein. WFP cites a published genotoxicity study which shows that a pea protein product, with a composition similar to WFP’s pea protein is non-mutagenic and non-genotoxic. WFP discusses a published subchronic toxicity study in which rats were fed pea protein isolate. This pea protein isolate was described to contain over 80% pea protein (dry matter basis) and is identical in fat, ash, and carbohydrate content to pea protein. The animals consumed the pea protein isolate at up to 10% of the diet without any adverse effects. WFP also cites published studies that assessed the physiological effects of pea protein concentrate, isolate, or hydrolysate in animals and humans. No adverse effects are reported in these studies. WFP also summarizes published studies in which different pea fractions were fed to either animals or humans to assess health effects. No adverse effects are reported in these studies.
The notifier discusses that allergenicity to pea has been reported along with cross-reactivity to other allergens. However, allergic reactions to pea protein are rare and there are no reports of such reactions in the United States.
In its GRAS notice, WFP also discusses the GRAS determination for plant protein (containing pea and wheat protein isolate) (GRN 000182). The source of the pea protein described in GRN 000182 is the same as that described in this GRAS Notice. FDA had no questions in response to this notice.
Based on the totality of the data and information described above, WFP concludes that pea protein is GRAS for its intended use in food.
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 WFP’s notice that pea protein is GRAS for use as an ingredient in foods, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing pea protein. Accordingly, FDA’s response should not be construed to be a statement that foods that contain pea protein, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Standards of Identity
In the notice, WFP states its intention to use pea protein 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 pea protein and in describing the information that WFP relies on to conclude that pea protein is GRAS under the conditions of its intended use, WFP raises a potential issue under the labeling provisions of the FD&C Act. This issue consists of efficacy studies cited by WFP involving the effects of pea protein products on blood pressure levels. 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 pea protein 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 pea protein on the label or in labeling.
Use in Products under USDA Jurisdiction
During its evaluation of GRN 000581, FDA consulted with the Risk, Innovations, and Management Staff (RIMS) of the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA). Under the Federal Meat Inspection Act, Poultry Products Inspection Act, and the Egg Products Inspection Act, FSIS is responsible for determining the efficacy and suitability of food ingredients in meat, poultry, and egg products as well as prescribing safe conditions of use. Suitability relates to the effectiveness of the ingredient in performing the intended purpose of use and the assurance that the conditions of use will not result in an adulterated product, or one that misleads consumers.
FSIS advises that WFP has provided sufficient data to support their assertion that pea protein is suitable as a binder and flavoring agent in various whole muscle and comminuted meat and poultry products and RTE meat and poultry products. The federal meat inspection regulations list specific binding additives for use below 3.5% of the total product formulation. In most cases, FSIS has viewed the use of binders and extenders at levels greater than 3.5% as re-characterizing of products. Currently, binders used in standardized meat and poultry products are limited to a maximum of 3.5% of total product formulation with a few exceptions. Therefore, FSIS would not object to the use of pea protein as a binder and flavoring agent in various whole muscle and comminuted meat and poultry products and RTE meat and poultry products where binders are permitted, provided that it is used at a level not exceeding the product’s specific standard of identity limits and not more than 7% of the total product formulation in any case. Regarding labeling, FSIS states pea protein would be listed as ‘pea protein isolate’ in the ingredients statement of products that contain it.
Based on the information provided by WFP, as well as other information available to FDA, the agency has no questions at this time regarding WFP’s conclusion that pea protein is GRAS under the intended conditions of use as described above. The agency has not, however, made its own determination regarding the GRAS status of the subject use of pea protein. As always, it is the continuing responsibility of WFP 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 000581, 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