Agency Response Letter GRAS Notice No. GRN 000376
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CFSAN/Office of Food Additive Safety
October 11, 2011
Brian P. Waldman
Arent Fox LLP
1050 Connecticut Avenue NW
Washington, DC 20036-5339
Re: GRAS Notice No. GRN 000376
Dear Mr. Waldman:
The Food and Drug Administration (FDA) is responding to the notice, dated March 10, 2011, that you submitted on behalf of Armor Proteines 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 March 23, 2011, filed it on March 24, 2011, and designated it as GRAS Notice No. GRN 000376.
The subject of the notice is milk mineral concentrate (MMC). The notice informs FDA of the view of Armor Proteines that MMC is GRAS, through scientific procedures, for use as a salt (sodium chloride) substitute in foods, excluding meat and poultry.
Our use of "milk mineral concentrate" 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 of the U.S. Code of Federal Regulations (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, Labeling and Dietary Supplements (ONLDS) in the Center for Food Safety and Applied Nutrition.
Armor Proteines provides information about the chemical identity and specifications for MMC. Armor Proteines states that MMC is a white, water soluble powder, and is composed of sodium (8-20 percent), potassium (28-30 percent), chlorides (40-45 percent), calcium (2.5-3.0 percent), lactose (5-9 percent), protein (1 percent), free moisture (2-5 percent), and fat (< 0.5 percent). Armor Proteines notes that the components found in MMC are naturally found in milk and milk products. Armor Proteines also provides food grade specifications for MMC including heavy metals (mercury, cadmium, lead, and arsenic) as well as microbiological limits.
Armor Proteines describes the manufacturing process of MMC. Skim milk is first acidified with hydrochloric acid, and the acid whey product is separated from the coagulum by decantation. The acid whey product goes through an ultrafiltration process. The ultrafiltration permeate then undergoes reverse osmosis, followed by pH-adjustment with potassium hydroxide, and centrifugation of the osmosis water. The product is concentrated and dried to produce the finished product.
Armor Proteines states that the intended use of MMC is as a salt substitute for use in foods, excluding meat and poultry, and will partially or completely replace the added salt content of foods. Armor Proteines calculated an estimated daily intake (EDI) of MMC of 2,106 milligrams per person per day (mg/p/d) at the mean, and 3,525 mg/p/d at the 90th percentile. This calculation conservatively assumes that MMC will replace 30 percent of added salt in the total food supply. Armor Proteines uses the results of 2007-2008 National Health and Nutrition Examination Survey to calculate the EDI of MMC in the intended uses.
Armor Proteines discusses the safety the intended uses of MMC in foods, focusing on the estimated contribution of MMC to dietary intake of calcium, potassium, sodium, and chloride ions. Regarding sodium and chloride, Armor Proteines notes that the replacement of salt with MMC would lead to a decrease in the consumption of sodium and chloride ions. Armor Proteines estimates there would be a very slight increase (5 percent) in total calcium intake with the use of MMC (assuming 30 percent replacement of added salt). Armor Proteines states that these estimated levels of exposure to dietary calcium from the use of MMC would be well below the tolerable upper limit for calcium of 2,500 mg/p/d for adults established by the Institute for Medicine (IOM).
Armor Proteines estimates that the mean potassium intake resulting from the use of MMC in food would be below the current adequate intake (AI) of 4,700 mg/p/d set by the IOM.  Armor Proteines also states that potassium intake at the 90th percentile would be only slightly more than the IOM's AI, and still within safe levels. Armor Proteines discusses concerns about the potential for development of hyperkalemia among individuals with chronic renal failure or on potassium-sparing diuretic medications. Armor Proteines notes that the occurrence of severe kidney disease in the general population is uncommon (about 0.1 percent of the population), and susceptible individuals are typically under medical supervision. Armor Proteines concludes that the increased intake of potassium due to the replacement of salt with MMC would not be expected to have any adverse health effect.
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that the label of a food that is or contains an ingredient that bears or contains a "major food allergen" declare the presence of the allergen (section 403(w)). FALCPA defines a "major food allergen" as one of eight foods or food groups (i.e., milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans) or a food ingredient that contains protein derived from one of those foods. Issues associated with labeling food are the responsibility of ONLDS.
Standards of Identity
In the notice, Armor Proteines states its intention to use MMC 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 biological effects of increased potassium consumption resulting from the use of MMC, Armor Proteines raises a potential issue under the labeling provisions of the FD&C Act. 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 MMC bear any claims on the label or in labeling, such claims are the purview of ONLDS. The Office of Food Additive Safety neither consulted with ONLDS on this labeling issue nor evaluated the information in your notice to determine whether it would support any claims made about MMC on the label or in labeling.
Section 301(ll) of the FD&C Act
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the FD&C Act to, among other things, add section 301(ll). 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 Armor Proteines' notice that MMC is GRAS for use in foods, excluding meat and poultry, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing MMC. Accordingly, this response should not be construed to be a statement that foods that contain MMC, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by Armor Proteines, as well as other information available to FDA, the agency has no questions at this time regarding Armor Proteines' conclusion that MMC 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 MMC. As always, it is the continuing responsibility of Armor Proteines 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 000376, 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 http://www.fda.gov/grasnoticeinventory.
Mitchell A. Cheeseman, Ph.D.
Office of Food Additive Safety
Center for Food Safety
and Applied Nutrition
 The IOM did not establish an upper limit for potassium.