Agency Response Letter GRAS Notice No. GRN 000618
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See also Generally Recognized as Safe (GRAS).
CFSAN/Office of Food Additive Safety
May 27, 2016
Gary Burin, PhD, MPH, DABT
Technology Sciences Group, Inc.
1150 18th Street NW
Washington, DC 20036
Re: GRAS Notice No. GRN 000618
Dear Dr. Burin:
The Food and Drug Administration (FDA) is responding to the notice, dated December 11, 2015, that you submitted on behalf of Seawater Solutions, Inc. (SSI) 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 December 18, 2015, filed it on January 4, 2016, and designated it as GRAS Notice No. GRN 000618. FDA received additional information on March 7 and 21, 2016.
The subject of the notice is purified seawater. The notice informs FDA of the view of SSI that purified seawater is GRAS, through scientific procedures, for use as a flavoring agent to replace sodium chloride (table salt) in various food categories.[a]
SSI provides information on the identity and composition of purified seawater. The water used to produce purified seawater is obtained from the Mediterranean Sea. Purified seawater consists of water and sea salts, primarily sodium chloride (NaCl, CAS Registry Number 7647-14-5), potassium chloride (KCl, CAS Registry Number 7447-40-7), calcium sulfate (CaSO4, CAS Registry Number 7778-18-9), and magnesium chloride (MgCl2, CAS Registry Number 7786-30-3).
SSI describes the manufacturing process for purified seawater. The seawater is purified using a multistep filtration process that removes sand and plankton, followed by a selective ion exchange process that removes boron. Additional filtration steps remove bacteria and viruses. After purification, the seawater is stored in tanks for 48 hours and is then analyzed for the presence of potential microbial contaminants before the product is packaged.[b] SSI reports that purified seawater is produced in accordance with good manufacturing practices.
SSI provides specifications for purified seawater. These include specifications for color, turbidity, boron (<1 milligram per liter (mg/L)), and heavy metals (lead (≤5 micrograms (µg)/L), mercury (≤2 µg/L), and arsenic (≤10 µg/L)). SSI provides analytical data from three non-consecutive batches of its product to confirm that the product meets specifications. SSI also notes that purified seawater meets the standards for bacterial counts specified in 21 CFR 165.110 for bottled water.
SSI estimates the daily intakes of the major constituent ions of purified seawater from a 30 gram serving size (approximately 1 fluid ounce) of purified seawater. SSI states that the estimated daily intakes of sodium, potassium, calcium, and magnesium are 322, 12, 13, and 37 mg, respectively. SSI notes that these values are below the estimated dietary intakes from all other sources (per the Institute of Medicine (IOM) and the 1999-2000 National Health and Nutrition Examination Survey, Dietary Guidelines for Americans (United States Department of Agriculture (USDA), 2010)).
SSI discusses publicly available information supporting the safety of the constituent salts of purified sea water:
- SSI reports that sodium chloride is cited as an example of a GRAS substance under 21 CFR 182.1. The estimated average intake of sodium for all Americans aged two years and older is approximately 3400 mg/day as reported in USDA’s Dietary Guidelines for Americans (2010). The above average intake is higher than the Tolerable Upper Intake Level (UL) for sodium which is 2300 mg/day cited in the published IOM report (2005). SSI’s purified seawater product as described in this notice will replace sodium chloride and therefore will reduce sodium levels. The expected daily intake of sodium from purified seawater is only 322 mg/day.
- The use of potassium chloride is affirmed as GRAS under 21 CFR 184.1622. SSI cites from the published IOM report (2005) that the approximate median intake of potassium in the United States for men is 3200 mg/day and for women 2300 mg/day. The recommended intake of potassium for adults is 4700 mg/day. The daily intake of potassium expected from purified seawater is only 12 mg/day.
- The use of calcium sulfate is affirmed as GRAS under 21 CFR 184.1230. SSI cites a published European Food Safety Authority (EFSA, 2008) report stating the UL for calcium at 2500 mg/day. The daily intake of calcium expected to result from the intended use of purified seawater is only 13 mg/day.
- The use of magnesium chloride is affirmed as GRAS under 21 CFR 184.1426. Magnesium chloride is also described as an essential dietary ingredient in a report published by the Select Committee for GRAS Substances (1976). A published article reports that the recommended daily allowance (RDA) for magnesium for adults is 310-420 mg/day. SSI notes from the published IOM, 1997 report that there is no UL for magnesium in food. The daily intake of magnesium expected to result from the intended use of purified seawater is only 37 mg/day.
Based on the totality of the publicly available information, SSI concludes that purified seawater is GRAS under the conditions of its intended use.
Standards of Identity
In the notice, SSI states its intention to use purified seawater in several food categories, including foods for which standards of identity may 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 purified seawater and in describing the information that SSI relies on to conclude that purified seawater is GRAS under the conditions of its intended use, SSI raises a potential issue under the labeling provisions of the Federal Food, Drug, and Cosmetic Act (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 purified seawater bear any claims on the label or in labeling, such claims are the purview of the Office of Nutrition and Food Labeling (ONFL), in the Center for Food Safety and Applied Nutrition. 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 purified seawater on the label or in labeling.
Section 301(ll) of 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 SSI’s notice that purified seawater is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing purified seawater. Accordingly, this response should not be construed to be a statement that foods that contain purified seawater, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by SSI, as well as other information available to FDA, the agency has no questions at this time regarding SSI’s conclusion that purified seawater 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 purified seawater. As always, it is the continuing responsibility of SSI 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 000618, 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
[a] SSI states that purified seawater is not intended for use in foods under the jurisdiction of the United States Department of Agriculture, nor is it intended for use in infant formulas.
[b] SSI states that the microbial contaminants included in the analyses are aerobic plate counts, total coliforms, Clostridium perfringens, Escherichia coli, Enterococcus spp., and Vibrio spp. SSI states that if any bacterial contaminants are detected during the analyses, the batches are discarded.