Agency Response Letter GRAS Notice No. GRN 000003
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CFSAN/Office of Premarket Approval
June 5, 1998
Ms. Betty J. Pendleton
15505 Country Ridge Drive
Chesterfield, MO 63017
Re: GRAS Notice No. GRN 000003
Docket No. 98S-0104
Dear Ms. Pendleton:
This is in response to your GRAS notice dated February 11, 1998, which was received by the Food and Drug Administration (FDA) on February 26, 1998. This request was submitted to FDA on behalf of Jones-Hamilton Co. in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997). FDA designated your notice as GRAS Notice No. GRN 000003.
Your notice states that Jones-Hamilton Co. has determined that sodium bisulfate (NaHSO4; CAS Reg. No. 7681-38-1) is generally recognized as safe (GRAS) for use as (1) a pH control agent and leavening agent in cake mixes at a level of 1 to 10 grams sodium bisulfate per 1000 grams of total mix (0.1 per cent to 1.0 per cent by weight) and (2) a pH control agent and a processing aid in food at levels not to exceed good manufacturing practice. Your notice refers to the provision in 21 CFR 184.1095 (sulfuric acid) that current good manufacturing practice results in a maximum level, as served, of 0.014 per cent for alcoholic beverages and 0.0003 per cent for cheeses. Your notice describes the manufacturing process for sodium bisulfate, which is the sodium salt of sulfuric acid. The manufactured sodium bisulfate meets the specifications for this ingredient in the Food Chemicals Codex, Fourth Edition (1996). Its main characteristic is its acidity in water solutions.
Your notice states that the basis for the GRAS determination is through experience based on common use in food - i.e., that Jones-Hamilton Co. has experience based on common use in food. However, as we discussed by telephone on April 27, 1998, FDA considered your notice under scientific procedures (§ 170.30(b)). Based on the information provided by Jones-Hamilton Co., as well as other information available to FDA, the agency has no questions at this time regarding the conclusion of Jones-Hamilton Co. that sodium bisulfate is GRAS under the proposed conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of sodium bisulfate. As always, it is your continuing responsibility to ensure that food ingredients that you 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 this letter has been made available for public review and copying at the agency's Dockets Management Branch (Docket No. 98S-0104). As mentioned in our letter dated March 5, 1998, which acknowledged receipt of your GRAS notice, a copy of the information in your notice that conforms to the information in proposed § 170.36(c)(1) is likewise available in Docket No. 98S-0103.
Alan M. Rulis, Ph.D.
Office of Premarket Approval
Center for Food Safety and Applied Nutrition