Agency Response Letter GRAS Notice No. GRN 000629
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See also Generally Recognized as Safe (GRAS).
CFSAN/Office of Food Additive Safety
August 9, 2016
Hunan NutraMax Inc.
Changhai Base, 627 Lugu Rd
Changsa High-Tech Industrial Development Zone
Re: GRAS Notice No. GRN 000629
Dear Mr. Zhang:
The Food and Drug Administration (FDA) is responding to the notice, dated February 1, 2016, submitted by Dr. Susan Cho on behalf of Hunan NutraMax Inc. (NutraMax) 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 February 5, 2016, filed it on March 3, 2016, and designated it as GRAS Notice No. GRN 000629. In one of the e-mails dated July 15, 2016, Dr. Cho requested that this letter be addressed to Baotang Zhang of NutraMax.
The subject of the notice is Siraitia grosvenorii Swingle (Luo Han Guo) fruit extract (containing ≥7%, ≥12.5%, ≥20%, ≥25%, ≥30%, ≥40%, ≥50%, ≥55%, ≥60%, ≥90%, or ≥95% mogroside V) (SGFE). The notice informs FDA of the view of NutraMax that SGFE is GRAS, through scientific procedures, for use as a table top sweetener and as a general purpose non-nutritive sweetener in foods, excluding meat and poultry products, and infant formula, at levels determined by current good manufacturing practices.
In an initial e-mail from Dr. Cho on July 15, 2016, NutraMax withdrew the notice in order to change product profiles and specifications. Given this e-mail, we ceased to evaluate this GRAS notice, effective July 15, 2016, the date we received the e-mail.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000629, 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 via the FDA home page at http://www.fda.gov/grasnoticeinventory.
Antonia Mattia, Ph.D.
Division of Biotechnology
and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety
and Applied Nutrition