7 Citing briefs
McGee v. Diamond Foods, Inc.
REPLY to Response to Motion re MOTION to Dismiss for Failure to State a Claim
Filed December 15, 2014
This is a distinction without a difference, as the trans fat in the Popcorn Products indisputably achieved GRAS status through “[g]eneral recognition of safety through experience based on common use in food prior to January 1, 1958.” 21 C.F.R. § 170.30 (c)(1), (d) (1997); 78 F.R. 67169-01, at 67170-67171. 3.
Health Science Funding, LLC v. the United States Food & Drug Administration et al
MEMORANDUM in Opposition
Filed July 22, 2013
Neither of these exhibits establishes that plaintiff’s DHEA product is generally recognized as safe. See 21 C.F.R. § 170.30. Case 2:13-cv-03663-CCC-MF Document 10 Filed 07/22/13 Page 31 of 36 PageID: 241 27 IV.
Chacanaca et al v. The Quaker Oats Company
MOTION to Dismiss Notice of Motion and Motion And Memorandum of Points and Authorities in Support of Defendant's Motion to Dismiss Amended Consolidated Complaint
Filed October 14, 2011
The GRAS designation “may be based only on the views of experts qualified by scientific training and experience to evaluate the safety of substances directly or indirectly added to food.” 21 C.F.R. § 170.30(a). Listing a food additive as GRAS means there is “reasonable certainty in the minds of competent scientists that the substance is not harmful under its intended conditions of use,” id.
Guttmann v. Nissin Foods (U.S.A.) Company, Inc.
MOTION to Dismiss Class Action Complaint Pursuant to Rules 12
Filed March 19, 2015
3 Under both FDA and USDA regulations, TFAs may be included in food products because they are “Generally Recognized as Safe” (“GRAS”). 21 C.F.R. § 170.30(c)(1) (1993); see, e.g., 21 C.F.R. §§ 184.1555(c)(2), 184.
S.F., as Parent and Natural Guardian of S.E.F., an Infant v. Archer-Daniels-Midland Company et al
RESPONSE in Support re MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM Reply Memorandum of Law in Support of Motion to Dismiss
Filed November 1, 2013
(Resp. at 14.) The FDA based its affirmation not on 30-year- Case 1:13-cv-00634-WMS Document 39 Filed 11/01/13 Page 13 of 16 10 old secret documents, but on “the views of experts qualified by scientific training and experience to evaluate the safety of substances directly ... added to food.” 21 C.F.R. § 170.30(a). Those experts evaluated the “probable consumption of the substance,” the “cumulative effect of the substance in the diet,” and “[s]afety factors.” Id. § 170.3(i)(1), (2), (3).
Health Science Funding, LLC v. the United States Food & Drug Administration et al
REPLY BRIEF to Opposition to Motion
Filed August 12, 2013
172); (2) a color additive used in accordance with the color additive regulations (see 21 C.F.R. pts. 73 and 74); (3) a substance that is generally recognized, by qualified experts, to be safe under the conditions of its intended use (Generally Recognized As Safe, GRAS) (see 21 C.F.R. § 170.30 and 21 U.S.C. § 321(s)); or (4) a substance that is authorized by a prior sanction issued by FDA (see 21 C.F.R. § 170.3(l)).
Chacanaca et al v. The Quaker Oats Company
MOTION to Dismiss Notice of Motion and Motion And Memorandum of Points and Authorities in Support of Defendant's Motion to Dismiss Consolidated Complaint
Filed July 29, 2011
22(i).................................................................................................................9, 10 Case5:10-cv-00502-RS Document98 Filed07/29/11 Page5 of 23 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 iv NOTICE OF MOTION AND MOTION AND MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF MOTION TO DISMISS CONSOLIDATED COMPLAINT, CASE NO. 5:10-CV-00502-RS 21 C.F.R. § 101.81(c)(2)..............................................................................................................7, 8 21 C.F.R. § 170.30 ........................................................................................................................15 75 Fed. Reg. 76526 (Dec. 8, 2010) ................................................................................................15 Guidance for Industry: A Labeling Guide for Restaurants and Other Retail Establishments Selling Away-From-Home Foods, § III Nutrition Labeling of Restaurant Foods, ¶¶ 40-41, 45-46, 55, 60, Food and Drug Administration (Apr. 2008)....................................6 Health Claim Notification for Whole Grain Foods with Moderate Fat Content, FDA (Dec. 9, 2003), http://www.fda.gov/Food/ LabelingNutrition/LabelClaims/FDA ModernizationActFDAMAClaims/ucm073634.