61. Although FDA lacks statutory authority to require administrative exhaustion, its regulations provide that, before seeking judicial review of an FDA action or failure to act, an interested party first must petition the Commissioner pursuant to §10.25(a) to take or refrain from taking the relevant action or inaction. 21 C.F.R. §10.45(b).

Even if the SNDA and ANPR were considered part of the same proceeding, plaintiffs’ argument would fail. Submitting comments in an ANPR may, arguendo, serve to make one an “interested party” in the ANPR proceeding, but those comments do not make one an “interested party” in a separate and distinct proceeding, and they do not serve as a “petition” to the Commissioner to “issue, amend, or revoke a regulation or order” on an SNDA approval as contemplated by 21 C.F.R. § 10.25(a) (“[a]n interested person may petition the Commissioner to issue, amend, or revoke a regulation or order . . .”); see also 21 C.F.R. § 10.45(b) (providing that a request that the “Commissioner take or refrain from taking any form of administrative action must first be the subject of a final administrative decision based on a petition submitted under § 10.25(a) . . . before any legal action is filed in a court complaining of the action or failure to act.”).

Now that FDA has actually opened a formal public comment docket on “natural” labeling standards through its Request (pages 2-3, supra), the teachings of Astiana are all the more persuasive and applicable. In fact, FDA’s action is a direct response, in part, to requests made by “Federal district courts” addressing private “natural” false advertising lawsuits “for an Case 1:15-md-02645-WHP Document 66 Filed 03/07/16 Page 20 of 34 12 718618503 administrative determination under 21 CFR 10.25(c) . . . [of] whether food products containing ingredients produced using bioengineering may be labeled as ‘Natural,’ ‘All Natural,’ and/or ‘100% Natural.’” Giali Decl.

If C&D takes issue with FDA's decisions, C&D has recourse with the FDA: it may file a citizen's petition seeking further the FDA action. 21 C.F.R. §§10.25(a) ("An interested person may petition the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action"); Quick v. Thompkins, 425 F.2d 260, 261 (5th Cir. 1970) (Recourse must first be sought through administrative channels where allegations are mattes of internal prison administration); Frank v. Delta Airlines Inc., 314 F.3d 195, 201 (5th Cir. 2002) (alleged victims of improper drug testing by airline must first avail themselves of recourse through an administrative procedure under the FAA before seeking review in federal court). Under the SE With Limitations process, the advertising language C&D Case 1:14-cv-00585-AJN Document 59 Filed 05/22/14 Page 23 of 26 19 13277.

Case 1:12-cv-02918-PAB-BNB Document 77 Filed 08/16/13 USDC Colorado Page 9 of 12 10 III. THE CONTROLLING ISSUE OF WHETHER AND UNDER WHAT CIRCUMSTANCES GMO PRODUCTS CAN BE LABELED “NATURAL” IS CURRENTLY PENDING BEFORE FDA. Three other cases dealing with the identical legal question at issue in this case have recently been stayed, and two of the courts have referred the issue to FDA pursuant to 21 C.F.R. § 10.25(c). Now that the issue is squarely before FDA, resolution in one form or another is forthcoming, and dismissal or stay is even more appropriate and necessary.

Congress vested the FDA with primary jurisdiction to ensure that “foods are . . . properly labeled” to protect consumers. See 21 U.S.C. § 393(b)(2)(A) (FDA’s “mission” includes protecting public health by ensuring foods are safe and properly labeled); 21 C.F.R. § 10.25(b) (“FDA has primary jurisdiction to make the initial determination on issues within its statutory mandate”). As noted, FDA labeling Case 2:17-cv-02448-ODW-AGR Document 10 Filed 05/05/17 Page 24 of 27 Page ID #:105 17 DEFENDANT THE KROGER CO.’S MOTION TO DISMISS sf-3764313 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 regulations impose extraordinarily specific requirements for “NO SUGAR ADDED” claims.

Second, the labeling and use of substances such as PHOs is an issue that Congress has “placed within the [primary] jurisdiction of the FDA.” Syntek, 307 F.3d at 781; 21 C.F.R. § 10.25(b) (“FDA has primary jurisdiction to make the initial determination on issues within its statutory mandate.”) (emphasis added); 21 U.S.C. § 348 (addressing food additives).

In addition, citizens may petition the FDA to take action. 21 C.F.R. §§10.25(a), 10.30.

Accord Weinberger, 412 U.S. at 653-54.17 17Courts have applied the primary jurisdiction doctrine to dismiss cases involving FDA regulations. See 21 C.F.R. § 10.25(b); Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 627 (1973) (“The heart of the new procedures designed by Congress is the grant of primary jurisdiction to FDA, the expert agency it created.”); Israel v. Baxter Labs., 466 F.2d 272, 280 (D.C. Cir. 1972) (deferring to FDA because the question of whether a drug is safe and Case 1:14-cv-22113-MGC Document 21 Entered on FLSD Docket 08/15/2014 Page 26 of 28 -20- IV.

Plaintiffs’ claims would require the Court to resolve an issue that is squarely within FDA’s jurisdiction. 21 C.F.R. § 10.25(b) (FDA has “primary jurisdiction” to make “the initial determination on issues within its statutory mandate.”).