`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`LAUREN COYLE, on behalf of
`herself and all those
`HORNELL BREWING CO., et al.,
`Civil No. 08-2797 (JBS)
`ORDER LIFTING STAY
`The Court hereby advises all counsel of the receipt of the
`attached letter dated September 16, 2010, received September 21,
`2010, from Michael M. Landa, Acting Director, Center for Food
`Safety and Applied Nutrition, U.S. Food and Drug Administration,
`declining to provide an FDA determination of the question whether
`high fructose corn syrup qualifies as a “natural” ingredient.
`This Court had referred this issue to the FDA pursuant to the
`Order of June 1, 2010 [Docket Item 115] and the Order of June 25,
`2010 [Docket Item 118], and had stayed this litigation for six
`(6) months pending this referral.
`It now appears that the stay should be lifted so that the
`case may proceed, and the Plaintiff's remaining claims may be
`prosecuted and that a schedule should be set for the
`reinstatement of Plaintiff's motion for class certification
`[Docket Item 108] and for briefing and hearing of that motion;
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`and for these purposes a short scheduling conference will be
`convened by telephone on Wednesday, September 29, 2010 at 10:00
`23rd day of September, 2010, hereby
`IT IS, this
`ORDERED that the temporary stay of litigation from June 25,
`2010 will be dissolved and the case may proceed; and it is
`ORDERED that the Court will convene a telephone scheduling
`conference of all counsel on Wednesday, September 29, 2010 at
`10:00 A.M., and Plaintiff's counsel is requested to arrange for
`the telephone conference call at that time.
`s/ Jerome B. Simandle
`JEROME B. SIMANDLE
`U.S. District Judge
`5 _/CDEPARTMENT on HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
`College Park, MD 20740
`l 5 203
`The Honorable Jerome B. Simandle
`U s D’
`United States Courthouse
`One John F. Gerry Plaza
`PO. Box 888
`Camden, New Jersey 08101
`Re: Coyle V. Hornell Brewing Co., Inc, et al.
`Civil Number 08-2797 (JBS—J S)
`Dear Judge Simandle:
`.;.a%: W5 e. SW
`This is in response to your letter dated June 25, 2010, referring to the Food and Drug
`Administration (“FDA”) for an administrative determination under 21 C.F.R. l0.25(c) the
`question of whether high fructose corn syrup (“HFCS”) qualifies as a “natural” ingredient. For
`the reasons explained below, we respectfully decline to provide such a determination.
`First, for the FDA to resolve whether HFCS qualifies as a “natural” ingredient in defendants’
`beverages, in the absence of a pre—existing regulatory definition, the agency would expect to act
`in a transparent manner by engaging in a public proceeding to establish the meaning of this
`term. Given the issues involved, making such a determination without adequate public
`participation would raise questions about the fairness of FDA’s action. FDA’s experience with
`such proceedings suggests that it would take two to three years to complete. We recognize that
`such a timeframe would likely not be useful to the Court in resolving the current case.
`Second, priority food safety and applied nutrition matters are currently fully occupying the
`resources that FDA has available for public proceedings on foods matters. For example, the
`agency is involved in taking actions designed to improve (1) the safety of the food supply and (2)
`the dietary practices of Americans, because many of the underlying causes of chronic disease —
`high blood pressure, elevated cholesterol, obesity and diabetes — are the result of lifestyle factors,
`including unhealthy eating, and are largely preventable. Proceedings to define “natural” do not
`fit within these current priorities. See 21 C.F.R. § l0.25(c).
`Consumers currently receive some protection in the absence of a definition of “natural” because
`the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations require that all
`ingredients used in a food be declared on the food’s label. Thus, the label provides consumers
`with information to decide whether to purchase the food. So, for the food product at issue in the
`above-captioned case, the consumer would know from the label whether the product contained
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`Page 2 - The Honorable Jerome B. Simandle
`The most relevant statement of the agency’s views is provided by the preamble language cited by
`the Court on page 6 of its June 15, 2010 opinion. The FDA there reiterated its interpretation that
`“natural” means nothing artificial or synthetic. This interpretation was not established by
`regulation but it is the most definitive statement of the agency’s view. By contrast, Geraldine
`June’s letter, which the Court cited on page 7 of its June 15, 2010 opinion, is an informal
`communication and does not provide a binding agency interpretation for the Court to follow.
`The opinions of individual employees do not bind the agency, and FDA has made clear that only
`the Commissioner can speak definitively for the agency. See 21 C.F.R. § l0.85(k); see also
`Western III. Home Health Care v. Herman, 150 F.3d 659, 662 (7th Cir. 1998) (agency action not
`final if only the ruling of subordinate official); Regenerative Sciences v. FDA, No. 09—cv-0041 1,
`2010 WL 1258010, at *7 (D. Colo. March 26, 2010) (finding that statements of lower level FDA
`officials do not rise to level of agency action even when contained in regulatory
`correspondence); Genendo Pharmaceutical v. Thompson, 308 F. Supp.2d 881, 885 (N.D. Ill.
`2003) (statements of FDA officials in warning letter do not constitute final agency action).
`We hope that this information is helpfiil to you.
`Michael M. Landa
`Center for Food Safety
`and Applied Nutrition
`Counsel for Plaintiff
`Daniel R. Lapinski, Esq.
`Wilentz, Goldman & Spitzer, PC
`90 Woodbridge Center Drive, Suite 900
`Woodbridge, NJ 07905
`Counsel for Defendants
`Robert P. Donovan, Esq.
`McElroy, Deutsch, Mulvaney & Carpenter LLP
`100 Mulberry Street
`Newark, NJ 07102