1 See U.S. Food & Drug Admin., Healthy Innovation, Safer Families: FDA's 2018 Strategic Policy Roadmap 7 (2018) (one of four strategic policy areas is to “Empower consumers to make better and more informed decisions about their diets and health; and expand the opportunities to use nutrition to reduce morbidity and mortality from disease.”); Scott Gottlieb, Comm'r, U.S. Food & Drug Admin., Reducing the Burden of Chronic Disease, Remarks at National Food Policy Conference (Mar. 29, 2018), https://www.fda.gov/NewsEvents/Speeches/ucm603057.htm [https://perma.cc/4XDV-5KRJ].

2 See Winters, Diana R. H., Food Law at the Outset of the Trump Administration, 65 UCLA L. Rev. Disc. 28, 30-37 (2017)Google Scholar; Philip Rucker, Bannon: Trump Administration Is in Unending Battle for ‘Deconstruction of the Administrative State’, Wash. Post (Feb. 23, 2017), https://www.washingtonpost.com/news/powerpost/wp/2017/02/23/bannon-trump-administration-is-in-unending-battle-for-deconstruction-of-the-administrative-state/?noredirect=on&utm_term=.99409262e767 [https://perma.cc/9YPK-TBDQ].

3 See Michael J. Bologna, Cook County Puts Soda Tax on Ice in December, Daily Tax Report: State, Bloomberg BNA (Oct. 12, 2017), https://www.bna.com/cook-county-puts-n73014470769/ [https://perma.cc/UKU8-EYG5] (“At least eight other localities have some tax on sweetened drinks. They are Seattle; Philadelphia; Boulder, Colo.; and four cities in California: San Francisco, Oakland, Berkeley, and Albany.”).

4 New York City banned trans fats in 2007. A national ban will go into place in 2018. See Nicholas Bakalar, Trans Fat Bans Tied to Fewer Heart Attacks and Strokes, N.Y. Times (Apr. 12, 2017), https://www.nytimes.com/2017/04/12/well/eat/trans-fat-bans-tied-to-fewer-heart-attacks-and-strokes.html?login=smartlock&auth=login-smartlock [https://perma.cc/U8N6-ATYS]. New York City put menu-labeling requirements for chain restaurants into place in 2008, and the Affordable Care Act codified it on a national basis in 2010, for implementation in 2018. See N.Y.C. Dep't of Health & Mental Hygiene, Calorie Posting: About, NYC Bus., https://www1.nyc.gov/nycbusiness/description/calorie-posting [https://perma.cc/X4VR-UVBQ]; Menu Labeling Requirements, U.S. Food & Drug Admin., https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm515020.htm [https://perma.cc/S7QA-7CWR].

5 See Erbsen, Allan, Horizontal Federalism, 93 Minn. L. Rev. 493, 496, 500, 502-504 (2008)Google Scholar; Winters, Diana R. H., The Benefits of Regulatory Friction in Shaping Policy, 71 Food & Drug L.J. 228, 228-229, 238-239 (2016)Google ScholarPubMed.

6 Also referred to as “empowerment federalism,” “polyphonic federalism,” “interactive federalism,” and “vertical regulatory competition.” See Engel, Kirsten H., Harnessing the Benefits of Dynamic Federalism in Environmental Law, 56 Emory L.J. 159, 161 (2006)Google Scholar (“Absent constitutional changes that would lock in a specific allocation of authority, broad, overlapping authority between levels of government may be essential to prompting regulatory activity at the preferred level of government.”).

7 See New State Ice Co. v. Liebmann, 285 U.S. 262, 311 (1932) (A phrase made famous by Justice Brandeis describing the ability of the states to experiment with laws and policies without harm to the nation at large).

8 A term developed by the authors to describe the relationship between different levels of government as it pertains to the regulation of food in the United States.

9 See, e.g., Maggie Gosselin, Inst. for Agric. & Trade Policy, Beyond the USDA: How Other Government Agencies Can Support a Healthier, More Sustainable Food System 3 (Feb. 2010) (citing myriad governmental departments and agencies beyond the FDA and the USDA with roles a role in regulating the food system, including the EPA, Department of Interior, Department of Defense, Department of Commerce, Department of Transportation, Department of Housing and Urban Development, Department of Energy, Department of Homeland Security, and the Department of Labor, among others).

10 See Rénee Johnson, Cong. Research Serv., RS22600, The Federal Food Safety System: A Primer 1 (2016).

11 See Merrill, Richard A. & Francer, Jeffrey K., Organizing Federal Food Safety Regulation, 31 Seton Hall L. Rev. 61, 85, 92 (2000)Google Scholar.

12 21 U.S.C. §§ 601-695 (2012 & Supp. II 2014).

13 Id. §§ 451-472.

14 Id. §§ 1031-1056.

15 See Wesley Dunn, Charles, The Federal Food, Drug, and Cosmetic Act and the Food Industry, 3 Food Drug Cosm. L.Q. 166, 167 (1948)Google Scholar; Salthe, Ole, A Brief Review of the Legislative History of the Federal Food, Drug, and Cosmetic Act, 3 Food Drug Cosm. L.Q. 148, 152-53 (1948)Google Scholar.

16 See generally Dunn, supra note 15, at 167-71.

17 See generally Barton Hutt, Peter & Barton Hutt, Peter II, A History of Government Regulation of Adulteration and Misbranding of Food, 39 Food Drug Cosm L.J. 2 (1984)Google Scholar.

18 Id. at 39.

19 Id. at 40.

20 Id. at 39.

21 See Wesley Dunn, Charles, Its Legislative History, 1 Food Drug Cosm. L.Q. 297, 306 (1946)Google Scholar.

22 See id. at 42-43; Hutt & Hutt, supra note 17.

23 See Marc T. Law, History of Food and Drug Regulation in the United States, EH.Net Encyclopedia (Oct. 11, 2004), http://eh.net/encyclopedia/history-of-food-and-drug-regulation-in-the-united-states [https://perma.cc/X8MZ-D7EF].

24 Id.

25 Id.

26 Id.

27 Id. (citing John J. Wallis & Douglass C. North, Measuring the Transaction Sector of the American Economic, 1870-1970, in Long Term Factors in American Economic Growth 95-148 (Stanley Engerman & Robert E. Gallman eds., 1986); Susan Strasser, Satisfaction Guaranteed: The Making of the American Mass Market (Pantheon Books 1989) (1989); James H. Young, Pure Food: Securing the Federal Food and Drugs Act of 1906 (1986); Lorine S. Goodwin, The Pure Food, Drink, and Drug Crusaders, 1879-1914 (1999); and Donna J. Wood, Strategic Uses of Public Policy: Business and Government in the Progressive Era (1986)).

28 By way of example, states were grappling with food adulteration issues that had long plagued food consumers such as “water … added to wine, cream skimmed from milk, and chalk added to bread.” Law, supra note 23.

29 21 U.S.C. §11 (1906), repealed by Federal Food, Drug, and Cosmetic Act of 1938, Pub. L. No. 75-717, 52 Stat. 1040.

30 See Wesley Dunn, Charles, Original Federal Food, and Drugs Act of 1906, As Amended: Its Legislative History, 1 Food Drug Cosm. L.Q. 297, 299 (1946)Google Scholar (noting that prior to the passage of the Act, 103 bills were introduced to and defeated in Congress).

31 See id. at 307.

32 Gabriel Kolko, The Triumph of Conservatism: A Reinterpretation of American History 103 (McMillan 1967) (noting that meat packers already experiencing regulations were eager to ensure that their competitors were also made to comply with regulations).

33 See e.g. Part I: The 1906 Food and Drugs Act and Its Enforcement, U.S. Food & Drug Admin., https://www.fda.gov/AboutFDA/History/FOrgsHistory/EvolvingPowers/ucm054819.htm [https://perma.cc/XGD4-S3GK] (“In fact, the nauseating condition of the meat-packing industry that Upton Sinclair captured in The Jungle was the final precipitating force behind both a meat inspection law and a comprehensive food and drug law.”).

34 See Hutt & Hutt, supra note 17, at 9-10.

35 Id. at 10-11.

36 Id. at 11, 13 (the Act today is “more than 30 times the length it was in 1938”and that while there have been some “departures” from the original food and drug legislation, there has not been a “fundamental shift in legislative policy.”).

37 See Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947) (holding that when Congress legislates in an area historically regulated by the states, courts start with the assumption that Congress did not intend to displace state authority “unless that was the clear and manifest purpose of Congress.”); Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 144 (1963) (upholding a state law that rejected avocados based on maturity, which Federal law deemed marketable, holding that “[T]he supervision of the readying of foodstuffs for market has always been deemed a matter of peculiarly local concern. Many decades ago, for example, this Court sustained a State's prohibition against the importation of artificially colored oleomargarine (which posed no health problem), over claims of federal preemption and burden on commerce.”); Hillsborough Cty., Fla. v. Automated Med. Labs., Inc., 471 U.S. 707, 718 (1985) (“Given the presumption that state and local regulation related to matters of health and safety can normally coexist with federal regulations, we will seldom infer, solely from the comprehensiveness of federal regulations, an intent to pre-empt in its entirety a field related to health and safety.”).

38 Mitchell, Charles P., State Regulation and Federal Preemption of Food Labeling, 45 Food Drug Cosm. L.J. 123, 139 (1990)Google Scholar.

39 See Nutrition Labeling Education Act, 21 U.S.C. § 343(q)(4)(A) (2012) (stating that the FDA Secretary will issue both mandatory and voluntary nutritional guidelines. See also Mitchell, supra note 38, at 130 (“Far from discerning ‘clear and manifest’ intent to exclude state regulation, courts interpreting the Act have found only silence and have declined to find wholesale preemption.”); Sciortino v. Pepsico, Inc. 108 F. Supp. 3d 780, 796-797 (N.D. Cal. 2015).

40 See Winters, Diana R. H., The Magical Thinking of Food Labeling: The NLEA as a Failed Statute, 89 Tul. L. Rev. 815, 832-833 (2014)Google Scholar; Consumer Justice Ctr. v. Olympian Labs, Inc., 121 Cal. Rptr. 2d 749, 755 (Cal. Ct. App. 2002) (“As far as the Food, Drug, and Cosmetic Act is concerned, it would be more accurate to say that the act evidences, far from implied preemption, an instance of implied nonpreemption.”). See also POM Wonderful LLC v. Coca-Cola Co., 134 S. Ct. 2228, 2238 (2014) (“By taking care to mandate express pre-emption of some state laws, Congress if anything indicated it did not intend the FDCA to preclude requirements arising from other sources.”).

41 See Florida Lime, 373 U.S. at 144-145 (stating “the States have always possessed a legitimate interest in ‘the protection of … [their] people against fraud and deception in the sale of food products' at retail markets within their borders.”).

42 Hillsborough Cty., 471 U.S. at 713 (explaining preemption doctrine).

43 21 U.S.C. §§ 343-1(a)(2)-(4) (2012).

44 Id. §§ 343-1(a)(4)-(5).

45 Id. This exemption allowed localities, such as New York City, to establish menu-labeling requirements for certain restaurants. See New York State Rest. Assoc. v. New York City Board of Health, 556 F.3d 114, 120 (2d Cir. 2009) (“Though appearing complex, this scheme is simple when it comes to restaurant food – the NLEA does not regulate nutrition information labeling on restaurant food, and states and localities are free to adopt their own rules.”). This exemption has been narrowed, however, by the Patient Protection and Affordable Care Act, which imposes menu-labeling requirements on larger chain restaurant establishments. § 343-1(a)(4).

46 Hillsborough Cty., 471 U.S. at 714, 716; Jones v. Rath Packing Co., 430 U.S. 519, 525-26 (1977); Florida Lime, 373 U.S. at 146.

47 Hillsborough Cty., 471 U.S. at 713.

48 Id. (“Even where Congress has not completely displaced state regulation in a specific area, state law is nullified to the extent it actually conflicts with federal law…. [including] when state law ‘stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.’”) (citing Hines v. Davidowitz, 312 U.S. 52, 67 (1941)).

49 For example, a state trial court in Connecticut found that the plaintiff could not use state law to impose labeling requirements regarding allergens different than those found in the FDCA because “it would be an obstacle to the accomplishment and execution of the purposes and objectives of Congress in the field of labeling food products containing potential food allergens.” Cardinale v. Quorn Foods, Inc., No. X05CV096002022S, 2011 WL 2418628, at *8 (Conn. Super. Ct. May 19, 2011).

50 See e.g., Nat'l Meat Ass'n v. Harris, 565 US. 452, 458-62 (2012) (striking down a state law that prohibited the holding, processing, or butchering of a nonambulatory animal on the basis that the Federal Meat Inspection Act and its implementing regulations preempted more restrictive state proscriptions); Rath Packing Co., 430 U.S. at 540-43 (invalidating a California law regulating labeling and weights of food products as preempted by the Federal Meat Inspection Act and an obstacle to fulfillment of the Fair Packaging and Labeling Act).

51 Inst. of Med. & Nat'l Research Council, Enhancing Food Safety: The Role of the Food and Drug Administration 43-51, 212 (Robert B. Wallace & Maria Oria eds., 2010).

52 Id. at 205-12. See also Pomeranz, Jennifer L. et al., The Potential for Federal Preemption of State and Local Sugar-Sweetened Beverage Taxes, 53 Am. J. Preventive Med. 740 (2017)CrossRefGoogle ScholarPubMed (discussing the rationale for federal preemption of sugar-sweetened beverage taxes and concluding that these taxes should not be preempted).

53 Food Safety Modernization Act of 2011, Pub. L. No. 111-353, 124 Stat. 3885; 29 C.F.R. § 1987.100 (2012).

54 See e.g., U.S. Gov't Accountability Office, GAO-16-425, FDA Coordinating with Stakeholders on New Rules but Challenges Remain and Greater Tribal Consultation Needed 16 (2016) (State officials contacted by the GAO regarding whether the FDA met its mandate to coordinate with state departments of agriculture had mixed opinions about the efficacy of the agency's communication. “Specifically, officials from 2 departments characterized the quality as very good, 3 characterized it as good, 2 characterized it as moderately good, and 1 characterized it as very poor. Officials from one of the departments that characterized the coordination as very good explained that FDA was very open to discussing states' concerns. One of the officials that characterized the coordination as moderately good stated that FDA did not seek as much input from states as the official would have liked. The official that characterized the coordination as very poor noted that states had many outstanding concerns that had not been addressed, including the produce rule's complexity and compliance costs.”). See also Fisher, Laura, Administrative Law - All (Food) Politics Is Local: Cooperative Federalism, New England Small Farms, and the Food Safety Modernization Act, 37 W. New Eng. L. Rev. 337, 367 (2015)Google Scholar (arguing that FSMA should embrace true cooperative federalism and allow the states to develop workable plans based on regional differences that implement the broader goal of food safety); Walters, Emily, The Food Safety Modernization Act's True Implications for Sustainable Agriculture, 4 Wash. & Lee J. Energy, Climate & Env't 391, 406 (2013)Google Scholar (by broadening the FDA's reach under FSMA, the Act has taken away authority from the states in areas they historically regulated).

55 Food Safety Modernization Act of 2011.

56 U.S. Gov't Accountability Office, GAO-04-588T, Federal Food Safety and Security Systems: Fundamental Restructuring is Needed to Address Fragmentation and Overlap (2004).

57 Renee Johnson, Cong. Research Serv., R42885, Food Safety Issues for the 113 Congress (2013).

58 Id.

59 U.S. Gov't Accountability Office, supra note 54, at 16. There have also been repeated calls for, at the very least, a simplification and rationalization of federal food systems oversight, by combing all federal food oversight into one agency, but this idea has not gained much traction.

60 “The FDA has examined the impacts of the proposed rule under Executive Order 13563 and 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.” U.S. Food & Drug Admin., Analysis of Economic Impacts – Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption 2 (2014).

61 See id.; U.S. Food & Drug Admin., FDA-2011-F-0171, Regulatory Impact Analysis – Food Labeling: Calorie Labeling of Articles of Food in Vending Machines (2014).

62 U.S. Food & Drug Admin., supra note 60, at 301.

63 Id.

64 Id.

65 See Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, 79 Fed. Reg. 58,524 (proposed Sept. 29, 2014) (to be codified at 21 C.F.R. pts. 1, 16, & 117).

66 See e.g., Richard Williams, Regulations Implementing the Food Safety Modernization Act, (Mercatus Working Paper, 2015); James Gattuso & Diane Katz, Red Tape Rising 2016: Obama Top Regs Top $100 Billion Annually, The Heritage Found. (May 23, 2016), https://www.heritage.org/government-regulation/report/red-tape-rising-2016-obama-regs-top-100-billion-annually [https://perma.cc/64ZV-LLM2] (“Foodborne illness is indeed a public health concern. However, America's food supply is remarkably safe, and yet the Food and Drug Administration (FDA) has cast an exceedingly broad regulatory net rather than focusing on the biggest risks. That means higher food costs across the board without regard to consumer benefit. In addition to consumers, the biggest burden will fall on small farms and “local” food producers who are forced to implement controls, training, and record-keeping systems fashioned for much larger operations. And because the rules are rigid, producers of specialty crops are particularly concerned that advances in food science and technology will become more difficult to adopt.”); Baylen Linnekin, The Feds Modernize Food Safety Without Making Food Safer, Reason (Nov. 1, 2014,), http://reason.com/archives/2014/11/01/fdas-fsma-modernizes-food-safety-without [https://perma.cc/U5D4-PZGD] (“Even giving the FDA the maximum possible benefit of the doubt—even if I assume that the FDA will prevent every single one of the illnesses the agency itself doesn't expect to prevent—the maximum benefit of these FSMA rules would be a reduction of 5.4 percent of food-borne illnesses. Meanwhile, the agency also floats a break-even figure of reducing 228,000 cases of food-borne illness under the manufacturing rules. This would mean the two rules, taken together, would reduce cases of food-borne illness by up to 3.7 percent.”).

67 U.S. Gov't Accountability Office, supra note 54, at 32-37.

68 National Sustainable Agriculture Coalition, Comment Letter on Proposed Rule for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Nov. 15, 2013), http://sustainableagriculture.net/wp-content/uploads/2008/08/NSAC-Produce-Rule-Comments-FINAL-11-15-13.pdf (“Regulations must be scale- and supply-chain appropriate to be effective; a one-size-fits-all approach will put small and mid-sized farms and processors out of business, undermining public health goals, such as increased production of, availability of, and access to healthy foods, as well as economic opportunity, equity, and job-creation goals.”). See also Diana R.H. Winters, From Industrial to Artisanal: A New Regulatory Framework for a Changing Food Landscape 10-11 (Ind. Univ. Robert H. McKinney Sch. of Law Research Paper No. 2013-23, 2013) (arguing that the complexity of regulation makes it difficult for small food producers to enter the market, even if they are exempted from FSMA rules).

69 See e.g., Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, 76 Fed. Reg. 58,433 (proposed Sept. 29, 2014) (to be codified at 21 C.F.R. pt. 112) (proposing to amend provisions addressing microbial standards for agricultural water and minimum time intervals for the application of raw manure to account for regional growing conditions and practices); FSMA Strategy for Engaging Stakeholders, U.S. Food & Drug Admin., https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm564350.htm [https://perma.cc/K5WK-HVH3] (“Meeting with the people on the front lines who would be covered by FSMA rules definitely helped educate our staff. The issues that face each region of the country are unique. We received a lot of useful information during our outreach, including local, regional, and commodity-specific concerns.”).

70 Id.

71 See e.g., Schmidt, Charles W., ENVIRONMENT: California Out in Front, 115 Envtl. Health Persp. A144 (2007)Google ScholarPubMed (Frustrated with the lack of progress at the Federal level to combat global warming, California's legislature has responded with some of the nation's strongest environmental laws); Madison Park, California Sets Trends in Health Regulation, CNN (Feb. 10, 2012), https://www.cnn.com/2012/02/10/health/california-leads-health-laws/index.html [https://perma.cc/R2DH-K3C6] (“The state has been first to pass major public health initiatives that have spread throughout the country.”).

72 The definition of what constitutes an additive in the food supply is broad. Under Federal law, an additive is any substance that “may reasonably be expected to result, directly or indirectly, either in [its] becoming a component or otherwise affecting the characteristics of any food. 21 U.S.C. § 321(s) (2012).

73 The definition of what constitutes an additive in the food supply is broad. Under Federal law, an additive is any substance that “may reasonably be expected to result, directly or indirectly, either in [its] becoming a component or otherwise affecting the characteristics of any food. 21 U.S.C. § 321(s) (2012).

74 Developments in the Law: The Federal, Food, Drug, and Cosmetic Act, 67 Harv. L. Rev. 632, 634 (1954)Google Scholar.

75 Food Additives Amendment of 1958, Pub. L. No. 85-929, 72 Stat. 1784 (codified as amended at 21 U.S.C. §§ 301–399 (2006)).

76 See e.g., Complaint at 1, Ctr. for Food Safety v. Price, No. 1:17-cv-03833 (S.D.N.Y May 22, 2017) (“The GRAS Rule allows potentially unsafe food additives to be used in the food supply (human and animal) without FDA review, approval, oversight, or knowledge, in violation of the Federal Food, Drug, and Cosmetic Act ….”); Erin Quinn & Chris Young, Why the FDA Doesn't Really Know What's in Your Food, Ctr. for Pub. Integrity (Apr. 14, 2015, 5:00 AM), https://www.publicintegrity.org/2015/04/14/17112/why-fda-doesnt-really-know-whats-your-food [https://perma.cc/V9SL-CP4G].

77 21 U.S.C. § 348(a) (2012).

78 Id. § 348(b).

79 A list of prior approved substances is included in 21 C.F.R. §§ 181.1-181.34 (2012).

80 See § 321(s).

81 Id.

82 Id.

83 Id.

84 See, e.g., U.S. Gov't Accountability Office, GAO-10-246, Food Safety: The FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS) 8 (2010) (“FDA reviews those GRAS determinations that companies choose to submit to the voluntary notification program. However, FDA generally does not have information about other GRAS determinations because companies are not required to inform the agency of their GRAS determinations. Furthermore, FDA has not taken certain steps that could help ensure the safety of GRAS determinations, particularly those for which the agency has not been notified. Notably, a trade association routinely informs FDA of its GRAS determinations, even though it does not submit notices to FDA's voluntary notification program.”); Neltner, Thomas G., et al., Conflicts of Interest in Approvals of Additives to Food Determined to Be Generally Recognized as Safe, 173 JAMA Internal Med. 2032, 2032 (2013)CrossRefGoogle ScholarPubMed (“Between 1997 and 2012, we found that financial conflicts of interest were ubiquitous in determinations that an additive to food was GRAS. The lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply, particularly in instances when the manufacturer does not notify the FDA of the determination.”).

85 See Substances Generally Recognized as Safe, 62 Fed. Reg. 18,938 (proposed April 17, 1997) (to be codified at 21 C.F.R pts. 170, 184, 186, & 570) (“It is on the basis of the GRAS exemption to the food additive definition that many substances (such as vinegar, vegetable oil, baking powder, and many salts, spices, flavors, gums, and preservatives) are lawfully marketed today without a food additive regulation.”); 21 C.F.R. § 182.1(a) (2018) (“It is impracticable to list all substances that are generally recognized as safe for their intended use. However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, sugar, vinegar, baking powder, and monosodium glutamate as safe for their intended use.”). See also Degnan, Frederick H., Rethinking the Applicability and Usefulness of the GRAS Concept, 46 Food Drug Cosm. L.J. 553, 580 (1991)Google Scholar (arguing that the agency should spend its scarce resources on “those substances truly in need of prompt agency attention” rather than the “thousands of other substances considered to be of little public health consequence”).

86 The Pew Charitable Trs., Fixing the Oversight of Chemicals Added to Our Food 1 (2013).

87 See, e.g., Beyranevand, Laurie J., Generally Recognized as Safe: Analyzing Flaws in the FDA's Approach to GRAS Additives, 37 Vt. L. Rev. 887, 887-89 (2013)Google Scholar (arguing that the FDA needs to reevaluate its approach to regulating GRAS substances and consider “safety” in the broadest sense to more adequately protect consumers).

88 See Substances Generally Recognized as Safe, 62 Fed. Reg. at 18,938 (FDA proposed to revoke the petition process which required rulemaking for each GRAS substance and replace it with a notification procedure whereby individuals could notify the agency of GRAS determinations). This rule was never finalized until the recent 2016 rulemaking.

89 U.S. Gov't Accountability Office, supra note 83, at 6.

90 Substances Generally Recognized as Safe, 81 Fed. Reg. 54,960, 54,966 (Aug. 17, 2016) (to be codified at 21 C.F.R. pts. 20, 25, 170, 184, 186, & 570).

91 Id. at 54970-71.

92 Id.

93 Noah, Lars & Merrill, Richard A., Starting from Scratch?: Reinventing the Food Additive Approval Process, 78 B.U. L. Rev. 329, 443 (1998)Google Scholar; Scrufari, Carrie A., Substances Generally Recognized as Safe-Until They're Not: Challenges in Protecting the Food Supply in A Processed World, 36 Stan. Envtl. L.J. 219, 243-44 (2017)Google Scholar (“An examination of the FFDCA and its attendant rules and regulations demonstrates that FDA is not regulating GRAS substances in any meaningful pre-market way, and for most intents and purposes, it is not regulating GRAS substances in a meaningful post-market way. In addition, because the safety of GRAS substances is already legally presumed, they appear to evade regulatory scrutiny by falling into another large loophole–one Congress intended to close in 1958 with the Delaney Clause.”).

94 U.S. Gov't Accountability Office, supra note 83, at 12. See also Dragich, Martha, GRAS-Fed Americans: Sick of Lax Regulation of Food Additives, 49 Ind. L. Rev. 305, 339 (2016)Google Scholar (“The FDA's current inability to oversee the safety of food additives is amenable to a solution that promises significant benefit to consumers at a relatively low cost to producers and regulators. Simply put, the FDA should promulgate a regulation requiring producers to notify the FDA of all SRAS substances and the self- (or industry-) determinations of their safety before introducing them into the market. Producers ought to be required to monitor on an ongoing basis the safety of all substances in use in their products and to report credible adverse information to the FDA as that information develops.”); Quinn & Young, supra note 75 (“Two industry consultants told Center for Public Integrity reporters that two-thirds of their safety reviews are never sent to regulators. An international food company told the GAO that it introduces five new ingredients yearly without telling the FDA.”).

95 Complaint at 16, Ctr. for Food Safety v. Price, No. 1:17-cv-03833 (S.D.N.Y May 22, 2017).

96 Cal. Health & Safety Code, Div. 104, Part 105 (2018).

97 Id. § 110445.

98 Id. § 110085.

99 See Sciortino v. Pepsico, Inc., 108 F. Supp. 3d 780, 806 (N.D. Cal. 2015).

100 Id. at 806-807.

101 Id. at 807.

102 Id. at 809 (citing Wyeth v. Levine, 555 U.S. at 582 (2009)).

103 Id. at 811.

104 See Cal. Food & Agric. Code §§ 14402, 14401 (2016).

105 See id. § 14405.

106 See Nat. Res. Def. Council, Inc. v. U.S. Food & Drug Admin., 872 F. Supp. 2d 318, 341-42 (S.D.N.Y. 2012); Winters, Diana R. H., Intractable Delay and the Need to Amend the Petition Provisions of the FDCA, 90 Ind. L. J. 1047, 1060 (2015)Google Scholar.

107 Nat. Res. Def. Council, Inc., 872 F. Supp. 2d at 322-23.

108 Dep't of Health, Educ. & Welfare, Antibiotic and Sulfonamide Drugs in Animal Feeds, 37 Fed. Reg. 2411, 2444–45 (proposed Feb. 1, 1972) (to be codified at 21 C.F.R. pt. 135).

109 See 21 C.F.R. § 558.15 (2013).

110 Dep't of Health, Educ. & Welfare, New Animal Drugs for Use in Animal Feeds; Penicillin and Tetracycline (Chlortetracycline and Oxytetracycline)-Containing Premixes, 48 Fed. Reg. 4490, 4490 (proposed Feb. 1, 1983) (to be codified at 21 C.F.R. pt. 558); Dep't of Health, Educ. & Welfare, Drugs for Human Use; Drug Efficacy Study Implementation; Certain Anticholinergic Drugs Containing Tridihexethyl Chloride; Withdrawal of Approval, 48 Fed. Reg. 4554, 4554 (Feb. 1, 1983); Dep't of Health, Educ. & Welfare, Tetracycline (Chlortetracycline and Oxytetracycline)-Containing Premixes; Opportunity for Hearing, 42 Fed. Reg. 56,264, 56,264 (Oct. 21, 1977); Dep't of Health, Educ. & Welfare, Penicillin-Containing Premixes; Opportunity for Hearing, 42 Fed. Reg. 43,772, 43,772 (Aug. 30, 1977).

111 See Nat. Res. Def. Council, Inc., 872 F. Supp. 2d at 329-30.

112 Id. 341.

113 See Nat. Res. Def. Council, Inc. v. U.S. Food & Drug Admin. 760 F.3d 151, 175 (2d Cir. 2014) (“[T]he decision whether to institute or terminate a hearing process that may lead to a finding requiring withdrawal of approval for an animal drug is a discretionary determination left to the prudent choice of the FDA; but see id. at 177 (Katzmann, J. dissenting) (stating that any reading of the provision in its larger context would show that once FDA had made a preliminary finding that the drugs were unsafe, it was required to hold hearings on their withdrawal.

114 See Phasing Out Certain Antibiotic Use in Farm Animals, U.S. Food & Drug Admin (Dec. 11, 2013), http://www.fda.gov/forconsumers/consumerupdates/ucm378100.htm [https://perma.cc/6TA6-M9AQ].

115 See Nat. Res. Def. Council, Inc., 760 F.3d at 175.

116 See Heinzerling, Lisa, The FDA's Continuing Incapacity on Livestock Antibiotics, 33 Stan. Envtl. L.J. 325, 333 (2014)Google Scholar (identifying identifies four specific problems with FDA's voluntary approach: the reliance on industry cooperation, the fact that antibiotics can still be issued herd-wide for disease prevention, the weakening of the meaning of veterinary oversight, and the lack of transparency in the process); Diana R. H. Winters, The Inadequacy of Voluntary Measures to Reduce the Use of Antimicrobials in Animal Feed, Bill of Health (Oct. 14, 2014), http://blogs.harvard.edu/billofhealth/2014/10/04/the-inadequacy-of-voluntary-measures-to-reduce-the-use-of-antimicrobials-in-animal-feed [https://perma.cc/2DXM-E359].

117 See The White House, National Strategy For Combating Antibiotic-Resistant Bacteria 13 (Sept. 5, 2014), https://obamawhitehouse.archivesavailable at http://www.whitehouse.gov/sites/default/files/docs/carb_national_strategy.pdf.

118 Livestock: Use of Antimicrobial Drugs, 2015 Cal. Stat. ch. 675 (2015) (codified at Cal. Food & Agric. Code §§ 14400-14408 (2017)); Aguirre, Emilie, Contagion Without Relief: Democratic Experimentalism and Regulating the Use of Antibiotics in Food-Producing Animals, 64 UCLA L. Rev. 550, 578 (2017)Google Scholar.

119 See Aguirre, supra note 118; Letter from Edmund G. Brown, Jr., Governor of Cal., to the Members of the Cal. State Senate (Sept. 29, 2014), http://gov.ca.gov/docs/SB_835_Veto_Message.pdf.

120 See Aguirre, supra note 118, at 592 (concluding that a suit against the law on preemption grounds should fail).

121 Id. at 593.

122 Id.

123 See Engel, Kirsten H., Harnessing the Benefits of Dynamic Federalism in Environmental Law, 56 Emory L.J. 159, 168 (2006)Google Scholar (noting that states, most often California, “impose standards on nationally distributed products to address and environmental health or safety problem.”).

124 See Variyam, Jayachandran A., Do Nutrition Labels Improve Dietary Outcomes?, 17 Health Econ. 695, 704 (2008)CrossRefGoogle ScholarPubMed; Richard Williams, Why the New Nutrition Labels Won't Work, Politico: The Agenda, (May 23, 2016), https://www.politico.com/agenda/story/2016/05/the-nutrition-facts-panel-failed-policy-000125 [https://perma.cc/6RFS-2MU] (“How am I so sure that the nutrition facts panel has been a failure? Because I made all of the upbeat predictions about how helpful it would be when, in 1993, we implemented the Nutrition Labeling and Education Act of 1990. That law created, among other things, the Nutrition Facts Panel that you see on the back of packaged food. At the time, I was the chief economist at the Center for Food Safety and Applied Nutrition in the FDA and I asserted that people would see this information and use it to make wise, healthy choices, which would lead to better health outcomes for the nation. We thought we would see about 40,000 fewer cases of cancer and heart disease over the next 20 years and prevent 13,000 deaths.”); but see FDA Nutrition Innovation Strategy, U.S. Food & Drug Admin. (Oct. 18, 2018), https://www.fda.gov/Food/LabelingNutrition/ucm602651.htm [perma.cc/DV4B-S22V] (detailing FDA Commissioner Scott Gottlieb's recently announced “Nutrition Innovation Strategy” as part of the agency's “Healthy Innovation, Safer Families: FDA's 2018 Strategic Policy Roadmap” focused on prioritizing science based food label claims, cleaning up the ingredients label for greater consumer understanding, reconsidering existing standards of identity in light of updated nutrition science, implementing the enacted changes to the nutrition facts panel and menu labels, and voluntary measures to reduce sodium in food products, in response to the failed nutrition labels).

125 See, e.g., Deloitte, Capitalizing on the Shifting Consumer Food Value Equation 4 fig. 4 (2016), https://www2.deloitte.com/content/dam/Deloitte/us/Documents/consumer-business/us-fmi-gma-report.pdf; Beth Kowitt, Special Report: The War on Big Food, Fortune (May 21, 2015), http://fortune.com/2015/05/21/the-war-on-big-food/ [https://perma.cc/3KWN-M2JG] (“‘We look at our business and say, “How can we remake ourselves?”’ said Richard Smucker, CEO of [Smuckers].”); Hans Taparia & Pamela Koch, Opinion, Real Food Challenges the Food Industry, N.Y. Times, Nov. 8, 2015, at SR4 (“[F]ood manufacturers are reacting [to changing consumer demand] by cleaning up their ingredient labels, acquiring healthier brands and coming out with a prodigious array of new products.”).

126 See generally Gostin, Lawrence O., General Justifications for Public Health Regulation, 121 Pub. Health 829 (2007)CrossRefGoogle ScholarPubMed (examining three general justifications for government intervention: (1) risk to others; (2) protection of incompetent people; and (3) risk to self).

127 Id. at 831.

128 Id.

129 See Resnik, David B., Paternalistic Food and Beverage Policies: A Response to Conly, 7 Pub. Health Ethics 170, 171 (2014)Google Scholar.

130 Gostin, supra note 126, at 831, 833.

131 Nonbinding agency guidance is exempt from the notice and comment requirements under Title V of the United States Code section 553. See 5 U.S.C. § 553 (2012).

132 See generally Light, Sarah E., Advisory Nonpreemption, 95 Was. U. L. Rev. 327 (2017)Google Scholar (describing advisory nonpreemption).