On July 7, 2016, the U.S. Senate passed an important amendment to S. 764 to establish a mandatory nationwide labeling approach for genetically engineered (GE) foods, more popularly referred to as genetically modified organisms, or GMO.1 Such move—which is not without controversy and comes only a week after Vermont’s GE labeling law went into effect—may signal the end of a long road to determine whether states or the federal government will ultimately regulate food labeling to require the disclosure of GE substances.
FDA Does Not Require GE Disclosures
Since the 1980s, the U.S. Food and Drug Administration (FDA or Agency) has regulated the use and labeling of GE foods, finding ample authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to ensure the safe and appropriate use of any product derived from or made with genetic engineering.2 In 1992, FDA reconfirmed that it would continue to regulate genetically engineered foods under its existing statutory framework, and that labeling of such foods as GE will only be required in the rare instances when they differ so significantly from their traditional (not genetically engineered) counterparts that the “common or usual name” does not apply, or when “a safety or usage issue exists to which consumers must be alerted.”3 Since then, the Agency has reiterated on multiple occasions its position that a food need not disclose the fact that it is the product of genetic engineering.4 Most recently, in November 2015, FDA denied two Citizen Petitions requesting that it establish mandatory labeling disclosures for GE foods.5 In short, the Agency reasoned that without evidence sufficient to show that foods derived from genetically engineered plants differ in any meaningful way from foods derived from non-GE plants, or that such GE foods present “any different or greater safety concerns” than non-GE foods, it “cannot compel food manufacturers to label their foods with information regarding whether such foods were produced from, or otherwise contain ingredients derived from, GE plants.”6
Ongoing Congressional Efforts
Despite FDA’s position, consumer interest for GE labeling disclosures has increased significantly over the years, culminating in greater demands for labeling transparency and the “right to know” what is in food. Over the last few years, Congress has introduced various bills to address GE food disclosures, none of which have been successful. For example, the Genetically Engineered Food Right-to-Know Act—originally introduced in 2013 and reintroduced in 2015—would amend the FD&C Act to require a GE food to disclose such fact in its label or risk a “misbranding” violation.7 Similarly, the Safe and Accurate Food Labeling Act proposed to establish a federal system of voluntary labeling of genetically modified foods,8 and the Biotechnology Food Labeling Uniformity Act proposed a uniform federal labeling standard for disclosing the presence of GE substances in food products.9
The most recent Senate bill, S.764, would amend the Agricultural Marketing Act of 1946 by adding new provisions for the National Bioengineered Food Disclosure Standard. Although S.764 would create uniform requirements to disclose whether a food is genetically engineered, the method of disclosure would not be limited to the food label and could instead be made by electronic or digital means, at the option of the manufacturer. It would also preempt any state or local requirement for GE disclosures that is not identical to the federal standard. Despite general industry support, the bill was met with strong opposition by proponents of GE transparency, including Vermont Senators Bernie Sanders and Patrick Leahy. As of July 8, S. 764 will move to the House of Representatives, where its fate will ultimately be determined.
State Regulation: Vermont
In the absence of a federal standard for the disclosure of GE foods, states have actively pursued their own regulation. In recent years, many states have proposed legislation requiring, in varying degrees, label disclosures for GE foods. Indeed, a variety of “right to know” bills have been proposed in at least 30 states, with laws passed in Alaska, Connecticut, Maine, and Vermont. Alaska’s law is narrowly tailored to labeling for genetically engineered fish, whereas the Connecticut and Maine laws will not go into effect until similar legislation passes in other states.
Vermont’s Act 120 is the cornerstone of state “right to know” acts for GE labeling. Enacted in 2014 and effective July 1, 2016, it is the first state law to require mandatory labels on genetically engineered foods.10 Act 120 requires food offered for sale in Vermont by a retailer to disclose on the label if it is entirely, partially, or possibly produced with genetic engineering. The law also prohibits the use of the term “natural” on foods that are made with genetic engineering—a claim that is already the subject of numerous lawsuits challenging it as misleading when used on foods that contain GE ingredients.
Act 120 has been challenged in federal court by several food industry associations, including the Grocery Manufacturers Association, Snack Food Association, International Dairy Foods Association, and National Association of Manufacturers.11 Coupled with significant industry concerns that Vermont’s law is the beginning of a 50-state patchwork of GE labeling requirements, the lawsuit is based primarily on arguments that the law violates the First Amendment by interfering with free speech, the Commerce Clause by regulating interstate commerce, and the Supremacy Clause by imposing new food labeling requirements that are preempted by the FD&C Act. A motion for a preliminary injunction to enjoin Act 120 was denied in April 2015, and the decision was subsequently appealed to the Second Circuit Court of Appeals.
While the legal challenge remains pending, the Vermont Office of Attorney General continued its planned implementation of Act 120, including the formal adoption of Consumer Protection Rule CP 121, which implements Act 120, and guidance in the form of an annotated version of CP 121 to clarify how the rule will be implemented.12
Effective July 1, 2016, food manufacturers found to be in violation of the labeling requirement face civil penalties of up to $1,000 per day per product; however, the Vermont Attorney General is prioritizing its initial enforcement to target willful violations and has suspended all private rights of action until July 1, 2017. Further, between July 1, 2016, and June 30, 2017, no enforcement action will be brought unless the manufacturer continues to be in violation of the law 30 days after it receives notice of the alleged violations.13 Such period may provide manufacturers time to comply and avoid penalties.
On the Flipside: Voluntary Marketing Claims
Whether prompted by consumer demand, a desire to avoid Vermont’s mandatory labeling statement, commercial considerations or otherwise, the focus on GE labeling disclosures is matched by growth in the formulation and marketing of foods that are not produced with genetic engineering. The ever-increasing use of voluntary “Non GMO” labeling claims by food manufacturers led FDA to finalize guidance in 2015 on the use of such claims.14 The guidance does not change FDA’s fundamental position that there is no material difference between genetically engineered and non-genetically engineered foods, but rather provides the Agency’s recommendations for how to make and substantiate claims about whether a food is derived or is not derived from genetically engineered plants. For meat and poultry products, “Non GMO” and similar claims that a product is “made without genetically engineered ingredients” are considered to be “special” statements or claims subject to “sketch” review and approval by USDA’s Labeling and Program Delivery Staff (LPDS).15 To date, such claims have been approved by LPDS based on third-party certification provided by the Non-GMO Project.
Because challenges to food labeling and advertising claims extend beyond FDA and USDA, and are more frequently the target of the Federal Trade Commission, consumers, and competitors, the use of “Non GMO” and similar claims should be carefully scrutinized to ensure they are truthful and appropriately substantiated.
1 S.Amdt. 4935 to S.764, 114th Cong. (2016), available at https://www.congress.gov/amendment/114th-congress/senate-amendment/4935/text.
2See, e.g., Statement of Policy for Regulating Products of Biotechnology, 51 Fed. Reg. 23309 (June 26, 1986).
3 Statement of Policy: Foods Derived From New Plant Varieties, 57 Fed. Reg. 22984 (May 29, 1992).
4See, e.g., Food Labeling; Foods Derived from New Plant Varieties, 58 Fed. Reg. 25837, 25839 (April 28, 1993).
5 U.S. Dept. Health and Human Servs., Citizen Petition Denial Response from FDA to Center for Food Safety, Docket No. FDA-2011-P-0723 (Nov. 19. 2015); U.S. Dept. Health and Human Servs., Citizen Petition Denial Response from FDA to Truth in Labeling Coalition, Docket No. FDA-2010-P-0081 (Nov. 19. 2015).
6 U.S. Dept. Health and Human Servs., Citizen Petition Denial Response from FDA to Truth in Labeling Coalition, supra, at 2.
7See H.R. 913, 114th Cong. (2015); S. 511, 114th Cong. (2015).
8 Safe and Accurate Food Labeling Act, H.R. 1599, 114th Cong. (2015).
9 S. 2621, 114th Cong. (2016).
10See No, 120 (H.112), 2013-2014 Leg., Reg. Sess. (Vt. 2014), available at http://ago.vermont.gov/assets/files/Consumer/GE_Food/ACT 120 As Enacted.pdf.
11 Grocery Manufacturers Association v. Sorrell, No. 5:14-CV-117 (D. Vt.).
12See Consumer Prot. R. 121 (Vt.), available at http://ago.vermont.gov/assets/files/PressReleases/Consumer/Final Rule CP 121.pdf; see also Public Prot. Div., Vt. Office of the Attorney Gen., Consumer Protection—Labeling Foods Produced with Genetic Engineering, Annotated Consumer Prot. R. 121, adopted pursuant to 2013, No. 120 (Adj. Sess.) §3 (eff. July 1, 2016), available at http://ago.vermont.gov/assets/files/Consumer/GE_Food/Guidance - Rule CP 121 Annotated.pdf.
13 Memorandum from Vermont Attorney General William H. Sorrell re: Updated AGO Enforcement Priorities for Act 120 (GE Food Labeling Law) (May 16, 2016), available at http://www.ago.vermont.gov/assets/files/Consumer/GE_Food/AGO GE Food Labeling Law Enforcement Priorities Memo.pdf.
14 Notice of availability, “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants; Guidance for Industry; Availability,” 80 Fed. Reg. 73194 (Nov. 24, 2015); see also FDA, “Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants” (Nov. 2015), available at http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm059098.htm.
15See USDA, FSIS Compliance Guide for Label Approval, 7 (Nov. 2015).