Significant statutory and regulatory changes are on the horizon this year in the world of food labeling as regulators and lawmakers introduce rules that can potentially impact the food industry and its compliance obligations.

The US Department of Agriculture (USDA) is expected to release its long-awaited bioengineered (GMO) disclosure label rules in the next several days or weeks, which will establish a national standard for labeling foods containing GMO ingredients. Meanwhile, the US Food and Drug Administration (FDA) confirmed that it is pressing ahead with many label issues and initiatives, such as conducting a review to modernize standards of identity, ingredient statement requirements, and food label claims, such as creating a definition for the term “healthy” with a corresponding label symbol. Further, Congress has stepped into the conversation. Recently, the House of Representatives passed a bill called the “Common Sense Nutrition Disclosure Act”[1] to weaken menu label requirements for restaurants and retailers as was mandated by the Affordable Care Act.[2]

USDA Expected to Release GMO Disclosure Label Rules

The USDA is expected to release (most likely this month) rulemaking that implements a nationwide product labeling solution for food products containing GMO ingredients.

Congress passed and President Barack Obama signed into law the National Bioengineered Food Disclosure Law in the summer of 2016.[3] The statute gave USDA three options to consider for such a disclosure, including a written text, symbol, or electronic or digital disclosure method printed directly on a food label.[4] Based on recent comments by USDA Marketing and Regulatory Programs Under Secretary Greg Ibach at the Nebraska Governor’s Agriculture Conference in Kearney, Nebraska, it is likely the GMO disclosure will include either a symbol or some sort of electronic or digital disclosure method (e.g., a QR code consumers can scan for more information on the use of GMOs in food).

USDA has shown interest in providing unique pathways for consumers to utilize in order to conduct their own research as it relates to the use of GMOs by way of an electronic or digital disclosure. For example, USDA hired a consulting firm to conduct research related to whether an electronic or digital disclosure would be feasible and beneficial to consumers, given consumers would need access to certain types of technology to benefit from any electronic or digital disclosure method (e.g., smartphones and relevant applications). While the study outlined setbacks related to technical challenges using mobile software applications for scanning digital links, overall the study seemed to offer favorable results for the use of an electronic or digital disclosure.[5]

Given USDA has publically stated it does not want the GMO disclosure to come off as a “warning” to consumers, the electronic or digital disclosure may be the best solution for USDA to meet its statuary obligation for implementing the nationwide GMO disclosure law while not alarming consumers that there is any sort of safety issue in the use of GMOs in the food supply. While there are very heated debates pertaining to the safety of GMOs on both sides of the argument, USDA has made an effort to claim that this disclosure is not due to a public safety concern.

USDA is on track in meeting its statutory deadline to publish final rules on GMO label requirements by the July 2018 deadline. This is surprising, given USDA is considering many important questions in order to publish these final rules. For example, USDA must consider what the disclosure text, symbol, or electronic or digital disclosure code will say to inform consumers that a food product contains GMO ingredients. More complex questions include whether there should be an actionable threshold limit related to the amount of GMO ingredients present in a food item and also what “breeding techniques” would trigger the GMO disclosure requirement.[6]

As it relates to “breeding techniques,” USDA recently provided greater clarity as to what we can expect in the ultimate GMO disclosure rules. Specifically, USDA issued a statement on March 28 on plant breeding innovation, indicating that “USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques as long as they are not plant pests or developed using plant pests (emphasis added).”[7] This should be welcome news for those entities using new methods for plant breeding, such as genome editing.

USDA sent its proposed rules to the White House Office of Management and Budget (OMB) on December 27, 2017. It is expected these rules will be published in the next several days or weeks, with a 30-day comment period from the public. Current discussions among industry indicate USDA is likely to embrace a symbol or electronic or other digital disclosure method. Please follow our blog for the latest updates on the GMO labeling disclosure regulations, which we should be expecting very soon.

FDA Recognizes “Clean Label” Principles and Confirms Rulemaking for “Healthy” Term

FDA Commissioner Dr. Scott Gottlieb confirmed the agency plans to continue the Obama-era push to modernize food label claims by creating a definition for the term “healthy” with a corresponding labeling symbol.

This is the second time Dr. Gottlieb has shown a commitment to define the term “healthy” under a scientific framework that focuses less on nutrients and more on overall wholesome foods.[8] At the National Food Policy Conference (NFPC) held in Washington, DC on March 29, Dr. Gottlieb did not shy away again from unveiling that the agency is open and willing to conduct a complete overhaul on the use of the product claim “healthy.”[9] He suggested using a symbol or a standard icon or other symbol that represented the term “healthy.” He also said the criteria surrounding the use of this symbol would be based on current science in order to promote better consumer eating habits, including possibly expanding the term beyond just nutrient qualifications to better reflect food groups, such as “whole grains, low fat dairy, fruits and vegetables and healthy oils.”[10]

Redefining the requirements for the term “healthy” is not a new endeavor for FDA.[11] Currently, the agency codified requirements for the use of the term “healthy” in 21 CFR § 101.65(d)(2).[12] However, back in 2016, FDA issued a guidance document on stating that it would exercise enforcement discretion related to “healthy” claims that

  • are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or
  • contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.[13]

The agency published this guidance document given FDA wanted to “re-evaluate the regulatory criteria for use of the implied nutrient content claim ‘healthy’ in light of the latest nutrition science and the current dietary recommendations and seek input on possible future rulemaking to update the existing regulations for this claim.”[14] Dr. Gottlieb confirmed the agency is pursuing rulemaking to update the definition of “healthy,” with plans to solicit stakeholder input in the near future.

FDA Recognizes the Importance of “Clean Label” Principles

During his NFPC speech, Dr. Gottlieb acknowledged current trends in diet and nutrition, stating that “consumers are seeking out foods that meet criteria like minimally processed, lower in sugar, and produced with wholesome ingredients.”[15] We have written and presented on the “clean label” movement and topics, which you can read more about here and here.

During his speech, Dr. Gottlieb announced his Nutrition Innovation Strategy, indicating that FDA intends to modernize its approach to food labeling in order to ensure consumers are more knowledgeable about the foods they eat and how food labels and labeling deliver this information to consumers. The Nutrition Innovation Strategy will include work to modernize (i) label claims, (ii) ingredient statements, (iii) standards of identity, (iv) health claims, and (v) sodium daily values. The commissioner also renewed the agency’s commitment to implement the new Nutrition Facts Panel and Serving Size final rule, whose compliance date has been extended to January 1, 2020, for manufacturers with $10 million or more in annual sales, and January 1, 2021, for manufacturers with $10 million or less in annual sales.[16]

Whether there will be much movement on these topics is subject to debate, given the agency’s current primary focus is on matters affecting immediate public health and consumer safety. However, Dr. Gottlieb’s recent comments at NFPC seem notable, as it suggests the agency is now willing to take on the arduous rulemaking tasks related to these topics with the start of public comments as soon as this summer. It should be noted that the commissioner also addressed defining the term “natural,” but offered no substantive update. Please follow our blog for the latest updates on the Nutrition Innovation Strategy agenda.

Congress Presses Ahead to Weaken Menu Labeling Laws, and Recognizes Internet Labeling as a Sole Method for Nutrition Disclosure

While FDA’s current menu labeling compliance date for restaurants and retailers is set for May 7, 2018, Congress is stepping in to upend some of the menu labeling requirements as mandated by the Affordable Care Act.

The House of Representatives recently passed the “Common Sense Nutrition Disclosure Act” to ease menu labeling rules for restaurants and retailers as required by the Affordable Care Act.[17] Notably, this is the first statutory recognition that we know of that contemplates allowing a food establishment who receives orders by consumers placed off-premises (such as a pizza restaurant) to disclose nutritional information solely on a remote access-menu, such as a website. The bill also eliminates criminal penalties and allows retailers to implement corrective actions before further enforcement actions. Importantly, the bill also preempts civil litigation for violations of the federal menu labeling law and any state laws that may exist.[18]

If enacted, this bill will no doubt make it easier for restaurants and retailers to comply with menu labeling laws by utilizing websites as a sole means for displaying nutrition information. However, it should be noted that many of these entities have already invested in on-premise displays to comply with FDA’s fast approaching menu labeling compliance deadline. For those entities that have yet to comply, the bill’s enactment will surely ease regulatory burdens. However, it is unlikely this will occur before FDA’s current May 8, 2018, compliance deadline. The House of Representative passed the bill on February 6, 2018, and it is now with the House Committee on Energy and Commerce: Subcommittee on Health. The bill has 86 cosponsors (80 Republicans and 6 Democrats).

It is unknown how the bill will impact FDA’s current menu labeling deadline. However, we know FDA has extended the menu labeling deadline in the past when Congress dealt with matters related to the Affordable Care Act. For example, FDA extended the previous menu labeling requirement enforcement deadline from May 5, 2017, to May 7, 2018, the same week the House of Representatives passed repeal of the Affordable Care Act. While repeal of the Affordable Care Act ultimately failed, it is an indication that FDA is willing to extend these deadlines in light of continued congressional action.