Happy New Year! This blog entry will revisit and update the status of significant regulatory issues covered by the Well Done Blog in 2015 and assess 2016 FDA priorities in the food area.

2015 Overview

  • Office of Dietary Supplement Programs

    On December 21, 2015, the FDA announced the creation of the Office of Dietary Supplement Programs (ODSP).1 The program was formerly a division under the Office of Nutrition Labeling and Dietary Supplements, now known as the Office of Nutrition and Food Labeling. As discussed in our December 2, 2015 blog post, the Department of Justice brought a significant number of civil and criminal cases against the makers of dietary supplements in 2015. The creation of ODSP supports the mission of monitoring the safety of dietary supplements and taking action against entities that present a risk of harm to the consumer.

  • “Natural” Label Claims

    In 2015, the FDA received three Citizen Petitions asking that the agency define the term “natural” for use in food labeling. The term “natural” has been the subject of many food labeling lawsuits, as mentioned in our November 19, 2015 blog post. In direct response to requests from the public, the FDA has extended the comment period on the use of the term “natural” in food labeling to May 10, 2016.2 The Morgan Lewis FDA team is currently working on an analysis of the comments submitted to date. Please contact the FDA team if you are interested in submitting a comment.

  • Food Safety and Modernization Act (FSMA) Regulations

    As discussed in our November 16 blog post, in late 2015, the FDA published three final rules under FSMA: the Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety rule),3 the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP rule),4 and the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Accredited Third-Party Certification rule).5 These rules implement sections of FSMA geared toward protecting the US food supply. As discussed below, the FDA plans to take further action to implement sections of FSMA in 2016.

  • Menu Labeling Requirements

    As discussed in our blog posts of December 4, 2014 and July 13, 2015, FDA released its final rule on menu labeling in restaurants on December 1, 2014, and later extended the date for compliance from December 1, 2015 to December 1, 2016. The rule will require restaurants and similar retail food establishments that (1) sell “restaurant-type food,” (2) are part of a chain of 20 or more locations, (3) do business under the same name or slight variations of each other, and (4) offer for sale substantially the same menu items as the other business locations, to disclose calorie information on menus and menu boards.

  • New York Sodium Warning

    As discussed in our December 11, 2015 blog post, the New York City Department of Health and Mental Hygiene Board of Health (Board of Health) Sodium Warning Label Rule went into effect on December 1, 2015. The Rule requires food service establishments in New York City with 15 or more locations nationwide to provide a warning for menu items that contain 2,300 mg or more of sodium. New York City is the first city in the United States to require chain restaurants to include sodium warnings on menus or menu boards. Chains with 15 or more locations have 90 days to comply with the new rule before they face a $200 fine. The rule elicited responses from the National Salt Institute and the National Restaurant Association. The National Restaurant Association filed suit against the Board of Health, claiming that it did not have the authority to require such a warning. We will monitor this lawsuit and provide updates in 2016.

The food industry has become a fertile ground for class-action lawsuits over the last few years and shows no signs of slowing down. New cases are decided daily. There are several factors that drive this trend and that are likely to propel forward new cases in the coming years. As a detailed review of some of the cases in this area reveals, these factors make it probable that litigation in this area is likely to continue, even if not at the same rate that it has over the last couple of years.

In the white paper titled “Appetite for Litigation: Why Plaintiffs’ Lawyers Hunger for Food-Labeling Lawsuits,” partner Tom Sullivan provides an overview of federal statutes and regulations, outlines the different types of cases, summarizes the recent court trends and defenses to food-labeling litigation, and forecasts the emerging trends in the industry.

Read the white paper in full.

In late October, the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), along with state and local officials investigated an outbreak of E. coli infections linked to food served at a major fast-casual restaurant chain. Much of the underlying information documenting the outbreak has been derived from an advanced laboratory technique called “whole genome sequencing” (WGS). This is a fairly new instrument in the CDC toolbox. WGS reveals the complete DNA make-up of an organism, thereby enabling health officials to better understand variations both within and between potentially pathogenic species. Such information can then be compared with clinical isolates from sick patients, and, if they match, there may be a reliable link established between the illness and the pathogen. This new technique has the potential to define the scope of a foodborne illness outbreak more quickly and ideally will help to prevent additional cases. Traditionally, this analysis has been done via a process known as pulse-field gel electrophoresis (PFGE). But PFGE has a shortcoming in that it is unable to differentiate between related species of organisms, which can be critical when health officials are trying to delineate the specific source of the outbreak, and want to know whether to recall a product or not.

Reuters reports that California is considering adding processed meats (such as hot dogs, ham, and sausages) to its list of cancer-causing products. This comes after the World Health Organization (WHO) classified processed meats as carcinogenic to humans and advised people to moderate consumption of processed meat to reduce the risk of cancer. The WHO based its classification “on sufficient evidence from epidemiological studies that eating processed meat causes colorectal cancer.”

Under California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), the state is required to maintain a list of all substances known to cause cancer. Companies that sell products associated with these listed substances, either in combination with unlisted substances or alone, in California must provide “clear and reasonable” warnings on the label to inform consumers about the risk. Once a substance is listed, businesses are required to provide the warning within 20 months or otherwise must demonstrate that the anticipated exposure level will not pose a significant risk of cancer (stating “[n]othing in this article shall preclude a person from using evidence, standards, risk assessment methodologies, principles, assumptions or levels not described in this article to establish that a level of exposure to a listed chemical poses no significant risk.”).

However, if processed meats are included on the list, the meat industry can likely avoid the requirement of a Proposition 65 label on preemption grounds. The Federal Meat Inspection Act of 1906 (FMIA) contains a preemption provision that prohibits states from imposing labeling requirements “in addition to, or different from” the labeling required under FMIA. Pursuant to that provision, in American Meat Institute v. Whitney R. Leeman, a California appellate court concluded “that the FMIA expressly preempts [labeling] requirements imposed by Proposition 65 with respect to meat.” Although Leeman concerns fresh meat as opposed to processed meats, we expect preemption to extend to processed meats as well.

On August 3, a federal judge struck down an Idaho law that created the crime of “interference with agricultural production.” Chief Judge B. Lynn Winmill of the US District Court for the District of Idaho found that the Idaho law violates the First Amendment and Equal Protection Clause. The Idaho “ag-gag” law, a term used to describe antiwhistleblower laws that apply within the agricultural industry, is the first such law to be struck down by a federal court.

The Idaho ag-gag law was drafted after the animal rights group Mercy for Animals released a video showing workers at the Bettencourt Dairies’ Dry Creek Dairy in Hansen, Idaho, abusing milk cows. In response to the negative publicity that followed, the Idaho Dairymen’s Association, a trade industry organization that represents the state’s dairy farmers and producers, sponsored a bill that criminalized the types of undercover investigations that exposed the activities at the Dry Creek Dairy, including criminalizing all employment-based undercover investigations, investigative journalism, and whistleblowing by employees that occur in the agricultural industry. I.C. 18-7042. A person who violates the law faces up to a year in jail, and a journalist or whistleblower may be fined for damages up to twice the economic loss that a business suffers as a result of any publication revealing animal abuse or unsafe working conditions.

On June 10, the Agricultural Marketing Service (AMS), which administers the Shell Egg Surveillance Program (a mandatory inspection program for shell egs), published a proposed rule that would streamline the importation of table eggs, hatching eggs, and inedible liquid eggs. The proposed rule is intended to shorten the importation process by requiring that applications for inspection be submitted electronically.

This proposed rule conforms to Executive Order 13659, which aims to streamline the import/export process by using the International Trade Data System (ITDS). ITDS allows importers and exporters to complete a single electronic report that will distribute the appropriate data to relevant agencies. The goal of this streamlined process is to not only reduce cargo processing time, but also to increase the safety of the US public by identifying unsafe, dangerous, or prohibited cargo. Thus, AMS will integrate its system into ITDS to reduce processing time and increase safety by identifying restricted eggs that may contain dirty or cracked shells, leaking eggs, and eggs with interior meat or blood spots.

In a related measure, the USDA announced for the first time in a decade that it will allow imported pasteurized eggs from a European nation: The Netherlands. Prior to this announcement, only Canada was certified to export liquid, dried, and frozen eggs to the United States. The Netherlands was previously certified to export pasteurized egg products to the United States in 1987 but voluntarily stopped. In 2014, the Netherlands requested reinstatement. Subsequently, the USDA’s Food Safety and Inspection Service reassessed the laws, regulations, and inspection procedures in the Netherlands and conducted an on-site audit June 2–26, 2014. The review procedures confirmed that “The Netherlands’ processed egg products inspection system continues to be equivalent and to employ the necessary verification activities to result in safe product.” The final report on the Netherlands’ reinstatement can be found here.

Calling food industry professionals! Keeping abreast of the latest developments in food laws, regulations, and policy initiatives is absolutely critical for being compliant and anticipating that next step. Presented as a one-day program, the Institute of Food Technologists’ (IFT’s) Food Policy Update is an opportunity to hear from and network with officials from the FDA Center for Food Safety and Applied Nutrition (CFSAN) and the USDA Food Safety and Inspection Service (FSIS), along with leading lawyers and industry leaders.

Topics will include:

  • Regulatory Update from FDA CFSAN
  • Regulatory Update from USDA FSIS
  • Lunch & GMO Legislative Update: Keynote Speaker John Bode
  • GRAS Update – Building GRAS for the Future
  • FDA’s Menu & Vending Labeling Rules – Overview and Challenges

Come and make new connections with your colleagues.

This program is targeted for professionals in regulatory, marketing, product development, quality assurance/quality control, and supply chain fields.

Earlier this month, the U.S. District Court for the Central District of California agreed with a group of foie gras producers that California’s ban on the product’s sale was preempted by federal law, and the court overturned the ban that has been in place since July 1, 2012. The plaintiffs—foie gras producers from Canada and New York and a California restaurant owner—challenged the portion of California’s Health & Safety Code § 25982, which banned the sale of products made through gavage, the practice of feeding geese through an esophageal tube to fatten their livers.

On New Year’s Eve, the USDA’s (Department’s) Food Safety and Inspection Service (FSIS) released its final rule requiring meat and poultry processors to include added solutions in their product labeling.

FSIS issued the added solutions proposed rule on July 27, 2011, in response to petitions calling on the Department to address the notion that some product labels may not clearly and conspicuously identify that the raw meat or poultry products contain added solution.

The original petitions were driven by competitive disagreements within the poultry industry. More specifically, the petitioners originally asserted that some companies were marketing fresh chicken items extended with broth in a manner that confused such products with traditional single-ingredient products. Nevertheless, FSIS extended the scope of both the proposed and final rules to encompass the broader range of meat and poultry products within its jurisdiction. In doing so, FSIS chose to more formally codify a number of longstanding labeling precedents and guidance within this area.

The growing trend of retroactive recalls for already distributed food products calls into question commonly held beliefs about food safety. Americans expect that the foods they eat are safe, and, when a company becomes aware of a potential health hazard related to its food products, consumers expect that it will recall the products before people eat them. Consumers also expect that the USDA official mark of inspection on a meat or poultry product means the product is safe to eat because it has been certified by USDA’s Food Safety and Inspection Service (FSIS). In other words, the USDA seal is interpreted as a guarantee that the product is safe to eat because an FSIS inspector, who is continuously present in the facility, has verified the company’s compliance with regulations designed to protect the public health. What undermines this assumption, however, is a growing trend of retroactively recalling product after FSIS has inspected it and after the product has entered into commerce. This trend may confuse industry and consumers alike and creates uncertainty regarding the value for consumers of the USDA inspection seal.