YOUR SOURCE ON FOOD LITIGATION AND REGULATION

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.

On Friday, the US Food and Drug Administration (FDA) announced the public availability of three new rules that will help prevent the contamination of foods: the Standards for Growing , Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety rule), the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP rule), and the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Accredited Third-Party Certification rule). The rules, which will be published on November 27, implement several important sections of the FDA Food Safety Modernization Act (FSMA).

The Produce Safety rule establishes standards for growing, harvesting, packing, and holding produce grown for human consumption. Specifically, the rule sets criteria to prevent contamination of produce through the water supply, soil, domesticated and wild animals, ill or infected farm workers, and insanitary equipment, tools, and buildings. Special standards are included to prevent the contamination of sprouts, which are frequently associated with food-borne illnesses.

Notably, the Produce Safety rule does not apply to produce that is not a raw agricultural commodity (food in its raw or natural state); certain produce commodities that FDA has identified as rarely consumed raw (such as coffee beans, potatoes, and pumpkins); food grains; produce that is used for personal or on-farm consumption; produce from farms that had average sales of $25,000 or less in the past three years; or produce that receives commercial processing that adequately reduces the presence of microorganisms under certain conditions.

The Produce Safety rule also includes qualified exemptions for farms that had average sales of $500,000 or less in the last three years and, additionally, those whose sales to qualified end-users exceed sales to all others combined during the previous three years. States, tribes, and foreign countries may submit a petition requesting a variance from one or more of the requirements. Compliance with the rule is required within two to four years, depending on the average annual produce sales during the previous three-year period (and within one to three years for activities involving sprouts).

Compliance for the FSVP rule must be achieved, for some businesses, within 18 months. Under the rule, importers must perform certain risk-based activities to verify that food imported into the United States has been produced according to the applicable US safety standards. These standards ensure that “foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations” and to further ensure that food is not adulterated and has proper allergen labeling. Modified FSVP requirements are in place for small importers (sales of no more than $1 million for human food and $2.5 million for animal food) and for certain small suppliers.

The Accredited Third-Party Certification rule establishes a voluntary program for the accreditation of auditors to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals produced therein. Foreign entities can use the certifications to establish eligibility for participation in the Voluntary Qualified Importer Program, which expedites review and entry of food into the United States. The rule does not apply to alcoholic beverages manufactured by foreign facilities or to meat, poultry, and egg products subject to US Department of Agriculture oversight at the time of importation. Although no specific compliance deadline is mentioned, FDA stated that it “intends to implement this program as soon as possible after publication of the final Model Accreditation Standards guidance, and the final user fee rule, both of which will be published separately.”

Collectively and when read in conjunction with the rules for preventive controls for the production and handling of human and animal foods, these regulations complete the major portion of FDA’s efforts to establish the regulatory architecture of FSMA (final rules regarding transportation and intentional product adulteration remain to be published). FDA contemplates oversight of a regulatory system with global reach that will affirmatively establish and document the safety of the vast majority of food available to US consumers.

Now that the rules have been established, it is incumbent upon the members of all segments of the food industry, well in advance of any official compliance deadlines, to either initiate or accelerate their own efforts to ensure appropriate compliance. Toward that end, FDA has announced two upcoming webinars (a webinar on the Produce Safety rule on Tuesday, November 17, 2015, 2:00–3:00 p.m. eastern time, and a webinar on the FSVP rule and the Accredited Third-Party Certification rule on Monday, November 23, 2015, 10:00–11:30 a.m. eastern time) that may be of interest. In addition, we anticipate the generation of other guidance materials and other forms of outreach from the agency in the coming weeks and months.

On November 6, 2015, the Food and Drug Administration (FDA) issued long-awaited guidance on its fortification policy for adding nutrients to foods in the form of a Questions and Answers Guidance for Industry. The FDA originally issued the fortification policy more than 30 years ago, in 1980, to “promote the rational addition of nutrients to foods in order to preserve a balance of nutrients in the diet of American consumers.” The fortification policy was then amended in 1993 to conform to the Reference Daily Intakes and Reference Daily Values issued by the FDA. However, this new announcement is the first time since 1980 that the FDA has provided guidance specifically on the fortification policy. The underlying principle of the fortification guidelines is to provide a uniform nutritional benefit to consumers without misleading consumers to believe that the fortified food will provide a complete and nutritionally sound diet.

The policy provides guidance on how to properly fortify food with vitamins and minerals, so as to avoid indiscriminate fortification of foods. For example, the FDA has issued Warning Letters stating that it is inappropriate to fortify snack foods and carbonated beverages. Additionally, the new guidance states that fortification of snack foods, including unsweetened carbonated beverages and low-calorie and calorie-free snack foods, “could mislead consumers to believe that substitution of naturally nutrient dense foods with fortified snack foods would ensure a nutritionally adequate diet.” For the same reason, FDA states it is inappropriate to fortify alcoholic beverages.

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.

In April 2015, the US Right to Know (US RTK), a non-profit organization that reports on food industry issues on behalf of consumers, sent a letter to the Federal Trade Commission (FTC) and a citizen petition to the Food and Drug Administration (FDA) with requests to investigate diet soda manufacturers for misbranding and deceptive advertising on the grounds that the “diet” products contain artificial sweeteners that US RTK alleges actually contribute to weight gain.

The request for FTC investigation states that the soft drink companies deceptively imply that artificially sweetened beverages contribute to weight loss rather than weight gain and requests that the FTC prohibit the companies from using the term “diet” in advertising such products. US RTK argued that representing that such products are “diet” is likely to mislead reasonable consumers, and that consumers will rely on the claims to their detriment.

In the FDA citizen petition, US RTK requests that FDA 1) issue a warning letter for use of the term “diet” as being false and misleading, and 2) investigate the use of the term “diet” (and other terms implying weight loss in other artificially sweetened products) to determine if the product brand names or labels are misbranded.

The FDA has issued two important final rules that will implement requirements of the Food Safety and Modernization Act (FSMA):

  • Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food
  • Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Animal Food

Both rules will require manufacturers and other elements of the food chain to evaluate, implement, and document the effectiveness of science-based preventive food safety programs.

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 July 23, the US Food and Drug Administration (FDA) issued a proposed rule that will, if finalized, support a new program to help foreign companies affirmatively establish that their imported food meets US food safety requirements (80 Fed. Reg. 43987, July 24, 2015) (the Proposed Rule). The Proposed Rule is authorized under Section 307 of the Food Safety Modernization Act (FSMA) (Pub.L. 111-353). FSMA aims to protect public health through ensuring safety and security in the food supply chain. The Proposed Rule would help to ensure the safety of imported foods, which make up about 15% of the US food supply.

The Proposed Rule would supplement the previously proposed rule “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” (78 Fed. Reg. 45782, July 29, 2013) and establish a user fee program to reimburse the FDA for the services performed in the accreditation of third-party auditors/certification bodies. Additionally, the FDA published draft guidance titled “Draft Guidance for Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards” (the Draft Guidance) as a companion document for the Proposed Rule.

The US Food and Drug Administration (FDA) published a Federal Register notice on July 10 that extends the compliance date for menu labeling in certain restaurants and retail food establishments. The final rule was published on December 1, 2014 and established a compliance date of December 1, 2015. The notice extends the compliance date one year from December 1, 2015 to December 1, 2016.

FDA stated that the decision to provide the extension was influenced by requests from large retailers and trade associations seeking additional time to develop new software, information systems, staff training programs, standard operating procedures, and consistent menu boards, and it acknowledged that it had yet to provide sufficiently detailed public guidance in this area. FDA also stated that the compliance date extension was also to address its concern that consumers receive accurate, clear, and consistent nutrition information for foods sold in covered establishments. Thus, FDA believes that the extension will help achieve the final rule’s original purpose—to provide consumers with accurate nutritional information to help reduce obesity and promote public health. Nevertheless, the scope and potential effect of the labeling requirement, particularly on those qualified facilities that market a wide variety of food choices, will continue to be a point of controversy throughout this extended compliance period.

See our post on the final rule.

The Food and Drug Administration (FDA) issued final guidance for industry on June 19 titled “Food Allergen Labeling Exemption Petitions and Notifications.” This guidance was preceded by draft guidance by the same name. The FDA received comments on the draft guidance and considered them when making revisions to the final guidance. The final guidance explains the FDA’s thinking on the submission of petitions and notifications for obtaining exemptions from labeling requirements for major food allergens under the Food, Drug, and Cosmetic Act (FD&C Act).