Highlights:

  • Food labeling claims and food safety issues are responsible for the majority of lawsuits against food companies
  • ‘Natural’ labeling claims, foodborne illnesses, and chemical hazards have triggered several lawsuits this year
  • FDA is required to publish a highly anticipated and potentially controversial proposed rule to define high-risk foods
  • There is an upward trend in the annual number of 60-day notices associated with food products for Proposition 65
  • Lawsuits were filed this year to push the FDA to finalize specific FSMA regulations


The majority of Americans would probably agree with musician Gavin Rossdale’s statement that “the only people who benefit from lawsuits are lawyers.” The proliferation of lawsuits against food companies in recent years supports this sentiment, but some of the legal challenges could result in positive outcomes in terms of public health and food safety. Of course, any change imposed by external forces such as lawsuits will likely result in new operational and financial burdens for food companies.

Based on a review of the food industry and legal news from the past year, the vast majority of lawsuits involving food products were prompted by unsubstantiated labeling claims and food safety issues. Additionally, the Food and Drug Administration (FDA) has been challenged in recent lawsuits due to its failure to complete food regulations mandated by the Food Safety Modernization Act (FSMA). Following are five significant issues that triggered food-related lawsuits within the past year.

1. ‘Natural’ Labeling Claims

Since 2017, there has been an upward trend in lawsuits related to food labeling issues. In particular, the lack of a federal regulatory definition of the term ‘natural’ on food labels has plagued both consumers and the FDA for years.

This year, numerous lawsuits have been filed to challenge the ‘natural’ labeling claims on a wide variety of food and beverage products ranging from trendy sparkling water to nutrition bars containing ingredients derived from genetically-modified canola, corn, and soy. Since 2015, the FDA has been considering a regulatory definition for ‘natural’ and the agency recently indicated it was “actively working” on defining the term for food labels.

The FDA is expected to communicate a new policy related to the labeling term sometime in 2019.

2. Foodborne Illnesses

Microbial contaminants are a leading reason for food recalls and associated with an estimated 48 million cases of foodborne illness annually in the United States. Each year, numerous lawsuits are filed against food businesses due to food safety issues related to product liability or negligence.

In recent years, lawsuits were filed in response to foodborne illnesses and outbreaks involving a national restaurant chain, Salmonella traced to pre-cut melon, Salmonella in breakfast cereal, Shiga toxin-producing E. coli (STEC) in romaine lettuce, a Cyclospora outbreak involving restaurant chains, and pathogens in beef products. Beyond the high cost of settling a lawsuit, the impact of lawsuits upon food companies and retailers can entail increased monitoring of food facilities, revised purchasing specifications, new traceability requirements, rebranding and changes in executive leadership.

3. Proposition 65 Chemicals

Proposition 65 is a California law requiring “clear and reasonable” warning labels on products containing chemicals determined by the state to cause cancer, birth defects or other reproductive harm. California’s Office of Environmental Health Hazard Assessment (OEHHA) manages the list of more than 950 naturally occurring and synthetic chemicals found in a broad range of products, including food and beverage products.

Since August 2018, the law was amended to require companies to post a new warning statement if a product may expose consumers to specific Proposition 65 chemicals.

The Proposition 65 chemicals most commonly associated with food include acrylamide, arsenic, BPA, cadmium, lead and lead compounds, and mercury.

In addition, furfuryl alcohol is another chemical associated with baked goods, toasted nuts, coffee, and some dairy products. While furfuryl alcohol triggered only 2 notices in 2018, the chemical has been named in 6 notices to date this year.

The enforcement of Proposition 65 is accomplished through lawsuits. Under the law, a plaintiff must provide the state with a 60-day notice of its intent to file a lawsuit related to a Proposition 65 non-compliance or violation. If the state does not take action within 60 days, then a lawsuit can be filed against a business. An upward trend in the annual number of 60-day notices associated with food products has persisted for several years. In fact, 330 notices were linked to food products in 2018, but more than 300 notices were filed during the first half of this year.

4. High-risk Foods

In October 2018, the Center for Food Safety (CFS) and the Center for Environmental Health (CEH) filed suit against the FDA for its failure to comply with the FSMA deadline for issuing a list of high-risk foods.

Under a recent legal settlement, the FDA is required to publish a highly anticipated and potentially controversial proposed rule to define high-risk foods and related recordkeeping requirements by September 8, 2020. The final rule must be published no later than November 7, 2022.

The ramifications of the final rule could include new recordkeeping protocols, mandatory tracing procedures, and increased FDA inspections of facilities producing high-risk foods.

5. Laboratory Accreditation

On August 20, the Center for Food Safety (CFS) and Center for Environmental Health (CEH) filed a lawsuit citing the FDA failed to meet a statutory deadline to establish a program for food testing by accredited laboratories, including a public registry of laboratories accredited by a recognized accreditation body. Laboratory accreditation was mandated by the FSMA law, but the FDA has not yet issued a proposed rule.

The objective of laboratory accreditation per FSMA is to align commercial laboratories with government labs, which would enable the FDA to accept analytical data from third-party labs for regulatory testing only.

Consumer advocacy groups have filed several lawsuits in order to force the FDA to issue specific regulations mandated by the Food Safety Modernization Act (FSMA). In recent months, lawsuits were filed to force the FDA to issue a final rule to define high-risk foods, and a rule to establish an accreditation program for laboratories involved in the regulatory testing of food.

Luck Favors the Prepared

Due to the current climate of excessive litigation, all food companies should be prepared for a potential lawsuit. Comprehensive knowledge of the relevant food labeling requirements and food safety hazards is the best defense against a legal challenge.

Food industry professionals can obtain a wealth of food safety information from the scientific literature, food recall data, public records of facility inspections, warning letters and outbreak investigation reports.

A scientific literature review can support compliance with FSMA regulations by identifying the potential microbial, chemical and physical hazards associated with a specific food matrix, technology, process or environment. A specific literature review can be developed for your company – for more information, see our Contact us about Literature Review Services.

Food label reviews and the analysis of food products by an accredited laboratory are proactive ways for food companies seeking to demonstrate due diligence and compliance with the appropriate regulations. Our Labeling Compliance & Nutrition Services experts can review specific aspects of your food label, such as the statement of identity, ingredient list, allergen declaration, or the entire label, including claims.

The content contained in this blog is an excerpt from our North American Regulatory Report.

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