Tag Archives: Prop 65

Julie Holt, Decernis
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California Proposition 65: Every Company Should Know Their Risk

By Julie Holt
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Julie Holt, Decernis

Known officially as The California Safe Drinking Water and Toxic Enforcement Act of 1986, California Proposition 65 reaches far beyond state boundaries and has potential regulatory implications for almost any company that manufactures, imports, and / or sells products containing listed chemicals in the state. California Prop 65 prohibits the sale of a product in California that knowingly and intentionally exposes an individual to a California Office of Environmental Health Hazard Assessment (OEHHA) listed chemical without a specific stated warning. For many food and supplement companies, the risk of opportunistic litigation based on California Prop 65 drives the need to monitor updates, new amendments and enforcement of the law.

Prop 65 Background

California Proposition 65, also known by the shortened name Prop 65, is not a ban on products or ingredients. The law is intended to inform consumers in California about exposure to a list of chemicals exceeding a defined level in products for sale, including product packaging. The regulation mandates a warning label for exposure to chemicals at a level that could cause cancer, birth defects or other reproductive harm. Guidance for upper limits (“Safe Harbor Level”) on chemicals is based on expected daily exposure. If no Safe Harbor Level exists for a chemical, the product containing a listed chemical must include a warning, unless the exposure level can be proven to not pose a significant risk of causing harm.

With the size of the California economy and the interconnected U.S. supply chain, the state law effectively reaches other states and U.S. importers. More recently, the Prop 65 requirements impact online and catalog sales, which have increased significantly during the global pandemic.

Know Your Suppliers

All companies need to proactively evaluate and document Prop 65 risks. Enforcement occurs primarily through civil litigation, resulting in specialized legal firms profiting from a company’s ignorance of the law’s extent. Even the threat of publicity from a lawsuit can cause targeted companies to settle a case.
At each point of manufacturing and distribution—supplier, manufacturer, packager, importer or distributor—regulatory teams should ask about Prop 65 compliance. The main point of responsibility is at the manufacturer, but a retailer can also be obligated for introducing a chemical at point-of-sale.

What’s New with Prop 65

The OEHHA issues notices regarding amendments to the California Code of Regulations Title 27, Article 6, covering “Clear and Reasonable Warnings”. Recently the OEHHA requested public comments on proposed amendments that would modify the content and methods for providing “short-form” warnings. The short form was originally intended for products with restricted label space.

The proposed rule would modify the existing short-form warning provisions to:

  • Only allow use of the short-form warning on products with five square inches or less of label space.
  • Eliminate use of short-form warnings for products sold via the Internet and catalogs.
  • Clarify how short-form warnings can be used for food products.
  • Require the name of at least one chemical be included in the short-form warning.

Bottomline: Know Your Business and Risk

As an advisor with more than 20 years of regulatory compliance experience in food and food ingredients, my guidance for business best practice on Prop 65 is to be proactive, maintain supply chain knowledge, and understand risk. Regulatory or legal staff, or consultant teams specializing in Prop 65, should regularly monitor for additions to the chemical list and rulemaking changes to the far-reaching law.

Steven Blonder, Much Law
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Food Litigation Trends Lay the Foundation for an Industry-Defining 2021

By Steven Blonder
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Steven Blonder, Much Law

The year 2020 brought with it continued court filings within the food safety litigation space, and it should come as no surprise the pandemic presented its own set of unique challenges. We’ve seen disruptions to the food and beverage supply chain, noteworthy changes with recalls, and continued developments in litigation specific to product labeling. These challenges have impacted everyone involved in the industry and laid the groundwork for what’s to come in 2021.

The most notable impact the food industry has faced as a result of the pandemic has been the massive disruption of the food supply chain. Grocers and other retail food providers have seen an immense spike in demand, whereas foodservice locations, such as restaurants, universities, and hotels, have seen the exact opposite. This disruption to the supply chain has required regulatory agencies to take notice and implement temporary policies to support these businesses and consumers alike. Employees across the food industry supply chain, including agriculture and food processing, have further been classified as essential, leading federal agencies to issue guidance to these employers to help them assess COVID-19 control plans and protect their employee’s health. Further, safety concerns and bumps in unemployment compensation have imposed additional strains on worker retention and attendance.

Another interesting facet of the pandemic’s impact on the industry has been its influence in the product recall space. Believe it or not, companies have strayed from pulling their products off the shelf even if it subjects them to potential liability. Why is this? Because as mentioned earlier, the demand for food in the retail space has increased so much, it has become a necessary choice to avoid food shortages across the United States. Don’t worry, if a product possesses a health or safety threat, companies are still recalling those to protect consumers and address safety concerns, but voluntary non-health or safety related recalls may have become a thing of the past. For example, rather than recall a box of cereal or other dry good for not meeting a fill-line requirement, providers may elect to risk a false-advertising lawsuit to meet the recent shift in retail food demand.

Since 2012, there have been more than 200 class action lawsuits filed related to the labeling on food products. This past year, we observed a continuation of this trend. Class action lawsuits were filed addressing the authenticity of “all-natural” products or claims based on the “origin” of a product, while we witnessed a sharp decline in slack-fill lawsuits. Consumers are becoming increasingly aware of the ingredients in food products and are continuing to demand transparency from companies to disclose how their products are made. There has been a particular increase in claims related to the definition of vanilla—is it pure? Is it natural? The same goes for citric acid, a product that can be made naturally or synthetically. There has been continued debate within the industry about citric acid in its use within other products where some citric acid is naturally occurring either from citrus fruit, tomatoes or other fruits with citric acid. If all-natural citric acid is added into tomato paste to help with the taste, can the tomato paste still be classified as being all-natural, even if the use of citric acid is displayed on the label?

To help combat the discrepancies around all-natural products, the USDA is currently working on developing an official definition of “all-natural,” which upon its completion is anticipated to have a major impact on the labeling industry and the number of false-advertising class actions. This definitional development comes at a crucial time especially as plant-based protein continues to rise in popularity.

The next wave of claims are being filed related to plant-based protein products. These claims include trademark and First Amendment issues. For example, when is a burger, a burger? Everyone assumes a burger means a hamburger, traditionally deriving from beef, and there has been an increase in debate around when the sale of plant-based products infringe on the rights of ranchers selling traditional beef products. Can food created in a petri-dish claim the same title as products created through traditional harvesting methods? What about other genetically modified products? These issues will likely spawn additional litigation in the coming year.

Looking ahead towards 2021, we can fully anticipate cases addressing food labeling issues to continue. Historically many of these claims were filed in Northern California with one federal court there earning the moniker of the “Food Court”. Recent years have seen increased filings in New York and Illinois, but the coming year may see a decrease in cases filed in New York as a result of recent court decisions relating to pre-emption and a recent opinion of a federal appellate court disallowing the settlement of class claims on an injunction-only basis. California may also see changes in their total cases as food producers curtail product sales in California to avoid the ambit of Prop 65.1

2021 will continue to bear witness to the effects of the COVID-19 pandemic. The supply chain will continue to adjust to the varying demands of the public as they navigate safety regulations, and companies will maintain an “only-recall-if-absolutely-necessary” mindset. Many of the adjustments that businesses, consumers and regulators have had to make in light of the pandemic may also lead to long-term or permanent shifts. In fact, the Consumer Brands Association has identified a few select areas ready for change, such as the maintenance of flexibility in food labeling to ease the transfer process of products between foodservice and food retail providers. We just might find 2021 to be one of the most industry-defining years in the food safety litigation space.

Reference

  1. California Office of Environmental Health Hazard Assessment. (n.d.). Proposition 65. Accessed December 17, 2020. Retrieved from https://oehha.ca.gov/proposition-65
Prop 65 label

California Proposition 65 To Impact Food Labels

By Nick Recht
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Prop 65 label

The fast-approaching August 30th deadline for California’s Proposition 65 has food manufacturers of all sizes working to make sure affected labels comply with the new labeling requirements. According to the California Office of Environmental Health Hazard Assessment (OEHHA), Proposition 65:

“…requires businesses to provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects or other reproductive harm. These chemicals can be in the products that Californians purchase, in their homes or workplaces, or that are released into the environment. By requiring that this information be provided, Proposition 65 enables Californians to make informed decisions about their exposures to these chemicals.”

Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act, is intended to help better equip Californians to make informed decisions about the products they purchase. The OEHHA is responsible for determining which chemicals meet the legal and scientific requirements for inclusion on the Proposition 65 list, a list which has grown to more than 900 chemicals since it was originally published in 1987.

The new law will be enforced by the California Attorney General’s Office as well as any district attorney or city attorney for cities whose population exceeds 750,000. Individuals acting in the public’s interest may also seek to enforce Proposition 65 by filing a lawsuit against companies alleged to be in violation. Companies that are found to be in violation may be fined as high as $2,500 per violation per day.

To ensure compliance with the new law, food manufacturers must reference the list of included chemicals to determine which of their products, if any, are impacted. Manufacturers must then provide “clear and reasonable warnings” that chemicals used in the production of their goods or products sold in California are known to cause cancer, birth defects and/or other reproductive harm. The ruling impacts goods sold in California as well as those sold via catalog or the internet.

Proposition 65 underscores the importance of an agile labeling environment for food manufacturers, particularly as it relates to their ability to adjust labels prior to compliance deadlines. It also implores manufacturers to look to automation to reduce the room for human error. For example, labeling software can be leveraged to create a table look up so if an impacted ingredient is included in a product and printed on a label, the required warning statement is also automatically included on the label.

Leveraging a database connection to apply such warnings can help businesses mitigate risk, as failing to include a required warning could result in fines, business disruption and lost revenue. It is also important to note that compliance with Proposition 65 will require food manufacturers to stay up to date on changes, as new chemicals may be added and/or revisions to law may continue to occur. Food retailers must also stay abreast of labeling changes required by Proposition 65 to ensure the products they sell are in compliance. Learn more about Proposition 65 at the OEHHA’s official website: https://www.p65warnings.ca.gov.

Prop 65 label
Label design products can help a company add a warning statement to a current label. Image courtesy of TEKLYNX.