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Surveying the Phthalate Litigation Risk to Food Companies

By Kara McCall, Stephanie Stern
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Boxed macaroni and cheese—comforting, easy, and, according to a 2017 article by The New York Times, containing “high concentrations” of “[p]otentially harmful chemicals.” Roni Caryn Rabin, The Chemicals in Your Mac and Cheese, N.Y. TIMES, June 12, 2017. Those “chemicals” referenced by the Times are phthalates—versatile organic compounds that have been the focus of increased media, advocacy, and regulatory scrutiny. But what are phthalates and what is the litigation risk to food companies who make products that contain trace amounts of this material?

Background

Phthalates are a class of organic compounds that are commonly used to soften and add flexibility to plastic.1 Ninety percent of phthalate production is used to plasticize polyvinyl chloride (PVC).2 Di-(2-ethylhexl) phthalate (DEHP) is the most commonly used phthalate plasticizer for PVC.3 Due to the prevalence of plastics in the modern world, phthalates are everywhere—from food packaging to shower curtains to gel capsules. Consequently, almost everyone is exposed to phthalates almost all of the time and most people have some level of phthalates in their system.4

Recently, various epidemiological studies have purported to associate phthalates with a range of different injuries, from postpartum depression to obesity to cancer. However, as the Agency for Toxic Substances and Disease Registry (ATSDR) stated in its 2019 toxicology profile for DEHP, these epidemiology studies are flawed because, inter alia, they often rely on spot urine samples to assess exposure, which does not provide long-term exposure estimates or consider routes of exposure.5 To date, claims regarding the effects of low-level phthalate exposure on humans are not supported by human toxicology studies. Instead, phthalate toxicology has only been studied in animals, and some phthalates tested in these animal studies have demonstrated no appreciable toxicity. Two types of phthalates—DBP and DEHP—are purported to be endocrine disrupting (i.e., affecting developmental and reproductive outcomes) in laboratory animals, but only when the phthalates are administered at doses much higher than those experienced by humans.6 Indeed, there is no causal evidence linking any injuries to the low-level phthalate exposure that humans generally experience. Nonetheless, advocacy and government groups have extrapolated from these animal studies to conclude that DEHP may possibly adversely affect human reproduction or development if exposures are sufficiently high.7 Indeed, in the past two decades, a number of regulatory authorities began taking steps to regulate certain phthalates. Most notably:

  • In 2005, the European Commission identified DBP, DEHP, and BBP as reproductive toxicants (Directive 2005/84/EC), and the European Union banned the use of these phthalates as ingredients in cosmetics (Directive 2005/90/EC).
  • In 2008, Congress banned the use of DBP, DEHP, and BBP in children’s toys at concentrations higher than 0.1%. See 15 U.S.C. § 2057c.
  • The EU added four phthalates (BBP, DEHP, DBP, and DIBP) to the EU’s list of Substances of Very High Concern (SVHCs) and, subsequently, to its Authorization List, which lists substances that cannot be placed on the market or used after a given date, unless authorization is granted for specific uses. BBP, DEHP, DBP, and DIBP were banned as of February 21, 2015, except for the use of these phthalates in the packaging of medicinal products.
  • In 2012, the FDA issued a statement discouraging the use of DBP and DEHP in drugs and biologic products. At the time, the agency said that these phthalates could have negative effects on human endocrine systems and potentially cause reproductive and developmental problems.8

More recently, phthalate exposure through food has become a trending topic among consumer advocates. Phthalates are not used in food, but can migrate into food through phthalates-containing materials during food processing, storing, transportation, and preparation. Certain studies report that ingestion of food accounts for the predominant source of phthalate exposure in adults and children. However, in assessing DEHP, the ATSDR noted that the current literature on “contamination of foodstuffs comes from outside the United States or does not reflect typical exposures of U.S. consumers; therefore, it is uncertain whether and for which products this information can be used in U.S.-centered exposure and risk calculations.”9 Further, the concentration of phthalates found in food are very low-level—multiples lower than the doses used in animal toxicology studies.10

In 2017, a study published on the advocacy site “kleanupkraft.org” stated that phthalates were detected in 29 of 30 macaroni and cheese boxes tested.11 The study notes that “DEHP was found most often in the highest amounts.” Notably, however, the “amounts” are provided without any context, likely because there is no universally accepted threshold of unsafe phthalate consumption. Thus, although the boxed macaroni and cheese study found “that DEHP, DEP, DIBP, and DBP were frequently detected in the cheese items tested,” and “[t]he average DEHP concentration was 25 times higher than DBP, and five times higher than DEP,” none of this explains whether these numbers are uniquely high and/or dangerous to humans. Meanwhile, on December 10, 2019, the European Food Safety Authority announced an updated risk assessment of DBP, BBP, DEHP, DINP, and DIDP, and found that current exposure to these phthalates from food is not of concern for public health.12

Phthalate Litigation

For years, phthalates in food have been targeted by environmental groups seeking to eliminate use of phthalates in food packaging and handling equipment. Most recently, several lawsuits were filed against boxed macaroni and cheese manufacturers alleging misrepresentation and false advertising due to their undisclosed alleged phthalate contamination. See, e.g., McCarthy, et al. v. Annie’s Homegrown, Inc., Case No. 21-cv-02415 (N.D. Cal. Apr. 2, 2021). Perhaps acknowledging that the amounts contained in the food packages have not been shown to present any danger, these claims are being pursued as consumer fraud claims based on failure to identify phthalates as an ingredient, rather than as personal injury claims.

Besides this recent litigation, however, there has been a notable dearth of phthalate litigation. This is likely due to several factors: First, in general, courts have rejected false claim lawsuits involving trace amounts of a contaminant chemical. See, e.g., Tran v. Sioux Honey Ass’n, Coop., 471 F. Supp. 3d 1019, 1025 (C.D. Cal. 2020) (collecting cases). For example, in Axon v. Citrus World, Inc., 354 F. Supp. 3d 170 (E.D.N.Y. 2018), the Court dismissed plaintiff’s claim that the use of the word “natural” constituted false advertising because the product contained trace amounts of weed killer. Id. at 182–84. The Court based this dismissal, in part, on the fact that the trace amounts of the commonly used pesticide was “not an ‘ingredient’ added to defendant’s products; rather, it is a substance introduced through the growing process.” Id. at 183. Similarly, phthalate is not an intentionally added ingredient—instead, it is a substance introduced, if at all, in trace amounts at various points throughout the manufacturing, handling, and packaging process. Second, proving that phthalate exposure from a particular food item caused an alleged injury would be extremely difficult. As mentioned above, there is no direct scientific evidence linking low-level phthalate exposure in humans to reproductive problems, cancer, or any other injury. Instead, plaintiffs must rely on animal studies where the subject, most commonly a rat, was exposed to enormous amounts of phthalates, many multiples of the amount that would be found in food. Moreover, the pervasive nature of phthalates makes it difficult to pinpoint any particular product as the source of the injury. If every food item a plaintiff ever consumed has been touched by a phthalate-containing material, it seems near impossible to prove that one particular food caused the alleged injury.

Although phthalate litigation has thus far proven unpopular, this landscape could change in the near future due to increased regulatory scrutiny. On December 20, 2019, the EPA stated that DEHP, DIBP, DBP, BBP, and dicyclohexyl phthalate were five of 20 high-priority chemicals undergoing risk evaluation pursuant to the Toxic Substances Control Act.13 The categorization of these phthalates as high-priority initiates a three- to three-and-a-half-year risk evaluation process, which concludes in a finding of whether the chemical substance presents an unreasonable risk of injury to health or the environment under the conditions of use.14 Although the same causation and product identification issues will remain, a revised risk analysis by the EPA may lead to increased phthalate litigation.

The views expressed in this article are exclusively those of the authors and do not necessarily reflect those of Sidley Austin LLP and its partners. This article has been prepared for informational purposes only and does not constitute legal advice. This information is not intended to create, and receipt of it does not constitute, a lawyer-client relationship. Readers should not act upon this without seeking advice from professional advisers.

References

  1. The most commonly used phthalates are di-(2-ethylhexyl) phthalate (DEHP), diisononyl phthalate (DINP), benzyl butyl phthalate (BBP), di-n-butyl phthalate (DBP), and diethyl phthalate (DEP). See Angela Giuliani, et al., Critical Review of the Presence of Phthalates in Food and Evidence of Their Biological Impact, 17 INT. J. ENVIRON. RES. PUBLIC HEALTH 5655 (2020).
  2. COWI A/S, Data on Manufacture, Import, Export, Uses and Releases of Dibutyl Phthalate (DBP), As Well As Information on Potential Alternatives To Its Use 10-11 (Jan. 29, 2009). http://echa.europa.eu/documents/10162/
    13640/tech_rep_dbp_en.pdf (observing European Council for Plasticizers and Intermediates (ECPI)); Agency for Toxic Substances & Disease Registry, DI-n-BUTYL PHTHALATE, Production, Import/Export, Use, and Disposal (Jan. 3, 2013). http://www.atsdr.cdc.gov/ToxProfiles/tp135-c5.pdf; Peter M. Lorz, et al., Phthalic Acid and Derivatives. ULLMANN’S ENCYCLOPEDIA OF INDUSTRIAL CHEMISTRY (Wiley-VCH: Weinheim, 2000); Lowell Center for Sustainable Production, Phthalates and Their Alternatives: Health and Environmental Concerns 4 (Jan. 2011). https://www.sustainableproduction.org/downloads/PhthalateAlternatives-January2011.pdf.
  3.  Michael D. Shelby, NTP-CERHER Monograph on the Potential Human Reproductive and Developmental Effects of Di (2-Ethylhexyl) Phthalate (DEHP). National Toxicology Program, HHS. NIH Publication No. 06-4476 at 2–3 (Nov. 2006).
  4.  See Chris E. Talsness, et al., Components of Plastic: Experimental Studies in Animals and Relevance for Human Health, 364 PHIL. TRANS. R. SOC. B 2079, 2080 (2009). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2873015/pdf/rstb20080281.pdf.
  5. Agency for Toxic Substances & Disease Registry, Toxicology Profile for Di(2-Ethylhexyl) Phthalate (DEHP), Draft for Public Comment 3 (Dec. 2019). https://www.atsdr.cdc.gov/toxprofiles/tp9.pdf.
  6. FDA Guidance for Industry, Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products. HHS, FDA. (Dec. 2012).
  7. NIH Publication No. 06-4476 at 2–3, supra n.3.
  8. FDA Guidance for Industry. Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products. HHS, FDA. (Dec. 2012).
  9. Toxicology Profile for Di(2-Ethylhexyl) Phthalate (DEHP) at 362, supra n.5.
  10. Compare id. at 5 (measuring effects of phthalate oral exposure in mg/kg/day) with Samantha E. Serrano, et al., Phthalates and diet: a review of the food monitoring and epidemiology data, 13 ENVIRON. HEALTH 43 (2014) (measuring phthalate concentration in food in μg/kg).
  11. Testing Finds Industrial Chemical Phthalates in Cheese, Coalition for Safer Food Processing and Packaging. http://kleanupkraft.org/data-summary.pdf.
  12. FAQ: phthalates in plastic food contact materials. European Food Safety Authority. (Dec. 10, 2019).
  13. EPA Finalizes List of Next 20 Chemicals to Undergo Risk Evaluation under TSCA. U.S. Environmental Protection Agency. (Dec. 20, 2019).
  14.  Risk Evaluations for Existing Chemicals under TSCA. U.S. Environmental Protection Agency.
Recall

JBS Recalls Nearly 5000 Pounds of Imported Australian Boneless Beef Due to Potential E. Coli Contamination

By Food Safety Tech Staff
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Recall
JBS Boneless Beef product
Label of recalled JBS Australia beef product. (Image from FSIS)

JBS USA Food Company is recalling about 4,860 pounds of imported raw and frozen boneless beef products over concern of contamination with E. coli O157:H7. The products were imported on or around November 10, 2020 and shipped to distributors and processors in New York and Pennsylvania.

The issue was uncovered during routine product sampling collected by FSIS, which confirmed positive for the presence of E. coli O157:H7, according to an FSIS announcement. “FSIS is concerned that some product may be frozen and in cold storage at distributor or further processor locations,” the announcement stated. “Distributors and further processors who received these products are urged not to utilize them.”

No illnesses or adverse reactions have been reported.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

Embrace Those Curves

By Susanne Kuehne
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Susanne Kuehne, Decernis
Near infrared spectroscopy
Find records of fraud such as those discussed in this column and more in the Food Fraud Database, owned and operated by Decernis, a Food Safety Tech advertiser. Image credit: Susanne Kuehne

Lab methods for the analysis of adulterated food can be time-consuming, expensive and impossible to use in the field. A new study shows promising results for hand-held near infrared (NIR) spectroscopy tools. The investigated method proved to be very quick and highly accurate, and could open new possibilities for remote testing. This was shown in a study with oregano samples, a common target for food adulteration.

 

 

Resource

  1. Mc Grath, T.F., et al. (to be published on August 15, 2021) “The potential of handheld near infrared spectroscopy to detect food adulteration: Results of a global, multi-instrument inter-laboratory study”. Abstract. Science Direct.
Susanne Kuehne, Decernis
Food Fraud Quick Bites

Olive Oil Detectives in the Lab

By Susanne Kuehne
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Susanne Kuehne, Decernis
Olive tree, food fraud
Find records of fraud such as those discussed in this column and more in the Food Fraud Database, owned and operated by Decernis, an advertiser in Food Safety Tech. Image credit: Susanne Kuehne

Canola oil, sunflower oil or soybean oil, colorants and low-quality olive oil, anyone? Olive oil, especially extra virgin olive oil adulteration is rampant, since the risk of getting caught is low and the profits are huge. A new expert-reviewed Laboratory Guidance Document on olive oil, published by the Botanical Adulterants Prevention Program (BAPP), lists a variety of laboratory methods at different levels of complexity, as well as the most common methods of adulteration. This Laboratory Guidance Document is an indispensable guide for regulatory and research personnel in the food, supplement and cosmetics industries.

Resource

  1. Mailer, R.J. and Gafner, S. (March 2021). “Botanical Adulterants Prevention Program Publishes Olive Oil Laboratory Guidance Document”. Botanical Adulterant Prevention Program.
Recall

Sabra Recalls Hummus After Salmonella Discovered During FDA Routine Screening

By Food Safety Tech Staff
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Recall

On Monday Sabra Dipping Company, LLC and the FDA announced a voluntary recall of the company’s Classic Hummus due to potential Salmonella contamination. The discovery was made when the FDA conducted a routine screen of one tub. Sabra has recalled about 2100 cases of its 10 oz Classic Hummus (1 SKU), which was produced on February 10 and has a “Best Before” date of April 26. The product was distributed to 16 states, but according to the company announcement posted on FDA’s website, since the hummus is more than halfway through its shelf life, “it’s unlikely you’ll find this product on the shelf.”

Thus far no illnesses have been reported in connection with this recall.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

The Automated Nose of a Master of Wine

By Susanne Kuehne
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Susanne Kuehne, Decernis
Wine fraud
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne

Since only 417 Masters of Wine exist globally (and their palates and noses)—and they are amazing in identifying wines by grape varietal or blend, type, vintage and location—it is a good idea to have some automated backup when it comes to wine fraud detection. Aside from other analytical methods, nuclear magnetic resonance (NMR) spectroscopy can be used in the authentication of wine. The new proton measurement 1H NMR Method with easier sample preparation is recommended for the investigation of wine fraud, to detect for example the addition of water or sugar. NMR spectroscopy measures several compounds of a wine at once and therefore is able to detect a fingerprint of a wine, such as the geographic origin or grape varietal.

Resource

  1. Solovyev, P.A., et. al. (January 27, 2021) “NMR spectroscopy in wine authentication: An official control perspective”. Comprehensive Reviews in Food Science and Food Safety. Wiley Online Library.
Listeria

Virtual Event Targets Challenges and Best Practices in Listeria Detection, Mitigation and Control

By Food Safety Tech Staff
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Listeria

Next month, Food Safety Tech will host the first event in its Food Safety Hazards Series, “Listeria Detection, Mitigation, Control & Regulation” on April 15. The virtual event features Sanjay Gummalla, Ph.D., senior vice president of scientific & regulatory affairs at AFFI; April Bishop, senior director of food safety at TreeHouse Foods; and Douglas Marshall, Ph.D., chief scientific officer at Eurofins. These experts will address Listeria from the perspective of food manufacturing and preventing the introduction of the pathogen; risk based and practical approaches to address the presence of Listeria in food production and achieve key publish health goals relative to the pathogen; how to implement a strong Listeria control program; and the testing challenges from a lab perspective.

The event begins at 12 pm ET on Thursday, April 15.

Presentations are as follows:

  • Listeria Control and New Approaches to Addressing Risks, by Sanjay Gummalla
  • Managing Food Safety and Sanitation in the Digital Age, by April Bishop
  • Listeria Testing: Choosing the Right Method and Target, by Doug Marshall

The presentations will be followed by a panel discussion and a live Q&A with attendees.

Register now for the Food Safety Hazards Series: Listeria Detection, Mitigation, Control & Regulation

FDA

FDA Responds to Subcommittee Report on Toxic Metals in Baby Food

By Food Safety Tech Staff
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FDA

Following a report released nearly two weeks ago about the potential danger posed by toxic heavy metals found in baby foods manufactured by several major companies, FDA has issued a response. The report, “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury”, was released by the U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy on February 4. The Subcommittee stated that FDA should require baby food manufacturers to test their finished products for toxic heavy metals and require any toxic heavy metals be reported on food labeling. It also stated that FDA should set maximum levels of toxic heavy metals allowed in baby foods.

“The FDA has been actively working on this issue using a risk-based approach to prioritize and target the agency’s efforts. Consumers should know that FDA scientists routinely monitor levels of toxic elements in baby foods, along with other foods consumed in the country’s diet, through the Total Diet Study,” the agency stated in a CFSAN update. “Further, the FDA also monitors baby food under the FDA’s compliance program for Toxic Elements in Food and Foodware, and Radionuclides in Food and through targeted sampling assignments.”

FDA cited its work in sampling infant rice cereal for arsenic, which it says has resulted in safer products on the market, along with its recent court order to stop a U.S. company from distributing adulterated juice that had potentially harmful levels of inorganic arsenic and patulin (a mycotoxin).

The CFSAN update, however, did not specifically address the companies or baby foods called out in the Subcommittee’s report.

U.S. House of Representatives Seap

House Subcommittee Releases Report on Dangerous Levels of Toxic Heavy Metals in Baby Food

By Food Safety Tech Staff
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U.S. House of Representatives Seap

Last week a report released by Congress cited dangerous levels of toxic heavy metals in several brands of baby food. Back in November 2019, the Subcommittee on Economic and Consumer Policy asked for internal documents and test results from baby food manufacturers Nurture, Inc. (Happy Family Organics), Beech-Nut Nutrition Company, Hain Celestial Group, Inc., Gerber, Campbell Soup Company, Walmart, Inc., and Sprout Foods. According to the staff report, Nurture, Beech-Nut, Hain and Gerber responded to the requests, while Walmart, Campbell and Sprout Organic Foods did not.

The findings indicate that significant levels of arsenic, lead, cadmium and mercury were found in the baby foods of the four manufacturers who responded to the Subcommittee’s requests (Nurture, Beech-Nut, Hain and Gerber). It also stated the alarming point that, “Internal company standards permit dangerously high levels of toxic heavy metals, and documents revealed that the manufacturers have often sold foods that exceeded those levels.”

The Subcommittee voiced “grave concerns” that the baby food made by Walmart, Sprout Organic Foods and Campbell was “obscuring the presence of even higher levels of toxic heavy metals in their baby food products than their competitors’ products” due to their lack of cooperation.

In addition, the report states that the Trump administration “ignored a secret industry presentation to federal regulators revealing increased risks of toxic heavy metals in baby foods” in August 2019.

“To this day, baby foods containing toxic heavy metals bear no label or warning to parents. Manufacturers are free to test only ingredients, or, for the vast majority of baby foods, to conduct no testing at all,” the report stated (infant rice cereal is the only baby food held to a stringent standard regarding the presence of inorganic arsenic).

As a result of the findings, the Subcommittee has made several recommendations:

  • FDA should require baby food manufacturers to test their finished products for toxic heavy metals.
  • FDA should require manufacturers to report toxic heavy metals on food labels.
  • Manufacturers should find substitutes for ingredients that are high in toxic heavy metals or phase out the ingredients that are high in toxic heavy metals.
  • FDA should set maximum levels of toxic heavy metals allowed in baby foods.
  • Parents should avoid baby foods that contain ingredients that test high in toxic heavy metals.

The 59-page report, “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury”, is available on the U.S. House of Representatives’ website.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

The Not-So-Green Pistachio

By Susanne Kuehne
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Susanne Kuehne, Decernis
Pistachio, food fraud
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne

Organic produce is a lucrative and growing market and an easy target for food fraud. Mislabeled organically certified pistachios were bringing in up to 80% more revenue than conventional nuts, resulting in a €6 million profit. European officials including Europol uncovered the illegal operation and made 14 arrests in Spain. Forensic analysis showed that the pistachios contained illegal pesticides.

Resource

  1. Europol. (December 18, 2020). “€6 million in illegal profit of fraudulent of fraudulent organic pistachio sales”. Press release. Europol.