Category: Food & Hospitality

The Sesame Seed Scandal!

Back in September, Belgium informed French authorities, via the RASFF, that ethylene oxide had been found in imported sesame seeds. The amount of ethylene oxide surpassed the maximum amount allowed under regulations. Subsequent DGCCRF checks have shown that other products (like spices) may also be contaminated.

Investigations are ongoing, but French health authorities and EU member states have taken measures to withdraw or recall any contaminated substances, the list of which continues to grow…

Le scandale des grains de sésame prend de l’ampleur !

Ce qui – en septembre – semblait être limité aux « graines de sésames », prend aujourd’hui une toute autre dimension. En effet, il s’agit de signaler comme potentiellement dangereux tout ingrédient alimentaire ayant été traité à l’oxyde d’éthylène.

Et la liste s’allonge…..

© 2021 Keller and Heckman LLP

ARTICLE BY Food and Drug Law at Keller and Heckman
For more articles on food and drug law, visit the NLR Biotech, Food, Drug section.

Ninth Circuit Drowns Out Alkaline Water Suit

The Ninth Circuit recently affirmed the dismissal of a putative class action alleging Trader Joe’s misled consumers by representing its Alkaline Water product as “ionized to achieve the perfect balance.”  In rejecting plaintiff’ allegations that the advertising referred to balancing the consumer’s internal pH rather than the balanced pH of the product itself, the Court recognized “a reasonable consumer does not check her common sense at the door of a store.”  Weiss v. Trader Joe’s, No. 19-55841 (9th Cir. Mar. 3, 2021).

The Alkaline Water product label states the water is “ionized to pH 9.5+,” will “refresh & hydrate,” and depicts “hundreds of plus symbols.”  An advertisement for the water in Trader Joe’s store newsletter likewise touted that the water was purified and charged through electrolysis, changing the structure of the water and raising the pH to 9.5+, making the product “water and then some.” Plaintiff alleged these representations were misleading because they implied that the water would “balance” a consumer’s internal pH after he or she has eaten acidic foods and would provide superior hydration as compared to other water.

The district court found several of these representations (including “water and then some,” “a drink that can satisfy,” and “refresh”) constituted non-actionable puffery.  The remaining challenged statements concerning the drink’s pH and ionization, the court found, would not mislead a reasonable consumer.

Agreeing with the district court’s analysis, the Ninth Circuit likewise found a reasonable consumer would not misinterpret these representations as suggesting internal pH balancing benefits or superior hydration.  When considered in the context of the package as a whole, the Court found the phrase “ionized to achieve the perfect balance” clearly referred to the water itself being balanced – rather than to balance within the body.

The Ninth Circuit also rejected plaintiff’s allegation that the term “hydrate” would mislead consumers into believing the water provided better hydration than other water. Plaintiff did not dispute that the water does, in fact, “hydrate.”  Finding this statement about the water’s hydrating capability true and undisputed, the Ninth Circuit agreed with the district court that it would not plausibly deceive a reasonable consumer.

The Court also affirmed the district court’s dismissal of plaintiffs’ breach of warranty claims based on the same advertising. The Court noted that though the reasonable consumer standard technically does not apply to warranty claims, those claims still require some sort of actionable representation. No such misrepresentation existed here because nothing in the challenged labeling promised health benefits or superior hydration.

This case serves as a reminder that allegations founded on fanciful interpretations of advertising claims may cause a “splash” when filed, but courts exercising common sense will not hesitate to dispose of them at the pleading stage.  While the Ninth Circuit’s decision in Weiss is unpublished, it is consistent with other precedential decisions from the court.  See for example Ebner v. Fresh, 838 F.3d 958 (9th Cir. 2016) – a case we have previously blogged about.

© 2020 Proskauer Rose LLP.
For more articles on water lawsuits, visit the NLR

Vanilla Flavoring Class Action Lawsuit Against McDonald’s Dismissed

On March 24, 2021, the U.S. District Court for the Northern District of California dismissed a consumer class action lawsuit against McDonald’s which had alleged various causes of action relating to McDonald’s sale of vanilla ice cream that the plaintiff alleged derived some portion of its vanilla flavor from vanillin rather than vanilla bean.

The Court found that the Plaintiffs had not established that their claim—that consumers were misled by the vanilla flavor labeling—was plausible as required to survive a motion to dismiss. Specifically, the court found that the allegations of consumer deception were merely conclusory and did not establish that it was “probable that a significant portion of the general consuming public or of targeted consumers, acting reasonably in the circumstances, could be misled.” The court noted the labeling regulations that govern the retail sale of vanilla ice cream added no support for Plaintiffs’ claims because they indisputably did not apply to sales at fast-food establishments. Additionally, and serving as an independent grounds for dismissal, the court found that Plaintiffs’ had not established that they had paid a premium for the vanilla ice cream; rather the court found it to be “counter-intuitive” in the market context presented.

We have reported on a variety of vanilla flavoring class action lawsuits, many of which have not survived the motion to dismiss stage. This case is another demonstration of the difficulty that plaintiffs have had in convincing the court that consumers expect vanilla flavored products to contain not only the flavor of vanilla but also the ingredient vanilla bean. An amended complaint may be filed within 30 days of the order.

© 2020 Keller and Heckman LLP

ARTICLE BY Food and Drug Law at Keller and Heckman
For more articles on food flavoring, visit the NLR Biotech, Food, Drug section.

$15 Million Settlement in Post Cereal Lawsuit

On February 24, 2021, a California federal judge tentatively approved a settlement over nutrition-related claims for breakfast cereal whereby Post would establish a $15 million non-reversionary common fund to compensate a nationwide class of consumers who purchased Raisin Bran, Honeycomb, Honey Bunches of Oats, or Waffle Crisps, and Post would  also refrain from using claims including “less processed,” “no high fructose corn syrup,” “natural,” and “wholesome” on boxes of cereal where 10% or more of the calories come from added sugar.  An award for fees, costs, and expenses will be determined in a final hearing scheduled for June 23, 2021.

The same team of attorneys also filed proposed class action lawsuits in 2016 with a common lead plaintiff in the Northern District of California against cereals marketed by General Mills and Kellogg involving similar false-advertising claims.  As we previously reported, the case against General Mills was dismissed in June 2020, based on the judge’s finding that plaintiffs could not possibly have been misled because the amount of sugar in the cereals is clearly disclosed on the product labels.  Further, a settlement has not yet been reached in the class action lawsuit against Kellogg (subscription to Law360 required).

Although legal results are mixed, and complex issues surround the impact on health of added sugars in a single product and a product’s role in the total diet, nutrition claims that could imply the product is healthy seem risky for foods with added sugars.  Meanwhile, FDA has not indicated how it will act on a citizens petition (discussed here) requesting a regulation to establish disqualifying levels of added sugar that would prohibit the use of a “healthy” claim.

© 2020 Keller and Heckman LLP

ARTICLE BY Food and Drug Law at Keller and Heckman
Keller and Heckman LLP
For more, visit the NLR Biotech, Food, Drug section.

USDA Certified Organic Ciders: One of a Kind?

Anheuser-Busch introduced its Michelob Ultra Organic Seltzer last month, advertising the beverage as the “First-of-its-kind organic option to the hard seltzer category,” “First USDA-certified organic seltzer,” “First National USDA Certified Organic Hard Seltzer,” and “First-ever national USDA certified organic hard seltzer.” Anheuser-Busch even aired commercials during the nationally televised, highly viewed NFL Division Championship games, along with the Super Bowl that took place on Sunday, February 7. But now the question before an Oregon Court is whether these advertisements imply that it is the first and only kind in the country.

USDA Certified Organic Ciders

Suzie’s Brewery Company brews and packages Organic Hard Seltzer in Pendleton, Oregon. Suzie’s Brewery first launched its product line in July 2020 after obtaining its national organic certification from the USDA’s National Organic Program in June 2020. This program grants businesses the right to display the “USDA Organic” seal on their products should the business meet specific national standards. It also allows certified businesses to represent in advertising that their products have received national USDA organic certification. While most alcoholic beverages are regulated by the Federal Tax and Trade Bureau (“TTB”), and sugar fermented seltzers by the Food and Drug Administration (“FDA”), the USDA governs any food or beverage products that bear the “organic” label.

On February 2, 2021, Suzie’s Brewery sued Anheuser-Busch for false advertising and filed a motion for a temporary restraining order that would keep it from airing ads that Suzie’s Brewery claims are false. “Suzie’s Seltzer also has a national USDA organic certification, and was available on the market well before ULTRA Seltzer,” argued the attorney for Suzie’s Brewery, “In addition, there are several other hard seltzer brands on the market that have USDA organic certification.” Suzie’s Brewery further claims multiple consumers and product distributors contacted them regarding the Michelob Ultra Organic Seltzer advertisements, confused about it being the “first” or “only” USDA Organic certified seltzer. Others questioned the veracity of Suzie’s Brewery and their seltzers being USDA Certified organic, since Anheuser-Busch had claimed to be the “only” one on the market.

One of a Kind?

“Using the bully-pulpit its massive national advertising budget allows, Anheuser-Busch has premiered a new false and misleading advertising campaign aimed at convincing health-conscious drinkers that its new organic hard seltzer is a unique, one-of-a-kind product. To be clear, it is not,” Suzie’s Brewery stated, “and Anheuser-Busch will continue to pursue its strategy of unfairly squeezing out its smaller competitors in the organic hard seltzer market (like Suzie’s Brewery) unless this court puts a stop to its misconduct.”

On February 9, 2021, Judge Michael H. Simon of the United States District Court for the District of Oregon granted the temporary restraining order requiring Anheuser-Busch to immediately stop falsely claiming that its product – Michelob ULTRA Organic Hard Seltzer – is the only or first national USDA certified organic hard seltzer on the market. “It is false for Anheuser-Busch to say this,” the judge said, “because Suzie’s Organic Hard Seltzer is certified organic under the USDA’s National Organic Program and was certified under the national program before Michelob Ultra was.” This temporary restraining order will remain in effect until June 2, 2021, when Judge Simon is scheduled to rule on a motion for preliminary injunction filed by Suzie’s Brewery.

©2020 Norris McLaughlin P.A., All Rights Reserved
For more, visit the NLR Corporate & Business Organizations section.

Food & Food Packaging Is Unlikely to Spread COVID-19

The U.S. Food and Drug Administration (FDA) and Department of Agriculture (USDA) published a press release yesterday underscoring the international consensus that no credible evidence shows that food or food packaging is a source of viral transmission of SARS-CoV-2, the virus that causes COVID-19.

The press release highlights a September 2020 opinion from the International Commission on Microbiological Specifications for Foods that stated, “Despite the billions of meals and food packages handled since the beginning of the COVID-19 pandemic, to date there has not been any evidence that food, food packaging or food handling is a source or important transmission route for SARS-CoV-2 resulting in COVID-19.”  This consensus is consistent with literature reviews and research in other countries, and the fact that in the 100 million cases of COVID-19 worldwide, no epidemiological evidence suggests food or food packaging is a source of transmission to humans.

The U.S. Centers for Disease Control and Prevention (CDC) together with the U.S. Occupational Safety and Health Administration (OSHA) have provided guidance for food manufacturers to reduce the risk of spreading COVID-19 between workers. These guidelines complement the USDA and FDA food safety requirements that all U.S. food manufacturers must follow, such as the current Good Manufacturing Practices and preventative controls that focus on good hygiene practices and worker safety.

© 2020 Keller and Heckman LLP
For more, visit the NLR Biotech, Food, Drug section.

What is M-E-A-T?

M-E-A-T has become a complicated word.  A variety of alternative meat products are on the market or in development.  Plant-based meat substitutes are already commonplace in our grocery stores and restaurants.  Some of these plant-based substitutes can look much like meat from livestock.  However, cultured meats – “meat” created using animal cells – has been created and may soon be widely available.  Cultured meats, unlike the plant-based meat substitutes, can take cells from living animals and then grow those cells to create meat products which do not require the slaughter of animals.  A number of companies around the world are working to develop cultured beef, chicken, pork, fish, seafood, etc., and to bring those products to market.

Last year, Singapore became the first country to give regulatory approval for a cultured meat product for consumer sale.  The Singapore Food Agency approved Eat Just’s GOOD Meat cultured chicken product made by San Francisco-based Eat Just for use in chicken nuggets.  Eat Just’s GOOD Meat cultured chicken is grown in a bioreactor (a device that supports an environment in which cells and tissue can be grown).  The cells are grown in a nutrient cocktail until the “meat” can be harvested.

Just recently, Aleph Farms, an Israeli company, announced it has created a 3-D printed rib-eye steak.  Cells from a living cow were cultured to create the steak.  The resulting steak is intended to have the same texture, look and taste as traditional steak.  Aleph Farms can even control the tenderness of the steak and its marbling.

No cultured meat products have yet been approved for sale in the U.S.  Since cultured meat is a novel product, how it will be approved, regulated, and labeled remains to be determined.  In March of 2019, the FDA and the USDA entered an agreement to divide oversight authority for cultured meat products.  The FDA will do the premarket evaluations and oversee the collection and culturing of animal cells, along with all of the regulatory oversight and inspections up until the cultured meat is harvested.  At that point, regulatory oversight will be transitioned to the USDA.  The FDA and USDA also agreed to work together to develop principles for product labeling and claims.

In December of 2019 both the U.S. Senate and House of Representatives introduced bills to govern the regulation, inspection, and labeling of cultured meat.  Both bills provide for the promulgation of regulations to determine how the products will be labeled.  Neither of these bills have yet been enacted into law.  In October of 2020, the FDA invited comments for the labeling of cultured seafood products.  The comment period ends on March 8, 2021.

Even before the agreement between the FDA and USDA regarding cultured meat and the U.S. House and Senate bills were introduced, some states had begun taking action to regulate how substitutes for traditional meat would be labeled.  Missouri was the first state to pass a law to prohibit the label of “meat” being used for anything not derived from an animal carcass.  A number of states have now passed such laws.  More states have proposed such laws.

Needless to say, how producers of cultured meat will label their products is a controversial topic.  Ranchers, farmers, and those involved in the production of traditionally slaughtered meat want to make sure that cultured meat is not labeled as “meat.”  Producers of cultured meat products insist that their products are “meat” because they are made from animal cells.  While some states have already passed their own labeling requirements, whenever Congress, the FDA, and USDA act and determine labeling requirements, those requirements will likely preempt state laws.  Consequently, the battle is on for the definition of meat.

Copyright © 2020 Womble Bond Dickinson (US) LLP All Rights Reserved.

ARTICLE BY L. Christine Lawson of Womble Bond Dickinson (US) LLP
For more, visit the NLR Biotech, Food, Drug section.

Heavy Metals In Baby Food Pose Concern For Baby Food Industry

On February 4, 2021, the U.S. House of Representative’s Committee On Oversight and Reform (Subcommittee on Economic and Consumer Policy) issued a report entitled “Baby Foods Are Tainted With Dangerous Levels of Arsenic, Lead, Cadmium and Mercury“, which sent ripples of concern through the consumer ranks and the baby food industry. Heavy metals in baby food has received attention before, but never before in such a significant way from a House Subcommittee report like the one published this month. The findings and the proposed changes to regulations for the baby food industry that the subcommittee put forth will have significant compliance impacts on companies, as well as open certain baby food companies up to litigation risks that cannot be ignored.

Findings In the House Report

On November 6, 2019, the House Subcommittee requested internal documents from seven of the largest manufacturers of baby food in the United States, which included companies making both organic and conventional products. The request was prompted by reports that alleged that there are high levels of heavy metals in baby foods, specifically arsenic, lead, cadmium and mercury. The Food and Drug Administration (FDA) and World Health Organization (WHO) have both found these heavy metals to be dangerous to human health, especially infants and children. Four of the baby food manufacturers complied with the House Subcommittee’s request.

From the documents obtained from the four companies, the House Subcommittee concluded that there was evidence that “commercial baby foods are tainted with significant levels of toxic heavy metals,
including arsenic, lead, cadmium, and mercury.” The report said 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 FDA currently has maximum allowable limits for the heavy metals at issue in certain circumstances, including 10 parts per billion (ppb) of arsenic, 5 ppb of lead, and 5 ppb of cadmium in bottled water. The Environmental Protection Agency has also set the permissible level of mercury in drinking water at 2 ppb. However, the House Subcommittee concluded that  “the test results of baby foods and their ingredients
eclipse those levels: including results up to 91 times the arsenic level, up to 177 times the
lead level, up to 69 times the cadmium level, and up to 5 times the mercury level.”

The FDA indicated that it is reviewing the House Subcommittee’s report. It also noted that the heavy metals at issue in the report are present naturally in the environment and can enter baby food through the soil, water or air.

Recommendations From the House Report

As a result of its findings, the House Subcommittee outlined five recommendations:

(1) Mandatory testing – this would require baby food manufacturers to test finished products (not just ingredients) for heavy metals. The House Subcommittee urged the FDA to set this requirement;

(2) Labeling – the Subcommittee proposed that the FDA require baby food manufacturers to list all heavy metals in the finished product on labelling so that consumers are aware of the elements’ prsence;

(3) Phase Out – the House Subcommittee urged manufacturers to voluntarily phase out heavy metals from products entirely, or at least phase out products that have high amounts of ingredients that test high in heavy metals;

(4) FDA Standards – the Subcommittee urged the FDA to set limits for permitted heavy metals in baby foods; and

(5) Parental Vigilance – the report urges parents to avoid baby foods that contain ingredients that test high in heavy metals. The Subcommittee indicated that implementing recommendations 1 through 4 would inform parents to make determinations soundly.

Immediate Litigation Impact

The day after the House Subcommittee’s report was published, three major baby food companies were sued for selling products with elevated levels of certain heavy metals. One such lawsuit was filed in New Jersey, while the other was filed in California. While the class actions lawsuits present several legal theories for liability, the one that may have some weight with courts is the simple allegation that the products were unsafe for consumption by the very class (infants and babies) for which the products were made.

Baby food has been on California’s Proposition 65 target list for quite some time, and many companies that manufacture or sell baby food products in California have been receiving customer and retailer inquiries regarding heavy metals in baby food products. Companies have also begun testing baby food products to ensure compliance with Prop 65 regulations. Ensuring proper responses to consumer and retailer inquiries, compliance auditing of ingredients and end products, and developing risk management plans are key for any company right now in the baby food industry, especially with the potential for future FDA regulations.

©2020 CMBG3 Law, LLC. All rights reserved.

ARTICLE BY John Gardella of CMBG3 Law
For more, visit the NLR Biotech, Food, Drug section.

COVID-à manger: COVID-19 Takes a Bite out of French Lunch Traditions

The COVID-19 pandemic has changed dining habits across the world, as governments have shut down and restricted indoor and outdoor dining.  Even where restrictions have eased, many avoid sit-down dining out of concern for COVID-19 exposure and rely on take-away for their restaurant meals.  Clearly, the COVID-19 pandemic has limited dining options.

France, however, has decided to provide workers with a new, previously forbidden, dining option, although it remains to be seen how palatable it will be to French employees.  The Labor Ministry has decreed that to contain the spread of COVID-19, French workers now may eat lunch at their desks, which prior to the pandemic, Article R.4428-19 of the French Labor Code prohibited.

Gathering around a table for lunch with friends and colleagues has been long-standing French tradition, reflecting the country’s customs, habits and tastes.  The decree is intended to allow workers to return to the workplace and still limit the spread of COVID-19, by permitting them to lunch alone at their own workspace.  Until now, employers that allowed employees to eat lunch at their desks were subject to a fine, if caught, and employees who ate at their desks faced unspecified disciplinary action.

The French government has long been active in imposing regulations to prevent employers from exploiting their workers and in protecting workers’ rights, such as by imposing a 35-hour workweek, implementing the “right to disconnect” and mandating lunch hours.  Workers have become accustomed to dining out for lunch, and traditionally consider this time away from their work stations as an opportunity to refresh their bodies and minds prior to returning to work for the afternoon.  This simply is part of the French concept of maintaining a proper work-life balance.

While the French government continues to encourage remote work wherever possible, the new measure reflects the government’s effort to encourage businesses to reopen, where they can, with measures in place that will protect employees’ workplace health and safety.  Allowing workers to eat lunch at their desks offers workers and their employers a safer dining option, though arguably at the expense of traditional French cultural norms.  It is yet another example of how the COVID-19 pandemic has challenged, and changed, customary workplace standards.

©2020 Epstein Becker & Green, P.C. All rights reserved.

ARTICLE BY Erika C. Collins and Ryan H. Hutzler of Epstein Becker & Green, P.C.
For more, visit the NLR Global law section.

Japan Announces Process for Adding “Existing Substances” to PL

The Japanese Ministry of Health, Labour and Welfare (MHLW) has published a request for nominations for “existing substances” be included on the Positive List (PL) of “synthetic resins” for food-contact materials (FCMs) with corresponding submission forms. “Existing substances” include those marketed or used for food-contact utensils, containers and packages (UCP) in Japan prior to the effective date for the PL (i.e., June 1, 2020).  The deadline for filing such nominations is October 30, 2020.

For additional information on the PL system for “synthetic resins” that was MHLW published on April 28, 2020, see the PackagingLaw.com article, A Move to Mandatory: Japan Finalizes its Positive List for “Synthetic Resins”.)

As a component of MHLW’s process for nominating “existing substances,” the Ministry requires that companies include an attestation that such substances were marketed or used in food-contact UCP prior to June 1, 2020.  Submission forms are provided for each of the following materials:

  1. Base polymers (Plastics and Coatings);
  2. Minor monomers polymerized with base polymers; and
  3. Additives (including coating agents).

Additional information, including links to application form and submission instructions, is available here.

© 2020 Keller and Heckman LLP
For more articles on packaging law, visit the National Law Review Biotech, Food, Drug section.