• On June 23, 2020, a plaintiff filed a complaint against Pret A Manger in the United States District Court Southern District of New York.  The lawsuit seeks to remedy the “deceptive and misleading business practices” of Pret A Manger with respect to the marketing and sales of its “natural” food products throughout the State of New York and throughout the country.
  • In the complaint, plaintiff states that Pret A Manger manufactures, sells, and distributes its products using a marketing and advertising campaign centered around claims that appeal to health-conscious consumers (i.e., that its products are “natural”).  The lawsuit states that through its retail establishments, Pret A Manger includes prominent signage with statements, like “freshly prepared, good, natural food,” “natural food,” and “lovingly handmade throughout the day (with amazing, natural ingredients).” However, plaintiff alleges that Pret A Manger’s advertising and marketing campaign is false, deceptive, and misleading because the products contain soya, a genetically modified organism, as well as numerous other synthetic ingredients, including maltodextrin, citric acid, lactic acid, malic acid, diacetyl tartaric acid esters of mono- and diglycerides, mono- and diglycerides of fatty acids, and ascorbic acid.
  • By way of background, in March 2019, a different plaintiff filed a lawsuit against Pret A Manger claiming its marketing campaign is deceptive because its products contain soya as well as glyphosate, a synthetic biocide.  Eventually, the plaintiff voluntarily dismissed the March 2019 lawsuit.  We will continue to monitor any developments in regard to the June 23, 2020 complaint.
  • On June 22, a California federal judge dismissed a proposed class action against Kellogg Sales Company for their Bear Naked Granola V’nilla Almond product. In the complaint, plaintiff Harlan Zaback alleged that Kellogg falsely and misleadingly labeled and advertised the granola as being flavored “with vanilla flavoring derived exclusively from vanilla beans when the ingredient list reveals otherwise.” Zaback claims he would not have purchased the product or would have paid significantly less had he known it was not flavored with vanilla flavoring derived exclusively from vanilla beans.
  • U.S. District Judge Roger T. Benitez dismissed Zaback’s claims because he did not allege what might be in the product, if not vanilla flavoring from vanilla beans. Instead, Zaback concluded that Kellogg’s listing of “natural flavors” in the ingredient list, as opposed to “vanilla flavor” or “vanilla extract,” is acknowledgement that vanilla flavor or extract is not an ingredient in the product. Zaback provided no other factual basis that the product was mislabeled.
  • Judge Benitez agreed with Kellogg that Zaback was “merely speculating” and did not allege sufficient facts to “nudge [his] claims…across the line from conceivable to plausible.” Rather, Judge Benitez held that Zaback’s logic boiled down to “the omission is the admission.” Zaback may file an amended complaint within 14 days of the order.
  • Firms exporting food products from the U.S. are often required by foreign governments and companies to provide certain assurances regarding a product’s regulatory or marketing status in the U.S. The FDA Center for Food Safety and Applied Nutrition (CFSAN) issues different forms of export certificates including (1) the “Certificate to a Foreign Government,” which states that the food product(s) in question may be legally marketed and exported from the U.S., and (2) the “Certificate of Exportability,” which is available for food products that cannot be marketed in the U.S. but which nevertheless may be legally exported from the U.S. (the certificate states that the product(s) may be exported and that they comply with section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act).  However, even where an export certificate has been issued, the FDA may take regulatory action against a product covered by the certificate.
  • On June 22, 2020, the FDA announced that effective June 29th, the “Certificate to a Foreign Government” and “Certificate of Exportability” for human food products will include a unique QR code which will allow anyone inspecting the export certificate to scan the QR code and see the copy of the export certificate as issued by the FDA.
  • The change promises to streamline verification which currently requires stakeholders to create an account through CFSAN’s online verification system, contact FDA to activate the account, and login to view the certificate. However, FDA is also launching a new portal for faster verification without QR codes. Keller & Heckman will continue to monitor any changes to the FDA’s process of verifying its export certificates.

 

  • We reported on a November 14, 2019 citizen petition submitted to FDA by the Consumer Healthcare Products Associated (CHPA) requesting that the agency issue regulations to establish a clear pathway for the use of cannabidiol (CBD) in dietary supplements.  After public hearings and the first of two Congressionally mandated reports from FDA, discussed here, however, the market for FDA-regulated food and dietary supplement products that contain CBD continues to grow rapidly while a regulatory pathway for lawfully marketing such products still is not in place in the U.S.
  • Undeterred by FDA’s inaction on the CHPA petition, the Council for Responsible Nutrition (CRN) filed a similar citizen petition on June 16, 2020 urging FDA to regulate hemp-derived CBD as a dietary ingredient.  The petition distinguishes “full spectrum” hemp extracts from CBD isolates, which CRN argues is the substance that has been approved for use in a drug and is therefore prohibited from use in a food or a dietary supplement.  Regarding the petition’s focus only on dietary supplements, a CRN spokesperson told Food Navigator that FDA’s report to Congress indicates that FDA’s safety concerns may be limited to food uses of CBD, although CBD-infused beverage brands maintain that both categories can be safely accommodated under the current regulatory framework.  CRN recognizes that its petition could languish with FDA and told Food Navigator that the organization is focusing mainly on legislative initiatives to bypass FDA altogether.
  • A June 17, 2020 letter from the consumer organizations, Consumer Federation of America (CFA), Center for Science in the Public Interest (CSPI), Consumer Reports, and Public Health institute, urged lawmakers not to push FDA to act on CBD before it has adequate data or to by-pass FDA.
  • On June 4, 2020 the Food Safety and Inspection Service (FSIS) announced plans to expand Shiga Toxin-Producing Escherichia coli (STEC) testing to include additional raw beef products.  Specifically, FSIS is expanding its routine verification testing to include ground beef, bench trim, and other raw ground beef components.  FSIS will test six non-O157 STEC (O26, O45, O103, O111, O121, and O145), which are considered adulterants, in addition to Escherichia coli (E. coli) O157:H7.
  • Currently, FSIS only tests beef manufacturing trimming samples for the 6 non-O157 STEC and E. coli O157:H7.  The other ground beef component products are currently tested only for E. coli O157:H7.  These pathogens have been known to cause serious illness, such as the 2019 E. coli O103 outbreak linked to raw ground beef that sickened nearly 200 people in 10 states.  A 2018 E. coli O26 outbreak, also linked to raw ground beef, sickened 18 people in 4 states.
  • Additionally, FSIS intends to test for non-O157 STEC in ground beef samples it collects at retail stores and in samples of imported raw beef products.  FSIS is accepting comments on the proposed sampling and testing of ground beef, bench trim, and other raw ground beef components through August 3, 2020.
  • In response to the Mexican Council of the Consumer Products Industry’s (“ConMéxico”) request for the postponement of Official Mexican Standard NOM-051 (“NOM-051”), Mexican authorities have stated that food and beverage companies may use provisional stickers between October 1, 2020 and March 31, 2021, which will help companies gradually comply with NOM-051.  NOM-051 sets forth a frontal labeling system for prepackaged food and non-alcoholic beverages and informs consumers when products contain high calories, added sugars, saturated fats, sodium, and caffeine.  NOM-051 will come into effect on October 1, 2020.
  • NOM-051 was published in the Diario Oficial de la Federación (Mexico’s equivalent of the Federal Register) on March 27, 2020.  NOM-051 requires manufacturers to place octagonal warning symbols in consumer products that state “Excess Calories,” “Excess Saturated Fat,” “Excess Sugars,” and “Contains Caffeine – Avoid in Children.”  NOM-051 also prohibits the use of characters, drawings, celebrities, gifts, offers, toys, or contests on food packaging.
  • By way of background, on April 28, 2020, the Mexican Council of the Consumer Products Industry (“ConMéxico”), which represents more than 40 major food and beverage producers, urged the Mexican government to postpone the effective date of NOM-051 to remove the additional pressure for the food industry in the midst of COVID-19.  In a virtual conference, Jaime Zabludovsky, president of ConMéxico, urged the government to postpone NOM-051, which will require the relabeling of more than 800,000 products that will require the assistance of nutritionists, food engineers, designers, among others who are not working at their full capacity due to the pandemic.
  • The use of provisional stickers to comply with the octagonal warning requirement will give companies more time so that they do not have to print labels for all of their products before October 2020.  Moreover, companies will be able to place provisional stickers on packaging that they already have in stock to lessen the impact.   We will continue to monitor any developments.
  • A California federal judge denied Nestle USA Inc.’s motion for summary judgment in a suit that alleged they misled consumers on the trans fat content of Coffee-mate brand creamers. In Beasley v. Lucky Stores, Inc. et al, consumers of Coffee-mate brought a putative class action lawsuit against Nestle and a group of retail stores alleging that some flavors of Coffee-mate contained partially hydrogenated oil (PHO), an artificial form of trans fat, even though defendant’s labels included nutrient claims, such as “0g Trans Fat.”
  • In the motion for summary judgment, Nestle and the retailers argued that the Beasley’s claims were outside the four-year statute of limitations because he testified to knowing that PHOs were a source of artificial trans fat since the 1990s, and therefore, as a reasonable consumer concerned enough to avoid trans fat, he would have checked the ingredient list. However, Beasley later corrected his testimony, stating “I’ve known trans fat was bad since I’d guess in the late 1990s, and I learned that trans fat came from PHO in 2017.”
  • U.S. District Judge Maxine M. Chesney wrote that even if Beasley’s corrections are disregarded, a triable issue of fact remains of when he learned the ingredient was in Coffee-mate, and therefore when the offense accrued for the purpose of the statute of limitations: “The Court finds a triable issue of fact exists as to whether Beasley, faced with multiple clear statements about the absence of trans fat in Coffee-mate, should have investigated the ingredient list.”
  • A Nestle spokesperson stated that “[w]hile we disagree with this ruling, it pertains only to the timeliness of the plaintiff’s claims, and is in no way determinative of the merits of the plaintiff’s allegations, which remain unproven.”
  • In 2011, USDA’s Food Safety Inspection Service (FSIS) announced that raw, non-intact beef products and raw, intact beef products intended for use in raw, non-intact beef products are adulterated if they contain the following six non-O157 Shiga toxin-producing Escherichia coli (STEC): 026, O45, O103, O111, O121, and O-145. FSIS identified these pathogens as adulterants because of their high pathogenicity, low infectious dose, transmissibility from person to person, and their thermal resistance being high enough to survive cooking. Despite these concerns, FSIS testing for these pathogens has lagged behind testing for E. coli O157:H7, and currently FSIS only tests beef manufacturing trimmings samples for these non-0157 STEC.
  • In order to reduce the risk of food borne illness, FSIS recently announced that it is expanding its routine verification testing for these six non-O157 STEC to ground beef, bench trim, and other raw ground beef components (all of which are also currently tested for E. coli O157:H7). FSIS also intends to test for the six non-0157 STEC in ground beef samples that it collects at retail stores and in samples it collects from imported raw beef products.
  • Raw ground beef containing these non-0157 STEC has been linked to a number of serious foodborne outbreaks, and the changes are intended to both improve public health and reduce the costs associated with outbreak-related recalls. Comments on the proposed expanded testing are due August 3, 2020. Keller & Heckman will continue to monitor for any updates.

 9th Circ. Judge Doubts General Mills False Label Claims (subscription to Law360 required)

  • Proposed class action lawsuits against Kellogg, Post, and General Mills, with a common lead plaintiff in the Northern District of California federal courts, allege that “healthy” and other nutrition-related claims on various breakfast cereals are false and misleading because the cereals contain high amounts of sugar.
    • As we previously reported, the judge certified three classes of consumers in the case against Kellogg, and the case may be settled if an agreed upon deal is reworked to make it acceptable to the court.
    • A class was also certified in the lawsuit against Post, and the case is proceeding to trial after the judge found there is a material issue of fact as to whether the products are unhealthy given the amount of added sugar.
    • The case against General Mills was dismissed, however, with the judge finding that plaintiffs could not possibly have been misled because the amount of sugar in the cereals is clearly disclosed on the product labels.
  • On June 12, 2020, in a hearing by a three-judge panel of an appeal of the dismissal of the lawsuit against General Mills, a recently confirmed judge, Danielle J. Hunsaker, asked a line of questions regarding what amount of added sugar in a product makes the product unhealthy.  The judge reportedly was not swayed by the plaintiffs’ argument that a “healthy” claim is not appropriate on any product with added sugar.
  • While many consumers continue to be concerned about sugar in the diet, there are complex issues surrounding the impact on health of added sugars in a single product and a product’s role in the total diet.  Meanwhile, as it works on redefining the “healthy” nutrient content claim for food labeling, 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.
  • A group of seven CBD brands (Boulder Botanicals & Bioscience Labs, CBDistillery, CBD American Shaman, Charlotte’s Web Holdings, Columbia Care, HempFusion, and Kannaway) have committed to collectively sponsor ValidCare (a clinical trial outsourcing and market research company) in conducting observational research to evaluate the impact of daily CBD use (both full-spectrum, hemp-derived CBD and CBD isolate) on the liver function of healthy adults.
  • According to a press release issued by ValidCare on June 9, 2019, the liver study, the results of which will be provided to the U.S. Food and Drug Administration (FDA) for consideration in its efforts to regulate CBD, is scheduled to begin in July 2020 and expected to be completed by the end of this year.  The study intends to aggregate data from at least 700 consumers, which will be combined with information regarding personal history, blood tests, and product information.
  • Participants will be provided with oral CBD products from the study’s supporting brands for consumption in connection with the study.  Participants will be required to attest that they have used the products for at least 60 days prior to the start of the study, and continue consuming the products for the duration of the study.  Participants will document their CBD use and any observable effects for 30 days, and provide blood samples.  The study is observational (not a randomized double-blind placebo controlled human clinical study), and FDA’s treatment, consideration, and evaluation of these results has yet to be seen.  As previously reported here on this blog, FDA recently announced that it made “substantial progress” towards a goal of providing additional guidance on ingestible CBD products, but offered no specific details and continued to emphasize its ongoing questions and concerns about the science, safety, effectiveness, and quality of CBD products (which include concerns regarding liver toxicity).
  • We will continue to monitor the situation for any developments.