• 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.
  • In late May 2020, the North American Olive Oil Association submitted a citizen petition to FDA, asking the Agency to adopt science-based, enforceable standards for olive oil. In its petition to FDA, the group stated that standards would ensure that consumers know the quality of the olive oil that they purchase.  The North American Olive Oil Association’s petition is in addition to one filed in November 2019 by the American Olive Oils Producers Association and Deoleo, the world’s largest olive oil processor.  There is currently no nationally-mandated standard of identity (SOI) to define olive oil and its various categories and grades in the United States.
  • In its citizen petition, the North American Olive Oil Association noted that “an SOI will promote honesty and fair dealing in a product that is prized for its potential health benefits, and thus exposes consumers to the risks of bad actors looking to take unfair advantage of a largely unregulated industry.” The North American Olive Oil Association also stated that the U.S. SOI for olive oil should be based on the Codex Alimentarius standard, as FDA has suggested that “a proposal for a new SOI should reflect “[h]armonization with existing international food standards to the extent feasible.”  The Codex Alimentarius Commission is a standards-setting body recognized by the World Trade Organization, through which member countries formulate and harmonize international food standards.
  • Over 40 years ago, FDA solicited public comment on the adoption of a standard of identity for olive oils and olive-pomace oils based on the Codex Alimentarius Commission’s (“CAC’s”) international standard; however, FDA concluded there was “not sufficient need” to warrant a U.S. standard, citing a lack of data. We will continue to monitor any developments.
  • On June 4, a California federal judge dismissed a putative class action complaint challenging Nestle USA, Inc.’s labels on its “Nestle Toll House’s Premier White Morsels.”  Prescott, et al. v. Nestle USA, Inc., Case No. 19-cv-07471-BLF (N.D. Cal. June 4, 2020).
  • Plaintiffs alleged that Nestle’s labeling and advertising misled consumers into believing that the product contained white chocolate. As stated in the complaint, plaintiffs argued that Nestle violated FDA labeling standards by attempting to pass its “Premier White Morsels” as white chocolate through use of the words “white” and “premier,” even though the product did not contain any cocoa or cocoa derivatives. However, the product’s label did not state that it contained white chocolate, or even use the word “chocolate.”
  • U.S. District Judge Beth Labson Freeman noted that similar claims brought by the same plaintiffs were dismissed against Ghirardelli Chocolate Co. in April. In agreement with the Ghirardelli dismissal, Judge Freeman held that the word “white” alone does not lead reasonable customers to believe that the product is white chocolate. Likewise, she stated that the word “premier” was nonactionable puffery.
  • Judge Freeman also denied plaintiffs’ request for an injunction against Nestle, ruling that plaintiffs could not be harmed in the future given that they pled they would not have purchased the morsels had they known they were not white chocolate.
  • Lastly, Judge Freeman denied Nestle’s request to dismiss the complaint with prejudice. Plaintiffs were granted leave to amend the complaint, and stated that they plan to file an amended complaint with a “large-scale, statistically significant” consumer survey that shows 90% of consumers are deceived by Nestle’s white morsel marketing.
  • On June 3, 2020, the Sugar Association filed a Citizen Petition for Prohibition of Misleading Labeling Sweeteners and Request for Enforcement Action (the “Petition”).  The Petition seeks FDA guidance and enforcement on what the association believes are false and misleading sugar reduction claims.  The association observes that “added sugar” labeling requirements have led food manufacturers to replace sugar with alternative sweeteners.  As a result, the association argues that the reformulated products are not understood by consumers to contain alternative sweeteners and, further, use claims that mislead consumers into believing that the reformulated products are healthier.
  • In order to remedy the alleged misleading claims and lack of transparent labeling, the Petition calls upon the FDA to issue regulatory guidance requiring that food labels:
    1. Clearly identify the presence of each sweetening ingredient in the ingredient list that is not already disclosed on the Nutrition Facts label by providing the term “(Sweetener)” following the sweeting ingredient’s name.
    2. Indicate the type and quantity of alternative sweeteners on the fronts of food and beverage products consumed by children.
    3. Disclose gastrointestinal effects of various sweeteners, including all sugar alcohols, at minimum thresholds of effect.
    4. Accompany any “no/reduced sugar” claims with the following disclosures:
      • “Not lower in calories,” unless the reformulated products have 25% fewer calories than the comparison.
      • “Sweetened with [name of Sweeteners(s)]” when sugar alternatives are present.
  • By regulation, the FDA has 180 days to respond to the Petition but a substantive response can take much longer.  Including functional labeling for food additives is reserved only for a few select categories, such as preservatives.  Thus, the request to identify all sweeteners by their functional class name is a big change that could have an impact on the declaration of other food additives. Keller and Heckman will continue to monitor and report on the progress of this petition and any changes to food labeling regulations.

 

  • After public hearings and the first of two Congressionally mandated reports from FDA, discussed here, the market for FDA-regulated food and dietary supplement products that contain cannabidiol (CBD) continues to grow rapidly while a regulatory pathway for lawfully marketing such products still is not in place in the U.S.  Although FDA has not clearly formulated an interim enforcement discretion policy, its CBD enforcement actions thus far have targeted only CBD-containing products that make disease and health-related claims or contain unsafe contaminants.
  • An FDA spokesperson told Food Navigator-USA last week that the Agency has made “substantial progress” toward a goal of providing additional guidance on ingestible CBD products but offered no specific details and continued to emphasize that FDA has questions about the science, safety, effectiveness, and quality of CBD products.  The FDA spokesperson declined to comment on FDA’s “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry’” which was recently posted as pending review by the Office of Management and Budget (OMB) and was taken as an encouraging sign for industry.
  • It is not clear whether this new guidance document on human clinical studies of CBD represents progress toward a regulatory pathway for food and dietary supplements, since the title suggests that it addresses scientific issues rather than regulatory ones.  Nevertheless, human clinical studies would help address FDA’s safety concerns with the use of CBD in such products (although animal studies would certainly be important too).
  • Last year we reported on FDA’s announcement on the “New Era of Smarter Food Safety”, an effort intended to combine the implementation of Food Safety Modernization Act (FSMA) with new and emerging technologies. The effort was set to begin with the development of the “Blueprint for a New Era of Smarter Food Safety.”
  • On June 2, 2020, FDA released an update on the effort titled “Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety,” in which they announced that—due to the COVID-19 pandemic—plans to announce the Safety Blueprint had been delayed.
  • FDA announced that it will release the blueprint in the coming weeks that will outline its plan to create a safer food system over the next decade.  In light of lessons learned during the pandemic, FDA has revised and accelerated measures in the blueprint, including enhanced traceability, smarter tools for protecting food ordered online, and promotion of a food safety culture, as described below:
    • Food Traceability – FDA has noted that enhanced traceability could help FDA and the food industry anticipate marketplace imbalances, such as those that resulted in shortages of certain commodities during the pandemic.
    • Smarter Tools for Foods Ordered Online – Online food ordering and delivery have skyrocketed in recent months due to COVID-19 and are likely to continue in popularity; the blueprint will discuss tools like root cause analyses to understand how foods were contaminated and use data to anticipate the likelihood of contamination.
    • Food Safety Culture – the plan addresses the establishment and support of food safety cultures on farms, food facilities, and at home—primarily through education initiatives.