Survey Assessing Level of Consumer Confusion Over Whether Plant-Based Products and Dairy Products Contain Cow’s Milk

  • As previously reported in The Daily Intake, FDA has requested comments pertaining to consumer awareness and understanding of the use of milk and other dairy terms on plant-based alternatives.  Depending upon the feedback received, FDA could then potentially revisit its policy of not enforcing the standard of identity for milk as it pertains to labeling plant-based products like almond milk, soy yogurt, and vegan cheese.
  • FDA’s Standards of Identity define milk in part as the “lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.”  The International Food Information Council Foundation (IFIC Foundation) has released the responses from an on-line poll of 1,000 U.S. adults as to which of various products do or do not contain cow’s milk.
    • Percentages responding “contains cow’s milk” were:  Whole milk (90%), Chocolate milk (85%), Nonfat milk (78%), Skim milk (74%), Lactose-Free milk (48%), Coconut milk (9%), Soymilk (9%), Almond milk (9%), Cashew milk (8%), and Rice milk (7%).
    • Percentages responding “does NOT contain cow’s milk” were:  Whole milk (4%), Chocolate milk (7%), Nonfat milk (9%), Skim milk (14%), Lactose-Free milk (31%), Coconut milk (74%), Soymilk (75%), Almond milk (75%), Cashew milk (72%), and Rice milk (73%).
    • Percentages responding “Don’t know” were:  Whole milk (5%), Chocolate milk (9%), Nonfat milk (12%), Skim milk (13%), Lactose-Free milk (22%), Coconut milk (18%), Soymilk (16%), Almond milk (16%), Cashew milk (20%), and Rice milk (20%).
  • The IFIC Foundation characterizes the survey results above as demonstrating a “low level” of consumer confusion on the nomenclature and basic differences between milk and dairy based products as compared to plant-based alternatives.  According to Food Navigator, however, the National Milk Producers Federation (NMPF) believes the results show an unacceptable level of uncertainty or confusion.  The NMPF also notes that the survey did not gauge consumer understanding of the nutritional qualities of dairy milk versus plant-based beverages, which that group sees as a major concern.
  • The NMPF submitted a request for extension of the November 27, 2018 deadline for submitting comments to FDA regarding the use of the names of dairy foods in the labeling of plant-based products.  Thus far, no arguments from the dairy or plant-based industries are among the 561 comments posted to the docket.


Judge in Roundup Cancer Case Considers Reducing Punitive Damages

  • As previously reported in The Daily Intake, on August 10, 2018 Dewayne Johnson was awarded $289 million in his case against Monsanto, maker of the popular herbicide Roundup, by a San Francisco jury.  The award, which included $250 million in punitive damages, was to compensate Mr. Johnson for the lymphoma that he alleged was caused by exposure to professional strength Roundup.  Monsanto has vowed to appeal.
  • As reported in Law360 (subscription) and various other news outlets, on October 10, 2018 the trial Judge who presided over the case heard oral arguments regarding her tentative ruling to throw out the punitive damages portion of the award via a mechanism called Judgment Notwithstanding the Verdict.  Judge Suzanne Bolanos wrote in the tentative ruling that Mr. Johnson had not proven the requisite bad intent required to support punitive damages and that she was inclined to eliminate them entirely or, in the alternative, to grant a new trial regarding punitive damages.
  • Judge Bolanos also requested arguments regarding whether to grant a new trial with regard to liability.  Her tentative ruling specifically asked about:
    • exclusion of expert testimony that lacks legal sufficiency to show causation;
    • granting a new trial because there is no epidemiological evidence to show causation;
    • whether EPA reports were inappropriately excluded and whether such exclusion merits a new trial;
    • whether the plaintiff’s attorney unfairly prejudiced the jury during the closing arguments when he talked about jurors “changing the world” with their verdict, referencing the tobacco industry, and mentioning the response at Monsanto would include champagne if the jury ruled for Monsanto; and
    • whether the jury awarded damages of $1 million per year for expected loss of life and if that award was legally supportable.
  • Keller and Heckman attorneys will continue to monitor this case and many other important food-related cases.

USDA Secretary Signals USDA Role Over Animal Cell Culture Technology Regulation Ahead of Joint USDA-FDA Meeting

  • As previously reported on this blog, the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) announced that they will hold a joint meeting on October 23-24, 2018, to discuss the use of cell culture technology to develop products derived from livestock and poultry. The meeting will focus on potential hazards, regulatory issues, and labeling issues. There has been an ongoing debate as to whether USDA or FDA should have regulatory jurisdiction over cultured meat, but the upcoming joint meeting may be a sign that the two agencies are looking to partner with one another.
  • As a reminder to our readers, FDA was quick to assert its interest in jurisdiction over cell-cultured meat, holding a public meeting on the issue in July without any USDA officials participating as panelists. In a continuing sign of the FDA’s interest in cell culture technology, Susan Mayne, director of FDA’s Center for Food Safety, recently noted at the Wall Street Journal Global Food Forum, “we’ve been looking at biotech products for the last 20 years. Cell-cultured meat is really in the same framework.”
  • However, in a recent interview with the Wall Street Journal, USDA Secretary Sonny Perdue called for both agencies to play a role, stating that FDA “has equity in the lab, and if it is commercialized as a product, the USDA has the responsibility to inspect that. It needs to be clearly delineated who does what.” Speaking with reporters at a North American Meat Institute event, Secretary Perdue embraced the technology, “we don’t want this new technology to feel like they’ve got to go offshore or outside the United States to get a fair regulatory protocol.” He reiterated this stance in an interview with Organic Insider, “we’ve got new technology with stem cell protein growth [referring to cell-cultured meat technology]… shouldn’t we in the United States be about how we can grow and feed people more efficiently and more effectively … these techniques need to be embraced, not kept out.”
  • It remains to be seen how such a partnership between the two agencies will play out, but the upcoming USDA-FDA joint meeting on cell culture technology will provide an opportunity for startups and traditional meat producers to provide both agencies with their input to shape the future regulatory oversight of cell-cultured meat.



Flavored Sparkling Water, LaCroix, Sued Over Natural Claims

  • A class action lawsuit filed by Lenora Rice in Cook County, Illinois alleges that LaCroix manufacturer, National Beverage Corp, falsely markets its popular flavored sparkling water as “all natural.” The complaint states that LaCroix sparkling waters are “manufactured using non-natural flavorings and synthetic compounds,” but are labeled as “all natural” and “always 100% natural.” Specifically, LaCroix is alleged to contain ethyl butanoate, limonene, linalool, and linalool propionate. 
  • According to FoodNavigator  the substances named in the complaint (e.g., ethyl butanoate, limonene, linalool, and linalool propionate) can be derived from both natural and synthetic sources and may be discerned through sample analysis, but only if the ultimate molecule under consideration is different in its configuration or proportion of different configurations, when synthesized.  Notably, Rice’s complaint does not state the basis for her allegations. The product ingredient list declares two ingredients: carbonated water and natural flavor. But it is unknown how she has determined that the referenced substances are even in the products, and whether they were synthetically created as opposed to naturally sourced from plants.  
  • Unsurprisingly, National Beverage Corp has denied the allegations and issued a statement that the “natural flavors in LaCroix are derived from the natural essence oils from the named fruit used in each of the flavors. There are no sugars or artificial ingredients contained in, nor added to, those extracted flavors.” National Beverage Corp believes the lawsuit to be false, defamatory, and intended to intentionally damage the company’s reputation.
  • As we’ve previously posted on this blog, “natural” and “all natural” lawsuits have been the focus of much litigation in recent years. However, it appears, as evidenced by the suit against LaCroix and other cases focused on “natural flavors”, that the use of natural flavors may be a new focus of scrutiny for plaintiff’s lawyers.

FDA Removes Clearance for 7 Synthetic Flavoring Substances

  • As we previously reported on this blog, a group of non-government organizations (NGOs) sued FDA in an effort to compel the Agency to act on a Food Additive Petition (FAP) concerning seven synthetic flavoring food additives. The FAP, which the NGOs submitted to FDA, requested that FDA remove the clearances for these seven synthetically derived substances in 21 C.F.R. 172.515 (“Synthetic flavoring substances and adjuvants”) because the substance are carcinogens and therefore violate the Delaney Clause of the Federal Food, Drug, and Cosmetic Act.
  • The seven substances that are the subject of the NGOs’ FAP include: benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, styrene and pyridine.
  • We also previously reported that the Styrene Information and Research Center (SIRC) submitted its own FAP to FDA requesting that the clearance for styrene in Section 172.515 be removed because its use as a flavor additive has been permanently abandoned.
  • FDA responded to the NGOs’ FAP, as well as SIRC’s FAP, in two separate notices in today’s Federal Register. In response to the petition from the NGOs, FDA announced that it is amending Section 172.515  to remove the clearances in that regulation for benzophenone, ethyl acrylate, eugenyl methyl ether (methyl eugenol), myrcene, pulegone, and pyridine (83 Fed. Reg. 50490). FDA explained that this action was being taking under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act since the petitioners provided evidence that these substances caused cancer in animals. However, FDA stated in the Federal Register notice:
    • “…the use of these synthetic flavoring substances and adjuvants does not affect the legal status of foods containing natural counterparts or non-synthetic flavoring substances extracted from food, and there is nothing in the data FDA has reviewed in responding to the pending food additive petition that causes FDA concern about the safety of foods that contain natural counterparts or extracts from such foods.”
  • FDA also granted SIRC’s FAP to amend the food additive regulations to no longer provide for the use of styrene as a flavoring substance and adjuvant due to its abandonment by industry. (83 Fed. Reg. 50487). Since styrene was delisted due to abandonment, FDA did not consider whether styrene is a carcinogen.

FDA Collects Thousands of Pages of Documents in Inspection of JUUL Labs

  • On April 24, 2018, FDA announced its Youth Tobacco Prevention Plan to stop adolescent use of, and access to, vapor products.  FDA followed up on its announcement by issuing 17 warning letters for marketing e-liquids in allegedly misbranded and misleading packaging found  to be appealing to youth.  In September, FDA announced that it has issued 1,300 warning letters and imposed civil penalties for sales of cartridge-based e-cigarettes.  Also in September, FDA requested information within 60 days from JUUL Labs, and four other cartridge-based e-cigarettes, regarding how they will curb youth use.  FDA has threatened to remove flavored e-liquids from the market to prevent youth uptake.
  • On Tuesday October 2, FDA confirmed that it had inspected JUUL Labs on Friday September 28, obtaining more than 1,000 pages of records on marketing.  Kevin Burns, CEO of JUUL Labs, issued a statement that JUUL has released over 50,000 pages of documents to FDA since April in support of its position that it markets only to adults.
  • Keller and Heckman’s Tobacco and E-Vapor practice has covered FDA’s Youth Tobacco Prevention Plan extensively on The Continuum of Risk Blog.  As our colleagues point out, the majority of youth use is via cartridge-based e-cigarette but a flavor ban could destroy the vapor industry.
  • Two prominent e-vapor trade associations, American E-Liquids Manufacturing Standards Association (AEMSA) and the Smoke-Free Alternatives Tobacco Association (SFATA), jointly developed a youth prevention program, the Youth Education, Protection, and Prevention (YEPP) program. The YEPP program includes (1) youth education about the dangers of vaping and material discouraging vaping by young people, (2) parental education to identify the signs of youth vaping and use of vapor products,  (3) tools to help parents talk with their kids about vaping, and (4) retailer training to prevent minor sales.

Industry Group Agrees to Stricter Nutrition Criteria for Foods Advertised to Children under 12

  • Eighteen companies voluntarily participating in the Better Business Bureau’s (BBB’s) Children’s Food and Beverage Advertising Initiative (CFBAI) have updated the group’s 2011 Uniform Nutrition Criteria for foods and beverages advertised to children under 12.  Participants in the CFBAI include leading quick service restaurants, confectionery manufacturers, processed food companies, and ingredient manufacturers.
  • CFBAI members have committed since 2011 to advertising to children under 12 only those foods that meet the group’s Uniform Nutrition Criteria.  According to its 2018 White Paper, the group has developed stricter requirements (as compared to the 2011 criteria) for a number of nutrients, including sodium and added sugar.  For example, under the new criteria, fruits and vegetables that were previously exempt will need to meet “no added sugar” and “very low sodium” requirements when in canned or frozen form.  In addition, the limit on sodium in savory snacks is decreasing from 290 mg to 260 mg per serving .
  • CFBAI estimates that 40% of the products that met its 2011 Uniform Nutrition Criteria will not meet the new criteria, which were revised following the release of the 2015-2020 Dietary Guidelines for Americans and FDA’s updated Nutrition Facts regulations.   The new Uniform Nutrition Criteria are summarized here.  The implementation date is set for January 1, 2020, which is also the compliance date for FDA’s new Nutrition Facts and serving size regulations.

FDA Finds Exposure to Pesticides and Glyphosate in Food Samples Below Federal Limits

  • On October 1, 2018, the U.S. Food and Drug Administration (FDA) released a report showing the majority of human and pet foods produced and imported into the U.S. during FY 2016 tested below the federal limits for pesticide chemical residues. FDA tested for 711 pesticides and industrial chemicals in 6946 human food products and 467 animal foods during the fiscal year running from Oct. 1, 2015 to Sept. 30, 2016 under the FDA’s Pesticide Monitoring Program. For human food products, FDA found that over 99% of domestic and 90% of import human foods were compliant with federal standards. Further, no pesticide chemical residues were found in 52.9% of the domestic and 50.7% of the import samples that FDA analyzed.
  • FDA also publicized the findings of its “Collection of Selected Domestic and Imported Foods for Herbicides Analysis” study that examined residues of glyphosate, glufosinate, and 30 selected acid herbicides in foods.  Glyphosate, the active ingredient in popular garden weed killers and one of the most-used agricultural chemicals in the world, has been the subject of much controversy. As previously reported on this blog, on August 10, 2018, a San Francisco jury awarded a former school groundskeeper dying of non-Hodgkin’s lymphoma $289 million against Monsanto for claims that the Roundup herbicide was a substantial contributing factor in causing his cancer.
  • Analyzing 274 grain corn, 267 soybean, 113 milk, and 106 egg samples, FDA found non-volatile levels of glyphosate in 63.1% of corn samples and 67% of soybean samples. Non-volatile levels of glufosinate were found in 1.4% of corn tested and 1.1% of soybeans. In a statement accompanying the release of the results, FDA Commissioner Scott Gottlieb said, “…the results show that overall levels of pesticide chemical residues are below the Environmental Protection Agency’s tolerances, and therefore don’t pose a risk to consumers.”

German Scientific Advisory Body Calls for New EU Legislation on Gene Editing Technology

  • As previously reported on this blog, the European Court of Justice ruled that all techniques that induce DNA mutagenesis result in products that can be regulated as genetically modified organisms. As a result of the decision, new products created by using CRISPR and similar gene-editing techniques are genetically modified organisms within the scope of the European Union’s GMO Directive and are therefore subject to the stringent approval process for all genetically modified organisms.
  • In response to the decision, the German Bioeconomy Council, a panel of 17 researchers who advise the German Federal Government, has called for new EU legislation governing crops created by plant-breeding technologies, such as CRISPR. In a statement, the Council noted, “[i]n its current form, EU genetic engineering legislation cannot do justice to the opportunities and challenges of the technologies. We need an amendment to bring it in line with advances in the field. It is important to have a regulation that distinguishes between mutations and gene transfers and provides for risk-oriented approval and release procedures.” In addition to calling for legislation that is suited to the different applications of new technologies, the Council also argued that mandatory product labeling is not practical since modifications cannot always be scientifically or technically detected or proven in the end product. Scientists and industry leaders in the UK also put out an open letter calling on the UK government to provide clarity on the future of gene-edited crops following the EU ruling, particularly in the context of Brexit and the future relationship between the UK and the EU.
  • In March, the United States Department of Agriculture (USDA) Secretary Sonny Perdue announced that under its biotechnology regulations, it has no plans to regulate genome editing when used to produce new plants varieties that are indistinguishable from those developed through traditional breeding methods as long as they are not plant pests or developed using plant pests. Separately, USDA’s Agricultural Marketing Service (AMS) is working to implement the National Bioengineered Food Disclosure Standard, which will regulate the labeling of bioengineered foods in the US.

Keller and Heckman will continue to monitor developments on the domestic and foreign treatment of novel DNA techniques as well as the implementation of the National Bioengineered Food Disclosure Standard.


USDA Updates Poultry Line Speed Standards

  • On August 21, 2014, USDA-FSIS published a final rule called the “Modernization of Poultry Slaughter Inspection” (79 FR 49566, Aug. 21, 2014) which amended the Agency’s poultry regulations to establish an inspection system for young chicken and turkey slaughter establishments, called the New Poultry Inspection System (NPIS). Under the final rule, the maximum line speed for young chicken slaughter establishments that operate under NPIS is 140 birds per minute.  9 C.F.R. 381.69(a). As previously covered on this blog, on September 1, 2017, the National Chicken Council (NCC) petitioned USDA-FSIS to implement a waiver system to permit young chicken slaughter establishments participating in the NPIS and the Salmonella Initiative Program to operate without the line speed limitations imposed under the NPIS.
  • On January 29, 2018, FSIS rejected NCC’s petition and explained that instead of establishing a separate line speed waiver program under the conditions requested in the petition, FSIS would make available criteria that it will use under its existing waiver procedures to consider individual waiver requests from young chicken establishments to operate at line speeds of up to 175 birds per minute. FSIS published these criteria in the February 23, 2018 Constituent Update, which include, among other items, meeting specific Salmonella performance standards requirements, establishing compliance with NPIS requirements, demonstrating a history of regulatory requirements, and a demonstration that new equipment, technologies, or procedures that allow the establishment to operate at faster line speeds will maintain or improve food safety.
  • On September 28, 2018, FSIS published additional criteria that poultry slaughter plants will have to meet in order to seek approval to run line speeds faster than the current limit of 140 birds per minute (83 FR 49048, Sept. 28, 2018). FSIS also announced that the 20 young chicken establishments already operating under line speed waivers must meet the new criteria to be eligible for the waiver. FSIS will consider factors such as whether plants are complying with good commercial practices, which requires that the poultry be slaughtered in a manner that will result in thorough bleeding.

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