Looking Ahead: Proposed Regulatory Actions by FDA and USDA in the Fall 2018 Unified Agenda

  • The Executive Office of the President recently released its Fall 2018 Unified Agenda of Regulatory and Deregulatory Actions. Twice a year, federal agencies publish this comprehensive report describing regulations currently under development or recently completed. The agenda provides stakeholders with a preview of agencies’ top regulatory priorities for the coming months.
  • This fall’s agenda highlights significant regulatory undertakings by the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA). Of note for USDA is USDA’s National Organic Program plan to strengthen oversight of organic imports to deter fraud, enhance enforcement and protect organic integrity. This blog has actively covered the issues surrounding organic enforcement. In addition, USDA’s Animal and Plant Health Inspection Service is looking to revise its regulations regarding genetically engineered plants. This blog will continue to monitor developments surrounding genetically modified organisms, and specifically, gene-edited technologies, both in the U.S. and abroad.
  • In an FDA Voice blog, FDA Commissioner Gottlieb highlighted a number of the agency’s proposed regulatory actions related to tobacco, food claims and labeling. The Unified Agenda includes several actions related to tobacco products, including implementing product standards for testing battery safety of e-cigarettes and administrative detention of tobacco products. FDA also plans to remove all mention of partially hydrogenated oils in its regulations and revoke all prior sanctioned uses, and it has plans to update the definition of the claim “healthy” on food labels. Further, FDA is planning to revoke outdated standards of identity, including for French salad dressing and frozen cherry pie and will reopen the comment period on the proposed rule establishing general principles to update the framework for standards of identity.

California Appeals Court Grants Stay in Starbucks’ Proposition 65 Civil Penalties Trial

  • A California appeals court stayed a trial that had been scheduled for this week, to determine penalties in the Proposition 65 case against Starbucks and other defendants for failure to warn for acrylamide in coffee under Proposition 65.  It is the latest in the eight year saga of the case, which was filed by Center for Education and Research on Toxics (CERT).
  • The defense successfully argued that the trial should be delayed, pending the outcome of California’s Proposition 65 rulemaking that would amend the regulations to state that coffee does not require warnings for cancer.  The trial court judge had denied the request for a stay last month, holding that a stay was not justified based on a “hypothetical regulation.”
  • Public comments on the proposed rule were due by August 30, 2018.  The court has asked the defense to provide a written status update to the court by January 15, 2019.  In the meantime, CERT has filed a suit against California’s Office of Environmental Health Hazard Assessment in Los Angeles Superior Court to challenge the proposed coffee regulation.

FDA Sued for Failure to Implement “High-Risk” FSMA Provisions by the Statutory Deadlines

  • The Center for Food Safety (CFS) and the Center for Environmental Health (CEH) filed suit against the FDA on October 15 for failure to implement provisions of the Food Safety Modernization Act (FSMA).  CFS and CEH assert FDA has failed to meet several important FSMA action deadlines related to FDA’s mandate to classify and designate certain foods as “high-risk” for foodborne illness purposes, and to create additional recordkeeping requirements for facilities handling such foods. These requirements are codified at 21 U.S.C. §§ 2223(d)(1)-(2), which states that such designations should be made no later than 1 year after January 4, 2011.
  • As background, the overarching purpose of FSMA is to “rapidly and effectively” identify recipients of a food to prevent or mitigate a foodborne illness outbreak. Thus, under Section 204 of FSMA, Congress included numerous provisions that focused specifically on the goal of “rapidly and effectively” preventing or mitigating foodborne illness. CFS and CEH allege that FDA failed to complete the following Section 204 mandated actions:
    • (1) In order to enhance the tracking and tracing of food, Congress required FDA to conduct pilot projects on potential food-tracing systems and report their findings. The findings were to be reported by October 1, 2011.
    • (2) FDA was to designate a classification of “high-risk” foods, meaning foods that were at the highest risk of being carriers of foodborne illness. FDA was to base a “high-risk” classification on a set of criterion, including known safety risks of the food, the history and severity of foodborne illness, outbreaks attributed to such foods, and the steps taken during the manufacturing process to reduce possible contamination. The “high-risk” classification was to be designated by January 4, 2012.
    • (3) Congress required FDA to promulgate a proposed rulemaking to establish recordkeeping requirements for facilities that manufacture, process, pack or hold foods that are designated high-risk. The proposed rulemaking was to be promulgated no later than January 4, 2013.
    • (4) Congress required that FDA publish the list of designated “high-risk” foods on its website at the same time the agency promulgated the final rule food additional recordkeeping requirements.
  • According to CFS and CEH, FDA failed to meet the above-listed deadlines, and in some instances, did not adhere to Congressionally-required actions. While CFS and CEH acknowledge FDA belatedly conducted the pilot program and submitted its report to Congress in November 2016, they note that FDA has still not designated a “high-risk” foods classification, nearly five years after the Congressionally-mandated deadline. CFS and CEH state that FDA’s failure to implement these regulations by their statutory deadlines is “an abdication of the agency’s fundamental responsibilities.” And therefore, the organizations brought the lawsuit to require FDA to complete implementation of these actions by Court-established deadlines.
  • This pending litigation is, in essence, phase II of an action brought by CFS in 2012 against FDA after the agency missed seven statutory Congressional deadlines for promulgating FSMA’s food safety regulations. See Str. For Food Safety v. Hamburg, 954 F.Supp.2d 965 (N.D. Cal. 2013), referred to in the current complaint as FSMA I. The 2012 Court held that “FDA’s failure to promulgate the mandated regulations by their statutory deadlines constituted a failure to act under the Administrative Procedure Act (APA) and unlawful withholding of the regulations in violation of FSMA and the APA.” The Court granted injunctive relief and established a timeline for FDA to promulgate the final regulations. FDA met each Court-established deadline for FSMA I and promulgated the required rules. However, the “high-risk” classification was outside the scope of FSMA I, and hence is at the center of the current lawsuit.
  • FDA has yet to respond to the CFS and CEH complaint. Keller and Heckman will continue to monitor the developments of this case.

Washington and Oregon to Vote on Soda and Food Tax Bans

  • Washington State Initiative 1634 would ban local taxes on groceries. The initiative defines groceries as “any raw or processed food or beverage, or any ingredient thereof, intended for human consumption except alcoholic beverages, marijuana products, and tobacco. The ban would not apply to existing taxes, including Seattle’s sweetened-beverage tax (see our January 2, 2018, blog for more information on the Seattle tax).
  • Washington’s Initiative 1634 will be on the November 6 ballot. (Proposed initiatives needed to be submitted to the state by July 6 and include at least 259,622 signatures of registered voters to be certified and included on the November ballot.) However, according to a recent poll, only 31% of voters supported the initiative, while 51% were opposed. The poll, conducted by Elway Research for Crosscut, surveyed 400 registered voters Oct. 4-9. Elway Research president Stuart Elway explained that the high number of voter against the measure could be due to voter confusion since it is counter-intuitive to vote yes for a tax-related initiative when you oppose taxes.
  • Another tax preemption measures that will be voted on next month is Oregon’s Measure 103, which would prohibit the state and local jurisdictions from imposing taxes on groceries. The measure defines groceries as “raw or processed food or beverages intended for human consumption,” excluding alcohol, tobacco, and marijuana. A poll, conducted between Sept. 24-Oct. 7 by Riley Research Associates, found that 40% of the 356 likely voters interviewed supported the measure. (More information on Oregon’s Measure 103 and the poll can be found here.)
  • These attempts to ban new soda and grocery taxes follow California imposing a ban on new soda taxes until 2030, which was signed into law in June of this year (see our July 2, 2018 blog for details).

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.

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