• As our readers know, this blog has previously covered the romaine lettuce E. coli outbreaks that occurred in the spring and fall of 2018. Ultimately, FDA determined that the outbreak that occurred in the spring of 2018 may have been caused by Concentrated Animal Feeding Operations (CAFOs) in the Yuma, Arizona area, and the outbreak that occurred in the fall of 2018 may have been due to a contaminated on-farm water reservoir.
  • On November 19, U.S. Senator Kirsten Gillibrand, D-NY announced her new legislation to help improve food safety across the country. The Expanded Food Safety Inspection Act would expand FDA’s investigative authorities to trace the source of outbreaks of foodborne illness. Under existing law and regulations, FDA is limited to investigating the produce farms from where the outbreaks originated. However, FDA does not have the ability to access nearby farms that may be the source of contamination or that may have contributed to the root cause of a foodborne illness outbreak. As explained in a press release, the Expanded Food Safety Inspection Act would allow the FDA to coordinate with state and local public health organizations, the USDA, and the CDC in order “to better determine the source of outbreaks and give them the authority to investigate contamination from nearby farms.” This would help eliminate sources of contamination directly, decrease the chances of repeated outbreaks within the same region, and facilitate the quick recall of dangerous food products.
  • Senator Gillibrand is to introduce the bill in the Senate within the coming weeks. The legislation is endorsed by the Center for Science in the Public Interest and the Consumer Federation of America. We will continue to monitor developments on the Expanded Food Safety Inspection Act

The Daily Intake is taking a break for the Thanksgiving holiday and will return on December 2, 2019.  We wish you a wonderful Thanksgiving holiday! 

  • On November 25, 2019, FDA issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The products cited in the warning letters cover a wide range of forms including oils, drops, dietary supplements, conventional food (including gummies, peanut butter, and water), vape pens, oral sprays, creams, and pet treats. In all cases, FDA alleges that CBD lacks an appropriate regulatory status in the products and, in some cases along with product claims, causes them to be marketed unlawfully. FDA repeats its long-standing position that CBD is not eligible to be used as an ingredient in conventional foods and dietary supplements, although the letters invite companies to submit evidence to rebut this conclusion.
  • FDA also published a revised Consumer Update detailing its continued safety concerns about CBD products more broadly. Notably, for the first time FDA has directly stated that it “is not aware of any basis to conclude that CBD is [generally recognized as safe (GRAS)] for use in conventional [human or animal] food.” In a statement, FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D noted, “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’”
  • These latest warning letters suggest that FDA may be taking more aggressive enforcement action and increasing its scrutiny of CBD-containing products. The statement about the absence of a basis for GRAS status for CBD in food is significant because even if the ineligibility issue can be overcome, FDA’s view is that CBD would need to be the subject of an approved food additive regulation before it could be used in human or animal food.
  • The Agency continues to defer fulfilling its commitment to report on its progress in evaluating potential regulatory pathways for CBD products. In its press release discussing the warning letters, FDA states that it now “plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks.” Given FDA’s ongoing safety concerns and the present conclusion about the lack of GRAS status in food, it is clear that establishing a regulatory pathway for CBD in food and dietary supplements will need to address numerous significant challenges.
  • Keller and Heckman advises clients regularly on the status of CBD in FDA-regulated products. We will continue to monitor FDA’s development of a potential regulatory framework and the direction of additional enforcement action to assess the risks and opportunities for companies marketing these types of products.

 Swiss Miss Hot Cocoa Ingredients Not So ‘Simple,’ Buyers Say (subscription to Law360 required)

  • In a proposed statewide class of consumers who purchased Swiss Miss hot chocolate and similar products, an individual has sued ConAgra under various California consumer protection laws.  The plaintiff alleges that he made an on-line purchase of Swiss Miss Simply Cocoa Dark Chocolate Hot Chocolate Mix based on his belief that the product contained cocoa in its simplest form as suggested by the name ‘Simply Cocoa’ and the claim ‘Made with Real Cocoa.’  According to the complaint, the product actually contains alkalized cocoa, which the plaintiff alleges is not a simple form of cocoa because it is heavily processed and is inferior to “natural cocoa” in that it has less “real cocoa” taste and reduced levels of healthful antioxidants as compared to non-alkalized cocoa.
  • Although the Swiss Miss ingredient statement lists ‘Cocoa (Processed with Alkali),’ which could serve to clarify any potential confusion as to the nature of the cocoa ingredient, it is uncertain whether a “reasonable” consumer would be obliged to check the ingredient statement.  As we reported previously, a federal appeals court that reversed the dismal of a lawsuit charging New England Coffee’s Hazelnut Crème coffee violates Massachusetts’ consumer protection laws because the product does not contain hazelnuts found that a reasonable consumer who cared whether the coffee contained real hazelnuts may check the list of ingredients, but “perhaps a reasonable consumer would find in the product name sufficient assurance so as to see no need to search the fine print on the back of the package.”  Thus, the fact that the Swiss Miss ingredient statement lists alkalized cocoa may not necessarily undermine the plaintiff’s claims that the terms ‘simple’ and ‘real’ on the front of the package deceptively imply that the product is made with non-alkalized cocoa.
  • To the extent that claims against the Simply Cocoa product frame the alkalized cocoa as ‘unnatural,’ the case also raises an issue discussed in our coverage of lawsuits involving ‘natural flavors.’  Namely, is it the degree of processing and not just plant derivation that distinguishes a synthetic from a natural substance and, if so, what level of processing brings an ingredient outside of the realm of ‘natural’?  While allegations that the ‘simple’ version of cocoa contains higher levels of ‘healthy’ antioxidants and a different flavor than the alkalized version distinguish the cocoa ingredient from flavor ingredients where ‘natural’ versions are not chemically distinct from ‘synthesized’ versions, the issues involving the extent of chemical processing are still relevant to interpretation of ‘simply’ and ‘real,’ especially as the Swiss Miss product label also claims “no artificial flavors.”
  • On November 20, the Centers for Disease Control and Prevention (CDC), in conjunction with the Food and Drug Administration (FDA) and several state agencies, announced that it is currently investigating an outbreak of Shiga toxin-producing E. coli (STEC) O157:H7 infections that has so far impacted at least 17 people across 8 states. The first reported illnesses date back to September 24, 2019. Investigators are looking into a branded chicken Caesar salad as a potential source, after the Maryland Department of Health (MDH) identified E. coli O157 in an unopened package. However, MDH is still conducting a whole genome sequencing (WGS) analysis to determine if it is closely related genetically to the E. coli identified in this outbreak.
  • As previously reported on this blog, in January 2019, FDA’s Food Safety and Inspection Service (FSIS) transitioned to using only WGS for Shiga toxin-producing E. coli (STEC) in an effort to update its analytical methods to the state of the art. The method of WGS determines the order of all of the DNA building blocks (nucleotides) in an organism’s entire genome in a single laboratory process, and a comparison of the DNA sequence of an isolated bacterial pathogen to the sequences from other samples in a DNA database can pinpoint the source of a foodborne disease outbreak.
  • The recent outbreak follows a similar outbreak of E. coli 0157:H7 from 2018 that was ultimately traced to romaine lettuce. The 2018 outbreak included 62 cases from 16 states and the District of Columbia, and prompted FDA to issue recommendations for leafy greens growing operations as well as a partnership between FDA and leafy greens stakeholders in Arizona to enhance food safety. Subsequent research from the U.S. Department of Agriculture’s Agricultural Marketing Service found that pest flies were a potential vector in the spread of the E. coli O157:H7 and contamination of leafy greens.
  • On November 19, 2019, former FDA Commissioner Scott Gottlieb opined on how the FDA should proceed in regulating e-cigs to address the “youth epidemic” but also preserve the devices’ potential to help adult smokers quit cigarettes.  Gottlieb argues that “providing adult smokers with a safer alternative to cigarettes cannot come at the expense of addicting a generation of young people to nicotine with these same products.”  Gottlieb claims that the FDA must differentiate between cartridge-based e-cigs, which youth prefer, and open-tank vapes that are not popular among youth, as open-tank vapes are sold at higher prices.
  • Vaping product advocates argue that FDA restrictions on e-cigs will make it difficult for adult smokers to use the devices to quit cigarettes.  These advocates also note that regulatory action to ban flavored e-cigs, which appeal to children, could end up forcing the shutdown of small vape stores where adults shop.
  • Gottlieb argues that FDA should immediately remove cartridge-based e-cigs in order to address the youth epidemic, and once the cartridge-based e-cigs are removed from the market, companies that relaunch them would need to file FDA applications showing that they provide a net public health benefit.  He explains that this review process would allow FDA to impose additional restrictions to prevent their use by young people.  Additionally, Gottlieb notes that FDA should make the premarket tobacco product application (PMTA) process more “efficient” for small businesses that can demonstrate they are only selling products to adults, by, for example, allowing companies following common manufacturing processes to pool data and resources.  We will continue to monitor any developments.
  • FDA issued the 2019 edition of the Voluntary National Retail Food Regulatory Program Standards (“Retail Program Standards”) on November 14.  The Retail Program Standards define the key elements of an effective retail food regulatory program for state, local, tribal, and territorial food regulatory jurisdictions. The Retail Program Standards also provide recommendations for designing and managing retail food regulatory programs and help regulatory jurisdictions facilitate more effective inspections, implement foodborne illness prevention strategies, and identify program areas in need of improvement.
  • The 2019 edition incorporates changes based on recommendations discussed at the Conference for Food Protection 2018 Biennial Meeting. Such changes include updates to the standard that assists food regulatory jurisdictions in developing and implementing a program policy, as well as a new tool that helps food regulatory jurisdictions assess their food safety risk factors and interventions.
  • The Retail Program Standards are designed to help food regulatory programs enhance the services they provide to the public. When applied in the intended manner, the Program Standards should:
    • Identify program areas where an agency can have the greatest impact on retail food safety
    • Promote wider application of effective risk-factor intervention strategies
    • Assist in identifying program areas most in need of additional attention
    • Provide information needed to justify maintenance or increase in program budgets
    • Lead to innovations in program implementation and administration
    • Improve industry and consumer confidence in food protection programs by enhancing uniformity within and between regulatory agencies
  • According to the FDA, achieving national uniformity among regulatory programs responsible for retail food protection in the U.S. has long been a subject of debate among the industry, regulators, and consumers. As our readers may know, since 1993, the FDA has published the FDA Food Code, which is a model code that assists food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating retail and food service establishments. While the adoption of the FDA Food Code has been a keystone in the effort to promote greater uniformity, the Retail Program Standards address a missing link in that uniformity by establishing recognized standards for the regulatory programs that administer the Food Code.
  • In the wake of rapidly increasing sales, FDA has continued to maintain that dietary supplements containing hemp-derived cannabidiol (CBD) are illegal under the Federal Food, Drug & Cosmetic Act. FDA officials have previously stated that the agency is exploring additional regulatory pathways available to hemp products containing CBD, but predicted that completing a potential rulemaking proceeding could span 3 to 5 years even under the best of circumstances.
  • Amidst Congressional pressure for FDA to act quickly in establishing a regulatory framework for CBD and outside efforts urging Congress to pass legislation that would make CBD derived from hemp a legal dietary ingredient, the Consumer Healthcare Products Associated (CHPA) submitted a citizen petition to FDA requesting that the agency issue regulations to establish a clear pathway for the use of CBD in dietary supplement manufacturers. CHPA expressed a preference for an interim final rule as opposed to full notice and comment rulemaking but asked that if notice and comment rulemaking was used that FDA issue guidance or an enforcement discretion position at the same time.
  • Under CHPA’s proposal, FDA should require manufacturers of CBD-containing dietary supplements to submit a new dietary ingredient notification (NDIN) for CBD and comply with other applicable laws, including using appropriate labeling and claims, adhering to GMPs, and reporting serious adverse events. The petition notes that requiring NDINs would provide FDA with much-needed data on CBD that could help inform FDA’s broader regulatory framework for CBD products. CHPA’s petition is consistent with the approach that we believe FDA is considering as it evaluates whether CBD can be authorized for use in dietary supplements.

 Whole Foods Accused of Hiding Sugar In Oatmeal Ingredients (subscription to Law360 required)

  • As previously covered on this blog, a claim against Whole Foods involving the term “evaporated cane juice” (ECJ) was dismissed from the “Food Court” (i.e., the Northern District of California) in 2015 because inconsistencies in the plaintiff’s statements and actions make it implausible that he was misled to believe that “juice” means “healthy” or that ECJ is a healthy unrefined sugar.  We also reported that cases against other defendants alleging the use of ECJ is misleading on various product labels were put on hold while the Food and Drug Administration (FDA) worked to finalize relevant guidance.
  • As covered here, FDA released final guidance on May 25, 2016, reaffirming the Agency’s view that sweeteners derived from sugar cane should not be declared on food labels as “evaporated cane juice” and that the term is “false or misleading because it suggests that the sweetener is ‘juice’ or is made from ‘juice’ and does not reveal that its basic nature and characterizing properties are those of a sugar.”  Now a proposed class of consumers have alleged in a federal lawsuit, filed in New York on November 15, 2019, that they were misled by the term “organic dehydrated cane juice solids” in the ingredients statements on Whole Foods’ instant oatmeal labels.  According to the plaintiffs, the oatmeal labels use a term that is comparable to evaporated cane juice and similarly suggest that the ingredient at issue came from a fruit or vegetable, such as berries that are featured prominently on the front of the package.
  • The plaintiffs in this new lawsuit are seeking unspecified damages and an injunction against the use of the allegedly misleading ingredient statement.  The request for an injunction could be moot, however, as it appears that all of the sweetened instant oatmeal products on Whole Foods’ website currently list “cane sugar” or “organic cane sugar,” rather than any variation of “cane juice,” in the ingredient statements.

 

 

  • On November 14, the United States Department of Agriculture (USDA) announced that China plans to lift its ban on poultry imports from the United States. China originally instituted its ban on U.S. poultry in 2015, amid concerns over highly-pathogenic avian influenza (HPAI) outbreaks. While these concerns have subsided over the past four years, China had yet to lift its ban on U.S. poultry until now. As part of USDA’s announcement, United States Trade Representative Robert Lighthizer and U.S. Secretary of Agriculture Sonny Perdue released a statement hailing the decision as a win for U.S. farmers and expressing optimism about the new export opportunities.
  • This news comes one week after the USDA Food Safety and Inspection Service (FSIS) issued a final rule removing its own ban on Chinese imports of certain poultry products. While processed poultry products could already be imported from China, it was conditioned on the requirement that the products be derived from poultry slaughtered in the United States or in other countries with a poultry slaughter inspection system equivalent to that of the United States. Following an extensive evaluation of China’s laws, regulations, control programs, and inspection procedures, FSIS determined that these systems were equivalent to those of the United States. Notably, the new rule only covers fully cooked poultry products, and does not remove the current restrictions on Chinese raw poultry imports instituted by the USDA Animal and Plant Health Inspection Service (APHIS), due to concerns over animal disease risk.
  • The respective removals of U.S. and China poultry import restrictions are part of ongoing trade negotiations between the two countries. For several years, there have been growing congressional efforts to ease these restrictions, specifically with regard to poultry imports. As previously covered on this blog, in July 2017, a bipartisan group of 37 U.S. senators led by Senator Thad Cochran (R-Miss.) and Senator Mark Warner (D-Va.) called on Secretary of Agriculture Sonny Perdue to press for the swift reopening of the Chinese market to U.S. chicken and turkey exports. Today’s announcement marks an important milestone in the materialization of that effort.
  • On October 29, 2019, Plaintiff James Ehlers, a former Vermont gubernatorial candidate, filed a proposed class action complaint in the federal U.S. District Court in Vermont.  In the complaint, the Plaintiff alleges that Ben & Jerry’s and its parent company, Unilever, (collectively “Defendants”) falsely advertised that the milk and cream in Ben & Jerry’s ice cream products come exclusively from “happy cows.”  The lawsuit accuses the Defendants of breach of express warranty, unjust enrichment, and violating the Vermont Consumer Protection Act, which declares unlawful all “[u]nfair methods of competition in commerce and unfair or deceptive acts or practices in commerce.”
  • In the complaint, the Plaintiff argues that Defendants “breached consumer trust” by representing that the milk and cream in their products were sourced from cows on dairies that participate in Ben & Jerry’s “Caring Dairy Program.”  Ben & Jerry’s “Caring Dairy Program” offers farmers a program for “evaluating, implementing and continuously improving sustainable agricultural practices on their farms.”  Although the Plaintiff acknowledges that Ben & Jerry’s products are made from milk that comes from farms participating in the “Caring Dairy Program,” he alleges that products are also made with milk from cows on “factory-style, mass-production dairy operations.”  Ehlers alleges that Defendants acted “unfairly and deceptively…by omitting information about the percentage of milk and cream in Ben & Jerry’s Products that originates from regular factory-style, mass-production dairy operations.”
  • The plaintiff seeks damages for ice cream purchasers nationwide, and to stop Ben & Jerry’s from claiming its milk and cream came from “happy cows.”  We will continue to monitor this case as well as other interesting class action lawsuits that target the food industry.