FDA and CDC Identify One Source of E. Coli Contaminated Romaine

  • As discussed in this blog two and three weeks ago, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have been investigating a multistate outbreak of E. coli O157:H7 illnesses that were likely linked to romaine lettuce.  On November 20, CDC advised consumers, retailers, and restaurants not to eat, sell, or serve any romaine lettuce until the source of the outbreak was better understood.
  • On November 26, FDA announced that it had narrowed down the traceback to romaine lettuce grown in the central coast growing regions of northern and central California.  FDA also said that lettuce known to be grown outside of this region is safe to eat, sell, or serve.  On the same date, the United Fresh Produce Association issued a press release confirming that a number of grower shippers had negotiated an agreement with FDA.  Under the agreement, supported by multiple produce associations, including United Fresh Produce Association, grower shippers agreed to label their romaine products with the region where they were grown and the approximate harvest date.
  • On December 13, FDA provided an update on the outbreak.  The onset of the last of the 59 confirmed illnesses, with 23 hospitalized, was November 16.  FDA and CDC announced that they have narrowed down the source of the outbreak to “Monterey, San Benito, and Santa Barbara counties in California. Romaine lettuce from outside those counties need not be avoided. Consumers may notice that romaine lettuce is beginning to be available in stores with new labeling. Additionally, romaine from Ventura, San Luis Obispo, and Santa Cruz counties harvested after November 23, 2018 should be labeled with harvest area and harvest date, allowing it to be distinguished from romaine lettuce that should be avoided.”  FDA and CDC also confirmed that Hydroponically- and greenhouse-grown romaine are likely safe.
  • Of particular note, FDA and CDC confirmed via whole genome sequencing a sample from Adam Bros. Farming Inc. with the same strain of E. Coli as the outbreak.  Adam Bros. has not shipped romaine since November 20 and experts are working with the farm to identify the source of the contamination and safety measures to take before the next growing season.
    • Adam Bros. is likely not the only source of the contamination.  Per the FDA press release, “[t]he finding on this farm, however, does not explain all illnesses. The FDA’s traceback activities of romaine lettuce will continue as FDA works to determine what commonalities this farm may have with other farms and areas that are being assessed as part of the investigation.”

Contrary to Popular Reports, Farm Bill Will Not Affect FDA Status of CBD

  • Media outlets are reporting that a Farm Bill provision removing industrial hemp (Cannabis sativa L.) from Schedule I of the Controlled Substances Act will change the FDA status of cannabidiol (CBD) in foods.  However, the relevant provisions under Subtitle G (“Hemp Production”) affect only the Drug Enforcement Administration’s (DEA’s) authority over hemp farming and allow states to exercise authority over industrial hemp production.
  • The  2018 Farm Bill, which passed the Senate on December 11 and the House on December 12, does not affect FDA’s authority to regulate CBD or other hemp products, or change the regulatory requirements for such materials in FDA-regulated products like food, dietary supplements, cosmetics, or drugs.  In fact, Section 297D, paragraph (c)(1) (“Regulations and Guidelines; Effect on Other Law”) states “nothing in this subtitle shall affect or modify the Federal Food, Drug, and Cosmetic Act.”
  • FDA has stated on its “FDA and Marijuana: Questions and Answers” website that CBD is not permitted in food (including dietary supplements) and has sent warning letters to companies marketing CBD products for food uses.  Thus, companies that wish to market CBD-containing foods, dietary supplements, or cosmetics are still at risk of FDA enforcement action unless they can develop an appropriate regulatory status for CBD in those products.  Through its regulatory procedures, in June 2018, FDA approved Epidiolex, a drug product containing CBD as the active ingredient, as a treatment certain forms of epilepsy.

Second Circuit Remands “Whole Grain” Cheez-It Lawsuit

  • The United States Court of Appeals for the Second Circuit held that a New York district court erred in ruling that labeling Kellogg’s Cheez-It crackers as “whole grain” was not misleading, despite the fact that the snacks were primarily made from enriched white flour.  Thus, the Second Circuit vacated the decision and remanded the case for further proceedings.
  • In 2016, Kristen Mantikas and two co-plaintiffs filed a lawsuit against Cheez-It manufacturer Kellogg Co., alleging the “whole grain” Cheez-It labels violated New York and California’s consumer protection laws.  Plaintiffs sought declaratory and injunctive relief, as well as monetary damages, on behalf of a putative class of all persons residing in the U.S. and its territories who purchased whole grain Cheez-Its since May 19, 2010.  Plaintiffs argued they purchased the “whole grain” Cheez-Its because the “whole grain” label claims caused them to believe that the grain content of the crackers was predominantly whole grain.  However, U.S. District Judge Sandra J. Feurstein dismissed the case in 2017 and adopted Kellogg’s argument that the Cheez-It labeling was not misleading.  Judge Feurstein stated that the ingredient list clearly declared whole grain flour as the second or third ingredient, whereas enriched white flour – the most predominant ingredient in the cracker – was declared first.  Further, she stated that the Nutrition Facts Panel showed that only five or eights grams, out of a 29 gram serving size, were whole grain.
  • However, a three-judge panel sitting for the Second Circuit rejected that reasoning by stating it does not matter if “the side panel of the packaging discloses further detail about the product’s ingredients. […] reasonable consumers expect that the ingredient list contains more detailed information about the product that confirms other representations of the packaging.” The Second Circuit concluded that a reasonable consumer should not be expected to consult the Nutrition Facts Panel to correct misleading information set forth in large bold type on the front of the box.
  • The Second Circuit went on to rebuke Kellogg for its argument that as long as all of the details of a product are disclosed somewhere on the label, the product is not misleading.  “Moreover, the rule that Defendant contends emerges from these district court decisions [cited in its appellate brief]—that, as a matter of law, it is not misleading to state that a product is made with a specified ingredient if that ingredient is in fact present—would validate highly deceptive advertising and labeling. Such a rule would permit Defendant to lead consumers to believe its Cheez‐Its were made of whole grain so long as the crackers contained an iota of whole grain, along with 99.999% white flour. Such a rule would validate highly deceptive marketing.”

Mixed Reactions to Final Rule on School Meal Flexibilities

  • As previously posted on this blog on November 30, 2017, the U.S. Department of Agriculture (USDA) announced temporary exemptions to some of the rigid nutrition standards for school meals established by the Healthy, Hunger-Free Kids Act in 2010 and published an interim final rule, titled the “School Meal Flexibility Rule,” that would make some of those changes permanent.
  • USDA announced that it will publish a final rule in the Federal Register tomorrow, December 12, that will codify three menu planning flexibilities that were temporarily established by the interim final rule. (A pre-publication, unofficial version of the rule can be viewed here.) The three flexibilities are described below.
    • Flavored, low-fat (1%) milk will be included under the milk option in the National School Lunch and Breakfast Programs and will be allowed in the Special Milk Program for Children and in the Child and Adult Care Food Program for participants ages 6 and older.
    • Half of the weekly grains in the school lunch and breakfast menu must be whole grain-rich. (Previously, 100% had to whole grain unless an exemption was obtained.)
    • Schools in the lunch and breakfast program will have more time to reduce sodium levels and the final target will be lower than previously established.
  • Response to the final rule for school meals has been mixed. Some of the reactions are shown below.
    • “We hope all schools reject this regulation and continue their commitment to serve healthier foods on our kids’ plates.” American Heart Association
    • “[USDA’s] final rule strikes a healthy balance. Schools will continue to meet strong nutrition standards but can prepare meals that appeal to a wide range of students…Despite extensive efforts to boost consumption of healthy school meals, student lunch participation continues to gradually decline, as nearly 2 million fewer students choose school lunch each day since updated nutrition standards took effect.” The School Nutrition Association
    • “The new rule is good news for schools, students and American dairy farmers.” The National Milk Producers Federation
    • “[USDA’s] final rule on school nutrition standards runs counter to accepted science about quality school nutrition. By rolling back previous standards that were designed to limit students’ sodium intake and promote the consumption of healthier whole grains, USDA is threatening the progress we’ve made toward improving nutrition in schools.” Rep. Robert C. “Bobby” Scott (VA), ranking Democrat on the House Education Committee, as quoted in The Washington Post
  • In a press release concerning the final rule, Agriculture Secretary Sonny Perdue noted that schools have faced challenges serving meals that both are appetizing and meet nutritional standards. “If kids are not eating what is being served, they are not benefiting, and food is being wasted,” he added.

U.S. Department of Justice Sides with California Against States Opposing Egg Production Standards That Require Room for Chickens to Move

  • As reported here, Missouri and twelve other states asked the U.S. Supreme Court on December 4, 2018 to hear their challenge to provisions of the California Prevention of Farm Animal Cruelty Act that require any eggs sold in the state to come from hens that have space to stretch out in their cages. The plaintiffs allege that California’s egg law violates the U.S. Constitution’s Commerce Clause and is preempted by the Egg Products Inspection Act (EPIA). An earlier challenge was dismissed without prejudice in 2016 when the Ninth Circuit Court of Appeals ruled Missouri and other states lacked standing where they failed to show the California law would affect more than just individual farmers. The new lawsuit asks the Supreme Court to hear the case directly and includes an economic analysis intended to cure the standing defect by showing harm to consumers, including state institutions, such as prisons, that the plaintiffs argue must pay higher prices for eggs as a consequence of California’s egg law.
  • The U.S. Department of Justice (DOJ) filed an amicus brief on November 30, 2018 that recommends denying the states’ request. While grading standards under the EPIA must be uniform throughout the nation, the DOJ concludes that California’s egg law is not preempted because the federal law has no standards that address confinement conditions for egg-laying hens. Regarding negative prohibitions of the Commerce Clause, the DOJ questions whether the plaintiffs could ultimately demonstrate standing because their claim of injury depends on speculation about numerous decisions of third-parties in the marketplace. The DOJ further notes that resolving questions of standing and the merits of the case would require resolution of complex factual disputes that are better suited to a district court. Thus, the DOJ concludes there is no direct harm imposed by California of the type that the Supreme Court considers when exercising its original jurisdiction.
  • Unless the Supreme Court disagrees with the DOJ’s recommendation, egg producers will be left to make their case in the district courts while the issue of harm gets murkier as several restaurants and retailers pledge to switch to cage-free eggs in response to consumer concerns for animal welfare.

USDA Issues Final Rule Setting a Uniform Compliance Date for Food Labeling Regulations

  • The United States Department of Agriculture (USDA) Food Safety Inspection Service (FSIS) today issued a final rule establishing January 1, 2022 “as the uniform compliance date for new meat and poultry product labeling regulations that will be issued between January 1, 2019, and December 31, 2020.”  Any rules published during this two year timeframe will specify the January 1, 2022 compliance date and “products introduced into commerce on or after January 1, 2022” will need to comply with the rule.  If special circumstances dictate that a compliance date other than January 1, 2022 be set, USDA will publish the appropriate compliance date in the rule.
  • Since December 2004, FSIS has established via final rule seven prior uniform compliance dates spaced two years apart.  Initial rulemakings included a proposed rule and a comment period, but in the 2007 final rule, FSIS determined that further notice and comment rulemaking was unnecessary.  USDA has invited comment on each of the rules, including this one, but no comments were received for the 2014 or 2016 version of the rules.
  • This rule is meant to help industry plan for a consolidated labeling change rather than having to make multiple labeling changes within a small timeframe rather than complying with staggered compliance dates for multiple FSIS rules.  FDA announced a similar uniform compliance date of January 1, 2020 for food labeling regulations issued during calendar years 2017 and 2018.
  • We do not expect the USDA bioengineered (BE) food final rule to be impacted by the FSIS Uniform Compliance Date rule as the BE rule is being promulgated by USDA’s Agricultural Marketing Service (AMS).  Also, the Office of Management and Budget (OMB) has concluded its review of the BE rule, so we would expect publication of the BE rule in the coming weeks.

New York Single Service Expanded Polystyrene Ban Takes Effect on January 1, 2019

  • After years of delay, New York City’s ban on single use expanded polystyrene (EPS) will go into effect on January 1, 2019.  EPS is defined in the rule as “blown polystyrene and expanded and extruded foams that are thermoplastic petrochemical materials utilizing a styrene monomer and processed by any number of techniques including, but not limited to, fusion of polymer spheres (expandable bead foam), injection molding, foam molding, and extrusion-blown molding (extruded foam polystyrene).”  Rigid polystyrene is not included in the definition of EPS.  Affected products include single-use food packaging materials and packing peanuts.
  • Non-profits and small businesses with less than $500,000 in annual revenue can apply for hardship exemptions from the Department of Small Business Services if they can demonstrate that using an alternative product would cause an undue financial hardship.
  • The New York City Departments of Sanitation, of Health and Mental Hygiene, and of Consumer Affairs each have the authority to enforce the ban, which carries penalties ranging from $250 for the first violation up to $1,000 for the third and each subsequent violation, but fines will not be issued during a grace period that ends on July 1, 2019.
  • The original effective date for the ban was January 1, 2015, but implementation was delayed due to a lawsuit by industry.  Industry was unsuccessful at challenging the city’s basis for the ban, which was that it is not environmentally effective or economically feasible to recycle EPS.

FDA Alerts Consumers to Dog Food Recalls For Potentially Toxic Vitamin D Exposure

  • On December 3, FDA issued an alert to pet owners and veterinary professionals about the recalls of several dry dog foods with potentially toxic levels of Vitamin D. Thus far, FDA believes the affected dog food has been produced by one contract manufacturer who makes dry dog food for several national brands. However, the name of the contract manufacturer has not yet been released. In order to ensure all affected dry dog food brands are accounted for, FDA is working with the contract manufacturer to generate a comprehensive list of the dry dog food brands that they work with.
  • The issue came to FDA’s attention after one brand notified FDA that it was recalling their dry dog food due to potentially toxic levels of Vitamin D. The reason for the recall arose after the brand had received complaints from customers that their dogs were experiencing symptoms of Vitamin D toxicity. It appears that shortly thereafter, other pet food brands who use the same contract manufacturer, followed suit and also instituted recalls. Thus far, eight brands have instituted recalls of products that were sold nationwide, however FDA notes that the issue is still developing and additional brands could also be recalled.
  • Testing conducted on the dry dog food samples found excessive, potentially toxic levels of Vitamin D. In some cases, the dry dog food contained as much as 70 times the intended amount of Vitamin D. While Vitamin D is an essential nutrient that regulates the calcium and phosphorus balance in a dog’s body, exposure to very high amounts can cause serious health problems, such as kidney failure or death.
  • FDA’s alert warned pet owners to discontinue feeding the recalled dry dog food products – a list of the affected brands, flavors, and lot numbers is provided by FDA on their website. Retailers have also been advised not to sell the recalled products and to contact consumers who have purchased such products, if possible. Additionally, FDA asked veterinarians who suspect that their patients have Vitamin D toxicity to report the events through a Safe Reporting Portal or by calling local FDA Consumer Complaint Coordinators. Pet owners are also encouraged to report suspected cases.

FDA Develops Educational Module on Menu Labeling

  • The U.S. Food and Drug Administration (FDA) announced the availability of an online educational and training module that explains the types of establishments and foods that are covered by the menu labeling regulations. The Agency also recently published two fact sheets for industry on menu labeling and declaring calories.
  • By way of background, FDA issued a final rule on Nutritional Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments on Dec. 1, 2014 (see 79 Fed. Reg. 71155) and published a final guidance on the menu labeling provisions in April 2016. As reported on this blog, FDA issued a supplemental guidance document on the Menu Labeling Rule on May 7, 2018, the same day that the new requirements became effective. That guidance addresses concerns raised by stakeholders, such as calorie disclosure signage for self-service food, various methods for providing calorie disclosure, and criteria for distinguishing between menus and marketing material.
  • The objectives of the newly released Menu Labeling Regulation Module are:
    • To identify key factors that led to the regulation of menu labeling;
    • To describe the components of the menu labeling rule;
    • To explain the Agency’s current strategy; and
    • To locate appropriate resources.
  • FDA explained in a Constituent Update on the module that during the first year of implementation of the menu labeling regulations, it will focus on education and outreach and working cooperatively with establishments to help them comply.

EFSA Releases Evaluation of Cyanide Risk from Foods

  • The European Food Safety Authority’s (EFSA) Panel on Contaminants in the Food Chain (CONTAM) has opened a public consultation into a draft opinion on the health risks of cyanogenic glycosides in foods other than raw apricot kernels. Cyanogenic glycosides contain chemically bound cyanide and are present in foods such as apricot kernels, almonds, linseed, or cassava. When the plant cells are damaged, by for example grinding or chewing, cyanogenic glycosides and their degrading enzymes are brought into contact and cyanide is released. Cyanide is readily absorbed by the gastrointestinal tract and rapidly distributed to all organs. Cyanide poisoning can cause a number of health issues, and in extreme cases, can be fatal.
  • In 2016, EFSA evaluated the acute health risk of cyanogenic glycosides in raw apricot kernels. In that 2016 scientific opinion, EFSA set a safe level for one-off exposure (known as an acute reference dose (ARfD)) of 20 µg/kg body weight. EFSA recommended that adults could consume three small apricot kernels without exceeding the AFrD.
  • In its latest draft opinion on the health risk of cyanide in foods, the CONTAM panel reviewed 2,586 analytical results on total cyanide in foods, and the highest occurrence values were in bitter almonds and linseed. The panel concluded the AFrD of 20 micrograms per kilogram of body weight was applicable for acute effects of cyanide regardless of the dietary source. Ultimately, EFSA’s review concluded that it is unlikely that there is a health risk from cyanogenic glycosides in foods other than raw apricot kernels. Interested parties are invited to submit written comments by January 25, 2019.
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