This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape.

  • Cotton for dinner? Why not?   The FDA has approved a genetically engineered form of cotton for use in human food. Researchers believe that a modified species of cotton can become a new, cheap protein source for people and animals. The problem with most cotton products is that they contain a toxic chemical called gossypol. The GM cotton approved by the FDA on October 11, however, is low in gossypol. Dr. Keerti Rathore, a plant biotechnologist at Texas A&M University, has been working since 1996 to silence the gene in cotton that is responsible for gossypol production in cotton. He said, "The amount of protein locked up in the annual output of cottonseed worldwide is about 10.8 trillion grams.That is more than what is present in all the chicken eggs produced globally, and enough to meet the basic protein requirements of over 500 million people." USDA deregulated the genetically engineered cotton in 2018, so that farmers may plant it as a crop; the FDA's approval allows food manufacturers to use it in human food and animal feed.
  • FDA gives industry a grace period in complying with nutrition label. In response to requests from many members of the food industry, the FDA announced October 23 that during the six months following the January 1, 2020, compliance date for the new Nutrition Facts label, it will work cooperatively with manufacturers to meet the new label requirements. In that period, it will not focus on bringing enforcement actions against companies for alleged violations of those requirements. Among other groups, the Food & Beverage Issue Alliance, a coalition of food industry trade groups that includes the American Frozen Food Institute, the Corn Refiners Association and the Food Marketing Institute, had asked the FDA to provide this enforcement discretion.  The American Bakers Association had said about 20 to 30 percent of the products that its members make would “need additional time for the substantial label changes” that will be required after the effective date.
  • FDA moves toward new era of food safety with public meeting.  On October 21, the FDA called together food companies, retailers, consumer advocates and consultants for a high-level meeting on the future of food safety. The meeting was part of an FDA initiative known as the New Era of Smarter Food Safety. In early 2020, the agency plans to release a blueprint for food safety with "critical steps to protect public health and keep pace with the ever-changing global food supply chain." A public docket is open until November 20. According to FDA, the intention is "for the strategic plan to outline how this new approach will address public health challenges, including being able to trace sources of contaminated foods and using new analytics tools like artificial intelligence to assess risks and prioritize the agency’s work and resources." FDA is also working toward enhancing its efforts to implement the FDA Food Safety Modernization Act by creating a more digital, traceable, and safer system to help protect consumers from contaminated food.
  • FDA criticized for delayed announcement of E.coli outbreak. The FDA announced October 31 that an E. coli outbreak linked to romaine lettuce had sickened nearly two dozen people in 12 states between July and early September. No patients died of their illnesses, and officials said there is no ongoing public health risk. Both the FDA and CDC determined the probable cause of the outbreak by October 2, but FDA did not announce the outbreak until October 31; by that time, any potentially infectious lettuce was past date and had moved out of the commercial stream.  Consumer advocates and members of the produce industry criticized the delayed announcement. Trevor Suslow, vice president of produce safety for the Produce Marketing Association, told Produce Blue Book, "I'm not sure what we can learn from this incident," since so little information has been released. Consumer Reports noted that the agency had acted more swiftly in previous lettuce-related outbreaks and that the strain of E. coli involved in this outbreak produces a toxin that can lead to serious illness, kidney failure and death. A spokesman for the CDC said the delay was the result of a few variables and that the CDC "generally posts outbreak warnings when there is something actionable for consumers to do."
  • FDA is sued to take action on perchlorate in food. In 2017, the FDA denied a petition to ban the use of perchlorate in food packaging. On October 29, 2019, several nonprofit groups, including the Natural Resources Defense Council, filed suit against the FDA in the US District Court for the Southern District of New York, seeking to overturn that decision. Perchlorate is also used as an additive in plastic packaging and other food-contact articles to reduce the buildup of static charges in dry foods such as cereal, flour and spices; it is also used as a propellant in rocket fuel and an oxidizer in such products as fireworks, munitions and auto airbag initiators. From a health perspective, the FDA notes that perchlorate can disrupt thyroid function and that "pregnant women and their fetuses and newborns have the greatest potential for risk of adverse health effects following exposure to perchlorate." However, the FDA had concluded that the amount of perchlorate that gets into food is below the harmful level. Melanie Benesh, an attorney for the Environmental Working Group, said, "Rocket fuel chemicals shouldn't be in the food we feed to babies and toddlers. There is ample evidence that perchlorate causes developmental delays and impairs learning."
  • Olive oil industry petitions FDA for federal standards on the product. On November 4, the American Olive Oil Producers Association and Deoleo, a Spanish company that is the world's largest producer of olive oil, submitted a citizen petition to the FDA urging adoption of enforceable standards for the content of olive oil. No such standards currently exist. "Buying quality extra virgin olive oil is hard, but not because there aren't quality products on supermarket shelves. It's because there are just no rules to stop bad actors from misrepresenting what they're selling," said Adam Englehardt, chairman of the American Olive Oil Producers Association.
  • Early data shows that FSMA is working to improve the nation’s food system.   An early set of data, published on October 10, indicates that the Food Safety Modernization Act (FSMA) is working according to plan. Specifically, compliance with the law is improving, and food recalls have hit a five-year low. A newly launched web portal called the Food Safety Dashboard, established by the FDA, is helping to track that data. The purpose of FSMA is to transform the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it. Congress enacted the law in response to dramatic changes in the global food system and our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system. The FDA has finalized seven major rules to implement FSMA.
  • Bill introduced in Congress to regulate labeling of plant-based "meat" products.  Two members of Congress, one a Democrat and one a Republican, have introduced a bill in the House of Representatives that would require any products that simulate beef but do not come entirely from cows to be labeled as "imitation." The bill, introduced October 29, would also require a statement on the package saying that the product does not contain and is not derived from meat.  The establishment of rules such as this, regulating what plant-based meat producers can say about their products, is this year’s top legislative priority for the National Cattlemen's Beef Association. In the wake of the growth of products such as Beyond Meat and the Impossible Burger, legislation has been introduced in 26 states, with 17 bills already enacted in 14 states, to restrict their labeling. Jessica Almy, policy director of the Good Food Institute, said, "This bill is a bald-faced attempt to get the government to police food labels to benefit the conventional meat industry, not consumers."
  • Bill introduced to require country-of-origin labeling for beef. On October 30, US Senators Mike Rounds (R-SD) and John Thune (R-SD) introduced a bill intended to ensure that only meat from cattle raised and slaughtered in the United States can bear a "Product of the U.S.A." label. In 2015, Congress repealed a law that required country-of-origin labeling for beef. Rounds said, "Our cattle producers offer some of the highest-quality beef in the world. Consumers deserve to know where their food is coming from. When South Dakota families purchase beef labeled 'Product of the U.S.A.,' they should know with certainty that it is coming from one of our top-quality producers." And on October 31, Senator Jon Tester (D-MT) introduced a Senate resolution to support reinstating country-of-origin labeling for beef and pork. Congress had repealed the country-of-origin labeling law after the World Trade Organization ruled, four times, that the law violated US trade obligations and discriminated against cattle and hogs imported from Canada and cattle imported from Mexico, and authorized $1 billion in retaliatory tariffs.
  • Mississippi changes law on plant-based meat products in response to lawsuit. Upton's Naturals, a manufacturer of plant-based meat substitute products, and the Plant Based Foods Association have dropped a lawsuit challenging Mississippi legislation banning makers of plant-based foods sold in that state from using terms that relate to meat on their labels. They dropped the suit after Mississippi agreed to revise the pending legislation to permit them to use words like "burger" or "sausage" as long as they also use qualifiers, such as the words "vegan" or "meatless." Justin Pearson, a senior attorney at the Institute for Justice, a nonprofit that represented those challenging the law on First Amendment grounds, said the result of the litigation was "a total victory" for the plant-based meat companies. The institute said that the law had originally been passed at the behest of the Mississippi Cattlemen's Association.
  • Philadelphia passes bill mandating healthy drinks as default menu options. On October 3, Philadelphia Mayor Jim Kenney signed a bill that requires restaurants in that city to offer a healthy beverage (water, nonfat or lowfat milk, or 100 percent juice) as the default option for children's meals. The law will prevent restaurants from offering drinks such as soda as the default choice, while not prohibiting their sale upon request. California, Delaware and Hawaii have taken similar actions. Councilmember Reynolds Brown, who introduced the bill, said, "Ensuring that these healthy beverage options are available to families is a step in the right direction toward the health and well-being of our City's children." A spokesman for the American Beverage Association said, "Philadelphia's beverage companies know that parents and caregivers want to make the food and beverage choices that are best for their families. Many parents and caregivers believe water, milk and juice are some of the best beverage options they an offer their children, which is why the beverage industry is committed to working with policymakers . . . to support and adopt default beverages in children's meals across the City of Philadelphia."
  • Craft brewers argue for more EPA authority in upcoming Supreme Court case. On November 6, the US Supreme Court heard arguments in a closely watched water pollution case − a decision that may soon have a major impact on the US beer industry.  The case, County of Maui v. Hawai’i Wildlife Fund et al., will test the scope of the Clean Water Act – specifically whether pollution from a point of discharge into a groundwater source that can potentially reach navigable waterways must be regulated by the federal government. Craft brewers, who now command more than $27 billion in annual sales, or 24 percent of the US beer market, have weighed in, noting that their products demand extremely pure water and calling for additional, not less, regulation. A group of 60 craft breweries filed an amicus curiae brief in the high court, asking it to uphold the reach of the Clean Water Act.
  • Vending machines will soon feature a wider variety of healthy products.   On October 23, a major trade association representing the convenience-service industry announced a commitment to significantly increase the percentage of healthful foods that appear in vending machines across the nation. The National Automatic Merchandising Association (NAMA), with the support of the Partnership for a Healthier America and the Alliance for a Healthier Generation, announced that it has committed to a program in which 33 percent of the offerings in vending machines will be in the "better for you" category. "There are nearly four million vending machines serving snacks and beverages every day, 24/7, across this country," said NAMA CEO Carla Balakgie.  "Vending is everywhere consumers work, play and live and NAMA regards this initiative as a bold, ambitious, and meaningful step to meet the growing consumer demand for healthier choices." The Center for Science in the Public Interest said in response, "Modest changes to improve the food environment, like replacing sugar-sweetened soda with water or other healthier drinks, help people make healthier choices."
  • Wine and spirits companies denounce US and EU tariffs. On October 18, several major wine and distilled-spirits trade groups in the United States and the European Union issued a joint statement expressing opposition to tariffs on spirits and wines imposed recently by the United States. "We are united in our opposition to the imposition of tariffs and clear in our view that there are no winners in a trade war," the statement said. "Our 15 international beverage alcohol associations today sent a letter to the U.S. administration and the EU Commission calling for an immediate end to tariffs on distilled spirits and wines and welcoming their statements of their shared intent to reach negotiated solutions to the disputes. Our industries are collateral damage in trade disputes that have nothing to do with the beverage alcohol sector. This new round of tariffs will further damage a transatlantic industry that has already been negatively impacted by the EU's retaliatory tariff on American Whiskey." The Trump Administration recently imposed 25 percent tariffs on products such as Scotch whisky, French wine and Italian cheeses.
  • Alaska considers tighter rules on alcohol service in breweries, wineries and distilleries. In a comment period that ended October 4, Alaskans weighed in on a proposal that would significantly overhaul the state's liquor regulation regime as it applies to breweries, wineries, and distilleries. The proposal is likely to prohibit festivals, games, competitions, classes, parties, presentations, performances and other types of organized social gatherings at breweries, wineries and distilleries. More than 1,200 pages of comments were received concerning the proposal. Proponents of the change, many of whom are bar or liquor store owners, see it as stopping an overreach by manufacturers and closing an unintended loophole in the law.
  • Study contends that labeling restrictions will do little to aid the meat industry. A study by two food economists says that current efforts in state legislatures to support manufacturers of traditional meat products by regulating food labeling will likely have little effect on the markets for both traditional and plant-based meat products. Several states have recently passed laws restricting what can be said on the labels of plant-based meat products.Most of these laws are being challenged in court. The study, based on experiments with consumer behavior, concluded that "forcing alternative meat companies to use labels that more clearly distinguish themselves from the traditional offering is unlikely to transform the way consumers make decisions." The study concluded that pushing for such labeling legislation could be both costly and counter-productive.
  • Kombucha maker settles lawsuit about alcohol and sugar content of its product. On October 11, the US District Court for the Northern District of California approved an agreement under which Health-Ade will pay almost $4 million to settle two lawsuits concerning its kombucha products. The lawsuits alleged there were significant discrepancies between the actual sugar and alcohol labels in its kombucha and the levels stated on the packaging. The company also agreed to change the formulation of its kombucha and to add a new statement on its labels advising that kombucha should not be consumed if it is out of the refrigerator for an extended time and that pregnant or breast-feeding women should consult a doctor before consuming the product. Plaintiffs in the case will receive awards ranging from $20 to $80.
  • Ocean Spray agrees to settle class action on "no artificial flavor" claims. On November 8, Ocean Spray Cranberries Inc agreed to pay $5.4 million to settle a federal class action that claims the company misled consumers by saying some of its juices contained "no artificial flavors," when the juices otherwise contained synthetic malic acid and fumaric acid, which the plaintiff argued functions as a flavor in the products. The proposed settlement, filed in the US District Court for the Southern District of California, provides class-wide relief and would benefit any consumers who have purchased Ocean Spray products since 2011. Class members would be able to file a claim and receive $1 for each eligible bottle of Ocean Spray juice that they purchased.
  • Vaping in the news.  The CDC has now given a name to the lung injury that has affected more than 2,000 people across the United States: "e-cigarette, or vaping, product use associated lung injury," or EVALI. To date, victims have been reported in almost all US states. Of those, 39 have died.  Every EVALI patient has reported using vaping products; 86 percent have reported using illegally obtained THC vapes. On November 8, the CDC reported that biopsies of 29 patients found vitamin E acetate - an inexpensive substance used to cut costly THC in illegal vapes - in all the samples. Regulators face a difficult scenario regarding black market vapes, as there is little they can directly do to tackle the illegal market. However, the spotlight is now shining strongly on legal vaping products, particularly flavored e-cigarettes. Among many recent developments, two new studies to be presented at the upcoming American Heart Association 2019 Scientific Sessions meeting affirm that vaping may be harmful to heart health, possibly more harmful than cigarettes. Meanwhile, on November 12 doctors at Henry Ford Hospital in Detroit performed a double lung transplant on a teenaged EVALI patient and pleaded with the public to understand the dangers of vaping. And on November 13 in Washington, DC, the Trump Administration signaled that it may be backing away from its September announcement that it would seek to ban flavored e-cigarettes.

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