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

  • FDA holds public meeting on redefining "healthy" claims in food labeling. The FDA hosted a public meeting on March 9 to invite public comments on redefining the term "healthy" in the labeling of human food products. At the public meeting, the FDA held breakout sessions on three topics: healthy as a nutrient-based claim; healthy as a food component-based claim; and the consumer meaning and understanding of the term "healthy." The event was well attended by representatives of the food industry; food trade associations; food research scientists; nutritionists; private citizens; and local, state and federal regulators. Based on commentary at the meeting, industry representatives appear to favor a hybrid definition for "healthy" that combines elements of both a nutrient-based and a component-based definition. The FDA did not provide commentary on the agency's views, so it remains to be seen how the agency will redefine the term "healthy," if at all. The FDA is accepting written comments until April 26, 2017.
  • Scott Gottlieb, former FDA official, nominated to head the agency. On March 13, President Donald Trump nominated Scott Gottlieb as commissioner of the FDA. Gottlieb, a medical doctor and fellow at the American Enterprise Institute, served as deputy commissioner for medical and scientific affairs at the FDA in the George W. Bush Administration. The Grocery Manufacturers Association called him "an excellent choice" who can "quickly step into this important role" if confirmed by the US Senate. Michael Jacobson, president of the nonprofit Center for Science in the Public Interest, said, "We urge Senators to question Gottlieb intensively about his intentions for the food side of the agency. The FDA has the authority and the capacity to save tens of thousands of lives each year by improving America's food supply. While having safe and effective drugs is surely important, eliminating the last of the artificial trans fat, reducing sodium, and modernizing food labeling are measures that can help Americans from getting sick in the first place."
  • Leading food companies and associations urge more food safety funding. In a letter sent on March 15 to key Congressional budget writers, 20 leading food companies and trade associations are urging Congress to increase, not cut, food safety funds. Calling for "appropriate funding" for the Food Safety Modernization Act in the 2017 budget, the letter said, "In order to maintain consumer confidence in the safety and integrity of America's food supply and to reduce the number of foodborne illnesses, it is important that FDA also has the training, technical assistance and infrastructure in place to implement FSMA effectively." Among the 20 signatories: the American Bakers Association, American Frozen Food Institute, Cargill, Costco, Grocery Manufacturers Association, Nestle USA, Produce Marketing Association, United Fresh Produce Association and Wal-mart. "Our commitment to food safety is steadfast and we need a strong FDA as our partner to fully implement FSMA and to play its proper role in ensuring the safety of the nation's food supply," the letter adds.
  • Will Trump choose a deregulatory path and side with plant-based beverage companies? A March 3 article in the online magazine Quartz described the ongoing "war over the definition of 'milk' between dairy farmers and food startups" and hinted that President Donald Trump might resolve the issue against dairies. Manufacturers of soy milk, almond milk and similar plant-based beverages want to be free to continue to call their products "milk," while dairies are asking the government to crack down on the use of that term for plant-based products. According to the article, Trump sees himself as a foe of federal regulation, and in this case, the article speculates, the anti-regulatory side would be the plant-based companies – some of which are startups that complain about the heavy hand of government. "On one hand," the article says, "the people who eat and make plant-based foods are often lumped into a brand of hipster, metropolitan liberalism derided by so-called 'red meat' conservatives. But in this case, it's the environmentally conscious bunch seeking less regulatory red tape and more freedom of (commercial) speech."
  • California judge rejects Monsanto's challenge to listing glyphosate as cause of cancer. On March 10, a state judge in California rejected a constitutional challenge filed by the Monsanto Co. against that state's proposal to list glyphosate, the active ingredient in Monsanto's pesticide Roundup, to the state's list of chemicals that are "known to cause cancer" under Proposition 65. California proposed adding glyphosate to the list after health experts at the World Health Organization concluded that the pesticide is a probable cause of cancer. The nonprofit Center for Food Safety said that the ruling "is a huge victory for the health and well-being of Californians. Citizens deserve to know when they are being exposed to cancer-causing chemicals and no corporation should be able to keep it a secret." Monsanto responded that listing glyphosate would contradict findings by the US EPA, the European Food Safety Authority and other agencies that glyphosate does not cause cancer. "We disagree with the court's ruling, and we will continue to fight the decision on the basis of sound science and the law," the company said.
  • New report endorses omega-3 fish oil for heart patients but not for the general public. A report published March 14 in Circulation, an American Heart Association publication, endorsed omega-3 fish oil supplements as beneficial for people who have suffered a heart attack or heart failure in the past, but it found insufficient evidence to support their use in people without a history of heart trouble. Nearly 19 million Americans take fish oil dietary supplements on a regular basis. The report surveyed 13 randomized clinical trial studies of fish oil and concluded that the supplement has not been shown to have any benefit in preventing heart attacks or strokes – but that in people with a history of heart trouble, it can reduce the chances of dying from heart-related causes by 10 percent. Andrea Wong, vice president for scientific affairs at the Council for Responsible Nutrition, the leading supplement industry trade group, said, "Ideally people should strive to eat a diet high in fatty fish in order to obtain omega-3 fatty acids, but realistically, as data show, most people are not doing this. If you do not eat fatty fish on a regular basis, supplementing with omega-3s, along with eating a healthy diet and exercising, is a viable option for maintaining a healthy heart and for the other benefits the omega-3 supplements can provide."
  • Two die after eating unpasteurized cheese in New York state. The New York Times reported March 10 that two people have died in upstate New York from listeria after eating a raw milk cheese called Ouleout, which is made by Vulto Creamery in Walton, New York. Four others were hospitalized. The company is recalling that product as well as its other three soft washed-rind raw milk cheeses. Some food experts are saying the deaths highlight the risks of artisanal cheeses, especially those made from raw (unpasteurized) milk. More than half the artisanal cheese made each year in the US uses unpasteurized milk.
  • Dunkin' Brands will eliminate artificial colors from its products. Dunkin' Brands Group, which owns Dunkin' Donuts and Baskin-Robbins, announced on March 2 that it will remove all artificial colors from its products by the end of 2018. "We are committed to meet the evolving needs of our customers, including their preference for more nutritional transparency and simpler ingredients, while maintaining the great taste and the fun, vibrant colors expected from Dunkin' Donuts and Baskin-Robbins products," said Nigel Travis, the company's chairman and CEO. Michael Jacobson, president of the nonprofit Center for Science in the Public Interest, applauded the decision. "This commitment doesn't transform the nutritional quality of donuts or ice cream, but it is a commendable step in the right direction. We hope more restaurant chains and food manufacturers continue to adopt similar policies," Jacobson said.
  • Soy nut butter brand is recalled after E. coli outbreak. On March 2, federal and state health authorities issued warnings against consumption of I.M. Healthy brand SoyNut Butter products after consumers in three states reported they had suffered E. coli infections. Of the 16 currently known victims, 13 are children; 8 had to be hospitalized, and 5 developed hemolytic uremic syndrome, a potentially fatal form of kidney failure. On March 7, the manufacturer, which is based in Glenville, Illinois, issued a recall that included all of its soy nut butter and granola products. It also announced that the products are made by a contract manufacturer, leaving open the possibility that other brands of soy nut butter may also be affected. The investigation is continuing, involving the CDC, the FDA and nine state agencies.
  • Scientific journal finds that publicity campaign can reduce consumption of sugary drinks. According to a study published March 6 in JAMA Internal Medicine, a publicity campaign in Howard County, Maryland, against the consumption of sugary drinks may have resulted in a significant reduction in the consumption of those drinks. The three-year campaign used TV and outdoor ads, digital marketing, direct mail and social media to encourage "healthy beverage consumption" in schools, childcare, healthcare and government settings. Comparing shopping habits in the county with a comparable control group, the study found sales of sweetened beverages in Howard County had decreased significantly. Regular soda sales decreased by 19.7 percent, fruit drink sales decreased by 15.3 percent and juice sales decreased by 15 percent. The study concluded Howard County's experience could provide a "road map" for other jurisdictions wishing to reduce the consumption of these drinks for public health reasons.
  • Subway faces lawsuit over chicken in its sandwiches. Subway is facing a consumer class action in the wake of a media report that the chicken in its sandwiches may not be all chicken. The suit was filed in the US District Court for the District of Connecticut by a Connecticut resident on March 3, in the wake of a news report from the Canadian Broadcasting Corp. that claimed only about 53.6 percent of the meat in Subway's roasted chicken sandwiches has actual chicken DNA; the CBC said the percentage of chicken DNA in some Subway products is even lower. (The remainder of the DNA in these products, the CBC said, is soy.) On its website, Subway called the allegations "false and misleading" and said its chicken is and always has been 100 percent real chicken. It said that testing by two independent laboratories confirmed this conclusion.