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

  • Menu labeling goes into effect. The FDA's menu-labeling rule is now in effect nationwide. The rule requires thousands of retail food establishments with 20+ locations to post calorie counts on menus and menu boards. FDA Commissioner Scott Gottlieb said, "I do not see these nutrition issues as a right-versus-left issue. Using information as a vehicle to try to inspire competition is a conservative notion." Gottlieb said the rule will constitute a meaningful step in addressing the nation's obesity epidemic. The law, passed as part of the Affordable Care Act, was developed into a final rule by the FDA in 2014. In conjunction with the menu labeling rule taking effect, FDA issued an updated and finalized guidance on May 7 to assist subject retail establishments in complying with the federal requirements.
  • World health body announces move against trans fats. For the first time ever, the World Health Organization is attempting to remove an ingredient entirely from the world's food supply. WHO says its sweeping plan addressing artificial trans fats has the potential to save 10 million lives a year. Developed in partnership with global health group Vital Strategies, the campaign, announced May 14, proposes guidelines for governments to reduce trans fat consumption. The US ban on artificial trans fats goes into effect in June; a number of other countries already have bans or restrictions in place. In Asia and Africa, however, trans fats are not regulated but frequently used. The Indian cooking oil vanaspati, for instance, is thought to contribute to dramatically surging rates of heart disease among South Asians. A study in Nutrition found that, compared to men in England and Wales, men in Pakistan have a 62 percent higher mortality rate from heart attacks. WHO has no enforcement authority, but it intends to support regulation of trans fats and to promote information campaigns.
  • FDA confirms extension for compliance with new Nutrition Facts labeling. The FDA has formally granted an extension for compliance with the new and updated Nutrition Facts Panel. The FDA made its announcement on May 3. The compliance date has been extended by nearly 18 months, from July 26, 2018, to January 1, 2020, for manufacturers with $10 million or more in annual food sales, and from July 26, 2019 to January 1, 2021, for manufacturers with less than $10 million in annual food sales. Industry representatives had complained that the time limits were too tight to implement the necessary changes. "After considering a range of stakeholder comments, the FDA recognizes the need for manufacturers to have additional time to make required changes. The approximately 18-month extension accomplishes this goal and will provide sufficient time to transition to the new version of the Nutrition Facts label," the agency wrote.
  • USDA sets forth proposed rule on GMO disclosure. On May 3, the USDA published its highly anticipated National Bioengineered Food Disclosure Standard – a proposed rule seeking to establish labeling standards for the presence of genetically modified organisms (GMOs). The proposed rule uses the term "bioengineered" – the term appearing in the National Bioengineered Food Disclosure Law – rather than the more commonly known term "genetically modified organism." Under the proposed standard, products containing bioengineered (BE) ingredients must disclose the presence of BE ingredients in one of four options: (1) written text disclosure, (2) symbol disclosure, (3) electronic or digital link disclosure or (4) a text-message disclosure. Notably, the proposed rule clarifies that food from animals would not require a BE disclosure simply because the animal consumed feed "produced from, containing, or consisting of a bioengineered substance." The USDA is accepting comments on the rule until July 3 and, reports Food Navigator-USA, the initial wave of comment has been overwhelmingly critical of the USDA's approach. USDA has already indicated that it will not meet the congressionally specified deadline of July 26 for final action.
  • Hep A in the news. Since the CDC declared the multi-state Hepatitis A outbreak in March 2017, more than 1,200 cases of the same Hep A genotype have been identified in Arizona, Kentucky, California, Michigan, Indiana and Utah. In a May 7 report, "Hepatitis A outbreak definitely involves mainstream population," Food Safety News surveyed statistics for all the US states and found that many states that are not experiencing the outbreak genotype still are recording higher than average Hep A numbers. In the outbreak states, furthermore, "more cases of the highly contagious virus are also being confirmed in foodservice employees." On May 8, an employee of a Louisville Texas Roadhouse restaurant was diagnosed with Hepatitis A, as was an employee at an area Dairy Queen. Dr. Lori Caloia, medical director of Louisville's Department of Public Health and Wellness, said, "While we have had a very small number of food workers diagnosed with Hepatitis A in our community, there still has been no foodborne transmission. Also, our restaurant industry has really stepped up to the plate to get their workers immunized. About 5,000 local food service employees have been vaccinated against Hepatitis A." In addition, nearly 27,000 people have been vaccinated against Hep A in Kentucky since the state declared the statewide outbreak in November. Hep A vaccines are now routinely required for schoolchildren in Kentucky, Ohio and West Virginia. However, neither the CDC nor any states require food service workers to get the two-step vaccine.
  • House appropriations bill attempts to tackle "clean meat" issue. A US House of Representatives Agriculture appropriations subcommittee approved on May 8 a legislative provision that requires the USDA to develop regulations governing so-called clean meat, which is meat grown from animal cells using new technology. The US Cattlemen's Association had filed a petition with the USDA seeking to prohibit the commercial use of the term "meat" for clean meat. The appropriations provision, tucked into the lengthy farm bill, came as a surprise to many in the food industry. In response, the Good Food Institute, which represents companies in the plant-based and cultured meat sectors, wrote to the House Appropriations Committee asking that the provision be stricken from the appropriations bill. The institute said the USDA and the FDA are perfectly capable of devising regulatory regimes for clean meat and that an appropriations bill is the wrong way to tackle the subject.
  • Pennsylvania's highest court hears arguments on Philadelphia's soda tax. On May 15, the Supreme Court of Pennsylvania heard oral arguments in a case challenging the legality of Philadelphia's tax on soda and other sweetened beverages. The American Beverage Association and other groups have challenged the law, which went into effect at the start of 2017 and which taxes sugary beverages at the rate of 1.5 cents per ounce. The issue before the court was whether the tax violates a Pennsylvania law that prohibits localities in that state from taxing items that are already taxed statewide. In 2017, $78 million was raised via the tax, but Philadelphia has put off spending those funds (for including pre-K education, community schools, parks and libraries) pending the state supreme court's decision. Philadelphia was the first major US city to approve a tax on sweetened beverages.
  • Groups sue FDA over seven common food flavorings. On May 2, a coalition of health, consumer and environmental groups filed suit against the FDA in the US Court of Appeals for the Ninth Circuit to try to force the agency to decide whether to prohibit the use of seven artificial chemicals as food flavorings. These chemicals have been used in beverages, baked goods, candy, chewing gum and ice cream. All of them were approved by the FDA in the 1960s, but, according to the lawsuit, later studies showed that they cause cancer in humans and thus they cannot legally be used in food. According to the lawsuit, the organizations petitioned the FDA to act concerning these flavorings, but it has failed to do so. "We certainly don't want to deny anyone the convenience of processed food and drinks. We all have that choice, and we've all likely indulged in these products at least once in our lives. But we should also have the ability to choose foods that are safe for us to eat," said a statement by Earthjustice, which is representing the coalition.
  • FDA chief says agency is looking into issues surrounding plant-based "milks." FDA Commissioner Scott Gottlieb told a US Senate appropriations panel on April 24 that the agency is actively exploring whether consumers are being misled by the use of terms such as "milk" or "yogurt" for plant-based products. He added that the absence of any action by the FDA in recent years against the use of terms like "almond milk" may make it harder for the agency to act now without new data. In response to pointed questions at the hearing from Senator Tammy Baldwin (D-WI), Gottlieb said he wants to learn more about whether consumers expect plant-based products to be nutritionally equivalent to dairy milk products. Baldwin, who has introduced legislation to compel the FDA to act against allegedly mislabeled milk substitutes, told Gottlieb there is no need "for further review or study" but that the FDA should "issue guidance on enforcement of its existing dairy standards of identity."
  • Egg producer asks FDA to permit eggs to be termed "healthy." In an April 19 citizen petition to the FDA, Peter and Gerry's Organics LLC, a New Hampshire-based producer of organic free-range eggs, asked the agency to permit eggs to carry the term "healthy" as a matter of law. The petition said that the current state of scientific knowledge supports the idea that eggs can be an inexpensive and valuable portion of a healthy diet and that their level of dietary cholesterol is no longer viewed as harmful to the cardiovascular system. Permitting eggs to be termed "healthy," the petition said, "would make the FDA's regulatory regime consistent with current federal dietary recommendations, would be consistent with current scientific evidence about the health benefit of eggs, and would significantly benefit the public health by ensuring that consumers fully understand the dietary value of eggs."