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

FDA finalizes rule to combat antimicrobial resistance. The FDA this week finalized a rule that is part of its drive to slow the development of antimicrobial resistance. The rule revises drug makers' reporting requirements for all antimicrobials sold or distributed for use in food-producing animals or animals intended for human consumption. Now, drug makers' annual reports will need to not only estimate the amount of all such drugs they sell and distribute, but categorize drug usage by species. The reporting requirements start with calendar year 2016. In the US, 2 million people are sickened or hospitalized by antibiotic-resistant bacteria annually and about 23,000 of them will die.

Massive recall of chicken parts. Pilgrim's Pride, Inc., has issued a recall of 4.5 million pounds of chicken parts in the wake of consumer complaints about such "extraneous materials" as metal and plastic. The company's website – which at this writing does not refer to the recall – states that one in five US chickens are Pilgrim's Pride birds. None of the recalled chicken has been sold in stores – it was shipped for institutional use, particularly in schools. The USDA's Food Safety and Inspection Service website says the recalled parts, sold under the Gold Kist Farms, Pierce Chicken and Sweet Georgia brands, include nuggets, patties and tenderloins.

KIND may use "healthy" label again. Following a lengthy legal battle, the FDA has approved KIND's use of the word "healthy" in its marketing. Earlier in 2016, the agency had demanded that the word be removed from packaging of KIND dried fruit and nut bars. The FDA says this week that it is allowing KIND to use the formerly forbidden word not because it reflects the company's nutritional claims but because it expresses the company's "corporate philosophy."

Dole announces it is target of DOJ criminal probe in wake of a Listeria outbreak.On April 30, Dole Food Co. announced that the US Department of Justice has launched a criminal investigation against it following a Listeria outbreak linked to four deaths and other illnesses in the US and Canada. The company said it was cooperating with the investigation, which relates to packaged salad produced in Dole's Springfield, Ohio, facility. In January, the company ceased production at the facility and voluntarily removed products from stores in 23 US states and three Canadian provinces after it learned that salads it produced were linked to fatal illnesses. The company has resumed limited production in its Springfield plant and will expand production slowly. According to Food Safety News, company officials knew the plant was contaminated with Listeria for a year and a half before they shut it down – then only took action after the US and Canadian governments traced the deadly outbreak to the facility.

FDA puts forward latest version of menu labeling rule. On April 29, the FDA released a final guidance document on its proposed menu labeling rule to clarify portions of the rule, which requires calorie and nutrition disclosures, and to answer specific questions about it. See our alert about the final guidance.

Markey directs pointed letter to FDA regarding its GRAS requirements. In an April 26 letter to FDA Commissioner Robert Califf, Senator Edward Markey (D-MA) asked sharply worded questions about the FDA's process of declaring food ingredients to be "generally recognized as safe" (GRAS). He wrote that because of the FDA's procedures for declaring a substance to be on the GRAS list, "ingredient manufacturers have been permitted to secretly decide whether a new ingredient is 'generally recognized as safe' and therefore able to bypass the requirement for premarket FDA review." Markey concluded, "Many would be shocked to learn that numerous ingredients are used in food and beverages without ever being evaluated by the FDA."

Dannon announces new non-GMO initiatives. Dannon, the nation's largest yogurt maker, announced in advance of the July 1 effective date of Vermont's GMO-disclosure statute that it will no longer use GMO ingredients in its three flagship brands – Dannon, Oikos, and Danimals. On April 27, Dannon said these products, which constitute 50 percent of its sales, will move to all-natural and non-GMO ingredients. In addition, Dannon announced that by the end of 2018, it will complete a process in which the cows that supply milk for these three products will be fed exclusively non-GMO feed, a first for a leading non-organic yogurt maker. By the end of 2017, the company will label any of its products that do include GMO ingredients.

CSPI urges opposition to new school nutrition bill. The Center for Science in the Public Interest has begun an email campaign to urge consumers to express their opposition to a US House of Representatives bill that it says would "roll back healthy nutrition standards for school meals and snacks and decrease access to healthy meals for low-income children." CSPI says that currently 98.5 percent of participating school districts meet the Obama Administration's updated school lunch nutrition standards that provide more whole grains, fruits and vegetables, and healthier snacks and drinks to children while reducing salt intake. Representative Todd Rokita (R-IN), who introduced the bill, said the new legislation is needed because "in 2010, rather than heed Republican calls to continue and improve child nutrition assistance, the Democrat-led Congress vastly expanded the federal role in child nutrition. The Healthy, Hunger-Free Kids Act facilitated a host of new regulations that have led to higher costs for schools and fewer students being served."

Clinton says she supports plan to tax sodas. Democratic presidential front-runner Hillary Clinton said on April 20 that she is "very supportive" of a plan by the mayor of Philadelphia to tax sugary sodas to help fund universal pre-school in that city. At a forum in Philadelphia, Clinton said, "I'm very supportive of the mayor's proposal to tax soda to get universal pre-school for kids. I mean, we need universal pre-school. And if that's a way to do it, that's how we should do it." The proposal was introduced by Mayor Jim Kenney in early March and would tax soda at the rate of three cents per ounce.

CSPI calls for immediate ban on retail sale of pure caffeine products. On April 26, the Center for Science in the Public Interest called on the FDA to immediately ban the retail sale of pure caffeine products – in both powdered and liquid form – as dietary supplements. Describing pure caffeine as "an imminent public hazard," the CSPI noted that two tablespoons of the chemical is a fatal dose for adults. Last September, the FDA issued warning letters to five companies that sold pure caffeine, and they stopped marketing the products. But the CSPI says pure caffeine is still readily available online from at least 15 companies – "we easily purchased large bags of pure powder sufficient to kill several dozen people." Young people and health-conscious people, it noted, are likely to overdose on pure caffeine under the impression that they are taking a safe energy booster. See some of our earlier coverage of this story here.

Activist group calls for carrageenan to be removed from acceptable list for organic foods.The Cornucopia Institute, an organic-food watchdog group, has asked the National Organic Standards Board to declare that carrageenan, a widely used seaweed derivative, should no longer be an approved ingredient in organic foods. The NOSB, a 15-member panel that advises the USDA, was set to take up the issue at its semiannual meeting in Washington, DC, on April 25-27. Carrageenan supporters say the substance is a safe, affordable and sustainable ingredient that has many uses in prepared foods. Its opponents point to its suspected links to digestive problems. The NOSB deferred a decision on carrageenan's status in 2012 in order to gather more data on the long-running controversy.

FTC moves against five companies for claims that their products are "natural." In a step that may have major implications for food-industry claims concerning foods labelled "natural," the FTC on April 12 brought charges against five sellers of skin-care and hair-care products, alleging that the companies falsely advertised their products as "all natural" or "100% natural" despite the products containing some synthetic ingredients. Four of the companies agreed to change the marketing of their products, while one is litigating its case against the FTC. This series of actions marks the first time the agency has taken action against allegedly deceptive claims that a product is "natural." Jessica Rich, director of the FTC's Bureau of Consumer Protection, said that the agency's position is that "all natural" or "100% natural" means "just that – no artificial ingredients or chemicals."

GMO debate may enter a new phase as novel CRISPR genetic technology advances. In an important and novel variation on the debate over GMOs, the USDA ruled on April 13 that it will not regulate a particular type of mushroom as if it were an ordinary GMO because the mushroom's genes were modified via a new technique called CRISPR, which rearranges its existing DNA without introducing genetic material from other organisms. Using CRISPR, Yinong Yang, a plant pathologist at Pennsylvania State University, inactivated two of the mushroom's genes, making it resistant to browning and allowing it to stay fresher longer. As CRISPR technology advances, many observers see it as presenting regulators and society with a chance to more properly define the meaning of a GMO and to engage in a more scientifically informed debate.

FDA will reconsider its prior approval of a group of food additives. Responding to a petition filed by several nonprofits, the FDA on April 12 announced it is reconsidering its prior approval of a class of 30 chemicals known as ortho-phthalates. These chemicals are widely used in food packaging and food handling equipment. Academic studies have linked some of these chemicals to reproductive, developmental and endocrine health problems, including lower IQ in young children. The nonprofits that petitioned the FDA call the additives a "serious threat" to pregnant women, their fetuses and small children. The FDA has six months to evaluate whether some or all of these chemicals are potentially harmful to human health.

Bloomberg News suggests ways in which companies can counter obesity epidemic. On April 14, Bloomberg News, declaring that two out of every three Americans are overweight or obese and that this constitutes a major public health problem, suggested five steps businesses can take to reduce the resulting burden on society. Among them were to "make healthy food more readily available" in the workplace, as the Cleveland Clinic did when it closed down its fast-food outlet, and to "change the food supply." An example of the latter, according to Bloomberg, was the agreement made 10 years ago to remove full-calorie sodas from vending machines in schools. "Ultimately, market pressure may be the most effective way to get the food industry to address obesity," the influential business magazine said.

FDA at capacity to inspect growing volume of food imports. A USDA Economic Research Service report examining FDA's import refusal process – its primary border enforcement tool – notes that the number of refusals of food import shipments has remained relatively stable from one year to the next, while the volume of food being imported into the US is climbing. That is, Food Safety Newsobserves, "FDA resources and capacity to inspect, detain and refuse imported food have all leveled off." The article in Food Safety News leads with a statement that the FDA "freely acknowledges" that it "has neither the personnel nor the funding to physically inspect more than 1 percent of all shipments" of food imports.

Failure to fix food safety problems is in itself a crime, DOJ now says. Speaking during the biannual Conference for Food Protection in Washington, DC, Benjamin C. Mizer, Principal Deputy Assistant Attorney General of the US, told his audience of food industry professionals and consumer advocates that, increasingly, failure to solve known food safety issues is now being defined as a crime. Mizer reviewed the civil and criminal enforcement tools the Justice Department has as its disposal to protect the food supply, concluding, "We are committed to continuing to vigorously prosecute food safety cases."