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

  • Is it time for the FDA to revise its approach to food standards of identity? At a public comment period on September 30 run by the FDA, nearly every speaker from the food industry agreed it’s time for the agency to change its approach to food standards of identity. These standards date back to the 1930s, when food adulteration was common, and they are designed to set forth what ingredients are required and otherwise permissible to use in specific foods. But the industry believes that the standards now stifle innovation and provide no clear public benefit. For example, an attorney for Bumble Bee Foods said at the hearing that the canned tuna standard now “only permits the use of one flavor, lemon oil, which does not allow tuna manufacturers to adapt to consumer changing tastes. FDA should take a horizontal approach by permitting safe and suitable flavor ingredients in various standards.” Susan Mayne, the director of FDA's Center for Food Safety and Applied Nutrition, said at the hearing, “We know that many standards were established decades ago and have not been recently amended to reflect changes in consumer expectations or opportunities for innovation, including the ability to produce healthier foods.”
  • Hahn is expected to be nominated soon as new permanent FDA chief. Biocentury magazine reported October 1 that President Donald Trump has decided to nominate Stephen Hahn as the new permanent commissioner of the FDA. Hahn is currently the chief medical executive of the University of Texas MD Anderson Cancer Center. Under the terms of the Federal Vacancies Reform Act, Trump must nominate a permanent commissioner, or name a new acting commissioner, by November 1. Ned Sharpless, the acting FDA commissioner, is expected to remain in that post duringHahn’s Senate confirmation process.
  • CSPI urges passage of key nutritional initiatives. On September 19, the nonprofit Center for Science in the Public Interest issued a statement urging Congress to fund several crucial nutrition initiatives, mostly related to reducing sodium consumption. The group said Congress should provide $1 million for critical technical assistance to help schools in successful sodium reduction; provide $6 million for the FDA’s consumer-awareness education campaigns supporting the updated Nutrition Facts panel and menu labeling; and remove a policy rider blocking the FDA from advancing longer-term voluntary sodium-reduction targets for industry. That policy rider provides that the FDA may not use appropriated funds to issue or promote regulations designed to achieve population-wide sodium reduction actions.
  • Meat group sues to invalidate California law on animal confinement. On October 4, the North American Meat Institute filed a lawsuit in the US District Court for the Central District of California challenging the constitutionality of California’s Proposition 12, known as the Farm Animal Confinement Initiative. The law establishes minimum space requirements for the confinement of laying hens, breeding pigs and veal calves and bans the sale of raw pork or veal from animals not kept in appropriately sized pens. The trade group claims the law is unconstitutional and represents an “overreach” by California that will “hurt the nation’s food value chain by significantly increasing costs for producers and consumers.” The lawsuit asserts that the law violates the Constitution’s Commerce Clause because it imposes undue burdens on the interstate markets for pork and veal.Twelve US states currently ban forms of extreme confinement of farm animals.
  • FDA looks into whether peas and beans are causing serious health issues in dogs.Politico magazine reported September 23 that last year, the FDA opened an investigation into whether pet foods with a high concentration of peas, lentils and other so-called pulse crops might be a cause of a disease in dogs called canine dilated cardiomyopathy (DCM). The investigation has damaged the market for these crops, since pet food manufacturers, who form one of the largest markets for the pulse industry, are purchasing fewer peas, lentils and garbanzos. Tim McGreevy, the CEO of the USA Dry Peas and Lentils Council, said, “People are saying, ‘Wait and see. We’re not sure if we’re going to buy the amount of product that we have in the past.’” An FDA spokesperson said the agency “believes that the potential association between diet and DCM in dogs is a complex scientific issue that may involve multiple factors.”
  • Vaping in the news.State and local governments are scrambling to address a nationwide outbreak of a mysterious lung disease linked to the use of e-cigarettes.As reported in our previous issue, Michigan led the way when Governor Gretchen Whitmer announced an emergency ban of retail and online sales of flavored nicotine vaping products. Since then, Massachusetts, Rhode Island, Oregon and Montana have all instituted bans; New York implemented a ban that was appealed and has been temporarily blocked until at least October 18 when the Supreme Court in Albany is set to hear a case brought by the Vapor Technology Association; and in California, where Governor Gavin Newsom said he lacks the authority to ban e-cigarettes, some cities and counties have put in place their own bans; and in other states, such as Hawaii, state attorneys general and health regulators have issued advisories and warnings. Many of these bans specifically target vaping products with flavors – a vast commercial market. The Attorney General of Arkansas on October 7 issued an enforcement advisory warning online retailers that they stand to be fined up to $10,000 under the Arkansas Deceptive Trade Practices Act for selling or shipping e-cigarette products to Arkansas minors. She also called on eBay to ensure no vaping products are sold on its site. Furthermore, across the country, numerous schools and school districts are mobilizing their own efforts against what they regard as a health crisis.And a number of national bricks-and-mortar retailers have ended sales of e-cigarettes.

    Meanwhile, the FDA disclosed it is working with the Drug Enforcement Administration in a criminal investigation of the outbreak’s cause. On September 25, the Los Angeles Times suggested that federal authorities are investigating “a flood of counterfeit vape materials from China.” Acting FDA Commissioner Dr. Ned Sharpless said, “To be clear, if we determine that someone is manufacturing or distributing illicit, adulterated products that caused illness or death for personal profit, we would consider that a criminal act.”

    Finally, on October 7, research published in the Proceedings of the National Academy of Sciences found that e-cigarette nicotine vapor caused lung cancer in 22.5 percent of mice tested and is also a potential bladder carcinogen in mice – the first scientific study to clearly connect nicotine vaping with cancer.  The New York University researchers commented that vaping is the likely cause of a variety of chronic diseases in humans as well, but that further study is needed on that potential threat. The study may be read here.

    As of October 1, at least 1,020 people in 48 US states and the US Virgin Islands have fallen ill with the mysterious lung disease; at least 19 have died. All the victims had used vaping products, but no one product, brand or substance has been linked to all the cases.
  • TTB explains new status of “conditionally approved” alcohol labels.On September 27, the federal Alcohol and Tobacco Tax and Trade Bureau issued guidance concerning the COLA (certificate of label approval) status for alcohol label applications. COLA status requires some action on the part of the manufacturer, the TTB explained. In a COLA situation, the TTB is proposing changes to the online information entered by the manufacturer in order to make the label and the online information consistent with each other. The manufacturer has seven days to review the agency’s proposed changes and to either accept or decline them. If the changes are not accepted by the manufacturer, the application’s status is automatically changed to “Needs Correction” and must be fixed before the application is approved.
  • Michigan brewers hope for a change in state law. Michigan Radio, an NPR affiliate, reported September 23 that Michigan craft brewers are hoping to change state law to permit them to grow their businesses. At present, a Michigan brewer who produces more than 1,000 barrels of beer in a year may sell directly to restaurants and grocery stores, but smaller brewers must work with a distributor if they want to sell to restaurants and grocery stores. Some small breweries would like to see that 1,000-barrel cap increased to 30,000 barrels. Distributors, they say, often take a 30 percent cut of profits, which can be a major obstacle for a small brewery. A law change, some brewers say, would give them a better chance of success.
  • Columnist says Virginia alcohol laws are outdated and should be reformed. Nicole Merlene, a Northern Virginia politician and community leader, wrote in an October 3 column in arlnow.com, an Arlington, Virginia-based online publication, that it is about time for Virginia to modernize its alcohol laws. “Antiquated Prohibition-era laws are still alive and well in Virginia. These regulations have become a burden on restaurants and entertainment-oriented businesses operating in the Commonwealth. For Arlington and Northern Virginia at large, this means lost business opportunities to competitors in Washington, D.C. that don’t have to abide by such outdated regulations,” she wrote. She noted, for example, that the state Alcoholic Beverage Control Authority requires that 45 percent of the total sales of a restaurant must be composed of food and nonalcoholic beverages, a requirement that she said does nothing to reduce drunkenness or to improve public health.
  • Soda tax appears to be close to passage in District of Columbia. A new tax on sodas and sugary drinks was proposed in the District of Columbia Council October 7 with the support of a majority of council members. The new levy, a 1.5 cent-per-ounce excise tax on sweetened beverages, would add one dollar to the price of a two-liter bottle. The tax applies to sugary drinks with any “natural common sweeteners,” including sports drinks, sweetened iced coffee and fruit juice with added sugar. The bill would not affect diet soda and other drinks with artificial sweeteners, beverages with milk as the primary ingredient, alcoholic beverages, or all-natural juices. The legislation, the Healthy Beverage Choices Act of 2019, aims to improve public health in a city where residents in some low-income neighborhoods struggle with high rates of obesity and diabetes. “This piece of legislation is about saving lives,” said Stuart Anderson of the activist group Families and Friends of Incarcerated People. “Black folks are dying faster than anyone else from curable and preventable diseases, and sugar is a contributing agent to many of those. Sugar became our first addictive habit.”

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