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

  • Senators express concern about FDA’s use of draft guidance documents to make substantive changes in policy. On May 6, four Republican Senators – including Senate Finance Committee Ranking Member Hatch (R-UT) and Senate HELP Committee Ranking Member Lamar Alexander (R-TN) – wrote to FDA Commissioner Margaret Hamburg to express concern about “FDA’s use of draft guidance documents to make substantive policy changes.” Among other concerns, the letter stated that while these draft documents are technically only distributed for comment, they are increasingly viewed as the agency’s actual position. For example, in one guidance document, FDA indicated that some juices should not be labeled as “evaporated cane juice” and consumer lawsuits and settlements followed, even though the agency did not take a formal position against use of the term.
  • Senator Harkin advocates tougher rules on e-cigarettes. During a May 15 hearing on tobacco use and regulation, Senate HELP Committee Chairman Harkin (D-IA) indicated that he believes manufacturers of e-cigarettes are clearly targeting children as purchasers and that e-cigarettes occupy a “regulatory black hole.” In April, FDA proposed regulating e-cigarettes, including provisions that would ban sales to people under 18. Senator Harkin indicated that FDA should go further, and called for a ban on candy-flavored e-cigarettes since they appear to be marketed to children.
  • Appeals court hears arguments anew on country-of-origin labeling. On May 19, the US Court of Appeals for the DC Circuit, sitting en banc, heard arguments in a case brought by the meat industry challenging COOL as a violation of free speech under the First Amendment. In March, a panel of that court denied the meat industry’s bid to impose a preliminary injunction against the labeling and found the meatpacking industry’s effort was “unlikely to succeed on the merits of its claims.” Supporters of the labels, including many in the US farming industry, assert COOL helps consumers make informed decisions about the quality and potential safety of the meat they buy.
  • Senate, House committees mark up agriculture appropriations bills. On May 22, the Senate Appropriations Committee marked up its FY2015 agriculture appropriations bill. The bill provides total funding of $20.575 billion for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for fiscal year 2015. The bill also includes $100 million in disaster relief spending. It provides $2.588 billion for the FDA, which is $36 million above fiscal year 2014. On May 20, the Agriculture Subcommittee of the House Appropriations Committee marked up its version of the FY2015 agriculture appropriations bill. This bill provides $20.9 billion in discretionary funding.
  • Senators introduce bill to end tax subsidy for marketing “unhealthy” foods to kids. On May 15, Senators Tom Harkin (D-IA) and Richard Blumenthal (D-CT) introduced the Stop Subsidizing Childhood Obesity Act of 2014, a bill that would end the federal tax subsidy for the marketing of what they consider to be “unhealthy” foods and beverages to children. The legislation requires that money generated by eliminating the tax subsidy be used to fund the USDA’s Fresh Fruit and Vegetable Program for elementary school students in low-income schools. It is estimated by some health specialists that eliminating the tax subsidy could reduce the rates of childhood obesity by five to seven percent. “Our nation is facing a childhood obesity crisis that demands our urgent attention, and one effective way of combating this epidemic is to ensure that our children are not confronted by persistent advertising from soda, snack, and candy makers,” Harkin said.