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

  • KIND LLC faces challenges from FDA on its labeling claims. KIND LLC, a New York-based natural foods company, says it is working closely with the FDA to address issues raised by the agency in a warning letter over label claims on its bars and its website. In a March 17 warning letter, the agency pointed to, among other things, KIND’s use of the term “healthy” on its labels, which was flagged since the amount of the products normally consumed contains more than one gram of saturated fat and since more than 15 percent of some KIND bars’ calories come from saturated fat. On its website, KIND says its products are wholesome, even if some of them do not meet the FDA standard for the term “healthy.”
  • Schumer calls for ban on BMPEA in food supplements. Senator Charles Schumer (D-NY) has called upon the FDA to ban any products containing BMPEA, a positional isomer of amphetamine. Schumer said April 12 that BMPEA was found in 11 of 21 dietary supplements tested by a doctor affiliated with the Harvard Medical School. Schumer and other critics of BMPEA say the chemical may have unknown and untested stimulant, addictive, and other adverse effects in human beings. An April 7 New York Times article said that many popular weight-loss and other supplements contain BMPEA, which has never been tested as a food additive.
  • Class action claims quinoa crisps were mislabeled as GMO-free. A class action filed on April 7 by a consumer in federal court in Florida claims that Natural & Tasty, a health food manufacturer, falsely represented that its products were free of genetically modified ingredients. Natural & Tasty packages its Goldbaum’s Quinoa Crisps as all natural and “GMO Free.” However, the lawsuit claims the barbecue-flavored crisps contain maltodextrin, whole grain corn flour, barbecue seasoning and vegetable oil, all of which are allegedly either artificial or modified genetically.
  • Leading scientists support labeling requirement for soda drinks. On April 8, many prominent public health scientists expressed support for proposed state legislation in California and New York to require warning labels on soda and other sugar-added drinks. They expressed concern that consumers be made aware of the significant risks of diabetes, obesity and tooth decay from excessive consumption of sugary drinks. The scientists’ letter was organized by the Center for Science in the Public Interest and the California Center for Public Health Advocacy. It emphasized the importance of the states’ role in ensuring consumers receive full information about products’ sugar content, if the federal government is not going to take action on the issue.
  • Developments around regulating “GRAS” foods. Four nonprofit groups – the Center for Science in the Public Interest, Consumers Union, the Natural Resources Defense Council and Environmental Working Group – have told the FDA its process for determining what substances are “generally recognized as safe,” or GRAS, violates the law. In a formal regulatory comment filed April 15, the groups say that in 1997 the agency weakened the standards for what can be considered GRAS and proposed a permanent regime for GRAS determinations that they say amounts to an illegal program of determinations by the food industry itself. According to the groups, the GRAS regime contravenes a 1958 law requiring FDA oversight to determine whether ingredients are safe before they can be used in food. Just five days later, Susan Mayne, director of the Center for Food Safety and Applied Nutrition at the FDA, said the agency is considering working with industry to add pre- and post-market enforcement “enhancements” to the final rule that will govern the process of determining whether food substances are GRAS, including streamlining and updating the process. She called on industry to ensure that GRAS self-determinations are based on solid, publicly available scientific data.
  • Vermont GMO labeling law stands, for now, while case continues. On April 27, US District Court Judge Christina Reiss denied the food industry’s early constitutional challenges to the Vermont law requiring labeling of food containing genetically modified ingredients, but she is allowing the case to proceed. The court ruled the plaintiffs, led by the Grocery Manufacturers Association, failed to plausibly allege the law must be struck down in its entirety on either First Amendment or due process grounds. In doing so, the court rejected the industry’s argument that food manufacturers would suffer irreparable harm if the statute were to go into effect. Nonetheless, the judge indicated that the plaintiffs are likely to succeed in some of their claims, including that the statute’s restriction on the word “natural” is invalid under the First Amendment. In response to the ruling, the Grocery Manufacturers Association said that it was pleased that the court “found us likely to succeed on several of our claims” but was disappointed at the denial of its request for a preliminary injunction. Unless the law is blocked or delayed, it is scheduled to go into effect on July 1, 2016. Regulations implementing the law were formally adopted by the state last week.
  • Chipotle discontinues use of GMO products in its restaurants. On April 27, Chipotle became the first major US restaurant chain to only prepare food that it says is free of genetically engineered ingredients. Major grocery chains and a few restaurants have also moved to eliminate GMO products, but it is unclear whether other major restaurant chains will follow Chipotle’s lead – particularly given the costs of non-GMO foods and the difficulty in obtaining them. Steve Ells, Chipotle’s founder and co-CEO, said, “This is another step toward the visions we have about changing the way people think about and eat fast food. Just because food is served fast doesn’t mean it has to be made with cheap raw ingredients, highly processed with preservatives and fillers and stabilizers and artificial colors and flavors.”