Category Archives U.S. Government and Regulatory Agencies

The Humane Society of the United States (HSUS) has reportedly filed a complaint with the U.S. Federal Trade Commission (FTC) urging the agency to investigate Natural Pasteurized Eggs, producer of Davidson’s eggs, because the company allegedly keeps its “birds permanently locked in cages so tightly they can’t even spread their wings.” HSUS argues the packaging of Davidson’s eggs misleads consumers by featuring “lush open pastures, a red barn and free-roaming hens” even though those hens “never feel sunlight nor touch a blade of grass.” Further, HSUS asserts that the company “claims its process ‘eliminates the risk of Salmonella' from eggs even though caged hens are more likely to spread infection and disease.” According to the Chicago Tribune, FTC has not taken action on a complaint related to egg marketing since 1996. See HSUS Press Release and Chicago Tribune, October 14, 2016.   Issue 620

A California federal court has dismissed a lawsuit alleging the U.S. Department of Agriculture (USDA) and Department of Health and Human Services (HHS) allowed the American Egg Board to unduly influence the government’s nutrition advice on dietary cholesterol. Physicians Comm. for Responsible Med. v. Vilsack, No. 16-0069 (N.D. Cal., San Francisco Div., order entered October 12, 2016). Physicians Committee for Responsible Medicine (PCRM) filed the lawsuit following a change to the 2015 Dietary Guidelines that removed the recommended limit of 300 milligrams per day of dietary cholesterol; instead, the guidelines recommended consuming “as little dietary cholesterol as possible while consuming a healthy eating pattern.” PCRM alleged that the advisory body’s analysis and recommendations were compromised by the presence of scientists who had received funding from the American Egg Board or Egg Nutrition Center. The court assessed whether it had subject matter jurisdiction to consider PCRM’s claim by examining the underlying statutes…

The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) has completed a report reviewing nine allegations of misconduct asserted by Josh Tetrick, head of Just Mayo producer Hampton Creek, against the American Egg Board (AEB). The report concludes that AEB staff and board members engaged in inappropriate conduct, including failing to adhere to USDA guidelines, targeting a specific company and sending inappropriate emails. The report found substantiation for five of Tetrick’s nine allegations: (i) AEB employees exchanged inappropriate emails about Tetrick, including references such as, “Can we pool our money and put a hit on him?” and “old buddies from Brooklyn pay him a visit”; (ii) an AEB executive accepted a consultant’s offer to contact Whole Foods Market Inc. in an effort to persuade the company to stop stocking Just Mayo, although the consultant never actually contacted the company; (iii) a public relations expert conducted market research on egg-replacement products,…

The White House has issued a policy directive intended to promote “authorized engagements with Cuba to advance cooperation on areas of mutual interest, and increase travel to, commerce with, and the free flow of information to Cuba.” To this end, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) and the Department of Commerce’s Bureau of Industry and Security have announced amendments to the Cuban Assets Control Regulations and Export Administration Regulations that will lift restrictions on travelers bringing Cuba-origin alcohol, cigars and other products back to the United States for personal use. According to the announcement, OFAC considers “personal use” of imported merchandise “to include giving the item to another individual as a personal gift, but not the transfer of the item to another person for payment or other consideration.” In addition, the new rules permit a range of specific healthcare, humanitarian, trade, and commerce transactions, and…

A New York federal court has stayed a proposed class action alleging Kind LLC misleads consumers by describing its products as “all natural” and free of genetically modified organisms. In re Kind, No. 15-2645 (S.D.N.Y., order entered September 15, 2016). The court noted that the U.S. Food and Drug Administration (FDA) requested comments on the use of the term “natural” in food labeling in November 2015 and closed the comment period in May 2016, suggesting that FDA is “prepared to address the core issues in this case.” The plaintiffs voluntarily dismissed their claims that Kind’s use of “healthy” on its labels was misleading following FDA’s determination that it would permit Kind to use the term as the agency considers redefining it. Details on that determination appear in Issue 604 of this Update.   Issue 618

Shook Partner Frank Cruz-Alvarez and Associate Ravika Rameshwar have authored an article for the Washington Legal Foundation’s Legal Pulse discussing a New York federal court’s dismissal of a class action centered on infant formula marketed as organic. The complaint alleged that Abbott Laboratories, Inc. represented its Similac® Advance® as organic despite containing ingredients prohibited in organic products by the U.S. Department of Agriculture (USDA). Cruz-Alvarez and Rameshwar provide an overview of the case and detail the relevant provisions of the Organic Foods Production Act of 1990, which establishes that a product can be labeled “organic” if a USDA-accredited agency certifies it as such. The court compared the infant formula allegations to a U.S. Court of Appeals for the Eighth Circuit case challenging the organic label of milk and reached an analogous conclusion: the state laws supporting the complaint challenged the federal law’s certification determination and were thus preempted. Accordingly, the…

The U.S. Food and Drug Administration (FDA) has published a September 2016 Consumer Update describing how to determine if a product contains real maple syrup as a flavoring agent. Specifically, the agency urges consumers to look at the ingredient list for the term “maple syrup” and not rely solely on depictions of maple leaves or the word “maple” displayed on the front of packaging. “Current regulations allow use of terms like ‘maple,’ ‘maple-flavored,’ or ‘artificially maple-flavored’ on the food label without having any maple syrup in the product, as long as it contains maple flavoring,” clarifies FDA. “This flavoring could come from a number of sources, including sap or bark from the maple tree. Or it could come from the herb fenugreek, which can impart a maple-like flavor.” Noting that similar rules apply to some fruit flavorings, the agency explains that terms such as “artificial flavors” or “natural and artificial…

The U.S. Food and Drug Administration (FDA) has opened a docket and released industry guidance on the use of the term “healthy” in the labeling of human food products. Responding to Kind LLC’s citizen petition asking the agency to align its nutrient content claim regulations with federal dietary guidance, FDA invites “public comment on the term ‘healthy’, generally, and as a nutrient content claim in the context of food labeling.” Current regulations reportedly establish “the parameters for use of the implied nutrient content claim ‘healthy’ or related terms… on the label or in labeling of a food to suggest that a food, because of its nutrient content, may be useful in creating a diet that is consistent with dietary recommendations, if the food meets certain nutrient conditions, and the claim is made with an explicit or implicit claim or statement about a nutrient.” Among other things, the conditions take into…

A California federal court has denied the U.S. Department of Agriculture’s (USDA’s) motion to dismiss a lawsuit brought by several activist groups challenging aspects of the Organic Food Production Act’s sunset provision, which governs when substances are removed from the National List. Ctr. for Food Safety v. Vilsack, No. 15-1590 (N.D. Cal., order entered September 8, 2016). The plaintiffs objected to how USDA changed the process to remove a substance from the List, which documents permitted synthetic substances and prohibited non-synthetic substances in the production of organic food. Details about the complaint appear in Issue 561 of this Update. The court first determined that the plaintiff groups had standing to sue, then considered whether it had subject matter jurisdiction. USDA argued the sunset notice changes were not part of a final agency action, but the court determined the question of jurisdiction and the merits of the action were so intertwined…

Several consumer-protection groups, including the Natural Resources Defense Council (NRDC) and the Center for Science in the Public Interest (CSPI), have filed a citizen petition with the U.S. Food and Drug Administration (FDA) urging the agency to withdraw approval of seven antibiotics for disease prevention and growth-promotion use in livestock and poultry. “The use of medically important antibiotics in livestock production for growth-promotion or disease-prevention purposes is not shown to be safe,” the September 13, 2016, petition asserts. “FDA’s voluntary program will not end these drug uses. FDA must immediately begin proceedings to withdraw approval for these uses.” The day before the groups filed the petition, FDA announced a comment period about therapeutic uses of medically important antimicrobials. The agency seeks information about (i) “[t]he underlying diseases requiring these drugs for therapeutic purposes, and periods when livestock or poultry are at risk of developing these diseases”; (ii) “[m]ore targeted antimicrobial…

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