Category Archives Legislation, Regulations and Standards

Responding to a lawsuit filed by the Center for Science in the Public Interest (CSPI) and the Mercury Policy Project (MPP), the U.S. Food and Drug Administration (FDA) will soon update guidance on the permissible levels of mercury in seafood and the associated potential risks for pregnant women and young children. While CSPI and MPP urged the agency to mandate mercury-level labeling on seafood and at fish counters in grocery stores, FDA Commissioner Margaret Hamburg said that labels would not be mandated under its forthcoming guidelines. Previous guidance issued in 2010 indicated that pregnant women should limit seafood intake to less than 12 ounces weekly and discouraged consumption of shark, swordfish, tilefish, and king mackerel. See Associated Press, May 30, 2014.   Issue 525  

The U.S. Food and Drug Administration has announced a June 26, 2014, public meeting in Washington, D.C., to discuss two proposed rules aimed at updating nutrition information and serving size requirements on Nutrition and Supplement Fact labels. Introduced 20 years ago, the Nutrition and Supplements Facts labels “help consumers make informed food choices and maintain healthy dietary practices.” Among others, the agency has proposed the following changes: (i) to require information about “added sugars”; (ii) to update daily values for nutrients such as sodium, dietary fiber and Vitamin D; (iii) to require manufacturers to declare potassium and Vitamin D amounts on the label, because they are new “nutrients of public health significance”; (iv) to change the serving size requirements to reflect how much people “actually” eat; (v) to require that packaged foods, including drinks, that are typically eaten in one sitting be labeled as a single serving and that calorie…

In response to Affordable Care Act provisions, requiring restaurants and similar retail food establishments to provide calorie and other nutrition information for menu items, U.S. Sen. Claire McCaskill (D-Mo.) and a bipartisan group of senators have reportedly requested that the Office of Budget and Management (OMB) review nutrition labeling regulations to “ensure that any measures adopted will allow flexibility for restaurants and avoid unnecessarily burdening food retail establishments where nutrition information is already prevalent.” “Since FDA published its proposed rule to implement nutrition labeling of standard menu items at chain restaurants, many concerns have been raised about the regulations expanding to non-restaurants, such as grocery and convenience stores, where the vast majority of food products are already labeled with nutritional information,” wrote the senators in a May 30, 2014, letter to OMB Administrator Howard Shelanski. “The proposed rule also could affect restaurants with highly variable items or different food service…

In a putative class action alleging that a food company misled its customers by using the term “evaporated cane juice” (ECJ) instead of “sugar” on its labels, a California federal court has followed the lead of several other courts in recent decisions by dismissing the case without prejudice under the primary jurisdiction doctrine—this time, reversing its previous decision to allow the case to move forward. Swearingen v. Yucatan Foods LP, No. 13-3544 (N.D. Cal., order entered May 20, 2014). Guacamole producer Yucatan Foods had argued that the U.S. Food and Drug Administration (FDA) had primary jurisdiction over the matter, but Judge Richard Seeborg initially disagreed, finding that FDA had taken no action on ECJ since 2009 and thus that the agency considered the matter settled. On March 5, 2014, one month after the Yucatan decision was filed, FDA announced that it would reevaluate its previous draft ECJ guidance. Following the…

The World Health Organization (WHO) has released a report on the purported harmful effects of alcohol in 194 WHO member states. The agency attributes 3.3 million deaths in 2012 to the harmful use of alcohol, and it found that the 38.3 percent of the world’s population that drinks alcohol consumes an average of 17 liters of pure alcohol each year. The report highlighted the need for WHO member states to take action in the form of national alcohol policies, awareness-raising activities and health services for prevention and treatment of alcohol related diseases. WHO attributes higher risk of developing more than 200 diseases to alcohol use and further notes that harmful use can lead to higher susceptibility to infectious diseases such as tuberculosis and pneumonia. “More needs to be done to protect populations from the negative health consequences of alcohol consumption,” said WHO Assistant Director General for Noncommunicable Diseases and Mental…

As the World Health Assembly opened its 67th session in Geneva, World Health Organization (WHO) Director-General Margaret Chan reportedly expressed her deep concern about the increasing incidence worldwide in childhood obesity, stating, “Our children are getting fatter.” Chan announced the formation of a high-level Commission on Ending Childhood Obesity. Chaired by Peter Gluckman, the chief science advisor to New Zealand’s prime minister, the commission will produce a consensus report detailing measures that would be most effective in addressing the issue in different countries around the world. Its recommendations will be announced during the 2015 World Health Assembly. Two international membership bodies called on governments convening in Geneva to develop a global convention to address obesity, similar to the legal framework for tobacco control. The World Obesity Federation and Consumers International (CI) have launched their campaign by calling for controls on food marketing, improvements to nutrition information labels, the reformulation of…

The Netherlands and Sweden have issued a discussion paper arguing that labeling food with “best before” dates results in unnecessary food waste and that European Union (EU) requirements should be adjusted to allow some foods to be sold without them. The paper, which Germany, Denmark, Austria, and Luxembourg also back, echoes a report published in April 2014 by the U.K.’s House of Lords EU Committee urging the development of “aspirational targets for each level of the supply chain” to reduce food waste in Europe. According to the European Commission (EC), up to 100 million metric tons of food are wasted each year in Europe, and a 2013 report from the London based Institution of Mechanical Engineers found that 30 to 50 percent of food on shelves is wasted, possibly due to poor understanding of “best before” and “use by” dates. The EC said that it is examining possible avenues of…

According to a new Animal Welfare Institute (AWI) report titled “Label Confusion: How ‘Humane’ and ‘Sustainable’ Claims on Meat Packages Deceive Consumers,” the U.S. Department of Agriculture (USDA) fails to verify the accuracy of label claims on most meat and poultry products sold in the United States. The report suggests that food label claims used on millions of meat packages lack “any apparent verification,  and AWI has asked USDA to require independent third-party certification. Noting that the use of animal welfare and sustainability claims has increased dramatically during the past decade as consumers become more aware of—and concerned about—the well-being of animals raised for food and the purported negative impacts of animal agriculture on the environment, AWI contends that the public’s interest in these claims makes them ripe for exploitation. During the past three years, AWI researched the USDA approval process for 25 animal welfare and environmental claims, such as…

Despite its seven-year investigation into jerky pet treats that may have killed more than 1,000 dogs and left thousands more ill, the U.S. Food and Drug Administration (FDA) “has still not been able to identify a specific cause for the reported illnesses or deaths.” According to an FDA news release, as of May 1, 2014, the agency had received more than 4,800 complaints of illness in pets that ate jerky treats made of chicken, duck or sweet potato. In its ongoing efforts to find a cause for the illnesses, FDA has partnered with the Centers for Disease Control and Prevention to conduct a study to determine whether sick dogs eat more jerky treats than healthy dogs do. Studies of the jerky treats revealed the presence of the antiviral drug amantadine, but “FDA does not believe that amantadine contributed to the illnesses because the known side effects or adverse effects associated…

U.S. Sens. Lamar Alexander (R-Tenn.), Richard Burr (R-N.C.), Johnny Isakson (R-Ga.), and Orrin Hatch (R-Utah) have sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg expressing “significant concern” about the agency’s use of draft guidance to, in their view, make “substantive policy changes.” Noting that draft guidance is “increasingly becoming default FDA policy” although it is issued for comment purposes only, the letter expresses a number of concerns, including that (i) FDA’s website does not differentiate between draft and final guidance; (ii) draft guidance is not revised, finalized or withdrawn in a timely manner; and (iii) the agency issues guidance that “does not take into account, or may even conflict with, the scientific community.” Specifically, the senators request that FDA provide a list of all Level I draft guidances, including the date issued and the timeline on which the agency plans to withdraw, revise or finalize each guidance,…

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