U.S. Food and Drug Administration (FDA) researchers recently presented dietary exposure assessments for 4-methylimidazole (4-MEI) at the 248th American Chemical Society (ACS) National Meeting held August 10-14, 2014, in San Francisco. Contributing to FDA’s review of available toxicological data for 4-MEI found in Class III and IV Caramel colors produced using ammonium compounds, the scientists analyzed 4-MEI levels of caramel-containing foods and beverages using liquid chromatography-tandem mass spectrometry, then relied on intake data from the National Health and Nutrition Examination Survey (NHANES) to estimate dietary exposure levels for the following U.S. population groups: (i) “the U.S. population aged 2 years or more”; (ii) “infants (< 1 year old)”; (iii) “children aged 1 year”; (iv) “children aged 2-5 years”; (v) “children aged 6-12 years”; and (vi) “teenage boys aged 12-18 years.” According to the presentation poster, the caramel-containing food categories contributing more than 1 percent “to the cumulative dietary exposure to 4-MEI…
Category Archives Issue 535
Discussing the expedited approval process for food additives that took effect 17 years ago, U.S. Food and Drug Administration (FDA) Deputy Commissioner for Food Michael Taylor recently told Washington Post reporter Kimberly Kindy that the agency does not have “the information to vouch for the safety of many of these chemicals.” According to the August 17, 2014, article, the number of additives in the food supply has increased to 9,000 from 800 over a 50-year span, in part because a voluntary certification system dependent on industry safety data has eclipsed FDA’s independent review process. Under the Generally Recognized as Safe (GRAS) scheme, companies need only submit a summary of their safety research to FDA, shortening time to approval even for new and novel food additives. In particular, the Post highlights how a mycoprotein marketed as “Quorn” achieved GRAS status despite one undisclosed study allegedly showing that 5 percent of test…
Michael Specter has profiled “the Gandhi of grain,” Vandana Shiva, in a piece for the New Yorker that describes her as “a hero to anti-[genetically modified organisms (GMOs)] activists everywhere” while criticizing her inflammatory methods and unscientific arguments. Specter chronicles many of Shiva’s recent provocative statements—including a speech calling fertilizer “a weapon of mass destruction” and a tweet comparing GMOs on organic farms to rape—and attempts to debunk a few of her positions. In March 2014, Shiva told a Winnipeg food-rights group that GMOs and their associated herbicides caused the rise in autism, and Specter argues that she had merely confused causation with correlation, pointing out that the rise in autism also correlates with the sale of organic produce, the sale of high-definition televisions and the number of Americans who commute to work each day by bicycle. In addition, Shiva has apparently stated that the use of GM cotton in…
California-based ChangeLab Solutions, an interdisciplinary public health advocacy group focused on policy reform, is holding a September 24, 2014, Webinar to discuss the potential impact of mandatory warning labels on sugar-sweetened beverages in reducing the rates of youth and adult obesity and diabetes. Webinar panelists will reportedly discuss lessons learned from failed California legislation (S.B. 1000) that would have required such warnings on SSBs, resources for driving similar strategies at the state and local level, and SSB warnings’ impact on the health of communities of color. Program faculty will include a senior staff attorney at ChangeLab Solutions, the executive directors of the California Center for Public Health Advocacy and Latino Coalition for a Healthy California, and the director of health promotion policy at Center for Science in the Public Interest. To learn more about the event, please click here. Issue 535
In its October 2014 issue, Consumer Reports will publish an analysis of the U.S. Food and Drug Administration’s (FDA’s) data that supported the agency’s recommendations for fish intake by pregnant women and children, released jointly as draft guidance with the U.S. Environmental Protection Agency (EPA) in June 2014. The magazine compiled a list of low-mercury—including haddock, trout, catfish, and crab—and lowest-mercury fish—including shrimp, tilapia, oysters, and wild and Alaska salmon—and detailed the amounts considered safe for consumption for young children and women of childbearing age. The guide includes more conservative advice than the draft guidance from FDA and EPA, such as recommending that most women and young children avoid marlin and orange roughy in addition to the listed swordfish, shark, king mackerel, and gulf tilefish. The magazine cites Deborah Rice, co-author of the EPA document that established the current limit on methylmercury consumption as 0.1 microgram per kilogram of body weight…
The U.S. Public Interest Research Group (PIRG) Education Fund has published a white paper titled “Ending the Overuse of Antibiotics in Livestock Production: The Case for Reform.” Contending that the use of antibiotics in healthy animals to accelerate their growth or “prevent disease caused by unhealthy and unsanitary conditions” has accelerated the development of antibiotic-resistant bacteria, the paper calls on the U.S. Food and Drug Administration (FDA) to act immediately to restrict the use of antibiotics in livestock production. According to the consumer-interest group’s paper, the U.S. Centers for Disease Control and Prevention has found that some 2 million Americans are sickened each year by drug-resistant bacteria, and of those, 23,000 die. The paper also states that more than “70% of antibiotics in classes used in human medicine are sold for use in food animals.” FDA data reportedly indicate that in 2011, 29.9 million pounds of antibiotics were sold in the…
Shook attorneys Ann Havelka and Ryan Farnsworth have authored an August 18, 2014, Law360 article detailing “the first major overhaul of the nation’s poultry inspection system in nearly 60 years.” Describing the voluntary and mandatory aspects of the final rule issued by the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), the article provides an overview of the regulations most likely to affect industry as the onus for inspection shifts from government agencies to business operators. FSIS officially published the final rule in the August 20, 2014, edition of the Federal Register. Additional information about the regulations appears in Issue 532 of this Update. Issue 535
Two residents of Berkeley, California, have filed a lawsuit in state court alleging that the proposed 1-cent-per-ounce soda tax, which will appear on the ballot in November, uses “politically charged” language and affects beverages beyond the targeted “high-calorie, sugary drinks.” Johnson v. Numainville, No. RG14786763 (Cal. Super. Ct., Alameda Cty., filed August 13, 2014). The complaint accuses the city council of failing to define the term “high calorie, sugary drink,” and suggests “sugar-sweetened beverage” instead. The plaintiffs also argue that the tax would apply to “any beverage intended for human consumption to which one or more added caloric sweeteners has been added and that contains at least 2 calories per fluid ounce,” despite that under U.S. Food and Drug Administration guidelines, a 12-ounce, 24 calorie drink would actually be considered low calorie. They request that the court order the city council to insert their suggested phrases for the allegedly biased…
Attorneys representing the former Peanut Corp. of America owner and employees charged with conspiracy, mail and wire fraud, obstruction of justice and other counts involving the distribution of adulterated or misbranded food that allegedly led to a deadly Salmonella outbreak, had their opportunity on August 19, 2014, to cross-examine the company’s Blakely, Georgia, plant manager, Samuel Lightsey, who has been testifying as a government witness. United States v. Parnell, No. 13-cr-12 (M.D. Ga., Albany Div., filed February 15, 2013). Among other matters, the attorneys reportedly focused on the plea deal Lightsey struck with prosecutors; he was facing more than 30 years in prison, but could serve no more than six or go free if he substantially helps prosecute others. They also sought to show that (i) former owner Stewart Parnell was concerned about safety, (ii) Lightsey was responsible for plant safety, (iii) extensive retesting of samples positive for Salmonella came…
The parties to a putative class action against Merisant Co. and Whole Earth Sweetener Co. have agreed on settlement terms, including changes to the Pure Via sweetener’s website and packaging, class certification and a $1.65- million payment to a settlement fund. Aguiar v. Merisant Co., No. 14-670 (C.D. Cal., motion filed August 18, 2014). The plaintiff had alleged that Merisant and Whole Earth label, advertise and market Pure Via products as natural, which she argued was false and deceptive. Under the terms of the proposed settlement, Merisant and Whole Earth agreed to add an asterisk to Pure Via packaging with a statement that directs consumers to the product website, which will explain the process of producing Pure Via from stevia to provide consumers with “significant information to make their own determination as to whether they deem Pure Via to be ‘natural.’” In addition, Merisant and Whole Earth have agreed to…
