The U.S. Food and Drug Administration (FDA) has filed a motion for reconsideration or stay of a court order establishing rulemaking deadlines under the Food Safety Modernization Act. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., Oakland Div., motion filed July 19, 2013). More information about the litigation appears in Issues 481, 487 and 489 of this Update. Scheduled to be heard on August 28, 2013, the motion contends that two of the seven rulemakings at issue, the sanitary transport rule and the intentional adulteration rule, pose challenges that preclude their issuance by the court’s deadline. Requesting that the court reconsider its order largely on the basis of arguments already rejected, the agency also asks the court to stay the order pending the Solicitor General’s determination whether to authorize an appeal and, if an appeal is authorized, while the appeal is pending.
The European Food Safety Authority (EFSA) has concluded that the sweetener advantame is safe for human consumption. Derived from aspartame and vanillin, advantame is reportedly 37,000 times sweeter than sugar and 100 times sweeter than aspartame and can be used to enhance flavors such as fruit, citrus and mint and to extend the sweetness duration in chewing gum. The agency has established an acceptable daily intake of 5 mg per kilogram of body weight per day. See ajinomoto.com.
Japan has reportedly announced that it will resume purchasing U.S. white wheat, ending a two-month suspension that was implemented after genetically engineered crops were found on an Oregon farm in April 2013. According to a news source, Japan imports nearly five million tons of wheat per year—60 percent of which comes from the United States—but does not allow genetically modified wheat. Purchases of western white wheat reportedly resumed on August 1, while purchases of soft white wheat for livestock feed will resume August 7. See japantoday.com, August 2, 2013.
The European Food Safety Authority (EFSA) has issued a draft assessment of consumer exposure to bisphenol A (BPA), provisionally concluding that “for all population groups diet is the major source of exposure to [BPA] and exposure is lower than previously estimated.” According to a July 25, 2013, news release, EFSA used exposure modeling and new human biomonitoring data to refine its estimate of dietary BPA exposure levels for infants and toddlers (375 nanograms per kilogram of body weight per day) as well as the general population above age 18 (132 ng/kg bw/day). In addition, the agency found that dietary BPA exposure was highest among children ages 3 to 10, “explainable by their higher food consumption on a body weight basis.” “By comparison, these estimates are less than 1% of the current Tolerable Daily Intake (TDI) for BPA (0.05 milligrams/kg bw/day) established by EFSA in 2006,” stated EFSA, which identified canned food and non-canned meat and meat…
The U.S Food and Drug Administration (FDA) has announced a public meeting of the Food Advisory Committee on September 23-24, 2013, in Silver Spring, Maryland. The committee plans to discuss detection signals for chemical hazards in foods, dietary supplements and cosmetics, and review information sources and chemical hazard data. FDA will accept comments until September 16, 2013. See Federal Register, July 23, 2013.
The U.S. Food and Drug Administration (FDA) has proposed two rules under the Food Safety Modernization Act (FSMA) for verifying foreign suppliers and accrediting third-party auditors. Part of the agency’s effort “to ensure that imported food meets the same safety standards as food produced in the United States,” the proposed rules would (i) require importers to verify “that their foreign suppliers are implementing modern, prevention-oriented food safety practices,” and (ii) “strengthen the quality, objectivity, and transparency of foreign food safety audits on which many food companies and importers currently rely to help manage the safety of their global food supply chains.” In particular, the rules establishing foreign supplier verification programs would hold U.S. importers responsible for ensuring that human and animal food produced abroad meets the safety standards set forth in the Federal Food, Drug, and Cosmetic Act and is neither adulterated nor misbranded “with respect to food allergen labeling.” In addition, FDA has proposed creating…
The U.S. Food and Drug Administration (FDA) has issued a final rule defining the term “gluten-free” for voluntary food labeling. Among other things, the rule defines “gluten-free” to mean that a food does not contain (i) an ingredient that is a gluten-containing grain (e.g., spelt wheat); (ii) an ingredient derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or (iii) an ingredient derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch). In addition, a food must contain less than 20 parts per million of gluten to use the term “gluten-free” on its label. According to FDA, a food that bears the claim “no gluten,” “free of gluten” or “without gluten” on its label and fails to meet the requirements for a “gluten-free” claim will be deemed misbranded. The rule will take effect 30 days after its publication in…
The U.S. Senate Committee on Commerce, Science, and Transportation conducted a July 31, 2013, hearing to consider issues relating to the purported marketing of energy drinks to children and the alleged adverse health effects attributed to the use of products with elevated levels of caffeine and other stimulants. Among those testifying were Red Bull North America, Inc. Vice President and General Manager Amy Taylor, Monster Beverage Corp. Chair and CEO Rodney Sacks and Yale University Rudd Center for Food Policy & Obesity Senior Research Scientist Jennifer Harris. Sens. Jay Rockefeller (D-W.Va.), Richard Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) challenged the companies’ marketing practices and referred to data showing a surge in emergency room visits from consumption of the products. The executives defended their products, saying they had been proven safe and were targeted to the 18- to 34-year-old market. Sen. John Thune (R-S.D.) thanked the chair for calling the hearing,…
A new study has reportedly detailed how a common gene variant linked to obesity affects the production and reception of ghrelin, the hormone responsible for stimulating hunger. Efthimia Karra, et al., “A link between FTO, ghrelin, and impaired brain food-cue responsivity,” Journal of Clinical Investigation, July 2013. According to a July 15, 2013, press release, in the first part of the study, researchers with University College London, the Medical Research Council and King’s College London Institute of Psychiatry analyzed ghrelin levels and other indicators of hunger from two groups of participants—those with the high obesity-risk FTO gene (AA group) and those with the low obesity-risk version (TT group)—who were perfectly matched for body weight, fat distribution and social factors such as education level. The results evidently showed that AA group participants not only reported feeling hungrier after a meal than their TT group counterparts, but had “much higher circulating ghrelin…
A pair of recent articles in The New York Times has raised questions about the tracking and surveillance practices used by marketers to gather information about consumers shopping in stores and online. The first article, “Attention, Shoppers: Store is Tracking Your Cell,” discusses new technology that allows retailers “to track customers’ movements by following the Wi-Fi signals from their smartphones.” According to Times writers Stephanie Clifford and Quentin Hardy, these stores are experimenting with a combination of smartphone tracking, video surveillance and apps to glean data about shoppers “as varied as their sex, how many minutes they spend in the candy aisle and how long they look at merchandise before buying it.” “But while consumers seem to have no problem with cookies, profiles and other online tools that let e-commerce sites know who they are and how they shop, some bristle at the physical version, at a time when government…
