Category Archives Issue 370

The Baltimore City Health Department has reportedly issued its first environmental citation for repeat violations of the city’s trans fat ban. According to an October 25, 2010, press release, the department fined Healthy Choice $100 after inspectors twice found the Lexington Market food vendor using “a margarine product with trans fat levels in excess of 0.5 grams per serving.” “Businesses can make it easier for people to live healthier lives by simply replacing the use of partially hydrogenated vegetable oil with a healthier alternative,” Baltimore’s health commissioner was quoted as saying. “While we are pleased with the high rates of compliance we’ve seen since the ban took effect, we will continue to sanction businesses that repeatedly fail to comply.” See City of Baltimore Health Department Press Release, October 25, 2010.

A California resident has filed a putative class action against the company that owns the Breyers ice cream brand, alleging violations of consumer protection laws because its 23 chocolate-flavored products are labeled “All Natural” but also contain cocoa processed with alkali. Denmon-Clark v. Conopco, Inc., No. 10-7898 (C.D. Cal., filed October 20, 2010). According to the complaint, “Breyers Ice Cream products containing alkalized cocoa are processed with potassium carbonate which is a recognized synthetic substance.” While acknowledging that the Food and Drug Administration (FDA) does not directly regulate the use of the term “natural,” the plaintiff alleges that the agency has a policy that defines “the outer boundaries of the use of that term” and clarifies that “a product is not natural if it contains color, artificial flavors, or synthetic substances.” The plaintiff alleges that FDA requires products made with an “alkalization” process to include the statement “Processed with alkali.” Breyers’ website…

According to a news source, an appellate lawyer in California has submitted an amicus brief to the Ninth Circuit Court of Appeals, claiming that the state’s ballot initiative process, adopted 99 years ago, was improperly voted into law. He has asked the court to certify the question to the California Supreme Court. This issue arose in a case involving the validity of Proposition 8, a voter-approved ballot measure that banned same-sex marriage. A federal district court ruled that Proposition 8 violates the U.S. Constitution. If the process that led to the adoption of Proposition 8 is ultimately overturned, it could call into question the validity of Proposition 65, which has required manufacturers and retailers to warn consumers if their products contain chemicals known to the state to cause cancer or reproductive harm. The state has been considering in recent months how to effectively apply the law to the food industry.…

A judge from the U.S. Court of International Trade, sitting by designation in a New York federal district court, has determined that the obesity-related claims filed in 2002 against McDonald’s Corp. cannot be pursued as a class action. Pelman v. McDonald’s Corp., No. 02-7821 (S.D.N.Y., decided October 27, 2010). Essentially, the court found that individual causation issues predominated over common ones and that, as to any common issues, the plaintiffs had failed to show that the putative class was sufficiently numerous for the court to certify an issues class. A spokesperson reportedly indicated that the company was pleased with the decision, stating, “As we have maintained throughout these proceedings, it is unfair to blame McDonald’s for this complex social problem.” Teenagers alleging obesity-related health problems claimed that they were misled by the fast food chain’s deceptive advertising into believing that the food could be consumed daily without any adverse health effects.…

Washington State Attorney General Robert McKenna has issued an October 25, 2010, letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg, alleging that a recent incident involving alcoholic energy drinks (AEDs) sent nine college students to emergency rooms with alcohol poisoning. According to the letter, “Once at the hospital, medical staff found the blood-alcohol levels of the impacted students ranged from .123 percent (legally drunk) to .35 percent—a lethal level of alcohol poisoning… The investigation concludes that the students—all under 21 years old—combined AEDs with other kinds of alcohol.” Citing the October 8 police report, McKenna has claimed that the affected students were drinking an AED manufactured by Phusion Projects, LLC , known as “Four Loko,” which contains 12 percent alcohol and “high doses of caffeine and sugar.” Moreover, the letter continues, “The frightening incident… is hardly unique. In fact, AEDs are sweeping college campuses… Twenty-three students at New…

The European Commission (EC) has solicited feedback on its proposed definition of the term “nanomaterial.” In response to a European Parliament request, the EC’s draft recommendation recognizes the need for a definition “at the global level, to serve as a basis also for EU regulation and implementing measures and instruments.” The proposal defines a nanomaterial as that material which meets at least one of the following criteria: (i) it consists of particles with one or more external dimensions in the size range of 1 nanometer to 100 nanometers for more than 1 percent of their size distribution; (ii) it has internal or surface structures in one or more dimensions in the size range of 1 nanometer to 100 nanometers; or (iii) it has a specific surface area by volume greater than 60 square meters by per cubic centimeter, excluding materials consisting of particles with a size smaller than 1 nanometer.…

The Government Accountability Office (GAO) has just released a report that discusses how the Food and Drug Administration’s (FDA’s) new overseas food safety offices are functioning and offers recommendations for enhancing strategic planning and developing a workforce plan “to help recruit and retain overseas staff.” Titled “Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-Term Planning Is Needed,” the report was prepared for the House Committee on Oversight and Government Reform. According to the report, an FDA presence in foreign countries has improved the agency’s ability to build relationships with stakeholders abroad, to inspect foreign facilities and provide limited food safety training to overseas counterparts. Still, with only 42 total staff covering China, Europe, India, Latin America, and the Middle East, resources are apparently stretched and FDA has had some challenges with staffing. Foreign language capabilities and the domestic reintegration of staff serving abroad have apparently posed…

The Environmental Protection Agency’s (EPA’s) Science Advisory Board has scheduled a public teleconference on November 22, 2010, to conduct a quality review of a draft board report that analyzes EPA’s February 2010 toxicological review of inorganic arsenic. The board forwarded its review comments to EPA Administrator Lisa Jackson on October 25. Among other matters, the draft comments note that EPA has only partially responded to its 2007 suggestions about factoring background dietary intake of inorganic arsenic into its “assessment of lung and bladder cancer risk associated with exposures to arsenic in drinking water.” In this regard, the board recommends that EPA make “more transparent the scientific basis of the exposure assumptions used” and enhance “the rigor and transparency of the sensitivity analysis.” EPA’s review, which apparently proposes a 17-fold increase in cancer potency from oral exposure to inorganic arsenic, has been developed under the Integrated Risk Information System (IRIS), and the…

The U.S. Food and Drug Administration (FDA) has released a 10-year tracking report that calls for increased focus on food safety practices in retail food establishments. A companion 2009 retail food report highlights the need for certified food protection managers to help achieve higher food-safety compliance levels. The 1998-2008 tracking report, which studied more than 800 retail food establishments in 1998, 2003 and 2008, focused on five key risk factors: (i) food from unsafe sources, (ii) poor personal hygiene, (iii) inadequate cooking, (iv) improper holding of food (time and temperature), and (v) contaminated food surfaces and equipment. According to an FDA press release, “continued improvements are needed across the board” regarding personal hygiene, holding of food and food surfaces and equipment. The 2009 report found that the presence of a certified food protection manager in full-service restaurants, delicatessens, seafood markets, and produce markets was correlated with “statistically significant higher compliance…

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