The Food and Drug Administration (FDA) has requested public comments on how the agency can increase transparency in its interactions with regulated industry. According to a March 12, 2010, FDA press release, the agency regulates products responsible for approximately 25 percent of the U.S. gross national product, as well as overseeing the industries that manufacture these items, which include foods, veterinary medicines, human drugs, and medical devices. FDA’s Internal Transparency Task Force, which already held public meetings in 2009, is developing “recommendations for making information about FDA activities and decisions more useful, understandable, and readily available, while protecting confidential information.” Representing FDA’s third and final phase of its transparency initiative, the latest request particularly seeks ideas on how the agency can (i) improve training and education for regulated industry about its regulatory process in general and about specific new requirements, (ii) strengthen the guidance development process, (iii) maintain open channels of…
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The Food and Drug Administration (FDA) has reportedly met with spice industry representatives to consider ways to make spices safer amid a nationwide Salmonella outbreak linked to black and red pepper. According to a news source, FDA wants companies to prevent contamination by using one of three methods to rid spices of bacteria: irradiation, steam heating or fumigation with the pesticide ethylene oxide. The American Spice Trade Association is expected to address the issue at its annual meeting to be held April 25-28, 2010, in Naples, Florida. Although FDA does not possess authority to order manufacturers to treat their products, the agency recently reaffirmed its intention to take a closer look at spice handling “from farm to table” and to create a spice risk profile focusing on “microbiological contaminants and filth issues related to spices.” As FDA stated in a March 17, 2010, press release, this risk profile will help determine…
The U.S. Environmental Protection Agency (EPA) has submitted comments to USDA’s Animal and Plant Health Inspection Service (APHIS) indicating that it “does not object” to APHIS’s draft environmental impact statement (EIS) on genetically engineered (GE) alfalfa, prepared by court order after a successful court challenge to USDA’s decision to deregulate the bioengineered seed. Environmentalists convinced the court that APHIS erred in allowing GE alfalfa to be grown without conducting a detailed environmental review; they claimed that it would have deleterious effects on the environment and affect the livelihood of farmers who grow conventional or organic alfalfa. An injunction has been in place preventing the sale of GE alfalfa seed or its cultivation until the EIS is finalized. EPA did call for clarification to the EIS Surface Water discussion, which indicates that “glyphosate and its metabolite aminomethyphosphonate can be removed through standard water purification and disinfection processes such as ozonation and…
U.S. Senator Kirsten Gillibrand (D-N.Y.) has introduced legislation (S.B. 3114) that would require food distributors, retailers and health agencies to notify consumers and local officials in the event of a Class I food recall. Under the Consumer Recall Notification Act, the Food and Drug Administration (FDA) could ask grocery stores and other retailers to provide “on-site notification” where recalled foods are sold. In addition, purveyors that track data through customer card systems would need to alert, by phone and mail, the purchasers of recalled items or risk civil penalties of $100 per customer. Suppliers would also need to notify “applicable retail establishments and restaurants” within 24 hours of a Class I recall to avoid a $1,000 penalty per day, per notification of each level of distribution. “In America, in 2010, it is unconscionable that we don’t have an effective way to communicate food-borne illness outbreaks to consumers and health departments,”…
A recent psychology study has reportedly suggested that children younger than age 5 “have emerging knowledge of brands that are relevant in their lives.” Anna McAllister and T. Bettina Cornwell, “Children’s Brand Symbolism Understanding: Links to Theory of Mind and Executive Functioning,” Psychology & Marketing, March 2010. Noting previous research suggesting that “brand symbolism understanding does not develop until 7 to 11 years of age,” the study authors nevertheless found that younger children not only recognize brands, but are already beginning to understand brands “as social systems.” McAllister and Cornwell first asked 38 children ages 3 to 5 to identify brand name logos for 50 brands across 16 product categories, including fast food. The researchers then interviewed 42 3-to-6 year olds to determine their brand symbolism understanding. “Surprisingly, there were children as young as 3 who were making very strong judgments when comparing McDonald’s and Burger King,” one author was quoted…
The U.S. Government Accountability Office (GAO) recently released a report criticizing the Food and Drug Administration’s (FDA’s) oversight of food ingredients determined to be generally recognized as safe (GRAS). Noting that companies are not required to submit their GRAS determinations to regulators, GAO examined whether FDA can vouch for these substances, which increasingly include nanomaterials. The report apparently concludes that not only does FDA’s oversight process fail to ensure the safety of both new and preexisting GRAS determinations, but it allows engineered nanomaterials to enter the food supply without the agency’s knowledge. According to the report, FDA “has not systematically reconsidered GRAS substances since the 1980s,” nor has it responded to “concerns about GRAS substances, such as salt and the trans fat in partially hydrogenated vegetable oils, that individuals and consumer groups have raised through 11 citizen petitions submitted to the agency between 2004 and 2008.” The findings also fault…
Researchers at Yale School of Medicine have reportedly claimed in a new study that exposure to the food packaging chemical bisphenol A (BPA) during pregnancy can cause permanent abnormalities in the uterus of offspring, including altering their DNA. Jason G. Bromer, et al, “Bisphenol-A exposure in utero leads to epigenetic alterations in the developmental programming of uterine estrogen response,” Journal of the Federation of American Societies for Experimental Biology (March 2010). According to a March 8, 2010, Yale University press release, the study is the first to show that BPA exposure permanently affects sensitivity to estrogen. Using two groups of mice, one exposed to BPA as a fetus during pregnancy and another exposed to a placebo, researchers examined gene expression and the amount of DNA modification in the uterus. Results showed that the mice exposed to BPA as a fetus had an exaggerated response to estrogens as adults, long after the…
The Center for Science in the Public Interest (CSPI) has issued a report card that rates 128 companies for their policies on marketing food to children. According to CSPI, most of the food makers, restaurants and entertainment companies failed “either for having weak policies or for failing to have any policies whatsoever.” Based on research conducted in summer 2009, the report found that industry spends some $2 billion on youth marketing annually. Grades in the “Report Card on Food-Marketing Policies” ranged from a B+ for Mars, Inc., for its policy to exclude marketing to children ages 12 and younger, to an F for Denny’s “for marketing to children through its children’s menu, which includes many nutritionally poor items; games on its Web site; and a kid’s birthday club.” In all, seven of the companies earned a D, and 95 received an F. “Despite the industry’s self-regulatory system, the vast majority…
A European Court of Justice adviser has determined that Monsanto Co. cannot seek royalties from a company that imported from Argentina soy meal containing residues of Monsanto’s patented gene. Case C-428/08, Monsanto Tech. LLC v. Cefetra BV (Op. of Advocate Gen. Mengozzi, delivered March 9, 2010). Monsanto has no patent on its Roundup Ready® soybeans in Argentina. In 2005 and 2006, the company had shipments of soy meal from Argentina impounded in Amsterdam harbor, and testing showed that it contained some of the seed traits that Monsanto has patented in the European Union (EU). The company then sued the importers for infringement, and a Dutch court hearing the dispute sought guidance from the EU tribunal. Disagreeing with Monsanto, which argued that its EU patent covers the DNA sequence, the adviser opined that under Directive 98/44, “a DNA sequence must be regarded as protected, even as a self-standing product, only where it…
Over the past two years, little has taken place in Pelman v. McDonald’s Corp., the putative class action litigation brought in 2002 on behalf of obese and overweight teenagers who alleged that the fast food restaurant is responsible for their weight-related health conditions. On March 10, 2010, the case was reassigned to U.S. District Court Judge Donald Pogue. Since Judge Robert Sweet recused himself in 2008 from the case he had heard through two trips to the U.S. Court of Appeals, the matter has been passed to three different judges. Currently pending before the court is plaintiffs’ motion to certify the class. Pelman v. McDonald’s Corp., 02-7821 (S.D.N.Y., filed September 30, 2002).
