The Oversight and Investigations Subcommittee of the House Energy and Commerce Committee held a hearing on May 6, 2010, to consider food safety reports prepared by the Government and Accountability Office (GAO) and the Inspector General of the Department of Health and Human Services (HHS). Both the GAO report and testimony from an Inspector General administrator focused on Food and Drug Administration (FDA) and other agency weaknesses in ensuring that imported foods are safe and domestic food facilities are subject to meaningful inspection in terms of frequency and breadth. According to Subcommittee Chair Bart Stupak (D-Mich.), the hearing marked the 12th conducted since January 2007 to consider food contamination issues. He concluded his remarks by stating, “We are fortunate that today’s hearing was prompted by the HHS and GAO reports rather than another widespread food contamination outbreak like we saw with spinach in 2007, peppers in 2008 and peanut butter…
Category Archives U.S. Government and Regulatory Agencies
A federal court in Colorado has dismissed as premature a medical provider’s challenge to Food and Drug Administration (FDA) regulations potentially applicable to its medical procedures because the agency had issued only a warning letter against it, and warning letters are not final. Regenerative Sciences, Inc. v. FDA, No. 09-411 (D. Colo., decided March 26, 2010). The court’s analysis of the non-final nature of FDA warning letters may have some relevance in those consumer fraud actions against food makers citing such letters to establish a fact or using them as definitive evidence of wrongdoing or a violation of the law. The agency itself acknowledged that its warning letters do not constitute a determination that a particular statute or regulation applies to the specific circumstances that led FDA to issue the letters, noting “this is a factual issue that cannot be resolved until FDA brings an action against” the letter recipient.
Oral argument in litigation over whether the U.S. Department of Agriculture (USDA) properly deregulated a genetically engineered (GE) alfalfa seed took place before the U.S. Supreme Court on April 27, 2010. Monsanto Co. v. Geertson Seed Farms, No. 09-475 (U.S.). The Ninth Circuit imposed a ban on use of the GE seed until the USDA completes an environmental impact statement that accounts for potential contamination of conventional alfalfa crops. While several justices questioned the appellate court’s authority to fully ban the product’s sale, Justice Antonin Scalia contended that GE crop planting “doesn’t even destroy the current plantings of non-genetically engineered alfalfa. This is not the end of the world. It really isn’t. The most it does is make it difficult for those farmers who want to cater to the European market, which will not accept genetically engineered alfalfa.” According to press reports, environmentalists and agribusiness, watching the case closely, filed…
The National Milk Producers Federation has filed a petition with the Food and Drug Administration (FDA), calling on the agency to “significantly increase enforcement efforts to prevent the misbranding of certain food items that are imitations of standardized dairy products.” The federation claims that soy-, hemp-, almond- and rice-based products are marketed to consumers as “milk,” “cheese,” “ice cream,” and “yogurt,” but “do not meet the legal standard of identity for those standardized dairy products.” The petition cites several FDA warning letters sent to producers of products advertised as milk or cheese but not containing any “milk,” defined by federal law as the “lacteal secretion, practically free of colostrums, obtained by the complete milking of one or more healthy cows.” The federation contends that FDA’s lack of enforcement has resulted in the “traditional retail dairy case” becoming “a chaotic center of misbranded products and false and misleading labeling,” that threatens…
The Food and Drug Administration (FDA) has established a docket to obtain comments and other data related to point-of-purchase nutrition information, including front-of-pack (FOP) labeling and shelf tags. According to an April 29, 2010, press release, FDA wants to learn more about (i) “the extent to which consumers notice, use and understand nutrition symbols” on these types of labels; (ii) “research that assesses and compares the effectiveness of particular approaches to front-of-pack labeling”; (iii) “graphic design, marketing and advertising data and information that can help develop better point-of-purchase information”; and (iv) “how point-of-purchase information may affect decisions by food manufacturers to reformulate their products.” The agency will use this feedback to inform its deliberations about “approaches to enhancing the usefulness to consumers of point-of-purchase nutrition information.” The docket is part of ongoing efforts to reassess FOP regulations under the Nutrition Labeling and Education Act of 1990. FDA has stated that…
Without a Senate-confirmed leader for the U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS), target dates for ongoing rulemakings have apparently slipped in recent months. In January 2010, President Barack Obama (D) nominated Elisabeth Hagen to serve as USDA’s Under Secretary of Agriculture for Food Safety, but the Senate has failed to act on the nomination. According to USDA’s April 26, 2010, semiannual regulatory agenda, FSIS, which is responsible for the safety of meat, poultry and egg products, has completed only one rulemaking over the past six months, missing all 11 target dates set in its October 2009 agenda. Among the agency’s pending rules is a pathogen-reduction performance standard for all ready-to-eat and partially heat-treated meat and poultry products to control Listeria monocytogenes. It was initially proposed in 2001. See Federal Register, April 26, 2010; OMB Watch, April 28, 2010.
The U.S. Department of Agriculture’s (USDA’s) National Organic Program (NOP) has announced that its 2006 decision approving the fortification of organic infant formula and organic milk products with synthetic omega-3 fatty acid DHASCO (DHA) and omega-6 fatty acid ARASCO (ARA) resulted from an incorrect interpretation of nutritional guidelines and NOP board recommendations. Thus, DHA and ARA, present in 90 percent of organic infant formulas, will no longer be permitted in foods certified as organic, and NOP plans to issue draft guidance, subject to a 60-day public comment period, to “provide a transition time for businesses to reformulate products to comply with the regulations.” Organics watchdog Cornucopia Institute recently re-filed a complaint with the NOP contending that the use of DHA and ARA in organic infant formulas and organic dairy foods constitutes a possible violation of NOP regulatory standards. The institute claimed that a former NOP director overruled the determination of…
The U.S. Department of Agriculture (USDA) and Department of Health and Human Services (HHS) have announced the sixth and final meeting of the Dietary Guidelines Advisory Committee, which is soliciting public comment on its draft report titled “Dietary Guidelines for Americans.” USDA and HHS publish the report at least every five years “after a thorough review of the most current scientific and applied literature.” Topics to be discussed in the May 12, 2010, meeting include (i) “Nutrient Adequacy”; (ii) “Energy Balance and Weight Management”; (iii) “Carbohydrates and Protein”; (iv) “Sodium, Potassium and Water”; (v) “Fatty Acids and Cholesterol”; (vi) “Alcohol”; and (vii) “Food Safety and Technology.” Comments are requested by April 29, 2010. See Federal Register, April 20, 2010.
The Cornucopia Institute has called for action by the U.S. Department of Agriculture (USDA) and the Federal Trade Commission (FTC) to stop what it alleges is the misleading practice of companies using the word “organic” in their names while selling foods not certified organic. In its April 22, 2010, letter to the USDA’s deputy administrator, the institute contends that the agency has the authority “to take enforcement action against the misuse of the term ‘Organic’ in company names.” It specifically cites Oskri Organics, Organic Bistro and Newman’s Own Organics as companies that sell a variety of food products some of which, but not all, are certified organic. According to the institute, this practice “is not only highly misleading to consumers, but also in violation of the organic standards.” The letter addressed to the FTC chair calls the practice a violation of unfair competition law and calls for a formal investigation…
A coalition of groups representing farmers, public health, environmental, and organic food interests has submitted a comment to the Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) seeking changes to the draft position on labeling genetically modified (GM) products that the U.S. Codex delegate plans to bring to the May 3-7, 2010, meeting of the Codex Committee on Food Labeling. The coalition calls for the U.S. delegate to support “a Codex document that simply states that countries can adopt different approaches to labeling of GM/GE foods, in line with existing Codex guidance.” According to the April 20 letter, the current U.S. position opposing that document “could potentially create significant problems for food producers in the US who wish to indicate that their products contain no GE ingredients, including on organic food, where genetic engineering is a prohibited method.” The signatories, including the Consumers Union, Union of Concerned…
