The Institute of Medicine (IOM) this week published a consensus report titled Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, which urges the Food and Drug Administration (FDA) to apply “the same degree of scientific rigor for evaluating biomarker use across regulatory areas, including drugs, medical devices, biologics, foods, and dietary supplements.” IOM describes biomarkers, such as blood cholesterol levels, as “biological yardsticks” used to predict health effects when it is difficult to measure the actual incidence of disease or death. According to a May 12, 2010, press release, “FDA has been hampered in its ability to assess the proliferation of health claims being made by food and supplement manufacturers in part because it lacks a process broadly accepted across the regulatory, food, and medical communities to evaluate biomarkers as valid and appropriate measurements to substitute for clinical outcomes.” Commissioned by FDA, the report proposes a three-part framework for…
Category Archives Food and Drug Administration
The Food and Drug Administration (FDA) has issued industry guidance to advise food manufacturers on appropriate protocol for dealing with a boil-water advisory. The guidance is also “intended to assist food manufacturers in evaluating food that already was produced with water subject to the advisory.” According to FDA, once a boil-water advisory has been issued, food manufacturers “should stop using the water subject to the advisory until the water again meets the applicable Federal and State drinking water quality standards.” The guidance offers assistance to affected manufacturers in evaluating water used in heated foods, ice, bottled water, ready-to-eat foods, and water used for cleaning and hand-washing. The agency issued the guidance in response to the recent boil-water advisory that affected some two million residents of metropolitan Boston. Comments are requested at any time. See Federal Register, May 13, 2010.
The Food and Drug Administration (FDA) has issued an advance notice of proposed rulemaking (ANPRM) under the Sanitary Food Transportation Act of 2005 that establishes guidance on reducing the risk of food contamination during transport. The ANPRM is the first step in creating new federal regulations to govern sanitary practices by shippers, carriers by motor or rail vehicles, receivers, and others engaged in the transportation of food products for human and animal consumption. FDA has requested input from the food and transportation industries, consumer organizations and other parties on topics, including (i) whether and how information is shared among those involved, (ii) whether trucks used for transporting food should also be used for “nonfood products,” (iii) what reasons might waive “any and all” foreseeable rules intended to prevent contamination, and (iv) data on the risk of foodborne illness associated with the transportation of food. After evaluating responses to the notice,…
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…
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.
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…
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…
At the request of Congress, the Institute of Medicine (IOM) has prepared and released a report titled “Strategies to Reduce Sodium Intake in the United States.” Starting from the premise that “Americans consume unhealthy amounts of sodium in their food,” which puts some 100,000 at risk of premature death from conditions related to high blood pressure, the report calls for the Food and Drug Administration (FDA) to “set mandatory national standards for the sodium content in foods—not banning outright the addition of salt to foods but beginning the process of reducing excess sodium in processed foods and menu items to a safer level.” According to IOM, this reduction must be carried out gradually so consumers’ tastes could adjust, a process that could take up to 10 years. Other recommendations include an FDA modification of the generally recognized as safe (GRAS) status of sodium-containing compounds added to processed foods—“that is, change…
Following a recent American Chemical Society (ACS) meeting at which scientists discussed how wines could be authenticated by measuring carbon isotopes, whose levels varied in the atmosphere during the years nuclear weapons were tested, a number of recent articles discuss the subject of food fraud. Said to affect some 5 to 7 percent of a range of foods from cheeses, fish, honey, and wine to expensive spices such as saffron, the problem has not apparently received the attention required from the Food and Drug Administration (FDA), due to its focus on more pressing food safety concerns and contamination outbreaks. A consultant studying the matter for the Grocery Manufacturers Association was quoted as saying, “[Food fraud is] growing very rapidly, and there’s more of it than you might think.” Not only shoppers are fooled by mislabeled foods; major companies have been stung as well. Information about major food manufacturers and retailers…
