The Food and Drug Administration (FDA) is seeking public comments on a new federal law that requires certain chain restaurants and retail food operations to post the calorie content of individual items on menus, menu boards and drive-through menu boards. Enacted March 23, 2010, section 4205 of the Affordable Care Act applies to food establishments with 20 or more locations, such as restaurants, coffee shops, delis, movie theaters, bakeries, and ice cream shops. Per-serving information related to the amount of calories, cholesterol, fiber, sodium, sugars, total and complex carbohydrates, total and saturated fat, and total protein must be available in writing on request. The law also compels vending machine operators with 20 or more machines to list calorie information “in close proximity to” each article of food or the selection button. The law instructs FDA to issue proposed regulations to carry out these provisions by March 23, 2011. The agency…
Category Archives Food and Drug Administration
The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) has announced two public meetings with the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to hear stakeholder input on collective efforts to reduce illness, harm and death from contaminated food. Extensions of an initial workshop held in March 2010, the meetings will be held July 21, in Chicago, Illinois, and October 20 in Portland, Oregon. Presentations are expected from consumer groups, industry, public health experts, and state and local regulators on recommended measures for assessing food safety performance. CDC, FDA and FSIS will present information on the Food Safety Working Group’s “charge to create meaningful metrics to measure the effectiveness of the nation’s food safety system,” according to USDA. The agencies will also “present current thinking, focusing on how these metrics might be applied to evaluate the success of FDA’s shell…
The Food and Drug Administration (FDA) has announced that its Science Board will hold a public meeting on August 16, 2010, in Bethesda, Maryland. Tasked with advising officials on “specific complex and technical issues, as well as emerging issues within the scientific community in industry and academia,” the board keeps pace with “technical and scientific evolutions in the fields of regulatory science.” At this meeting, it will hear a subcommittee’s final report on research at the Center for Food Safety and Applied Nutrition (CFSAN), as well as discuss the agency’s nanotechnology research program, among other agenda items. FDA has stated that it intends to make background material available on its website “no later than [two] business days before the meeting.” The agency will also accept written data submissions on or before August 9, 2010, and proposals for formal oral presentations on or before August 2, 2010. See Federal Register, June…
The Food and Drug Administration (FDA) has issued draft guidance that urges the “judicious” use of antibiotics in food-producing animals to minimize drug resistance in humans. The guidance recommends limiting “medically important” antimicrobial drugs to uses deemed necessary for animal health on the basis of veterinary oversight or consultation. It supports the theory that “nontheraputic” or “subtherapeutic” antibiotic use for production or growth enhancing purposes “is not in the interest of protecting and promoting the public health.” FDA has requested written comments by August 30, 2010. See FDA News Release, June 28, 2010; Federal Register, June 29, 2010. FDA Principal Deputy Commissioner Joshua Sharfstein has called the matter an urgent public health issue, telling news sources that the agency would issue new regulations if farmers do not voluntarily adhere to them. “We’re not handcuffed to the steering wheel of a particular strategy, but I’m not ruling out anything that we…
The Food and Drug Administration (FDA) submitted two proposed information collections to the Office of Management and Budget (OMB) for review. The first collection pertains to the adoption of the model FDA Food Code by local, state and tribal governments, “an important step toward the agency’s goal for consistent, scientifically sound, and risk-based food safety standards and practices.” To facilitate the implementation of regulations based on the model Food Code, FDA in 2001 began surveying the rulemaking activities of these governments and has concluded that “an extension of OMB approval of the survey is needed in order to keep the current database accurate and up-to date.” Estimating that 75 respondents will provide four quarterly updates, FDA has requested written comments by July 26, 2010. The agency has also announced an information collection involving the threshold of regulation for substances used in food-contact articles. To determine whether a substance used in…
The Food and Drug Administration (FDA) has called for comment on “the information collection provisions of FDA’s regulations for submission of petitions, including food and color additive petitions (including labeling) and generally recognized as safe (GRAS) affirmations.” As required by the Office of Management and Budget, the agency has invited comments on the following: (i) “Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility”; (ii) “the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used”; (iii) “ways to enhance the quality, utility, and clarity of the information to be collected”; and (iv) “ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.” FDA has also…
The Food and Drug Administration (FDA) and the National Oceanic and Atmospheric Administration (NOAA) have announced joint efforts to secure the safety of Gulf of Mexico seafood in the wake of the April 20, 2010, oil spill. “It is important to coordinate seafood surveillance efforts on the water, at the docks and at seafood processors to ensure seafood in the market is safe to eat,” FDA Commissioner Margaret Hamburg said in a joint press release. The agencies plan a “multi-pronged approach” that includes precautionary closures of fishing areas, increased seafood testing inspections and a “re-opening protocol” for affected Gulf waters. NOAA has apparently created a “seafood sampling and inspection plan” and is using “ongoing surveillance to evaluate new seafood samples to determine whether contamination is present” outside closed fishing areas. If the samples have elevated levels of oil compounds, NOAA said it will consider expanding the closed areas. FDA, which…
The Institute of Medicine (IOM) has issued a June 2010 report claiming that the Food and Drug Administration (FDA) “continues to be reactive, lacking a systematic focus on prevention.” According to a June 8, 2010, press release, IOM has advised FDA to adopt a “risk-based model” that involves increased coordination “with state and other federal agencies that share responsibility for protecting the nation’s food supply.” The institute has also called on Congress to amend the Food, Drug, and Cosmetic Act “to explicitly provide the authority FDA needs to fulfill its food safety mission.” Enhancing Food Safety: The Role of the Food and Drug Administration apparently provides a blueprint for overhauling FDA, which IOM criticized in a report brief for continuing to address problems “on a case-by-case basis.” Its recommendations include integrating food safety programs and public education, enhancing the efficiency of the inspection process, and modernizing legislation in an effort…
The Government Accountability Office (GAO) this week released a report assessing Food and Drug Administration (FDA) efforts to address “serious deficiencies” in its food safety research. After a recent survey indicated that only 36 percent of FDA managers felt the agency “was making great progress in keeping pace with scientific advances,” GAO began investigating the ways in which “FDA may use science to more effectively support its regulatory work and to inform the public about food content and safety.” To this end, the report examines FDA’s “(1) progress in addressing selected recommendations identified by the Science Board; (2) incorporation of scientific and risk analysis into its oversight of the accuracy of food labeling, fresh produce, and the safety of dietary supplements; and (3) a new computer screening tool that may improve its efforts to screen imports using a risk-based approach.” It specifically notes the creation of the Office of the…
The Food and Drug Administration (FDA) has issued draft industry guidance in a question-and-answer format that provides information about complying with the reportable food registry requirements of a 2007 law. The purpose of the registry is to provide a “reliable mechanism to track patterns of adulteration in food [which] would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health.” The draft guidance is a second edition, updated to provide information about a new federal safety reporting portal. FDA requests public comments by July 26, 2010. The agency is particularly interested in comments addressing the meaning of the word “transfer” which is used in the context of an exemption from the requirement that “a responsible party submit a reportable food report.” For the exemption to apply, “the adulteration must have originated with the responsible party, the responsible party must have detected the…
