The Food and Drug Administration (FDA) has announced three public meetings to explain the purpose of the Reportable Food Registry, how it will work and the responsibilities of those required to submit reports. The registry, which requires reports to be filed through an FDA Internet portal if there is reason to believe that adulterated food or feed will cause “serious adverse health consequences or death to humans or animals,” is set to be implemented September 8, 2009. The meeting dates are July 23, August 5 and 25, 2009. See Federal Register, June 26, 2009.
Category Archives Food and Drug Administration
The Food Safety Working Group (FSWG) created by President Barack Obama (D) has unveiled a “new, public health-based approach to food safety based on three core principles: prioritizing prevention; strengthening surveillance and enforcement; and improving response and recovery,” according to a July 7, 2009, White House press release. Chaired by Health and Human Services (HHS) Secretary Kathleen Sebelius and U.S. Department of Agriculture (USDA) Secretary Tom Vilsack, FSWG has set in motion several new strategies to advance these principles, including plans to (i) tighten standards governing the safety of eggs, poultry and turkey; (ii) increase inspections at beef facilities; (iii) issue new industry guidance for leafy greens, melons and tomatoes; (iv) build a trackback and response system incorporating “clearer industry guidance, a new unified command system and improved use of technology to deliver individual food safety alerts to consumers”; and (v) strengthen the organization of federal food safety functions. FSWG…
The Food and Drug Administration (FDA) has announced that emergency processing is underway for the draft guidance titled “Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007.” When finalized, the guidance will assist industry in complying with the Reportable Food Registry requirements prescribed by the Act, which required FDA to establish within one year of enactment an electronic portal to facilitate reporting of adulterated foods. FDA has delayed until September 8, 2009, implementation of the registry to consider comments and to allow further testing of the electronic portal for reportable foods. Written comments are requested by July 16, 2009. FDA has requested approval of the emergency processing by August 17, 2009. See Federal Register, June 16, 2009.
The Food and Drug Administration (FDA) has announced the availability of draft industry guidance titled “Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007.” The Food Administration Amendments Act of 2007 required FDA to establish within one year of enactment an electronic portal to facilitate the reporting of adulterated foods. FDA has now delayed until September 8, 2009, implementation of the registry “to consider any comments received on the draft guidance and through the agency’s planned outreach initiatives, and to allow for further testing of the electronic portal for reportable foods.” In the interim, the agency has encouraged industry to continue reporting of adulterated foods through existing channels, such as the relevant FDA district office. See Federal Register, June 11, 2009.
The Food and Drug Administration (FDA) has announced a June 23, 2009, public meeting to present the background, approach, scope, and data needed for a recently initiated interagency risk assessment of Listeria in some ready-to-eat foods that are sliced, prepared or packaged in retail facilities. Several agencies, including the Food Safety and Inspection Service (FSIS) and the Center for Food Safety and Applied Nutrition (CFSAN), are conducting the risk assessment to determine the effects that current practices and potential interventions to prevent Listeria have on public health. See Federal Register, June 9, 2009.
U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg has expressed support for the Food Safety Enhancement Act of 2009, which seeks to increase the agency’s authority over U.S. and foreign food producers, including the power to issue mandatory recalls of tainted foods. “FDA needs new legal authorities to succeed in these roles and protect the public health,” she was quoted as saying before the U.S. House Committee on Commerce and Energy on June 3, 2009. “This legislation would provide those tools.” A group of congressional Democrats in late May released a discussion draft of the Act, which would take effect in 18 months if passed. The legislation includes provisions that would (i) create an up-to-date registry of all food facilities serving American consumers, (ii) require such facilities to pay a $1,000 fee to generate resources to support FDA oversight of food safety, (iii) strengthen criminal penalties and establish civil…
Food and Drug Administration (FDA) Commissioner Margaret Hamburg has reportedly indicated that the agency will review its 2008 decision that bisphenol A (BPA) in children’s food and beverage containers is, for the most part, safe. An agency spokesperson has apparently indicated that a new decision on the chemical, which is also used to seal canned food containers, will be released within “weeks not months.” The action comes after House Energy and Commerce Committee Chair Henry Waxman (D-Calif.) asked the commissioner to reconsider the agency’s decision in light of “longstanding questions about the scientific data relied on by FDA under the previous Administration, as well as new press accounts detailing the influence of industry lobbyists on FDA’s scientific analyses.” Waxman cites several Milwaukee Journal-Sentinel articles, based on agency emails and a leaked industry report of a public relations strategy meeting, apparently indicating that (i) “when FDA conducted its review of BPA,…
The U.S. Senate has reportedly voted unanimously to confirm former New York City Health Commissioner Margaret Hamburg, M.D., as commissioner of the Food and Drug Administration (FDA). A physician with expertise in bioterrorism and pandemics, Hamburg told the Senate Committee on Health, Education, Labor & Pensions that she intends to address the agency’s food safety record and possibly tighten tobacco regulations. See Bloomberg.com, May 18, 2009; The New York Times and FoodNavigator-USA.com, May 20, 2009.
The Food and Drug Administration has issued a warning letter to General Mills, Inc., alleging that labeling for the company’s Cheerios® Toasted Whole Grain Oat cereal contains “serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR).” FDA has specifically alleged that this Cheerios product “is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation and treatment of disease.” The warning letter singles out claims suggesting that Cheerios can “lower your cholesterol 4 percent in 6 weeks” and “reduce bad cholesterol by an average of 4 percent,” as well as a claim that “Cheerios is.. clinically proven to lower cholesterol. A clinical study showed that eating 1½ cups servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet…
The Food and Drug Administration (FDA) apparently failed to meet its 2007-08 goals for auditing food-safety inspections that states did on its behalf, according to a news source. State agencies apparently do half of FDA’s food inspections, and FDA aims to audit 7 percent to make sure states reach a satisfactory standard. But FDA fell short of its goal in 17 of 39 states, according to FDA data. In five states, including Kansas, FDA did no audits. But data show that FDA’s performance has apparently improved. For example, data for the 2006-07 contract year show its audit goal was unmet in 21 of 37 states, with no audits performed in eight states. In 1998, the FDA reportedly did no audits in 21 of 38 states. “We don’t meet our target ever year, but . . . we’re looking at continuous improvement,” Richard Barnes, FDA director of federal-state relations, was quoted…
