The Food and Drug Administration (FDA) has extended until April 26, 2013, the comment period for two draft environmental assessments of the proposed conditions of use submitted by AquaBounty Technologies, Inc., in support of a new animal drug application concerning a genetically engineered (GE) Atlantic salmon and a preliminary finding of no significant impact for those specific conditions of use. FDA has pushed back the deadline in response to “a request for an extension to allow interested persons additional time to submit comments.” Additional details about the proposed rule appear in Issue 466 of this Update. See Federal Register, February 14, 2013.
Category Archives Food and Drug Administration
The Food and Drug Administration (FDA) recently entered a consent decree with Puerto Rico-based Jonlly Fruits, Inc. requiring the company to hire independent experts in labeling, sanitation and Hazard Analysis Critical Control Point (HACCP) before it can begin again to make and sell its fruit and juice products. United States v. Jonlly Fruits, Inc., No. 13-1043 (D.P.R., approved January 17, 2013). The labeling expert is required to “review Defendants’ labeling and ensure that all such labels are in compliance with the applicable FDA regulations.” The other experts are required to develop written protocols and employee training programs and to conduct comprehensive facility inspections. In the meantime, the company has agreed to destroy “all in-process and finished articles of food” currently in its custody, control or possession. According to FDA, the company and its president, Bartolo Pérez Romàn, “have a long history” of failing to comply with current good manufacturing practice…
The Food and Drug Administration (FDA) has issued a final rule that adopts, without change, the interim final rule (IFR) titled “Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption” that was published in the Federal Register on May 5, 2011. Effective February 5, 2013, the final rule affirms IFR’s change to the criteria for ordering administrative detention of human or animal food as required by the FDA Food Safety Modernization Act (FSMA). Under the new criteria, “FDA can order an administrative detention if there is reason to believe that an article of food is adulterated or misbranded.” See Federal Register, February 5, 2013.
Food and Drug Administration (FDA) researchers recently published a study claiming that consumers found it easier to compare food items with singleserving or dual-column nutrition facts (NF) labels as opposed to the NF labels currently in use. Lando and Lo, “Single-LargerPortion-Size and Dual-Column Nutrition Labeling May Help Consumers Make More Healthful Food Choices,” Journal of the Academy of Nutrition and Dietetics, February 2013. Scientists with FDA’s Center for Food Safety and Applied Nutrition apparently asked 9,482 adults to determine the healthfulness of a single product or compare the nutrition information on two products using one of the following NF configurations: (i) a single-column format listing two servings per container; (ii) a dual-column format listing two servings per container, with one column showing NFs per serving and one column showing NFs per container; and (iii) a single-column format listing a larger single serving per container. Within each of these formats, “there were…
The Food and Drug Administration (FDA) has requested public comments on the information collection provisions of regulations that “require registration for domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.” According to FDA, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires food facilities to provide information via Form FDA 3537 (§1.231) or the electronic Food Facility Registration Module that will support FDA’s enforcement activities and help the agency issue notifications in the event of accidental or deliberate contamination. In 2011, the Food Safety Modernization Act amended these regulations to compel facilities to renew their registrations biennially and to submit additional information, such as “the email address for the contact person of a domestic facility and the email address of the U.S. agent for a foreign facility.” Based on the registrations received in previous years,…
The Food and Drug Administration (FDA) has recently drawn criticism over the delayed release of documents evaluating the environmental impact of genetically engineered (GE) salmon. Created by Massachusetts-based AquaBounty Technologies, the GE salmon in question evidently contain genes from Chinook salmon as well as ocean pout that allow the company to bring the fish to market in half the normal time. After a publicly contentious review process, FDA released the May 4, 2012, draft assessment and a preliminary finding of no significant impact in late December, raising questions among groups such as the Genetic Literacy Project (GLP) about whether the agency froze the application to avoid political turmoil during the election season. “The delay, sources within the government say, came after meeting with the White House, which was debating the political implications of approving the [GE] salmon, a move likely to infuriate a portion of its base,” GLP Executive Director…
The Food and Drug Administration (FDA) is seeking comments and other information, including data, to help determine whether the agency can establish regulatory thresholds for major food allergens such as milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. In a recent notice, FDA states that although “[We have] used several risk management strategies to reduce the risk from unlabeled major food allergens, such as targeted inspections or discussions with industry organizations, we have not established regulatory thresholds or action levels for major food allergens. The establishment of regulatory thresholds or action levels for major food allergens would help us determine whether, or what type of, enforcement action is appropriate when specific problems are identified and also help us establish a clear standard… Regulatory thresholds also would help industry to conduct allergen hazard analyses and develop standards for evaluating the effectiveness of allergen preventive controls.” In particular, FDA…
The Food and Drug Administration (FDA) has proposed two new food safety rules addressing foodborne illness prevention and produce safety under the Food Safety Modernization Act. According to FDA, the first rule would require both foreign and domestic food manufacturers “to develop a formal plan for preventing their food products from causing foodborne illness” and to establish plans “for correcting any problems that arise.” The second rule proposes “enforceable safety standards for the production and harvesting of produce on farms,” including “science- and risk-based standards for the safe production and harvesting of fruits and vegetables.” Before drafting the rules, FDA apparently conducted “extensive outreach” involving the produce industry, consumers, other government agencies, and the international community. It will accept comments on both rules until May 16, 2013, and plans to issue further proposals addressing the safety and oversight of imported foods. “We know one-size-fits-all rules won’t work,” said FDA Deputy…
The Food and Drug Administration (FDA) has extended for five years a 2007 food safety agreement with the General Administration of Quality Supervision, Inspection, and Quarantine of China (AQSIQ) to “enhance cooperation between the U.S. and China on food and feed safety.” The agreement includes provisions enhancing FDA’s “ability to identify high-risk food products entering the United States from China,” facilitating food facility inspections, focusing on “high-risk foods,” and creating processes for FDA to “accept relevant, verified information from AQSIQ regarding registration and certification.” See CFSAN Constituent Update, December 11, 2012.
The Government Accountability Project (GAP) has filed a lawsuit under the Freedom of Information Act (FOIA) against the Food and Drug Administration (FDA), alleging that the agency has wrongfully withheld information requested about the use of anti-microbial drugs in food-producing animals. GAP v. FDA, No. 12-1954 (D.D.C., filed December 5, 2012). GAP requests an order requiring FDA to make the requested information available within 10 working days and further seeks costs and attorney’s fees. According to the complaint, GAP sought information in February 2011 about anti-microbial drugs collected from animal-drug sponsors under 21 U.S.C. § 360b. While FDA produced, as requested, educational and outreach materials that assist drug sponsors in fulfilling their reported duties, it withheld (i) “FDA’s data for use of anti-microbial drugs in food-producing animals in 2009 as broken down by container size, strength, and dosage form”; and (ii) “FDA’s data for use of anti-microbial drugs in food-producing…
