The U.S. Food and Drug Administration (FDA) has secured the participation of all but one animal drug company in the agency’s plan to phase out the use of medically important antimicrobials in food animals for food production purposes, such as artificial weight gain. Each company has “committed in writing to seek withdrawal of approvals for any production uses of affected drug applications and change the remaining therapeutic uses of their products from over-the-counter (OTC) to use by Veterinary Feed Directive (VFD) or prescription.” See FDA News Release, March 26, 2014.
Category Archives Food and Drug Administration
The U.S. Food and Drug Administration (FDA) has issued an advance notice of proposed rulemaking under the Food Safety Modernization Act (FSMA) that seeks information to help the agency “implement and enforce” amendments to the reportable food registry (RFR) provisions of the Federal Food, Drug, and Cosmetic Act. Among other things, the new provisions permit FDA to (i) require that parties submit to FDA “consumer-oriented” information regarding certain reportable foods—defined as foods for “which there is a reasonable probability that use of, or exposure to, such food will cause serious adverse health consequences or death to humans or animals”; (ii) use such information to create consumer notification summaries for the agency’s Website; and (iii) obligate certain grocery stores that sell reportable food to display the notification summaries. FDA has requested input from the food industry, consumer organizations and other parties on certain topics, including (i) “what information should be required in…
The Center for Science in the Public Interest (CSPI) and Mercury Policy Project have sued the U.S. Food and Drug Administration (FDA), seeking a declaration that the agency’s delay in responding to their citizen petition on labeling fish with high levels of mercury is unreasonable and violates the Administrative Procedure Act and Federal Food, Drug, and Cosmetic Act. CSPI v. FDA, No. 14-0375 (D.D.C., filed March 10, 2014). Further details about the petition, which seeks labeling on seafood packaging and point-of-purchase signage, appear in Issue 401 of this Update. The plaintiffs also seek an order compelling the agency to issue a final response by a court-imposed deadline. According to the complaint, the plaintiffs submitted the petition to FDA in July 2011 and received a tentative response from the agency beyond the 180-day limit required by FDA regulations. The plaintiffs claim that they have not received any communication from FDA since then…
The U.S. Food and Drug Administration (FDA) has rejected objections filed after publishing its final rule amending “the food additive regulations authorizing the use of vitamin D2 bakers yeast as a source of vitamin D2 and as a leavening agent in yeast-leavened baked products at levels not to exceed 400 International Units (IU) of vitamin D2 per 100 grams (g) in the finished food.” According to the agency, “the objections do not provide any basis for us to reconsider our decision to issue the final rule,” and thus FDA has made no changes to it. See Federal Register, March 11, 2014. Issue 517
The U.S. Food and Drug Administration (FDA) will convene an April 4, 2014, public meeting in College Park, Maryland, to discuss “the scope of the Environmental Impact Statement (EIS) for the proposed rule to establish standards for the growing, harvesting, packing and holding of produce for human consumption (the produce safety proposed rule).” The agency has also extended the comment period for the EIS scoping period to April 18, 2014, to incorporate meeting input. Having discovered a number of areas where potential environmental impacts are likely, FDA notes that alternatives have been identified for the following key provisions: (i) “microbial standard for agricultural water used during growing activities for covered produce (other than sprouts) using a direct water application method”; (ii) “minimum application intervals for biological soil amendments of animal origin”; (iii) “measures related to animal grazing and animal intrusion”; and (iv) “scope of proposed rule and implications to land…
The National Association of Margarine Manufacturers (NAMM) and American Bakers Association (ABA) have submitted comments to the U.S. Food and Drug Administration’s (FDA’s) rulemaking docket about the agency’s tentative determination to remove partially hydrogenated oils from the generally recognized as safe (GRAS) list. NAMM contends that “the great majority of margarine products no longer contain partially hydrogenated oils (PHOs), the source of trans fat, and that margarine is not a significant contributor of trans fats to the American diet.” In fact, NAMM suggested that margarine, with two-thirds less saturated fat than butter, 25 percent fewer calories than butter, no cholesterol (compared to 30 mg in butter), and no trans fat, is a healthier alternative. The ABA, meanwhile, commented that “bakers face unique challenges in removing remaining low levels of trans fat containing PHOs from certain bakery products.” It also found FDA’s tentative determination flawed, including its burdens of proof and…
The U.S. Food and Drug Administration (FDA) has reopened the comment period on its draft industry guidance titled “Ingredients Declared as Evaporated Cane Juice” on food labels. First published for comments in October 2009, the draft guidance advises industry of “FDA’s view that the common or usual name for the solid or dried form of sugar cane syrup is ‘dried cane syrup,’ and that sweeteners derived from sugar cane syrup should not be declared on food labels as ‘evaporated cane juice’ because that term falsely suggests the sweeteners are juice,” and they are not “juice” as defined in federal regulations, 21 C.F.R. 120.1(a). FDA seeks “additional data and information to better understand the basic nature and characterizing properties of the ingredient, the methods of producing it, and the differences between this ingredient and other sweeteners.” Among the specific questions the agency has raised are (i) “How is ‘evaporated cane juice’…
Testifying before the House of Representatives Energy and Commerce Committee on February 5, 2014, U.S. Food and Drug Administration (FDA) Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor said that, while the agency has enough resources to issue the final rules for the Food Safety Modernization Act (FSMA), it lacks the resources to implement them. “We will continue efforts to make the best use of the resources we have, but simply put, we cannot achieve FDA’s vision of a modern food safety system and a safer food supply without a significant increase in resources,” Taylor said in his testimony. When FSMA was approved in 2010, the Congressional Budget Office estimated that FDA would need an increase of more than $580 million to fund the expanded food safety activities. Noting that FDA “cannot do all that is asked without additional resources,” Taylor cited in particular new FSMA mandates regarding imported…
The U.S. Food and Drug Administration (FDA) has issued a request for comments, scientific data and other information to help the agency develop its process for designating high-risk foods. Required under the Food Safety Modernization Act to designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary in order to “rapidly and effectively track and trace such foods during a foodborne illness outbreak or other event,” FDA specifically seeks information on (i) alternative approaches for identifying high risk foods; (ii) whether the criteria should be weighted equally; (iii) changes in the scoring system; and (iv) how foods should be categorized. Comments will be accepted until April 7, 2014. See Federal Register, February 4, 2014. Issue 512
The U.S. Food and Drug Administration (FDA) has proposed a rule that would require certain shippers, receivers and carriers that transport food by motor or rail vehicles to take steps to prevent the contamination of human and animal food during transportation. Noting that the proposed rule will “help reduce the likelihood of conditions during transportation that can lead to human or animal illness or injury,” FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor said, “We are now one step closer to fully implementing the comprehensive regulatory framework for prevention that will strengthen the FDA’s inspection and compliance tools, modernize oversight of the nation’s food safety system, and prevent foodborne illnesses before they happen.” The proposed regulation aims to establish criteria for sanitary transportation practices, such as properly refrigerating food, adequately cleaning vehicles between loads and properly protecting food during transportation. The agency will accept comments until May 31,…
