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…
Category Archives U.S. Government and Regulatory Agencies
The U.S. Department of Agriculture’s National Organic Standards Board (NOSB) has announced an April 29-May 2, 2014, public meeting in San Antonio, Texas, to discuss the work of its six subcommittees and receive input on proposed changes to the National List of Allowed and Prohibited Substances (National List), which governs what may be used in organic handling and production. Among other things, the meeting will address several petitions proposing the addition, extension or deletion of substances scheduled for reassessment under the National List’s sunset review rules. In particular, petitioners have requested (i) a National List extension for streptomycin—slated to expire October 14, 2014—to allow “adequate time for the transition from strep over to non-antibiotic, biological alternatives for fire blight control”; (ii) revisions to provisions governing the use of synthetic methionine in poultry feed; (iii) the addition of several synthetic substances used in aquaculture production; and (iv) the removal of synthetic…
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…
A federal court in Washington, D.C., has reportedly refused to reconsider its denial of hundreds of claims by African-American farmers who alleged that they were owed a share of the $1.25-billion settlement fund established to compensate a class of farmers allegedly discriminated against by the U.S. Department of Agriculture’s (USDA’s) loan application process. In re Black Farmers Discrimination Litig., No. 08-0511 (D.D.C., order entered March 5, 2014). Information about the lawsuit and a dispute over attorney’s fees appears in Issue 490 of this Update. According to a news source, the court determined that it lacked authority to alter the terms of the settlement agreement, which provided that claims determinations would be considered final and not subject to court review. “This may be cold comfort to claimants who feel that their claims were denied in error; but without the Settlement Agreement, the amount of relief attainable by members of the plaintiff…
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. Department of the Treasury’s Alcohol and Tobacco Tax and Trade Bureau (TTB) has issued a revised interim policy on gluten content statements permitted in wine, distilled spirits and malt beverage labeling and advertising. TTB took the action after reviewing the U.S. Food and Drug Administration’s (FDA’s) final rule on the use of “gluten-free” on labels for products within that agency’s jurisdiction with the goal of making its approach “as consistent as possible with the regulations that FDA issued.” Thus, TTB Ruling 2014-2 supersedes TTB Ruling 2012-2; it remains an interim ruling, however, until “FDA issues a final rule or other guidance with respect to fermented and hydrolyzed products.” Under TTB’s revised interim policy, “the term ‘gluten-free’ may be used on labels and in advertisements if the product would be entitled to make a gluten-free label claim under the standards set forth in the new FDA regulations at 21…
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
