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 U.S. Government and Regulatory Agencies
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…
Evidently in response to public comments, the Federal Trade Commission (FTC) has modified its agreement with Phusion Projects, LLC to require an alcohol facts panel on certain-sized cans of its Four Loko fruit-flavored malt beverage. In re Phusion Projects, LLC, No. C-4382 (FTC, order entered February 6, 2013). The agreement resolves charges that the company and its principals falsely claimed that a 23.5-ounce can contained “the alcohol equivalent of one or two regular 12-ounce beers, and that a consumer could drink one entire can safely on a single occasion.” To the contrary, according to FTC’s administrative complaint, the products contain the alcohol equivalent of four to five 12-ounce cans of beer. Without admitting liability, the company has agreed to label any container of Four Loko or other flavored malt beverage with more than two servings of alcohol with an alcohol facts panel. The panel will set forth the “the container…
According to a news source, the Council of Better Business Bureau’s National Advertising Division (NAD) has determined that Anheuser Busch promotions for Michelob ULTRA Light Cider® comply with Food and Drug Administration definitions and guidelines. The company apparently claims that the product has one-third fewer calories than its competitors, and the ad industry’s self-regulatory investigative unit “determined that the advertiser had provided a reasonable basis for the claim.” NAD considered the product’s calorie content, the calorie content of other leading hard ciders and their market share, as well as whether the brewer’s claim provided “meaningful and accurate information to consumers.” The company was reportedly “pleased with NAD’s decision.” See Law360, February 5, 2013.
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.
The U.S. Department of Agriculture’s Agricultural Marketing Service (AMS) has proposed amending the National List of Allowed and Prohibited Substances to change annotations pertaining to the use of peracetic acid in organic crop production and the use of potassium hydroxide, silicon dioxide and betacarotene extract color in organic handling. Following the recommendation of the National Organic Standards Board, AMS has also proposed removing non-organic annatto extract color from the list of approved substances for organic handling. In particular, AMS has requested comments that (i) “identify any formulated hydrogen peroxide products labeled for agriculture use that contain more than 5% peracetic acid,” and (ii) “describe whether product reformulation will be necessary to comply with the proposed amendment for silicon dioxide at section 205.605(b) and the proposed removal of annatto extract color from section 206.606.” The agency has requested comments on the proposed amendments by March 7, 2013. See Federal Register, February 5,…
The U.S. Department of Agriculture (USDA) has proposed new rules that would regulate the nutritional content of snacks, soft drinks and meals sold in school cafeterias, vending machines and snack bars. According to a USDA news release, the “Smart Snacks in School” proposal draws upon “recommendations from the Institute of Medicine, existing voluntary standards already implemented by thousands of schools around the country, and healthy food and beverage offerings already available in the marketplace.” Required under the Healthy, Hunger Free Kids Act of 2010, the new rules are part of the government’s efforts to combat childhood obesity by establishing nutrition standards for all food sold in schools—not just federally subsidized school breakfasts and lunches. “Parents and teachers work hard to instill healthy eating habits in our kids, and these efforts should be supported when kids walk through the schoolhouse door,” said Agriculture Secretary Tom Vilsack. “Good nutrition lays the groundwork…
The U.S. Department of Agriculture’s Food Safety and Inspection Service and the Food and Drug Administration (FDA) have announced an April 17, 2013, public meeting in Washington, D.C., to provide information and receive public comments on agenda items and draft U.S. positions for discussion during the 41st Session of the Codex Committee on Food Labeling of the Codex Alimentarius Commission in Charlottetown, Prince Edward Island, Canada, on May 14–17. Agenda items include (i) implementation of the World Health Organization global strategy on diet, physical activity and health, including a proposed draft revision of the “Guidelines on Nutrition and Health Claims concerning Non-Addition of Sodium Salts”; (ii) guidelines for the production, processing, labeling, and marketing of organically produced foods, including use of ethylene as a sprouting inhibitor for onions and potatoes, and organic aquaculture; (iii) date marking; and (iv) the labeling of food derived from crops biofortified by natural selection. See…
U.S. Rep. Rosa DeLauro (D-Conn.) has responded to a January 25, 2013, Federal Register notice describing a “new” Food Safety and Inspection Service (FSIS) method of conducting “ongoing equivalence verifications of the regulatory systems of countries that export meat, poultry, or processed egg products to the United States.” According to DeLauro’s letter to U.S. Department of Agriculture (USDA) Secretary Tom Vilsack, “it seems that FSIS fundamentally changed the process used to assess ongoing equivalency with our trade partners without publishing a single public notice in the Federal Register on the revisions or seeking public comment on the proposed changes. It appears that the agency has been implementing and refining these changes for several years.” She was particularly disturbed that FSIS has failed to disclose these changes in budgetary justification documents submitted to Congress since 2009. DeLauro also claimed in the letter that FSIS has exhibited “indifference to the advisory committees” that…
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…
