Following the release of U.S. Food and Drug Administration (FDA) final guidance finding that “evaporated cane juice” (ECJ) should be labeled as “sugar” on food products, Lifeway Foods has filed a motion arguing that the May 2016 rule should not affect the outcome of a consumer’s lawsuit against the company arguing it mislabeled its kefir smoothies. Figy v. Lifeway Foods Inc., No. 13-4828 (N.D. Cal., San Francisco Div., motion filed June 13, 2016). The case is one of many stayed or dismissed without prejudice awaiting FDA guidance after the agency announced it would reconsider the issue in March 2014. In its motion, Lifeway argues that the guidance is “intended to advise” and “does not establish any rights for any person and is not binding on the FDA or the public.” “The Guidance has no more bearing on Plaintiff’s claims under California’s consumer protection statutes than it has on his common…
Category Archives Food and Drug Administration
The Center for Science in the Public Interest (CSPI) has submitted a letter to U.S. Food and Drug Administration (FDA) Commissioner Robert Califf urging the agency to prohibit retail distribution of highly concentrated caffeine products, including powdered (PPC), liquid and inhaled caffeine. The recently released letter supplements CSPI’s 2014 citizen petition requesting the ban following the deaths caused by over-ingestion of caffeine powder. FDA sent warning letters to companies selling the substance, but “FDA’s five letters appear to have ceased the sale of powdered caffeine at only the companies to which the agency addressed the letters,” the CSPI document argues. “In the larger marketplace, sales of PPC remain commonplace, and the substance is still widely available. This compelling evidence demonstrates why a ban is the only step that will protect consumers from the hazards of PPC.” Issue 608
The Good Food Institute (GFI) has filed a lawsuit seeking to compel the U.S. Food and Drug Administration (FDA) to disclose records “related to FDA’s regulatory treatment of the common and usual name ‘soy milk’ or ‘soymilk’ to refer to a liquid food derived from the cooking and processing of whole soybeans with water.” Good Food Inst. v. FDA, No. 16-1052 (D.D.C., filed June 6, 2016). The organization asserts that FDA has been inconsistent in its opinion of “soy milk,” citing two warning letters to soy-milk producers requesting them to use “soy beverage” or “soy drink” instead. “Notwithstanding FDA’s varying positions on the matter, many major brands of soy milk continue to label their products as ‘soy milk’ or ‘soymilk.’ This has resulted in consumer confusion and an uneven competitive landscape,” the complaint argues. GFI submitted Freedom of Information Act requests to FDA in April 2016 and asserts that it…
The Center for Science in the Public Interest (CSPI) has filed a lawsuit seeking to compel the U.S. Food and Drug Administration (FDA) to act on the organization’s 2012 citizen petition seeking establishment of a performance standard for controlling Vibrio vulnificus, bacteria responsible for several deaths related to seafood consumption. Ctr. for Sci. in Pub. Interest v. FDA, No. 16-0995 (D.D.C., filed May 25, 2016). CSPI argues that FDA has violated the Administrative Procedure Act by delaying its response to CSPI’s citizen petition urging the agency “to establish a performance standard of nondetectable for V. vulnificus in raw molluscan shellfish” under the Food Safety Modernization Act. “Every year, people are getting sick and some are dying from what is a completely preventable disease,” CSPI Senior Food Safety Attorney David Plunkett said in a May 26, 2016, press release. “For too long the FDA has observed these illnesses and deaths from…
The U.S. Food and Drug Administration (FDA) has published draft guidance “that provides practical, voluntary sodium reduction targets for the food industry.” Titled ‘‘Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods,” the guidance sets short- and long-term sodium targets for the following food categories: (i) cheese; (ii) fats, oils and dressings; (iii) fruits, vegetables and legumes; (iv) nuts and seeds; (v) soups; (vi) sauces, gravies, dips, condiments and seasonings; (vii) cereals; (viii) bakery products; (ix) meat and poultry; (x) fish and other seafood; (xi) snacks; (xii) sandwiches; (xiii) mixed ingredient dishes; (xiv) salads; (xv) other combination foods; and (xvi) baby/toddler foods. “Our goal is to promote gradual, efficient voluntary reduction of overall sodium content using effective and sustainable strategies that maintain other measures of nutritional quality,” states the agency in its guidance. “The extent and speed of reduction will…
The U.S. Food and Drug Administration (FDA) has announced revisions to the Nutrition Facts label designed to emphasize “the link between diet and chronic diseases such as obesity and heart disease.” In addition to highlighting calories, servings per container and serving-size declarations through a combination of increased type size and boldface, the new labels will (i) require “added sugars” in grams and as a percent daily value, (ii) require Vitamin D and potassium values, and (iii) make Vitamins A and C optional. Citing scientific research, FDA has updated several daily values and eliminated “Calories from Fat,” but increased mandatory serving sizes to better reflect food consumption data. Food packages containing one to two servings that are typically consumed in one sitting must list calories and nutritional information for the entire packaged portion. Manufacturers must also use dual-column labels for 24-ounce sodas, ice cream pints and other foods and beverages that…
The U.S. Food and Drug Administration (FDA) will reconsider how “healthy” may be used on food packaging following the evaluation of a citizen petition filed by Kind LLC. FDA previously challenged Kind’s use of “healthy” on its nut bars, which contain more fat than permitted due to the inclusion of nuts, and Kind changed its packaging accordingly but filed a petition for reconsideration of the issue. The existing guidelines were created during the 1990s and reflect accepted standards of that time, including a preference for foods low in fat without regard to the nature of the fat. FDA has now allowed Kind to use “healthy and tasty” on its packaging “only in text clearly presented as its corporate philosophy, where it isn’t represented as a nutrient content claim, and does not appear on the same display panel as nutrient content claims or nutrition information.” Further details about the dispute appear…
Following a Listeria outbreak allegedly linked to a Dole Food Co. salad manufacturing plant, the company is reportedly facing investigations by the U.S. Department of Justice (DOJ) and Food and Drug Administration (FDA). Several media outlets have reported that an FDA investigation obtained through a Freedom of Information Act request found Dole knew of nine positive tests for Listeria at the plant taken as early as July 2014, more than a year before the company closed the plant. See The Wall Street Journal, April 29, 2016. In response, Dole issued an April 29 statement expressing concerns “about the recent stories in some publications about the FDA’s observation reports. Those FDA reports deal with issues at our plant that we have corrected. We have been working in collaboration with the FDA and other authorities to implement ongoing improved testing, sanitation and procedure enhancements, which have resulted in the recent reopening of…
The U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition has published a report finding that 77 percent of surveyed adults use the Nutrition Facts label at least some of the time when buying a food product. Intended to help the agency regulate food and dietary supplement labeling, the 11th edition of the FDA Health and Diet Survey relies on data from 2,480 participants interviewed by telephone or cellphone about their use of nutrition labels and understanding of nutrition claims, purchasing practices and general attitudes toward nutrition and health issues. The results highlight consumer attitudes about salt reduction, with almost all respondents agreeing “the nation eats more salt than we should.” Of these, 50 percent believe individuals are most effective in curbing their own salt consumption, while 25 percent believe the responsibility lies with food manufacturers and retailers, 5 percent with restaurants, and 5 percent with…
The U.S. Food and Drug Administration (FDA) has issued final guidance to help chain establishments with 20 or more locations (e.g., grocery and convenience stores, quick-service and fast-food restaurants, pizza delivery outlets, and movie theaters) comply with menu labeling requirements for standard menu items and self-service offerings under the Federal Food, Drug, and Cosmetic Act. According to FDA, the final guidance provides “additional examples and new or revised questions and answers on topics such as covered establishments, alcoholic beverages, catered events, mobile vendors, grab-and-go items, and recordkeeping requirements.” Enforcement of the menu labeling final rule will begin on May 5, 2017. See Federal Register, May 5, 2016. Issue 603
