Category Archives Legislation, Regulations and Standards

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…

Bompas & Parr has reportedly discontinued its “Anti-AGin Gin” after the National Advertising Division requested substantiation for claims that the product was “the alcoholic equivalent of a facial.” The company claimed the product “rejuvenates the skin while you drink” and was meant “for people who want to stay young but don’t want to give up alcohol.” The ingredients—including “drinkable collagen,” chamomile, witch hazel oil and green tea—were advertised as having skin-nourishing or healing properties. The product’s launch was reportedly accompanied by a press release calling it “a cheeky thank you” to Warner Leisure Hotels’ guests “for keeping our hotels fun and young.” The ad board noted that “humor does not diminish an advertiser’s obligation to make truthful and accurate advertising claims.” Bompas & Parr indicated that the product is no longer for sale and will not be reissued. See Advertising Self-Regulatory Council, May 26, 2016.   Issue 606

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…

Health Canada and the Canadian Food Inspection Agency have determined that AquAdvantage Salmon “is as safe and nutritious for humans and livestock as conventional salmon.” Approving the genetically engineered (GE) salmon for sale in Canada, the two agencies cited a similar decision issued by the U.S. Food and Drug Administration in November 2015. “Health Canada requires labelling for food products, including genetically modified foods, where clear, scientifically established health risks or significant changes to the nutritional qualities of the food have been identified and can be mitigated through labelling,” concludes the agency. “In this case, given that no health and safety concerns were identified, there are no special labeling requirements for AquAdvantage Salmon.” See Health Canada News Release, May 19, 2016.   Issue 605

Gov. Andrew Cuomo (D-N.Y.) has proposed legislation that would revise the Alcoholic Beverage Control Law (Blue Laws) to modernize the manufacture and sale of alcoholic beverages in New York state. The new rules would also consolidate licensing and reduce “burdensome fees for wineries, breweries, distilleries and cideries statewide.” In particular, the legislation would (i) lift restrictions on Sunday morning sales of alcoholic beverages at on-premises establishes; (ii) allow the New York State Liquor Authority to consider exceptions to the “Two Hundred Foot Law” that prohibits the dispensation of full liquor licenses to establishments within 200 feet of a school or place of worship; (iii) combine craft manufacturing licenses into one application to reduce the paperwork burden on small breweries, wineries and distilleries; (iv) authorize the sale of wine in growlers and allow customers to take home unfinished bottles of wine; (v) reduce fees for craft beverage salespeople; and (vi) reduce…

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. Supreme Court has denied certiorari in a Federal Trade Commission (FTC) lawsuit against POM Wonderful LLC and Roll Global LLC alleging the companies made false or misleading health claims about their pomegranate-derived products. POM Wonderful LLC v. FTC, No. 15-525 (U.S., certiorari denied May 2, 2016). The U.S. Court of Appeals for the District of Columbia previously upheld a Commission decision finding POM misled consumers by claiming its products treat, prevent or reduce the risk of heart disease and prostate cancer, with some claims purported to be supported by clinical studies. “I am pleased that the POM Wonderful case has been brought to a successful conclusion,” FTC Chair Edith Ramirez said in a May 2, 2016, press release. “The outcome of this case makes clear that companies like POM making serious health claims about food and nutritional supplement products must have rigorous scientific evidence to back them up.…

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