Food and Water Watch, the Center for Food Safety, Friends of the Earth and other consumer and environmental groups have filed a lawsuit against the U.S. Food and Drug Administration (FDA) arguing the agency approved the use of genetically engineered (GE) salmon AquaBounty for human consumption without properly investigating related environmental risks. Inst. for Fisheries Res. v. Burwell, No. 13-1574 (N.D. Cal., filed March 30, 2016). The complaint alleges that AquaBounty received approval for two facilities only but has told its investors that it will expand in 2016; the organizations assert that FDA should have investigated the environmental effects of AquaBounty’s “necessary outgrowth” rather than limiting its analysis to the effects of two facilities. The complaint further alleges that FDA “failed to consult with the federal fish and wildlife agencies to insure that its approval for AquaBounty’s application was not likely to jeopardize endangered and threatened species or adversely modify…
Category Archives Legislation, Regulations and Standards
Several consumer organizations, including the Center for Food Safety, Environmental Working Group and Natural Resources Defense Council, have filed a petition for a writ of mandamus in the U.S. Court of Appeals for the Ninth Circuit seeking a writ compelling the U.S. Food and Drug Administration (FDA) to address the groups’ administrative petition filed in December 2014. Breast Cancer Fund v. FDA, No. 16-70878 (9th Cir., petition filed March 31, 2016). FDA missed a June 2015 deadline to respond to the groups’ petition, which implored FDA to rescind foodcontact approval for perchlorate, “an endocrine-disrupting chemical that interferes with the thyroid gland” used in food packaging. “Perchlorate is primarily used in rocket fuel. There is no reason FDA should allow a chemical like this in or on food products,” Andrew Kimbrell, executive director of Center for Food Safety, said in a March 31, 2016, press release. “It is irresponsible, illegal, and…
The U.S. Food and Drug Administration (FDA) has issued a finalized rule under the Food Safety Modernization Act (FSMA) that is intended to help prevent the contamination of human and animal food during transportation. Among other things, the sanitary transportation rule requires those transporting food by motor or rail vehicle to follow recognized best practices for hygiene, including the provision of appropriate temperature control, cleaning between loads and security measures. The rule was initially proposed in February 2014 and its final iteration took into consideration the comments of some 200 stakeholders. See Federal Register, April 6, 2016. Issue 599
The U.S. Food and Drug Administration (FDA) has issued draft guidance proposing an action level of 100 µg/kg for inorganic arsenic in rice cereals for infants. The agency has also released supporting documentation for its proposal as well as a risk assessment that includes (i) “a quantitative estimate of lung and bladder cancer risk from long-term exposure to these products and the predicted impact of various scenarios to reduce the risk,” and (ii) “a qualitative assessment of certain potential non-cancer risks, in certain susceptible life stages.” “We conclude that the 100 µg/kg action level will help protect the public health and is achievable with the use of current good manufacturing practice, but we especially welcome comments and information bearing on the achievability and public health benefits and risks of 100 µg/kg, as compared with other potential action levels (including no action level),” states FDA, which will consider comments submitted by…
The Council of Better Business Bureaus (CBBB) and the National Confectioners Association have announced the Children’s Confection Advertising Initiative (CCAI), “a new self-regulatory initiative that promotes responsible advertising to children.” Modeled after the Children’s Food and Beverage Advertising Initiative (CFBAI), which includes six major confectioners, CCAI asks participating companies not to advertise to children younger than age 12 or in schools from pre-kindergarten through sixth grade. Six candy companies have already pledged to abide by CCAI advertising rules. As Federal Trade Commission (FTC) Chair Edith Ramirez remarked, “This new initiative is a welcome addition to the CBBB’s existing Children’s Food and Beverage Advertising Initiative and represents the type of self-regulatory solution the FTC has long advocated. The commitment by six confectionery companies to refrain from advertising in elementary schools and in media targeted at children is a positive step. I also hope that this new partnership with the National Confectioners…
The EU General Court has confirmed a European Commission decision finding that German company Dextro Energy's health claims for its glucose supplements are contrary to the messages of national and international authorities on the health risks associated with sugar consumption. The commission decided the issue in January 2015 despite advice from the European Food Safety Authority suggesting that the consumption of glucose could be linked to normal energy-yielding metabolism. "Even if those health claims were to be authorised only subject to specific conditions of use and/or were accompanied by additional messages or warnings, the Commission considered that the message nevertheless remained confusing for consumers, with the result that the claims in question should not be authorised," stated a March 16, 2016, press release from the General Court summarizing the opinion. Issue 598
The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed an emergency action to temporarily allow the use of standard point-ofsale warning messages for bisphenol A (BPA) exposures from canned and bottled foods and beverages. Under Proposition 65 (Prop. 65) regulations, consumer products that contain any chemical known to the state to cause reproductive toxicity or cancer must display a “clear and reasonable” warning on “labeling, shelf tags, shelf signs, menus or any combination thereof as long as the warning is prominent and conspicuous.” Starting May 11, 2016, all foods and beverages that result in BPA exposure must display a similar warning “unless the person causing the exposure can show that the exposure is 1,000 times below the no observed effect level for the chemical.” To avoid consumer confusion and give manufacturers time to transition to BPA-free packaging, OEHHA proposes allowing the temporary use of point-of-sale…
The U.K. Chancellor of the Exchequer George Osborne has announced a new levy on soft drink companies to be assessed “on the volume of sugar-sweetened drinks they produce or import.” In a budget presentation before Parliament, Osborne laid out a two-tiered tax scheme slated to take effect in April 2018, “to give companies plenty of space to change their product mix.” Under the levy, which exempts milk-based drinks and fruit juices, sugar-sweetened beverages will fall into one band with “a total sugar content above 5 grams per 100 milliliters,” or “a second, higher band for the most sugary drinks with more than 8 grams per 100 milliliters.” The U.K. Office for Budget Responsibility apparently anticipates that the levy will raise an estimated £520 million for increased sport funding in primary schools. “Many in the soft drinks industry recognize there’s a problem and have started to reformulate their products… So industry can…
The U.S. Department of Agriculture’s National Organic Program (NOP) has published revised National List Petition Guidelines for requesting amendments to the National List of Allowed and Prohibited Substances (National List). According to NOP, the National List not only identifies “the synthetic substances that may be used and the non-synthetic (natural) substances that may not be used in organic crop and livestock production,” but designates “a limited number of non-organic substances that may be used in or on processed organic products.” Clarifying the petition process as well as “the information to be submitted for all types of petitions requesting amendments to the National List,” the guidelines address, among other things, (i) who can submit a petition, (ii) what types of substances can be petitioned, and (iii) the criteria by which the National Organic Standards Board (NOSB) evaluates petitions. These criteria include: (i) “the potential of the substance for detrimental chemical interactions…
The U.S. Department of Agriculture’s Office of the Under Secretary for Food Safety and the U.S. Food and Drug Administration are holding an April 13, 2016, public meeting in College Park, Maryland, to discuss U.S. draft positions for consideration at the 43rd Session of the Codex Committee on Labeling in Foods (CCFL) in Ottawa, Canada, on May 9-13. CCFL is charged with drafting food labeling provisions and addressing issues related to the advertisement of food with particular claims or misleading descriptions. Agenda items for the April 13 meeting include discussion papers focused on Internet food sales and the labeling of non-retail containers; proposed revisions to guidelines for use of the term “Halal”; and date marking. See Federal Register, February 26, 2016. Issue 598
