The Second Circuit has reversed a district court’s decision that ordered the U.S. Food and Drug Administration (FDA) to initiate hearings responding to a livestock antibiotics challenge from the Natural Resources Defense Council (NRDC) based on a 1977 agency finding that the use of growth antibiotics for healthy animals was unsafe. NRDC v. FDA, No. 12-2106 (2d Cir., order entered July 24, 2014). Two judges were “firmly persuaded that Congress has not required the FDA to hold hearings whenever FDA officials have scientific concerns about the safety of animal drug usage,” that FDA has discretion on proceedings to withdraw approval of animal drugs, and that the law requires “withdrawal of approval of animal drugs or particular uses of such drugs only when the FDA has made a final determination, after notice and hearing, that the drug could pose a threat to human health and safety.” In 1977, FDA planned to…
Category Archives Issue
The U.K. Advertising Standards Authority (ASA) has dismissed a competitor’s complaint alleging that Unilever UK Ltd.’s commercial for its pyramid-shaped teabags “exaggerated the capability and performance of the advertised product.” Tata Global Beverages reportedly argued that (i) the visual demonstration used in a TV commercial for PG Tips tea was misleading, (ii) Unilever’s claim that “the tea has more room to move freeing the great fresh taste” could not be substantiated, and (iii) “the comparison with a round teabag denigrated Tata’s brand ‘Tetley’ because they believed that they were an identifiable competitor and that the ad portrayed the brand in a negative light.” According to ASA, Unilever not only countered that the visual demonstration in question “imitated consumer behavior when making tea,” but noted that the claims reflected the results of product testing and mathematical modeling supplied to ASA for review. Denying that the ad made a direct comparison to…
The Canada Food Inspection Agency (CFIA) has announced new administrative monetary penalties (AMPs) for businesses that fail to meet the requirements laid out in the Meat Inspection Act (MIA) and Meat Inspection Regulations, 1990 (MIR). According to a July 16, 2014, press release, the agency is amending the Agriculture and Agri-Food Administrative Monetary Penalties Regulations to “allow CFIA inspectors to issue an AMP for noncompliance with 84 provisions of [MIA] and [MIR],” which include items related to both food safety and non-safety issues such as labeling. “AMPs are an additional tool that will support the CFIA in delivering its mandate for food safety, explained Chief Food Safety Officer for Canada Martine Dubuc. “AMPs do not replace existing inspection and enforcement tools, but instead offer additional flexibility in addressing meat-related violations.” Issue 531
Health Canada has proposed nutrition labeling changes as part of an ongoing effort to make food and beverage labels easier for consumers to read. Based on a public consultation, the conclusions of Canadian Food Inspection Agency’s Food Labelling Modernization Initiative and a technical review of current labels, the amendments would revise the Nutrition Facts table, ingredient list and suggested Daily Values to take into account “the most up to date scientific information and consumption habits.” In particular, the proposed changes would (i) adjust serving sizes to reflect “the amounts of food that Canadians actually eat in one sitting,” (ii) update the Daily Values and nutrients displayed in the Nutrition Facts table; (iii) refresh the appearance of the Nutrition Facts table and ingredient list to emphasize calories, added sugars and other nutrients of concern to Canadian consumers, and (iv) create “an optional information box highlighting the presence of certain bioactive components,…
The European Union (EU) and the Southern African Development Community (SADC)—Botswana, Lesotho, Mozambique, Namibia, South Africa, and Swaziland—have agreed to protect each other’s geographical indication (GI) names on agricultural products. The EU lists 251 GIs it seeks to protect for a variety of products, focusing especially on dairy products like cheese, while South Africa’s 105 GIs are primarily wine-related. As a result of the agreement, the countries will allow the labeling of a product as the GI only if it originated from a designated area, but they will respect previously registered trademarks. “[GIs] are a key tool to protect the know-how of farmers and develop added value in quality agricultural products,” said EU Agricultural Commissioner Dacian Ciolos. See Law360, July 22, 2014. Issue 531
At the request of 13 member states, the Council of the European Union (EU) has adopted a draft directive granting its member states “more flexibility to decide whether or not they wish to cultivate genetically modified organisms (GMOs) on their territory.” In a July 23, 2014, press release, the council states that it sought “to provide a sound legal basis in the related EU legal framework in order to allow member states to restrict or prohibit the cultivation, in all or part of their territory, of GMOs that have been authorised or are under authorisation at the EU level.” The measure was originally proposed in 2009 but stalled after a 2011 draft; in June 2014, the EU Environmental Council reached a political agreement that led to this draft directive, which the council projects will be adopted in 2015. See Law360, July 23, 2014. Issue 531
Representatives of more than 170 countries, the European Union and governmental and non-governmental organizations convened in Geneva, Switzerland, on July 14-18, 2014, for the annual meeting of the Codex Alimentarius Commission. Delegates reportedly adopted a recommendation that no more than 0.01 mg/kg of lead be allowed in infant formula and that raw materials be sourced from geographical areas where lead is less prevalent, citing the particular vulnerability of infants and young children to developmental health effects from lead exposure. Codex also set a maximum allowable level for arsenic in rice of 0.2 mg/kg because long-term exposure to the naturally occurring chemical has been linked to the development of cancer, heart disease and diabetes. Other decisions made during the annual meeting related to restricting the use of eight veterinary drugs (chloramphenicol, malachite green, carbadox, furazolidone, nitrofural, chlorpromazine, stilbenes and olaquinadox) in food-producing animals to prevent any residual quantities in meat, milk,…
The National Nanotechnology Coordination Office will host a July 31, 2014, webinar to discuss research undertaken by U.S. government National Nanotechnology Initiative (NNI) agencies. NNI’s six core research areas include nanomaterial measurement infrastructure; human exposure assessment; human health; environment; risk assessment and risk management methods; and informatics and modeling. See Federal Register, July 22, 2014. Issue 531
Following the recent death of an Ohio teenager whose autopsy reportedly revealed blood levels of more than 70 micrograms of caffeine per milliliter, the Food and Drug Administration (FDA) this week issued “consumer advice” warning parents that powdered pure caffeine is a “powerful stimulant and very small amounts may cause accidental overdose.” Such products are unregulated and sold as dietary supplements. According to the agency, a teaspoon of pure caffeine is “roughly equivalent” to the amount contained in 25 cups of coffee. FDA is encouraging the public as well as health care providers to report any adverse events related to consumption of powdered pure caffeine to the agency. See Associated Press, July 19, 2014; FDA Consumer Advice on Powdered Pure Caffeine, July 21, 2014. Issue 531
The White House has issued a June 24, 2014, memorandum creating a federal strategy “to promote the health of honey bees and other pollinators.” Highlighting the critical role of pollinators in agriculture and the economy, the memorandum establishes an interagency Pollinator Health Task Force and directs members to develop a National Pollinator Health Strategy by December 21, 2014. Among other things, the strategy requires an action plan for understanding, preventing and recovering from pollinator losses through the use of longitudinal studies, expanded data collection and sharing, assessment of native pollinator populations, and development of affordable seed mixes for the maintenance of honey bees and other pollinators. Agency representatives appointed to the task force will also implement a number of policies designed to incorporate pollinator health into the management of federal land, rights-of-way, and restoration and reclamation projects. To this end, the White House has called for further education to help…
