The U.S. Federal Trade Commission (FTC) has filed a complaint in a New Jersey federal court against Gerber Products Co., alleging that since 2011 the company has falsely promoted its Good Start Gentle infant formula as a product that can prevent or reduce the risk of a child developing allergies. FTC v. Gerber Prods. Co., No. 14-6771 (U.S. Dist. Ct., D.N.J., filed October 29, 2014). The formula is apparently made with partially hydrolyzed whey proteins (PHWPs) that Gerber purportedly claims make the product easier to digest than formula made with intact cow’s milk protein. Product stickers and ads compare the product to breastfeeding as a way to naturally protect a baby from allergies and claim that the formula is the “1st and ONLY” “TO REDUCE THE RISK OF DEVELOPING ALLERGIES.” The company also allegedly claims that the formula “is the first and only infant formula that meets the criteria for…
Category Archives U.S. Government and Regulatory Agencies
A California state court has approved the settlement of a putative class action alleging that Barney’s Worldwide Inc., owner of the Barney’s Beanery restaurant chain, falsely advertised its beef as Kobe beef when a U.S. Department of Agriculture (USDA) ban on the import of beef from Kobe, Japan, was in effect. Nalbantian v. Barney’s Worldwide Inc., No. BC493145 (Cal. Super. Ct., Cty. of Los Angeles, approval entered October 23, 2014). The plaintiff had alleged that Barney’s advertised its menu as containing Kobe beef—which the plaintiff said indicates that the beef comes from Wagyu-breed cattle raised and slaughtered in Kobe, Japan—despite a USDA ban imposed due to fears of disease in May 2010. Under the settlement, the restaurant chain will use “Kobe beef” on its menu only if it is listed as “American Kobe beef” and will pay up to $220,000 in $10 gift certificates to any class member who submits a claim…
The U.S. Food and Drug Administration (FDA) will host a public meeting and is soliciting public input on whether to expand the products included in its guidance, titled “Toxicological Principles for the Safety Assessment of Food Ingredients”—also known as the “Redbook.” The agency is apparently considering this expansion “to include chemical safety assessments for all products over which FDA’s Center for Food Safety and Applied Nutrition (CFSAN) has statutory authority including regulatory contexts such as food additives, food contact substances, dietary supplement ingredients, food contaminants, and cosmetics.” According to FDA, “The Redbook would describe toxicological principles which apply across regulatory categories while still providing specific guidance for applying these principles within each particular context. The safety of foods containing microbial contaminants will continue to remain outside of the scope of the Redbook.” The meeting will take place December 9, 2014, in College Park, Maryland, and those wishing to participate in…
The U.S. Food and Drug Administration (FDA) has denied two citizen petitions asking the agency to prohibit the use of aspartame as a non-caloric sweetener. Dated July 16, 2002, the first petition argued that the Public Health Security and Bioterrorism Preparedness Response Act authorizes FDA to recall dangerous chemicals without manufacturer approval. Citing studies conducted by the European Ramazzini Foundation (ERF), the second petition urged FDA to revoke approval for the sweetener under the Delaney Clause in section 409(c)(3)(A) of the Federal Food, Drug, and Cosmetic Act, which provides that “no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal.” Responding to these claims, FDA reasoned that the first petition and subsequent comments…
The Center for Food Safety (CFS) has issued a report challenging the proposed organic aquaculture production regulations under consideration by the U.S. Department of Agriculture (USDA). Titled Like Water and Oil: Ocean-Based Fish Farming and Organic Don’t Mix, the report argues that USDA should reject proposed standards that would allegedly dilute the value of organic certification by allowing the agency’s seal to appear on fish products sourced from ocean-based farms. In addition to citing the high number of fish escapes reported in the previous two decades, CFS claims that “open-ocean fish farms can never be organic,” partly because synthetic chemicals prohibited under the Organic Foods Production Act (OFPA) are ubiquitous in the marine environment. The group also alleges that open-ocean farming not only alters the natural behavior of migratory fish in violation of OFPA, but harms wild fisheries by using wild-caught fish as a feed source. “It’s mind-boggling to think that…
The Pew Charitable Trusts and Center for Science in the Public Interest (CSPI) have released an October 2014 report urging the U.S. Department of Agriculture (USDA) to reevaluate its current meat and poultry inspection system. Seeking to identify innovations that could better protect consumers, Meat and Poultry Inspection 2.0 compares U.S. regulations to those used in Australia, Denmark, the Netherlands, New Zealand, and Sweden. It also examines scientific assessments undertaken by the U.K. Food Standards Agency and the European Food Safety Authority (EFSA) as part of their efforts to modernize food safety regulations. “Modernizing government inspection of meat and poultry plants would focus resources on the food safety risks posed by bacteria and other microbiological and chemical hazards, and away from some human and animal diseases, such as tuberculosis and brucellosis, that have been successfully controlled in most developed countries,” argues the report. “However, out of a concern that modernizing government…
According to a proposed consent decree filed in a D.C. district court, the U.S. Food and Drug Administration (FDA) will “submit a final rule regarding ‘Substances Generally Recognized as Safe’ [GRAS] to the Federal Register for publication no later than August 31, 2016.” Ctr. for Food Safety v. Burwell, No. 14-0267 (U.S. Dist. Ct., D.D.C., consent decree filed October 20, 2014). The Center for Food Safety apparently brought the action over concerns that food makers have been able to use an interim GRAS process and secure agency approval for allegedly unsafe ingredients, such as volatile oil of mustard, “olestra” and “quorn,” based on self-assessments. According to the Center’s complaint against the agency, FDA has unlawfully exempted GRAS substances from regulation as food additives under a rule proposed, but never finalized, some 15 years ago. That proposed rule purportedly eliminated a petition process requiring food companies to demonstrate that a substance satisfies…
The Government Accountability Office (GAO) has released a report assessing the U.S. Department of Agriculture’s (USDA’s) current approach to Salmonella and Campylobacter in chicken and turkey products and recommending that the agriculture secretary direct the Food Safety and Inspection Service (FSIS) to take steps to improve the approach. The report reviews past USDA action on these pathogens, including the establishment of standards limiting Campylobacter contamination and the tightening of existing Salmonella contamination standards. GAO recommended that the agriculture secretary direct FSIS to develop Salmonella and Campylobacter performance measures to monitor whether efforts to bring processing plants into compliance with the poultry products standards are meeting the agency’s goals. GAO also recommended that effectiveness measures be included in future revisions of compliance guidelines for controlling the pathogens. According to the report, USDA agrees with the recommendations. Issue 542
The U.S. Food and Drug Administration (FDA) has scheduled a November 13, 2014, public meeting in College Park, Maryland, to solicit stakeholder comments and respond to questions about revisions to four rules first proposed in 2013 to implement the Food Safety Modernization Act (FSMA). The proposals address (i) Preventive Controls for Human Food, (ii) Produce Safety, (iii) Preventive Controls for Animal Food, and (iv) Foreign Supplier Verification Programs. Information about registration and making oral presentations may be found at FDA’s website. See Federal Register, October 23, 2014. Issue 542
The U.S. Department of Health and Human Services (HHS) and Department of Agriculture (USDA) have scheduled a meeting of the 14-member committee charged with developing the federal government’s “2015 Dietary Guidelines for Americans” for November 7, 2014, from 10 a.m. to 5:30 p.m. EST. The meeting is accessible to the public by Webcast only and registration is required to view the proceedings. Aimed at promoting consumption of foods and beverages that assist in maintaining a healthy weight and preventing disease, the guidelines were first issued in 1980, are revised every five years and provide the basis for federal food and nutrition policy and education efforts. The next iteration of the guidelines will be published during fall 2015. Information about the November 7 meeting agenda, Webcast registration and the committee’s requests for written comments may be found at the Office of Disease Prevention and Health Promotion’s website. See Federal Register, October 20,…
