FDA Commissioner Margaret Hamburg offered her views on how the agency will move forward on food safety and labeling issues during a “Food Summit” sponsored by The Atlantic magazine at the Newseum in Washington, D.C., March 4, 2010. Hamburg stated that she plans to focus on two critical aspects of food policy: safety and how to make it easier for consumers to make more nutritious choices and reduce the risk of disease. She pointed to three converging factors that affect food safety. First, she stated that both consumers and the industry support reform measures and want a system focused on prevention, where everyone in the supply chain is held accountable and imports are required to meet U.S. standards. Second, she noted that current U.S. food safety legislation (H.R. 2749—passed by the House in July 2009 and expected to be taken up by the Senate this spring) would mandate a shift from reaction…
Category Archives Food and Drug Administration
With the recent uptick in consumer fraud class actions targeting food and beverage labels, and opinions like the Ninth Circuit’s in Williams v. Gerber, 552 F.3d 934 (2009) (reinstating a proposed class action and finding that consumers should not be “expected to look beyond misleading representations on the front of the box to discover the truth from the ingredient list in small print on the side of the box”), the findings of a recent Food and Drug Administration health and diet survey are good news to manufacturers of food and beverage products. On March 2, 2010, FDA released the results of a nationwide survey conducted in 2008 on consumer behaviors, knowledge, attitudes, and beliefs about health and diet. Specifically included were questions about consumer use of packaging labels. Fifty-four percent of consumers “often” read the food label the first time they buy a product. Of these, two-thirds do so to…
Taking aim at companies that make (i) nutrient content claims on foods and beverages intended for children younger than age 2, (ii) 0 gram trans fat claims on products high in saturated fats, and (iii) health-related claims, such as the treatment or mitigation of disease, the Food and Drug Administration (FDA) has issued warning letters to 17 companies and an open letter to industry indicating that it will crack down on false or misleading labeling and marketing claims. Among the targeted companies are Dreyer’s Ice Cream, Inc. (ice cream—no trans fat), Beech-Nut Nutrition Corp. (baby food—nutrient claims for children younger than age 2), Nestle (Juicy Juice products—implied 100 percent juice for juice blends with added flavors), Pompeian, Inc. (olive oil—treat, prevent and cure diseases), Redco Foods (green tea—antioxidants effective in the prevention of cardiovascular disease), and Diamond Food, Inc. (shelled walnuts—omega-3 claims about treating, preventing or curing diseases). Some of the…
Senator Charles Schumer (D-N.Y.), who introduced legislation that would prohibit the use of bisphenol A (BPA) in children’s products, has written to the U.S. Environmental Protection Agency’s (EPA’s) administrator seeking an explanation for the agency’s decision to omit BPA from its December 2009 chemical action plan. In the March 2, 2010, letter, Schumer refers to scientific research purportedly identifying BPA risks “particularly to infants and children,” and the Food and Drug Administration’s recent decision to reverse its conclusion that the chemical is safe for all uses. Schumer also refers to a Milwaukee Journal-Sentinel article reporting that “the agency does not plan to formulate any new plan for regulating BPA for two years. If this is true, it is alarming. At a time when we should be speeding up steps to limit Americans’ exposure to this potentially hazardous chemical, such a decision would apply the brakes.” That article apparently took note of…
The Food and Drug Administration (FDA) has announced a plan to address preventive controls aimed at reducing the risk of microbial contamination of fresh produce at farms and packing houses. The agency seeks information and public input so that it can develop safety standards and cooperative strategies to ensure compliance. FDA is requesting comments on topics including (i) standards for domestic and foreign growers and packers; (ii) identification and prioritization of risk factors; (iii) environmental hazard assessments and “possible pathways of contamination”; (iv) methods to tailor preventive controls to particular hazards and conditions affecting an operation and to the scale of the operation; (v) microbial testing; (vi) post-harvest operations; and (vii) records and other documentation that would be useful to industry and regulators in ensuring the safety of fresh produce. Comments must be submitted by May 24, 2010. See Federal Register, February 23, 2010.
The Federal Trade Commission (FTC) recently announced that it had sent warning letters to 11 companies that promote omega-3 fatty acid dietary supplements. The letters indicated that the companies should review their product labeling and packaging claims, as well as product advertising, to ensure that the claims are adequately substantiated. The commission’s issuance of these letters is significant because of the FTC’s action to regulate dietary supplement labeling claims, an area that has for nearly four decades been regulated by the Food and Drug Administration (FDA). Commission Takes Aim at Ad Links Between Omega 3 and Children’s Visual and Mental Development According to a February 16, 2010, press release, [FN 1] the FTC’s Division of Advertising Practices in January sent warning letters to 11 companies that promote supplement products containing omega-3 fatty acids intended for use by children ages 2 years and older. The letters reference an investigation the FTC conducted…
The Food and Drug Administration (FDA) has published a notice seeking public comments on its proposed collection of information on foods derived from new plant varieties including those created through biotechnology. Comments must be submitted by April 19, 2010. The types of information that developers of new plant varieties would be required to provide to the agency include (i) a description of the applications or uses of the bioengineered food, (ii) information about the sources, identities and functions of the introduced genetic material, (iii) information about any known or suspected allergenicity and toxicity, and (iv) information relevant to the safety and nutritional assessment of the bioengineered food. Commenters are asked to address whether the proposed collection “is necessary for the proper performance of FDA’s functions,” the accuracy of the agency’s estimate of the burden of the proposed information collection, ways to improve the quality of the information to be collected,…
The Food and Drug Administration (FDA) has submitted a proposed collection of information involving antimicrobial animal drugs to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act. According to the Federal Register notice, a 2008 amendment to the Federal Food, Drug, and Cosmetic Act requires that “the sponsor of each new animal drug that contains an antimicrobial agent submit an annual report to FDA on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals.” The first report under the law will be due March 31, 2010, and must specify (i) “The amount of each antimicrobial active ingredient by container size, strength, and dosage form”; (ii) “quantities distributed domestically and quantities exported”; and (iii) “a listing of the target animals, indications, and production classes that are specified on the approved label of the…
The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) have issued a joint statement to announce a collaborative effort to improve the safety and quality of fresh produce. As part of the announcement, the agencies report that USDA’s Agricultural Marketing Service “is in the midst of evaluating a proposed marketing agreement for the leafy green industry,” while the FDA “is currently developing a proposed produce safety regulation.” The notice calls for feedback and comments from stakeholders, noting that FDA would establish “a docket to receive information about current practices and conditions for the production and packing of fresh produce and practical approaches to improving produce safety.” See FDA News & Events, February 18, 2010.
This article discusses the Food and Drug Administration’s (FDA’s) renewed interest in revising its approach to food serving sizes as front-of-package labeling gains traction in the marketplace. According to Times writer William Neuman, “The push to re-evaluate serving size comes as the F.D.A. is considering ways to better convey nutrition facts to hurried consumers, in particular by posting key information on the front of packages. Officials say such labeling will be voluntary, but the agency must set rules to prevent companies from highlighting the good things about their products, like a lack of trans fats, while ignoring the bad, like a surfeit of unhealthy saturated fats.” Created in the 1990s to help shoppers “compare the nutritional values of different products,” serving sizes are based on eating habit surveys taken during the 1970s and 1980s. Neuman claims, however, that while many people “might eat two or three times” the serving size…
