Product Labeling & Marketing

Responding to a letter from eight trade associations asking for more time to prepare for compliance, the Food Safety and Inspection Service (FSIS), an agency within the Department of Agriculture, has decided to delay the effective date of final regulations requiring nutrition labeling for major cuts of single-ingredient raw meat and poultry from January 1

On December 9, 2011, the Food & Drug Administration (FDA) issued a notice announcing that a proposal to collect information for a “Experimental Study of Comparative Direct-to-Consumer Advertising” had been submitted to the Office of Management and Budget (OMB). FDA is required to submit the proposal to OMB for review and clearance under the Paperwork Reduction Act of 1995. FDA’s submission reveals its intent to study direct-to-consumer marketing of FDA-regulated products, with a focus on prescription drug advertising.

According to FDA, research findings on the effects of comparative versus noncomparative ads on purchase intentions indicate that comparative ads result in greater purchase intentions than noncomparative ads. Given the prevalence of comparative advertising, “FDA is embarking on the proposed research to ensure that it has adequate information to assess whether prescription drug comparative DTC ads provide truthful and nonmisleading information to consumers.”


Continue Reading FDA Proposes “Experimental Study of Comparative Direct-to-Consumer Advertising”

Responding to a request from Representatives Henry Waxman (D-CA), Frank Pallone (D-NJ), and John Dingell (D-MI), on October 24, 2011, the United States Government Accountability Office (GAO) issued a report which examines how the Food & Drug Administration (FDA) has addressed “economic adulteration” affecting the products it regulates and makes recommendations for strengthening regulatory and enforcement policies.

For purposes of the GAO evaluation and report, the GAO defined economic adulteration as “the fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e. economic gain.” The GAO study highlighted two specific cases of economic adulteration as indicators of the need for stronger policies to prevent economic adulteration of FDA regulated products. First, in 2007, vegetable protein products were found to contain melamine and cyanuric acid, industrial chemicals, in order to give the products an appearance of a higher protein content. The protein products were subsequently used in pet food and caused an unknown number of illnesses and deaths to dogs and cats. Notably, the melamine contamination case helped to inspire a number of food safety policy reforms, including the enactment of the Food Safety Modernization Act on January 4, 2011, which includes mandatory HACCP-type preventive controls and establishes new safeguards to prevent intentional adulteration of food products. The second case occurred in 2008, and involved the blood thinner known as heparin, which was found to contain oversulfated chondroitin sulfate, a toxic contaminant which was later linked to multiple human illnesses and deaths.


Continue Reading GAO Report Recommends FDA Adopt Definition of Economic Adulteration and Take Steps to Combat Independently from Other Types of Adulteration

On November 18, 2011, President Obama signed into law H.R. 2112, the Consolidated and Further Continuing Appropriations Act (Pub. L. 112-055), which, among other things, provides funding for the U.S. Department of Agriculture (“USDA”) for Fiscal Year 2012. The law includes policy “riders” blocking funding for key provisions of a rule proposed by USDA

On November 9, 2011, the Committee for the Right to Know, a consumer advocacy group that focuses on consumer, public health, environmental, and food issues, submitted the California Right to Know Genetically Engineered Food Act to the California state attorney general for title and summary–a necessary step needed to place citizen-created initiatives on the California

Yesterday, the Federal Trade Commission (“FTC”) approved a final settlement with marketers of the “Acne Pwner” and “AcneApp” mobile applications (“apps”). This is the first FTC settlement targeting health claims by mobile app developers/marketers, but one of several FTC mobile app enforcement actions.

In the AcneApp case, the defendants claimed that their apps could treat

On October 20, 2011, the Institutes of Medicine (“IOM”) issued Phase II of a two-part report regarding front-of-package nutrition labeling systems and symbols. The report, created by an IOM Committee convened in response to a 2009 Congressional request, provides recommendations regarding implementation of a front-of-package nutrition rating system designed to “encourage healthier choices and purchase

Posted by Sarah Roller

On August 18, 2011 the FTC issued a request for public comment and advance notice of proposed rulemaking (ANPR) as part of the Commission’s review of the costs, benefits, necessity, and regulatory and economic implications of its “Retail Food Store Advertising and Marketing Practices” rule, commonly called the “Unavailability Rule,” 16

On June 23, 2011, the Supreme Court rendered its decision in Pliva, Inc. v. Mensing holding that FDA regulations governing generic drug products directly conflict with and preempt state laws that would require generic drug manufacturers to modify the FDA-authorized labeling for their products to provide "adequate warnings" as defined by state law. The Court

Last week, the Center for Environmental Health, a non-profit organization, filed a complaint in California Superior Court alleging that 34 cosmetics companies violated the California Organic Products Act of 2003 (“COPA”) by selling, labeling, or marketing cosmetic products containing less than 70% organic ingredients as “organic.” The Center seeks an order enjoining the defendants from