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Most products sold in this country – whether imported or made here – are subject to a matrix of federal laws and regulations intended to provide Americans with significant benefits, such as safe food, safe products and a cleaner environment. The compliance costs for producers here and abroad are substantial. Further, imports can be subject

On July 10, 2012, the Food and Drug Administration (“FDA”) published a proposed rule implementing Federal Food, Drug, and Cosmetic Act (“FD&C Act”) provisions establishing a unique device identification system for medical devices over the next seven years. The rule would require medical device manufacturers—including a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, a relabeler, or any other person who applies a label to or modifies a label on a device that will not be modified again before sale—to place a unique device identifier (“UDI”) on the label and packaging of medical devices both in plain-text and also using automatic identification and data capture (“AIDC”) technology. The UDI itself will not hold any information. Manufacturers would have to submit identification information to FDA. FDA would aggregate the manufacturer-provided information in a new Global Unique Device Identification Database (“GUDID”). This public database would allow a physician to scan or manually enter the UDI of a device at a patient’s bedside and quickly access complete information regarding the device’s key attributes and proper use instructions.

The expected benefits of the new program include:
Continue Reading FDA Proposed Rule Would Place New Labeling and Reporting Requirements on Medical Device Manufacturers

Last month, the Food and Nutrition Service of the U.S. Department of Agriculture (“USDA”) issued a proposed rule that would establish regulatory requirements for the operation of the Fresh Fruit and Vegetable Program (“FFVP” or “Program”), as required by the Richard B. Russell National School Lunch Act (“NSLA”). 42 U.S.C. § 1758. Under the proposal, elementary schools that meet certain criteria could apply for and receive funding to purchase fresh fruits and vegetables that would be made available during the school day in an effort to improve the dietary habits of elementary school children and reduce childhood obesity.
Continue Reading USDA Proposal Would Establish Requirements for Program that Provides Fresh Fruits and Vegetables to Schools

On February 23, 2012, the Food and Drug Administration (“FDA”) issued an interim final rule and new guidance regarding provisions of the Food Safety Modernization Act (“FSMA”) that amended recordkeeping requirements of the Food, Drug, and Cosmetic Act (“FDCA”) for entities that manufacture, process, pack, transport, distribute, receive, hold, or import food. FSMA, which was enacted in January 2011, significantly expands FDA record access to allow FDA to view and copy records relating to an article of food where FDA has a reasonable belief that the food is reasonably likely to cause serious adverse health consequences or death to humans or animals, as well as records pertaining to food that FDA reasonably believes is likely to be affected in the same manner. FSMA’s expanded records access provisions are designed to help FDA better protect public health by enabling the agency to “focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.”
Continue Reading FDA Issues an Interim Final Rule and Guidance Regarding Expanded Recordkeeping Access Under the Food Safety and Modernization Act

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

Today, the Food and Drug Administration (“FDA”) released a guidance document for industry titled “What You Need to Know About Administrative Detention of Foods.” The guidance comes just a week after the FDA announced its first administrative detention under the expanded authority granted by Congress in the Food Safety Modernization Act. The FDA will issue

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

On October 19, 2011, the Food and Drug Administration (“FDA”) published a final rule amending its bottled water quality standard regulations by establishing an allowable level of di (2-ethylhexyl)phthalate (“DEHP”). The new DEHP limit and related requirements will take effect on April 16, 2012.
Under Section 410 of the Food, Drug, and Cosmetic Act (“FDCA”),