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The Federal Food Safety Working Group (“FSWG”) yesterday released a progress report highlighting the groups accomplishments over the last two years and outlining priorities for the future. Established by President Obama in 2009, the FSWG is responsible for building a modern food safety system. Secretary for Health and Human Services Kathleen Sebelius noted in a conference call that until recently, the federal government had been “monitoring a 21st century food system with 20th century tools.” The purpose of the FSWG is to correct that deficiency.…

Continue Reading Food Safety Working Group Releases 2009-2011 Progress Report

On December 14, 2011, the Inspector General of the Department of Health and Human Services issued a report finding that the Food and Drug Administration (FDA) failed to properly oversee food facility inspections conducted by states because FDA had not ensured the requisite number of inspections and failed to follow-up appropriately when inspections occurred. The report was issued in response to a request from Rep. Rosa L. DeLauro (D-CT), Ranking Member on the Labor, Health and Human Services Appropriations Subcommittee of the House Committee on Appropriations, following a salmonella outbreak attributed to a Georgia peanut processing plant in 2009.

FDA enters into contracts with state agencies where FDA pays the state to conduct inspections of its food facilities. FDA relied on states for a total of 59 percent of the agency’s food inspections in FY 2009, as opposed to only 42 percent in FY 2004, and spent over $8 million on such inspections.…

Continue Reading Health and Human Services Inspector General Report Identifies Shortcomings in FDA Oversight of State Food Inspections

On November 30, 2011, the Food and Drug Administration (FDA) held a public meeting to consider the need to amend pre-existing guidelines or adopt new ones addressing microbiological safety in cosmetics. The FDA presented the meeting as an opportunity for industry and other stakeholders to provide input on whether current guidelines sufficed to address cosmetic microbiological safety.

The FDA and industry members have long acknowledged the capacity for microorganisms to grow and reproduce in cosmetics if certain precautions are not taken. This growth can cause chemical changes to the products, which may adversely affect the consumer. In explaining the impetus behind the meeting, FDA representatives noted that current FDA guidelines on microbiological safety have not been revised in some time. These guidelines include the Cosmetic Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist (2008) and the Bacteriological Analytical Manual (BAM), Chapter 23 “Microbiological Methods for Cosmetics” (2001). FDA representatives stated that they were in the process of revising these guidelines and also considering issuing entirely new guidelines on microbiological safety.…

Continue Reading FDA Holds Public Meeting on Cosmetic Microbiological Safety Issues to Consider Need for New Guidelines

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 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”),…

The Food and Drug Administration (“FDA”) has released a question and answer guide to its implementation of the fee provisions of the Food Safety Modernization Act of 2011. The purpose of the fee provisions is to allow the FDA to recover reinspection, recall noncompliance, and importer program related costs from domestic and foreign facilities and…

Late last month, the U.S. Supreme Court ruled on a significant federal preemption case concerning an individual’s right to sue a vaccine manufacturer for injury that is alleged to have resulted from a defect in a vaccine’s design. The 6-2 decision (Justice Kagan recused herself) in Bruesewitz v. Wyeth held that a provision within the National Childhood Vaccine Injury Act of 1986 (NCVIA) preempts all design-defect tort claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by vaccine side effects. The NCVIA was originally enacted to establish a no-fault compensation program that serves as an alternative to the traditional tort system for resolving vaccine injury claims.

In 1995, the parents of Hannah Bruesewitz claimed that their daughter became disabled after receiving a vaccine manufactured by Lederle Laboratories (now owned by Wyeth). In response, they filed a vaccine-injury petition in the U.S. Court of Federal Claims, which the NCVIA designated to decide which vaccine injury claims should be compensated. After the Bruesewitz’s claim was denied, the parents sued Lederle in Pennsylvania state court alleging that Lederle was subject to strict liability and liability for negligent product design under Pennsylvania common law. The case was removed to the U.S. Third Circuit Court of Appeals, which sided with Wyeth on its summary judgment motion and held that the state law claim was preempted by the NCVIA.

The Supreme Court affirmed the Third Circuit decision based on a textual analysis of the NCVIA preemption provision, which reads:…

Continue Reading U.S. Supreme Court Upholds Federal Preemption In Childhood Vaccine Liability Case