Among its accomplishments since its inception, the FSWG has:

• issued an egg safety rule to control Salmonella contamination in egg shells
• published a draft guidance for salmonella in animal feed
• implemented stricter pathogen reduction performance standards for salmonella and new standards for campylobacter
• announced the classification of new strands of E. coli as adulterants in non-intanct raw beef
• issued commodity specific draft guidance on agricultural practices that reduce the risk of microbial contamination
• established the Produce Safety Alliance, a private-public partnership to provide access to food safety educational materials for produce growers and packers
• identified indicators of economically motivated adulteration
• established a Senior Executive Council to determine appropriate actions to reduce cancelled pesticide and environmental contaminant residue in the food supply
• launched the Reportable Food Registry

Going forward, the FSWG will focus on implementation of the Food Safety Modernization Act (“FSMA”). Efforts will include preventive controls, retail safety, enhanced domestic surveillance, and import safety. Stakeholders should be prepared to take advantage of opportunities to engage with the FSWG as they make progress on FSMA implementation.

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.

The report found that FDA failed to ensure that the requisite number of inspections were completed in 8 states, identifying a 10 percent shortage in inspections. FDA even paid for 130 of the 221 uncompleted inspections.

Additionally, FDA failed to appropriately classify state inspection results in at least 11 states. FDA policy dictates that inspections should result in one of three classifications. First, the inspection may reveal violations significant enough to potentially warrant regulatory action. Second, the inspection may reveal violations, but those violations do not cross “the threshold for regulatory action.” Third, the inspection may reveal no violations. While FDA guidance indicates that uniform classification is critical to the success of FDA’s food safety program, the report revealed that FDA officials overseeing inspections in 11 states used different criteria than used in classifying federal inspections.

The report also noted that FDA sometimes failed to appropriately follow-up after inspections to address identified violations. In order to promote the public health and ensure the effectiveness of state contract programs, the report recommended that FDA:

• ensure that all contract inspections are completed, properly documented, and appropriately paid for;
• ensure that contract inspections are properly classified in accordance with FDA guidance;
• ensure that all inspection violations are remedied by routinely tracking all actions taken to correct violations;
• ensure that the minimum audit rate is met in all states;
• address any systemic problems identified by audits

In response to the report, FDA indicated its concurrence with each general recommendation, but noted in response to the recommendation that all inspection violations be remedied and tracked that some violations may not require follow-up.

The Food Safety and Modernization Act of 2011 (FSMA) provides FDA with new prevention-focused authority to conduct food inspections and protect food safety generally. Implementation of FSMA will require an increase in the number of food inspections, thus making oversight of state inspections all the more significant.

A copy of the Inspector General report is available here.

This post was written by Sarah Roller and Donnelly McDowell.

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.

Industry members indicated a willingness to collaborate on any revised or new guidelines, but noted that current industry practice already ensured the safety of cosmetics. Dr. Jay Ansel of the Personal Care Products Council, which represents more than 600 companies manufacturing personal care products, referred to studies finding an incident report of one per every 270 million units sold. Phil Geis of Geis Microbiological Quality cited industry practice of monitoring product safety from start to finish of the product cycle as the reason for the low incident rate. Geis also argued that requiring complete sterility in all products would be unnecessarily expensive and stifle innovation for no discernible benefit.

Despite industry assurances of safety, FDA representatives responded that they were interested in taking a “preventative approach” to cosmetic microbiological safety and suggested this could be effectuated by updating and aligning various sources of information on microbiological safety.

It is important to note that the only action contemplated by the meeting was the issuance of nonbinding guidelines. Unlike its authority over drugs and medical devices, the FDA lacks authority to require pre-market approval of cosmetics. The FDA can only take action against a specific cosmetic product once it has been found to be adulterated or misbranded and therefore it cannot require cosmetic companies to comply with guidelines on cosmetic microbiological safety prospectively.

The FDA urged interested parties to submit written comments to the docket by January 30, 2012. More information, along with the link to submit comments to the docket, is available here.

This blog post was written by Sarah Roller and Donnelly McDowell.

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.

Both of the economic adulteration cases addressed in the GAO report involved products that were imported from China to the United States. The GAO report cites increased globalization as a key factor contributing to the increased risk of economic adulteration in FDA regulated products. According to FDA documents, 10 to 15 percent of all food, 80 percent of all pharmaceutical ingredients, 40 percent of finished drugs and half of all medical devices used in the United States are imported. With these numbers expected to continue to rise, the FDA Commissioner has suggested that the FDA may need to fundamentally alter the process by which it monitors safety and quality of food and medical products. The report also references an increase in supply chain complexity as one factor complicating the regulation of economic adulteration. As products may travel through many countries for manufacturing and processing before ultimately reaching the United States, it becomes increasingly difficult to trace an ingredient back to the original source.

While the Federal Food, Drug & Cosmetic Act prohibits the introduction of any adulterated food, drug or medical device into interstate commerce, it does not distinguish between ordinary adulteration and economically motivated adulteration. Among other things, a food is adulterated if it contains any poisonous or deleterious substance which may render it injurious to health or if any valuable constituent has been omitted, or if any damage or inferiority has been concealed.

The GAO interviewed a number of FDA officials in the course of its study and noted that the FDA currently addresses economic adulteration as part of broader efforts to combat adulteration generally. These efforts include using publicly available data to target products at risk for adulteration as part of the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting (PREDICT), sharing data with other federal and state agencies with authority over pet food to monitor outbreaks of illness in animals, and implementing a program allowing certain drug companies to import products on an expedited basis upon meeting certain criteria for safety.

While FDA has taken some steps specific to economic adulteration, the report found that the FDA missed opportunities for coordination and communication which would make those efforts more successful. For instance, the FDA’s Office of Regulatory Affairs (ORA) and the Center for Drug Evaluation and Research (CDER) both developed models to determine which human foods and drugs were at the greatest risk for economic adulteration, but did not adequately coordinate efforts or share valuable information with the other.

The report provides three broad recommendations to the FDA in order to address economic adulteration:

• Adopt a working definition of economic adulteration as done in May 2009;
• Provide written guidance to agency centers and offices on the means of addressing economic adulteration; and
• Enhance communication and coordination of agency efforts on economic adulteration.

The GAO report is available here.

This post was written by Sarah Roller and Donnelly McDowell.

• Bottled water may not contain more than 0.006 milligrams/liter (mg/L) of DEHP or the product will be deemed misbranded under Section 403(h)(1) of the FDCA;
• In accordance with FDA current good manufacturing practice (“CGMP”), bottled water manufacturers will be required to monitor their source water for DEHP as often as necessary, but at least once a year, unless they meet the criteria for exemptions under 21 C.F.R. § 129.35.
• Manufacturers will also be required to monitor finished products for DEHP at least once a year; and
• The FDA will determine compliance with the new rule by using the EPA’s analytical methods for measuring DEHP in bottled water.

Persons responsible for facilities subject to the fees should review the guidance and note that although the FDA began assessing fees for reinspection of domestic and foreign facilities and for failure to comply with a recall order on October 1, 2011, the fees for import reinspection will not be assessed until the FDA has resolved the issues raised in comments on the fee schedule released in the August 1, 2011 Federal Register.

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:

No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1998, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.

The Court considered the preemption provision’s applicability to the three common grounds for liability under product liability law ― defective manufacture, inadequate directions or warnings, and defective design. The Court noted that the preemption provision explicitly refers to the manufacturing process (“properly prepared”) and “directions and warnings,” yet it excludes design defects. The Court determined that this was an intentional omission by the NCVIA drafters based upon the Court’s reading of the NCVIA and related FDA regulations on vaccines. Specifically, the NCVIA and FDA regulations both extensively address vaccine manufacturing and the proper use of warnings, yet neither source mentions vaccine design defects. According to the Court, this omission “strongly suggests” that design defects are not a basis for liability.

The Court further stated that if a vaccine manufacturer could be held liable for failing to use a different design, as the petitioners argued, the word “unavoidable” within the preemption provision would be wrongly rendered meaningless because a side effect from a vaccine can always be avoided with a different design that excludes the harmful element. Thus, the Court held that where a vaccine is properly manufactured and accompanied by adequate warnings, any remaining adverse effects ― including those that result from design defects — are unavoidable and not subject to liability.

The Court’s opinion acknowledged that design-defect torts can prompt the development of improved design and provide compensation for injuries; however, the Court also noted that the NCVIA already provides sufficient means for achieving both of these objectives. For example, the opinion, in addition to discussing the compensation program, highlighted provisions within the NCVIA that mandate vaccine research and testing, and require manufacturers and health-care providers to report adverse side effects and monitor vaccine safety through a collaboration with managed-care organizations.