The United States Court of Appeals for the Fourth Circuit recently affirmed a West Virginia federal district court’s holding that a plaintiff’s common law tort claim was preempted by the 1976 Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”). Under the MDA, certain medical devices, known as Class III devices, are required to receive premarket approval from the Food and Drug Administration (“FDA”).  The MDA also allows the FDA to condition a grant of premarket approval on a requirement that a device meet certain performance standards. The establishment of a performance standard is a formal process that requires publication in the Federal Register and providing interested parties with an opportunity to comment.  The MDA expressly preempts state medical device regulations that are “different from, or in addition to, any [federal] requirement.”


Continue Reading Fourth Circuit Clarifies Scope of Federal Preemption for Requirements Governing Medical Devices

In a unanimous opinion published on January 23, 2012, the Supreme Court reversed the Ninth Circuit Court of Appeals and held that a California law prohibiting the sale, processing or holding of a nonambulatory animal was expressly preempted by the Federal Meat Inspection Act (FMIA).

The case, National Meat Association v. Harris, dealt with Section 599f of the California Penal Code, which was enacted in 2008 in response to an undercover video released by the Humane Society showing workers in California kicking and electroshocking sick and disabled cows in an attempt to move the cows. The law makes it a crime for any slaughterhouse to “buy, sell or receive a nonambulatory animal,” or to “process, butcher or sell meat or products of nonambulatory animals for human consumption,” or “hold a nonambulatory animal without taking immediate action to humanely euthanize the animal.”

The National Meat Association (NMA) sued to enjoin enforcement of the law as applied to swine slaughterhouses and argued that the FMIA’s broad express preemption provision prohibited California from enacting distinct requirements for the handling of nonambulatory pigs. The FMIA and implementing regulations enacted by the Department of Agriculture’s Food Safety and Inspection Service (FSIS) broadly regulate slaughterhouses to promote meat safety and humane treatment. With respect to the treatment of nonambulatory pigs, FSIS regulations permit slaughterhouses to hold and eventually sell nonambulatory animals, subject to a “post-mortem” examination.


Continue Reading Supreme Court Unanimously Holds California Law Prohibiting Sale, Processing or Holding of Nonambulatory Pigs Expressly Preempted under the Federal Meat Inspection Act

Today the United States Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published two proposed regulations that will affect companies that produce and market organic food products. One proposed rule would clarify which vitamins and minerals are permitted for use in organic food and infant formula, while the other proposed rule would renew the status

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

The FDA has published an interim final rule amending definitions related to required notifications regarding drug shortages. 21 C.F.R. 314.81(b)(3)(iii) requires an applicant who is the sole manufacturer certain approved drug products to notify FDA in writing at least 6 months prior to discontinuing manufacture of the drug product. 21 C.F.R. 314.81(b)(3)(iii) now refers to

The Presidential Commission for the Study of Bioethical Issues has released its report “Moral Science: Protecting Participants in Human Subjects Research.” The report was requested by President Obama to determine if current regulations adequately protect human subjects in federally funded research. The Commission determined that current regulations “generally appear” to protect participants from harm or unethical treatment, “as far as is feasible given limited resources,” but that it cannot say if current regulations are optimal for protecting against avoidable harm and unethical treatment because some agencies have limited ability to identify basic information about all human subject research.


Continue Reading Bioethics Commission Study Released

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”),

Senators Hatch and Harkin, the principle architects of the Dietary Supplements Health and Education Act (DSHEA) (amending the Federal Food Drug and Cosmetic Act (FDCA)), submitted a letter yesterday to FDA Commissioner Margaret Hamburg "exress[ing] their support for the upcoming new dietary ingredients (NDI) guidance." The Senators stated that the guidance should reflect the intent