Wednesday, November 26, 2008

Scientific Panel Rebukes FDA on BPA

“A scientific panel has issued a blistering report against the Food and Drug Administration, saying the agency ignored important evidence in reassuring consumers about the safety of the controversial chemical bisphenol-A,” wrote Tara Parker-Pope, “Panel Rebukes F.D.A. on Plastic Safety,” the New York Times. BPA is used to make plastic water and baby bottles and in the lining of soft drinks and canned food products.

“The panel . . . did not draw any conclusions about the safety of the chemical, known as BPA. But it criticized the F.D.A. for ignoring crucial studies and using what it said were flawed methods in reaching its conclusions.”

“In its statement, the F.D.A. said consumers should know that ‘based on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.’”

For a PDF of the scientific group’s full report, click here.

Wednesday, November 19, 2008

Philadelphia to Require Nutrition Labeling on Chain Restaurant Menus

Philadelphia has become the latest U.S. city to require restaurants to list calories on their menus. In a 12 to 5 vote, the city council approved an ordinance requiring food service establishments with 15 or more outlets to provide the total number of calories, saturated fat, trans fat, carbohydrates and sodium for all foods and beverages offered for sale on menus. For items not on menus but on menu boards or with food tags, the nutrition information may be limited to the total number of calories per item provided that the additional information is made available to customers upon request. Restaurants that fall under the ordinance must comply by January 1, 2010.

For a copy of the ordinance click here. For a copy of an article in click here.

UK Food Standards Agency Advises Pregnant Women to Limit Caffeine

The United Kingdom’s Food Standards Agency (FSA) is advising pregnant women to limit caffeine intake to 200 mg a day. The FSA had previously advised a maximum daily intake of 300 mg. The new guidelines follows research carried out on behalf of the FSA by the Universities of Leeds and Leicester.

Too much caffeine might result in a baby having a lower birth weight than it should, which can increase the risk of some health conditions for the baby in later life, or could possibly result in spontaneous miscarriage.” FSA Press Release. “Professor Justin Konje, Chair of the Project Steering Group from the University of Leicester, said: ‘This was a large study involving about 2,500 pregnant women, designed to overcome the limitations of previous research in this area.’”

“This new advice doesn’t mean that pregnant women have to cut out caffeine completely, simply that they should be careful and make sure they don't have too much,” said Andrew Wadge, FSA chief scientist. “We would emphasize that the risks are likely to be very small and believe our new advice, which is based on new research and has been considered by leading independent scientists, is sensible and proportionate.”

Thursday, November 06, 2008

Wyeth v. Levine – Supreme Court Oral Argument

The U.S. Supreme recently heard oral arguments on Wyeth v. Levine. The case is being watched closely by those interested in FDA preemption law. CNBC called it the “business case of the century.”

Diana Levine brought a common-law negligence claim against Wyeth, claiming that Wyeth should have revised a drug’s FDA-approved label to bar IV push administration. Wyeth argued that Ms. Levine’s state tort suit was preempted by federal law. The jury returned a verdict in favor of Ms. Levine, and the court opinion held that the jury’s state law based judgment presented no obstacle to FDA’s regulatory objectives. Wyeth appealed to the state supreme court.

In a divided opinion, the Vermont Supreme Court upheld the trial court’s ruling. The Court found that FDA approval is not required to strengthen label warnings, so Wyeth could have complied with both state and federal law. The court also held that FDA labeling regulations create minimum requirements, and that state tort liability for FDA-approved labels would not frustrate the objective of promoting the public health that led Congress to enact the FD&C Act. The Vermont Supreme Court did not afford any deference to recent FDA statements claiming that “FDA approval of labeling under the [FD&C Act] . . . preempts conflicting or contrary State law,” and that “FDA interprets the [FD&C Act] to establish both a ‘floor’ and a ‘ceiling,’ such that additional disclosures of risk information can expose a manufacturer to liability under the act if the additional statement is unsubstantiated or otherwise false or misleading.” Wyeth appealed the Vermont Supreme Court decision to the U.S. Supreme Court.

For additional information on this case and the issues:
· An excellent overview of the case is provided by Kurt R. Karst in the FDA Law Blog.
· Additional background on the case is available at the Drug & Device Law Blog.
· The briefs filed in the case and other background materials are available via the SCOTUS Wiki.
· A transcript of the oral argument is available here.
· Ed Silverman has predicted that the new President and a Democratic Congress will erase any preemption protection won in the last eight years.
· The American Association for Justice, the trial lawyers’ group, issued a preemption report last week, “Get Out Of Jail Free: How the Bush Administration Helps Corporations Escape Accountability.”
· A report prepared for Rep. Henry Waxman as Chair of the House Committee on Oversight and Government Reform found that some FDA career officials objected to Bush Administration drug labeling preemption policy. The senior officials viewed justifications for labeling preemption as “false and misleading,” based on “false assumption,” “na├»ve to what actually occurs in practice,” and relied on “gross overstatement.”

Tuesday, November 04, 2008

WSJ: Restaurants Prep For Rules On Menu Data

“While federal menu-labeling standards would unify a hodgepodge of local and state ordinances, restaurant operators will confront issues including costs associated with redesign and installation, overcrowded menu listings and customers coming face-to-face with their caloric intake before ordering.

Congressional leaders recently introduced the Labeling Education and Nutrition, or Lean, Act that would create a uniform standard requiring restaurants and grocery chains with more than 20 locations that serve prepared food to post calories on menus and menu boards.

Several national chains and the industry's largest trade group have thrown their weight behind the bill. Yum Brands Inc. has said it would voluntarily post calories on menu boards at company-owned restaurants by 2011.

The federal legislation follows similar menu-labeling laws passed in California, New York City and other places in recent months.

While some restaurant operators oppose additional regulation, having one standard for their menus and menu boards would solve a major concern: having different variations of laws aimed at providing nutritional information to customers.

"Imagine running a national chain and having 30 or 50 different menu-disclosure requirements," said Dennis Lombardi, a restaurant consultant with WD Partners. "Having to create space and produce these variations would become a nightmare." . . .

In New York, which passed a law requiring calorie counts to be displayed more prominently, consumers have changed their consumption habits. According to a survey by restaurant research firm Technomic Inc., most customers are either buying lower-calorie alternatives or cutting out certain items altogether.

Calorie-disclosure laws could have the most negative impact on casual-dining chains. Diners may be more aware that fast-food chains have a bevy of high-calorie meal options, but may be surprised to learn how many calories are in some casual-dining offerings, according to Buckingham Research Group analyst Mitchell J. Speiser.