Consumer Health Digest #06-34
Your Weekly Update of News and Reviews
August 22, 2007
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., and cosponsored by NCAHF and Quackwatch. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.
Appeal court upholds FDA ephedra ban. The U.S. Court of Appeals for the Tenth Circuit has upheld the FDA's ability to enforce a ban against the selling of ephedra products as dietary supplements. In 2005, a Utah federal judge limited the FDA's ability to enforce a ban against the selling of ephedra products as dietary supplements. That ruling temporarily prevented the agency from taking action against Nutraceutical Corporation, a Utah-based company that sued to block the ban. The 1994 Dietary Supplement and Health Education Act (DSHEA) states that to ban a product, the FDA must prove that it poses an "unreasonable risk of illness or injury." Ephedra products have been linked to several deaths and thousands of complaints from consumers, many of whom have filed lawsuits. The FDA has concluded that "in the absence of a sufficient benefit, the presence of even a relatively small risk of an important adverse health effect to a user may be unreasonable." But the lower court judge ruled that to ban all ephedra products, the FDA would have to prove that they are unsafe "when used as recommended and suggested in the labeling." Concluding that a single dose of Nutraceutical's 10 mg product would not be dangerous, that judge ruled that the FDA could not stop the sale of dietary supplements containing 10 mg or less of ephedra alkaloids. He also ruled that DSHEA did not permit the FDA to compare benefits and risks as part of its evaluation of unreasonable risk. (In other words, whether a product is completely worthless is not relevant to judging whether it is reasonable to permit it to continue to be sold.)
On August 17th, the Appeals Court disagreed and ordered the lower court judge to enter summary judgment in favor of the FDA. Its ruling concluded that Congress intended to integrate a risk-benefit analysis into DSHEA and that the FDA had met its legal burden by doing extensive research before ordering the ban.
Waxman concludes that FDA enforcement is too lax. Timed to coincide with the FDA's 100th anniversary, a new report by U.S. Representative Henry A. Waxman (D-CA) examines how the Bush Administration has carried out FDA’s enforcement responsibilities. [Prescription for Harm: The Decline in FDA Enforcement Activity. U.S. House of Representatives Committee on Government Reform Minority Staff Special Investigations Division, June 2006] The report is based on a 15-month investigation that included a review of thousands of pages of internal agency records. Concluding that FDA enforcement has dropped precipitously over the last five years, the report states:
- The number of warning letters issued by the agency for violations of federal requirements has fallen by over 50%, from 1,154 in 2000 to 535 in 2005, a 15-year low. During the same period, the number of seizures of mislabeled, defective, and dangerous products has declined by 44%.
- In at least 138 cases over the last five years involving drugs and biological products, FDA failed to take enforcement actions despite receiving recommendations from agency field inspectors describing violations of FDA requirements.
- Although the Federal Records Act and internal agency procedures require FDA to keep records that document agency enforcement decisions, FDA does not appear to comply with these requirements. FDA’s response to Committee requests for relevant enforcement documents was haphazard, incomplete, and untimely. FDA officials explained that FDA could not provide prompt and complete responses because the agency lacks a system that enables it to track enforcement recommendations from field offices.
Pertussis outbreak reported in Delaware. The U.S. Centers for Disease Control and Prevention has reported on a recent pertussis (whooping cough) outbreak in Kent County, Delaware. The report estimates that about 20% of the unvaccinated children in the Amish community got the disease, with 65 confirmed and 280 probable cases. During the same period, only seven pertussis cases were reported elsewhere in the state among people with no epidemiologic link to an Amish person. Although Amish religious doctrine does not prohibit vaccination, coverage levels for routine childhood vaccination are low in many Amish communities. In interviews with parents in 43 nonvaccinating households, 19 cited "fear of side effects" as the reason for avoidance, 13 reported that they "didn't think about it," and 11 did not provide specific reasons. [Pertussis outbreak in an Amish community—Kent County, Delaware, September 2004–February 2005. MMWR 55:817-821, 2006.]
This page was posted on August 22, 2006.