June 13th, 2006
More on the potential ban of 2,4-D in Canada:
The department’s Pest Management Regulatory Agency is expected to issue a final ruling on the safety of the herbicide, which is used to kill dandelions and other broadleaved plants, in early 2007. It issued a preliminary assessment indicating it favoured continued use of the product in February, 2005. A Health Canada spokeswoman said the government sent out the report in error. The department subsequently asked Weedman to take the report off its website, and the lawn company complied.
Edith Lachapelle, the spokeswoman, said she can understand why some people might accuse the agency of bias because the report was released but said, “It was a mistake.”
The herbicide is the target of an aggressive campaign by environmentalists and public health advocates, who say it is hazardous to spray 2,4-D close to homes, and an equally aggressive lobbying effort by some lawn-care companies defending its continued residential use.
See the full article: Globe and Mail.
Posted in Canada, PMRA | No Comments »
June 13th, 2006
Not everyone is happy with changes in drug labeling put into place by the FDA:
Experts say the new labeling system for prescription drugs about to launch in the United States will not radically improve patient safety or the prescribing process.
What’s more, the new rules include a clause, slipped in silently after the public-comment period had closed, that will make it almost impossible for patients to sue drug makers over adverse events, said the authors of a perspective piece in the July 8 New England Journal of Medicine.
“Along with the very modest alterations of drug labeling to be phased in over the next seven years, the changes the FDA [U.S. Food and Drug Administration] begin implementing next month include a regulatory time bomb that could severely limit the accountability of companies that fail to adequately evaluate or report the risks associated with their products,” the authors stated.
New FDA rules outlining an overhaul of the printed-package inserts that accompany prescription drugs are scheduled to go into effect June 30.
The revisions, the first since 1975, will require that inserts include a “prominently displayed summary of key information including indications, usage, dosage and administration,” said FDA Acting Commissioner Dr. Andrew von Eschenbach, when the new rules were announced in January. This summary, or “Highlights” section, will be about a half-page in length, he said.
Health-care professionals can also expect to see a table of contents, patient-consulting information to ease communication between doctor and patient, as well as information on a toll-free number and Internet address for reporting suspected side effects.
See the full article: Forbes.com.
Posted in Drug Labeling, FDA, United States | No Comments »
June 13th, 2006
Some new food regulations may be coming into place in Chicago:
f the City Council can ban foie gras, a fatty liver delicacy that most Chicagoans have never tasted and cannot afford, why not ban a product that’s known to cause obesity and heart disease? Chicago’s most powerful alderman raised that question Wednesday, then began to answer it — by thinking out loud.
Finance Committee Chairman Edward M. Burke (14th) has an ordinance pending that would ban Chicago grocers from selling meat treated with carbon monoxide to make it look pink and more appetizing.
Burke said it “might be a good jumping off point” to target french fries and other fast food that’s cooked in artery-clogging oil and food that’s processed or loaded with additives and preservatives.
See the full article: Chicago Sun-Times.
Posted in Food Labeling, United States | No Comments »
June 13th, 2006
A press release from the OEHHA:
The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding a chemical to the list of chemicals known to the State to cause reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 651). The chemical is environmental tobacco smoke (ETS). Environmental tobacco smoke (ETS) is listed effective June 9, 2006.
Environmental tobacco smoke (ETS) was considered by the “state’s qualified experts” (the Developmental and Reproductive Toxicant (DART) Identification Committee of the OEHHA Science Advisory Board2) at a public meeting held on May 24, 2006. The DART Identification Committee determined that environmental tobacco smoke (ETS) was clearly shown, through scientifically valid testing according to generally accepted principles, to cause developmental toxicity. Regulations governing the criteria for listing of chemicals by the “state’s qualified experts” (DART Identification Committee) mechanism are set out in Title 22, California Code of Regulations, section 12305(b)(1).
Download the latest list and all other relevant information at:
http://www.oehha.ca.gov/prop65/prop65_list/060906list.html
Posted in California, OEHHA, Prop 65, United States | No Comments »
June 13th, 2006
An article at FoodConsumer.org discusses labeling of cough medicines:
Carbinoxamine containing cough medicines and many other types on the market have been unapproved by the Food and Drug Administration. Some can pose serious health risks, particularly to young children. Because of this, the agency on Thursday launched a campaign to stop these unapproved drug makers.
Carbinoxamine-containing products are the first target of the federal agency’s action under the new guidance, “Marketed Unapproved Drugs–Compliance Policy Guide”. Many others may be dealt with later.
Products with carbinoxamine need FDA approval to be marketed, but numerous products such products, either alone or in combination with other active ingredients, are marketed without FDA approval, the agency states.
The FDA will begin its efforts by watching the use of the antihistamine carbinoxamine, which the agency states can be hurtful to younger children under the age of two.
The federal agency has given cough drop manufacturers using carbinoxamine 30 to 90 days to stop their sale of the unapproved drug.
See the full story: FoodConsumer.org.
Posted in Drug Labeling, FDA, United States | No Comments »