Natural Cures Under Attack
FDA bars clove oil dental products
THE ASSOCIATED PRESS
WASHINGTON -- A small Minnesota company has been barred from making and selling products with a clove oil derivative used to treat painful complications of some tooth extractions, federal health officials said Friday.
The Food and Drug Administration warned dentists and patients to stop using and discard the various eugenol-containing products made by C.R. Canfield Co. Inc. of Edina, Minn. Eugenol is the primary ingredient in clove oil.
The banned products all contain 20 percent eugenol and include dressings used to pack tooth sockets, as well as prefilled syringes and ointments. The products were sold for the treatment of "dry socket," a painful condition that sometimes occurs after a tooth is pulled. The company said the U.S. military was among its customers.
The FDA said the products contained an unapproved drug and were not made in accordance with current good manufacturing practices. The regulatory agency said it entered a consent decree of permanent injunction after "repeated FDA inspections, efforts and warnings."
The company has complied with the consent decree and has not shipped any of the products since June 7, president Garry Persons said.
"There was nothing really dangerous. They never asked for a recall, it was just a matter of I couldn't keep up with the big boys as far as federal regulations," said Persons, who runs the company out of the basement of his Edina home.
Eugenol has been used as a painkiller. However, there is a lack of reliable human clinical evidence to support its use in treating dry socket, according to the National Library of Medicine and National Institutes of Health. An overdose of eugenol can cause throat and kidney damage.
Note:"Yeah so can over the counter ibrofen and tylenol"
http://seattlepi.nwsource.com/health/1500AP_Dental_Injunction.html
THE ASSOCIATED PRESS
WASHINGTON -- A small Minnesota company has been barred from making and selling products with a clove oil derivative used to treat painful complications of some tooth extractions, federal health officials said Friday.
The Food and Drug Administration warned dentists and patients to stop using and discard the various eugenol-containing products made by C.R. Canfield Co. Inc. of Edina, Minn. Eugenol is the primary ingredient in clove oil.
The banned products all contain 20 percent eugenol and include dressings used to pack tooth sockets, as well as prefilled syringes and ointments. The products were sold for the treatment of "dry socket," a painful condition that sometimes occurs after a tooth is pulled. The company said the U.S. military was among its customers.
The FDA said the products contained an unapproved drug and were not made in accordance with current good manufacturing practices. The regulatory agency said it entered a consent decree of permanent injunction after "repeated FDA inspections, efforts and warnings."
The company has complied with the consent decree and has not shipped any of the products since June 7, president Garry Persons said.
"There was nothing really dangerous. They never asked for a recall, it was just a matter of I couldn't keep up with the big boys as far as federal regulations," said Persons, who runs the company out of the basement of his Edina home.
Eugenol has been used as a painkiller. However, there is a lack of reliable human clinical evidence to support its use in treating dry socket, according to the National Library of Medicine and National Institutes of Health. An overdose of eugenol can cause throat and kidney damage.
Note:"Yeah so can over the counter ibrofen and tylenol"
http://seattlepi.nwsource.com/health/1500AP_Dental_Injunction.html
posted by Dani @ 7:38 AM
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