Fluoride supplements designed to prevent tooth decay in children should be taken off the market until they are proven safe and effective, an Essex County legislator said yesterday.
At a press conference in Trenton, Assemblyman John Kelly (R-Essex) released a letter he has sent to the Food and Drug Administration (FDA) in Washington saying the availability of fluoride supplements seems to violate a federal law requiring a showing that prescription drugs work and not harmful before they can be dispensed.
“There does not appear to be any scientific or legal reason for these products to be on the market,” he added in his letter to Dr. David Kessler, FDA commissioner.
“With the mounting volume of evidence suggesting fluoride’s harmful effects, it is irresponsible to permit these products to be prescribed to the most vulnerable segment of our population — children,” wrote Kelly.
But a New Jersey state health official said Kelly may be “overreaching” in emphasizing possible dangers of fluoride. Kelly, however, said the FDA has the responsibility to the public to settle the issue and not allow fluoride supplements to be marketed if there is a question about their safety.
The FDA has told him and his staff that there are no studies on file proving that fluoride supplements are safe and effective or applications for their approval as drugs, Kelly added.
He said the disclosure “amazed and shocked” him. The FDA informed him that a review of the pros and cons must have “fallen through the cracks,” the Nutley lawmaker added.
“When the issue is our children’s health and safety, we cannot afford to take risks,” he said. “Therefore, I am calling on the FDA to immediately remove these supplements from the market. This is a major health issue. The people of our country depend on the FDA to screen out harmful drugs and chemicals.”
Kelly based his assessment of fluoride’s dangers, in large part, on a state Department of Health study released earlier this year that considered whether there might be a correlation between drinking fluoridated water and osteosarcoma (a rare form of cancer that affects the bone).
The analysis found 12 cases of cancer in males under the age of 20 between 1979 and 1987 in seven Central Jersey counties where water supplies are fluoridated, compared with eight cases in non-fluoridated towns. It concluded there was no “causal connection” between fluoridation and the cancer, although Kelly said the link was “obvious.”
Yesterday, a state health official labeled the study “incomplete” because its sample was so small and said he felt Kelly could be overreaching” in his conclusions.
The department would have pursued the investigation had it thought the data strong enough to support any link between fluoridation and bone cancer, added William Parkin, assistant commissioner for the division of epidemiology, environmental and occupational health services.
New Jersey’s fluoridated water is supplied primarily in Atlantic, Burlington, Middlesex, Mercer, Morris, Somerset and Union counties, he said. When asked if a more comprehensive study of fluoridation’s effects might be worthwhile, Parkin said any such report would have to be conducted on a national level since New Jersey’s fluoridated population is too small to come up with significant findings.
He also doubted Kelly’s claims that studies on the impact of fluoride as a supplement do not exist, saying there should at least be an examination of its effect on animals.
“There have to be some studies out there,” Parkin said. “Whether they are definitive enough to answer (Kelly’s) questions, I don’t know. I suspect not. I suspect they are equivocal, which means they could be interpreted to support more than one position.”
He also wondered why Kelly’s concerns to not extend to toothpastes. The legislator said he considers toothpastes to be “topical applications” that carry a stern warning against ingestion.
In his remarks, Kelly, a retired bank executive, acknowledged that he is not an expert on fluoride but rather a “Johnny-Come-Lately.” But nonetheless, he insisted his anxiety about fluoride was justified, saying the New Jersey report followed a national study that “showed increased bone cancer in males exposed to fluoride.”
All official inquiries to dental and medical groups about fluoride studies eventually were referred to the FDA. The agency classifies fluoride supplements as “unapproved new drugs” and has for more than 30 years, he said. Kelly charged that the federal Environmental Protection Agency (EPA) has been embroiled in a controversy about an alleged suppression of “many studies linking fluoride to a wide range of health problems, including cancer, hip and other bone fractures.”
A senior adviser in the EPA’s water division was fired for going public about the hazards of fluoride, he added. Kelly said the official, William Marcus, was later reinstated. Marcus was supposed to have attended yesterday’s briefing but could not make it.
Kelly was joined by Nancy Coleman of Parsippany, a member of New Jersey Citizens Opposing Forced Fluoridation, a group based in River Edge. Coleman accused federal agencies such as the FDA of not providing the public with enough information about fluoride so that citizens can come to their own informed opinions about its benefits or detriments.
Frank Fazzari, the FDA official who promised Kelly in April that the agency’s “medical and scientific specialists” would review his concerns, was unavailable for comment yesterday. Kelly said he has yet to learn what the FDA thinks about any connection between fluoride supplements and osteosarcoma.