Company using advertising and website to get around FDA decision to exclude claims about the benefits of fluoride in water intended for infants.
WASHINGTON – One of the nation’s biggest infant bottle water companies – Nursery Water – is misleading parents with erroneous information on its website and advertising materials touting the safety and benefits of fluoride in infant bottled water in clear violation of a Federal Trade Commission rules, noted Environmental Working Group (EWG) scientists in a letter sent today to officials at the FDA and FTC.
In an extensive review EWG uncovered how the company uses their website and advertising materials to make claims for fluoridated water that either have not been approved by the government and therefore cannot be put on labels, and to misrepresent the positions of health authorities like the American Academy of Pediatrics.
In their advertising materials, Nursery Water claims that fluoride in water will “strengthen your little one’s teeth”, and “prevent tooth decay.” But in 2006, when approving similar health claims for fluoride in bottled water, the Food and Drug Administration specifically excluded claims for products like Nursery Water, stating “the health claim is not intended for use on bottled water products specifically marketed for use by infants.”
The company also flagrantly misrepresents the position of numerous health authorities including the American Academy of Pediatrics, stating, for example, that Nursery Water is, “Made according to recommendations by the American Academy of Pediatrics.” In fact the Academy recommends no intentionally added fluoride at all for young infants, stating “Supplementary fluoride should not be provided during the first six months of life.”
“Nursery Water’s behavior is completely irresponsible. They are misleading parents, misrepresenting the facts, and placing profits above the health of babies,” said EWG Vice President for Research Jane Houlihan.
Both the American Dental Association (ADA) and the Centers for Disease Control (CDC) have raised questions or published warnings about the risks of fluoride for infants, driven by their susceptibility to fluoride-induced damage to tooth enamel called fluorosis, a defect of the permanent teeth resulting in staining and, in severe cases, substantial corrosion of the enamel.
EWG’s analysis shows that a significant percentage of infants drinking between one and two bottles daily of powdered formula using Nursery Water would be exposed to fluoride at levels the exceed the Environmental Protection Agency’s (EPA’s) safe dose for infants, established to protect against fluorosis. (EPA 1989)
An EPA mandated review of fluoride safety published in 2006 by the National Academy of Sciences (NAS) raised further questions about additional risks, including elevated rates of bone cancer (osteosarcoma), IQ reduction, thyroid disruption, bone fractures, and a condition very similar to arthritis called skeletal fluorisis.
Under the FFDCA, FDA requires manufacturers to submit a Health Claim Notification prior to using a claim, and gives FDA the authority to deny the claim under the law. In 2006 a law firm (Covington and Burling, LLP) representing the bottled water industry submitted the required notification for claims on tooth decay prevention, but specifically excluded water marketed to infants in their request. FDA’s health notification includes the identical exclusion.
The FTCA prohibits the dissemination of false advertising of health claims and gives FTC the authority to enjoin misleading statements. Nursery Water is clearly trying to circumvent FDA’s petition process for health claims by limiting the assertion of unapproved or un-reviewed claims to advertising in violation of FTC requirements.
In their letter to FDA and FTC calling for an investigation, EWG Senior Scientists wrote, “Among the misleading information the company publishes are direct and implied claims that fluoride in water for infants is recommended by the Centers for Disease Control and Prevention (CDC), the American Dental Association (ADA), and the American Academy of Pediatrics (AAP). Our review of these organization’s positions on fluoride shows that none of them support the use of added fluoride in water during infancy, when risks for fluoride-induced tooth damage (fluorosis) and other potential health impacts are higher than at other times of life.”
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EWG is a nonprofit research organization based in Washington, DC that uses the power of information to protect human health and the environment. The group’s letter and research on the issue can be found online at http://www.ewg.org/node/25951.
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