EWG calls for Investigation of Nursery Water

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February 1, 2008

Lydia B. Parnes, Director

Bureau of Consumer Protection

Federal Trade Commission

600 Pennsylvania Avenue, NW

Washington, DC 20580

Food and Drug Administration

Harvey W. Wiley Federal Building

5100 Paint Branch Parkway

College Park, MD 20740-3835

Dr. Kathleen Ellwood, Director

Division of Nutrition Programs and Labeling

Office of Nutritional Products, Labeling and Dietary Supplements (HFS-800)

Center for Food Safety and Applied Nutrition

Subject: Request for Investigation of Nursery Water – Potential False Advertising and Misleading Health Claims on Fluoride in Bottled Water That Is Marketed to Infants

Dear Ms. Parnes and Dr. Ellwood:

We are writing to request your investigation of apparent false advertising and misleading health claims by Nursery Water, a bottled water company that markets water with added fluoride for use in infant formula.

Federal Trade Commission (FTC) enforcement policy clearly states that companies cannot skirt federal health claim regulations by selectively publishing health claims in advertising but not on product labels: “Food marketers should not expect to circumvent FDA’s petition process for health claims simply by limiting the assertion of unapproved or unreviewed claims to advertising,” (emphasis added) and that “The absence of an FDA determination that a health claim is scientifically valid will be a significant factor in the Commission’s assessment of the adequacy of substantiation for the claim” (FTC 1994).

Not only is Nursery Water making unapproved and unreviewed health claims in its advertising materials without notifying the FDA as required by federal law, but the company is also making a health claim that has been specifically excluded by the FDA, as detailed below (emphases added):

  • Nursery Water’s health claim: “The added fluoride will help strengthen your little one’s teeth” and water fluoridation is endorsed “as the single most effective measure to prevent tooth decay” (www.nurserywater.com/nursery/product.php and www.nurserywater.com/nursery/fluoride.php).
    • FDA’s position: Certain fluoride-containing bottled waters are eligible for the following claim language: "Drinking fluoridated water may reduce the risk of [dental caries or tooth decay]" but “the health claim is not intended for use on bottled water products specifically marketed for use by infants” (FDA 2006).

The company then violates the spirit if not the letter of the regulations by publishing on its website a smorgasbord of misleading direct and implied claims asserting and implying 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 supports 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. These positions are detailed below, with emphases added.

  • Nursery Water’s advertising claim: “Made according to recommendations by the American Academy of Pediatrics (AAP)” (www.nurserywater.com/infants/bfeed.php).
    • American Academy of Pediatrics position: Supplementary fluoride should not be provided during the first 6 months of life (AAP 2005).
  • Nursery Water’s advertising claim: “Drinking distilled water with added fluoride in the proper amounts has been shown to be so effective that the ADA supports municipal water fluoridation and refers to this as the single most effective measure to prevent tooth decay. This has also been endorsed by the Center for Disease Control and Prevention, labeling municipal water fluoridation as one of the greatest public health achievements of the 20th century” (www.nurserywater.com/nursery/fluoride.php).
    • Centers for Disease Control and Prevention’s position: “…when infant formula concentrate is mixed with fluoridated water and used as the primary source of nutrition, it may introduce fluoride at levels above the amount recommended to minimize the risk for fluorosis” (CDC 2007).
  • Nursery Water’s advertising claim: “Specially formulated to contain the ADA recommended level of added fluoride, the steam distilled water helps to strengthen teeth” (www.nurserywater.com).
    • American Dental Association’s (ADA’s) position: “[Fluoride] Supplements are not recommended for children under six months of age….[T]he occasional use of water containing optimal levels of fluoride should not appreciably increase a child’s risk for fluorosis,”… but “ready-to-feed formula is preferred,” since it typically contains no added fluoride, and concentrated or powdered formula “can be mixed with water that is fluoride free” or that contains little to no fluoride, such as water that is “purified, demineralized, deionized, distilled, or reverse osmosis filtered water.” (ADA 2006).

It also appears that Nursery Water’s bottled water may contain fluoride in excess of the Environmental Protection Agency’s (EPA’s) safe limit for infants. Our analyses show that infants drinking between one and two 8-ounce bottles daily of powdered formula reconstituted with Nursery Water’s bottled water would be exposed to fluoride at levels that exceed the EPA’s safe dose for infants, established to protect against fluorosis (EPA 1989). Of further concern, a 2007 review published in The Lancet listed fluoride as one of three emerging developmental neurotoxins (Grandjean and Landrigan 2007), and a 2006 National Research Council review raised concerns about fluoride’s potential impacts to the thyroid gland and IQ, with measured effects in some studies at fluoride levels below those added by Nursery Water (NRC 2006). To our knowledge, Nursery Water provides no warnings to parents about potential risks from infants’ exposures to fluoride.

Overall, our review of Nursery Water advertising materials suggests that the company is providing parents with advertising information about the benefits of fluoride-containing water for infants that is misleading, erroneous, and appears to be in violation of the exclusion of fluoride-related health claims for water marketed for infants published by the Food and Drug Administration (FDA 2006), health claim notification requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA), and the Federal Trade Commission Act’s (FTCA) prohibition on the dissemination of false advertisements (21 U.S.C. §52).

These advertising materials are likely to lead a reasonable person to mistakenly believe that adding fluoridated bottled water to formula strengthens teeth and prevents cavities without risk, when, in fact, there is significant scientific agreement that fluoridated water increases infants’ risk of fluorosis. Because of the potential ill effects and the egregious nature of these misleading advertisements, we call on the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) to investigate immediately the improper fluoride health claims made by Nursery Water, to enforce restrictions on such claims for bottled water marketed for infants, to enjoin the company from making further misleading health claims, and to pursue other appropriate legal remedies. We also request that FDA publicly release the identity of the clients represented by Covington & Burling LLP in the law firm’s health claim notification for fluoride in bottled water and in the firm’s subsequent clarification of the claim’s exclusion for bottled water marketed to infants (Covington & Burling 2006a,b). Lastly, we request that FDA release all communications between the agency and Covington & Burling regarding the health claim notification.

Potential Violation: Use of Excluded Fluoride Health Claims for Bottled Water Marketed to Infants.

As you are aware, the Federal Food, Drug, and Cosmetic Act (FFDCA) requires manufacturers to submit a Health Claim Notification to FDA prior to using a health claim, and provides FDA with authority to deny the claim via regulation. Pursuant to this, FDA recently published an allowable notification for a claim regarding dental benefits of fluoride that specifically excludes its use on bottled water marketed for infants (FDA 2006). Nursery Water markets its bottled water for infants, and makes direct or strongly implied health claims regarding added fluoride in water, despite the specific exclusion published by FDA.

The Notification for a Health Claim for fluoride in bottled water was submitted to FDA on June 14, 2006 by the law firm Covington & Burling LLP. The notification proposed to allow bottled water containing between 0.6 and 1.0 ppm (parts per million) fluoride to bear the following claim: “Drinking fluoridated water reduces the risk of [dental caries or tooth decay]” (Covington & Burling 2006a). The original submission for a health claim notification included discussion of fluoride’s benefits during infancy, before teeth have erupted through the gum.

On October 3, 2006, 11 days before the deadline for FDA action, the firm modified its claim. The revised proposed claim contained the qualifier “may”: “Drinking fluoridated water may reduce the risk of [dental caries or tooth decay].” And, Covington & Burling LLP specifically stated in its proposed revision that the health claim would not be made on bottled water products marketed for use by infants: “In addition, this health claim is not intended for use on bottled water products specifically marketed for use by infants” (Covington & Burling 2006b).

The claim became legal for use as proposed on October 14, 2006, 120 days after submission, the waiting period prescribed in FFDCA (403(r)(3)(C) (21 U.S.C. §343(r)(3)(C)). As FDA notes, the claim is now allowed for use on all bottled water except that marketed specifically to infants (FDA 2006). Nevertheless, Nursery Water makes or implies health claims in the advertising materials they provide to parents about their water, marketed for infants, with added fluoride. Details of specific claims made are provided in this letter.

Potential Violation: Requirement for Health Claim Notification under FFDCA. In light of the published exclusion on fluoride health claims for bottled water marketed to infants, the Federal Food Drug and Cosmetics Act (FFDCA) (21 U.S.C. §343(r)(3)(C)) would require companies marketing fluoridated bottled water to infants like Nursery Water to submit a new Health Claim Notification to FDA prior to making any such claims. To the best of our knowledge, the company has not submitted this required Notification in advance of claiming or strongly implying dental benefits for infants consuming water with added fluoride.

Among Nursery Water’s claims are: “the added fluoride will help strengthen your little one’s teeth,” and “Specially formulated to contain the ADA recommended level of added fluoride, the steam distilled water helps to strengthen teeth.”

Nursery Water’s advertising of health benefits from fluoride in bottled water. Nursery Water, manufactured by DS Waters of America, Inc., is a popular brand of bottled water that is specifically marketed for infants and toddlers. In their online advertising materials (www.nurserywater.com), the company makes multiple direct or indirect claims of the health benefits of fluoride for infants and toddlers, that appear to be in direct violation of the health claim exclusion. In addition, the company’s marketing materials contain numerous implied claims about the prevention of tooth decay. The company also misrepresents the views on fluoride safety of the AAP, CDC, and ADA.

All claims appear on web pages with a prominent banner featuring a photograph of an infant and the words “A first step to your baby’s good health. Since 1948. Nursery purified water with added fluoride processed by steam distillation,” and a lower banner, also prominently featuring another infant photo with the words “pure love for your infant & toddler.” The navigation menu on the left-hand side of the page lists “mixing with formula,” “dental care,” and “tooth decay” under the heading “Nursery for infants.” The juxtaposition of health statements with infant photographs, and the words “health,” “fluoride,” “dental care,” and “tooth decay” appearing together prominently on each page amplifies the implied and direct health claims. Health claims and misrepresentations in Nursery Water advertising materials are outlined below, with all emphases added:

  • The primary purpose in adding fluoride to distilled drinking water is to help strengthen teeth. Nursery Water is a purified water that is steam distilled for purity. Drinking distilled water with added fluoride in the proper amounts has been shown to be so effective that the ADA supports municipal water fluoridation and refers to this as the single most effective measure to prevent tooth decay. This has also been endorsed by the Center for Disease Control and Prevention, labeling municipal water fluoridation as one of the greatest public health achievements of the 20th century.” (www.nurserywater.com/nursery/fluoride.php)
  • “Nursery is a steam distilled water for babies from infants to toddlers… that has added fluoride up to the recommended ADA level of 0.7 ppm… a healthy source of steam distilled water for babies, infants, and toddlers.” (www.nurserywater.com/info/about.php)
  • “Prevention of tooth decay… “Give his/her [stet] enough fluoride. If your local water supply does not contain fluoride, ask your dentist how your child should get it.” (www.nurserywater.com/infants/care.php)
  • “…we are happy to provide you with Nursery that is purified water with added fluoride processed by steam distillation that will do much more than simply hydrate your child. Specially formulated to contain the ADA recommended level of added fluoride, the steam distilled water helps to strengthen teeth.” (www.nurserywater.com)
  • “Nursery Water is a purified water with added fluoride that is processed by steam distillation that will help nourish your infant or toddler.” (www.nurserywater.com)
  • “Nursery for Infants: A first step to your baby’s good health… Since 1948, Nursery Purified Water with added Fluoride, processed by steam distillation, has been trusted by new mothers like you for mixing with infant formulas, diluting juices and as a good source of pure drinking water. Nursery is a convenient source of fluoride and is available in economical one gallon bottles. You’re doing everything you can to give your baby a healthy start in life. Trust Nursery as an important part of your plan during those precious infant years. (www.nurserywater.com/infants)
  • “Nursery… comes in convenient one gallon bottles so it’s easy to keep a supply on hand for mixing with cereals and formulas. Remember, ready-to-feed formula does not contain fluoride, so if you use it on a regular basis, you may want to consider supplementing your little one’s diet with Nursery purified water with added fluoride.” (www.nurserywater.com/infants/usage.php)
  • “…the proper amount of fluoride has been added for your child. Nursery Water follows the strict guidelines set forth by the ADA recommending the optimal fluoride level in drinking water is 0.7 – 1.2 parts per million (ppm) of fluoride for infants.” (www.nurserywater.com/infants/usage.php)
  • “Natural benefits…. Nursery can be ideal for mixing with formula since it is distilled and contains the fluoride your baby may need.” (www.nurserywater.com/infants/bfeed.php)
  • “Drinking our purified and steam distilled water has many benefits for your little one. The added fluoride will help strengthen your little one’s teeth… You can use Nursery for many purposes: from mixing with formula and cereals to diluting juices or simply using Nursery as your child’s drinking water.” (www.nurserywater.com/nursery/product.php)
  • “Is fluoride in water safe for my child? Yes. According to the ADA, having fluoride in the water you drink is safe between the levels of 0.7 – 1.2 parts per million (ppm). Nursery steam distilled drinking water contains up to 0.7 ppm, well within ADA recommendations. This means when your child is drinking Nursery Water you can be sure that they are getting the proper level of fluoride… (www.nurserywater.com/nursery/fluoride.php)
  • “Is drinking water with fluoride safe for my child? Yes. The American Dental Association continues to support the optimal level of fluoride in drinking water as 0.7 – 1.2 parts per million (ppm). Nursery Waters has a level up to 0.7 parts per million – well within ADA recommendations. This means that when your child is drinking Nursery Water, you can be confident that your child is getting the right level of fluoride… Fluoride, in the amount of up to 0.7 mg/L is added, which conforms to fluoride levels recommended by American Dental Association.” (www.nurserywater.com/info/faq.php)

False advertising: affirmative deceptive statements. The FTC has jurisdiction over false advertising of health claims under FTCA section 5 (21 U.S.C. §52), pursuant to a Memorandum of Understanding with FDA under which FTC assumes primary responsibility for regulating food advertising, with FDA taking primary authority for food labeling (FTC and FDA 1971).

Despite the specific exclusion of health claims regarding the benefits to infants from fluoride in bottled water, Nursery Water has published extensive, misleading advertising in online materials. This appears to be an intentional attempt at circumventing FDA’s health notification process by placing in its advertising materials misleading claims that it cannot place on its labels in violation of FTCA.

FTC has stated that companies cannot expect to evade requirements for health claim notification and substantiation by limiting health claims to advertising materials.

On this point FTC has written that:

“The Commission also recognizes the importance of the petition process, established under the NLEA and FDA’s regulations, as a mechanism for authorizing health claims in food labeling. The Commission will look with particular care at any health claims specifically considered by the FDA in the process. The absence of an FDA determination that a health claim is scientifically valid will be a significant factor in the Commission’s assessment of the adequacy of substantiation for the claim. Food marketers should not expect to circumvent FDA’s petition process for health claims simply by limiting the assertion of unapproved or unreviewed claims to advertising” (FTC 2004).

Despite FDA’s specific exclusion of infants from the Health Notification, Nursery Water appears to be circumventing the petition process by the assertion of unapproved claims in advertising. Nursery Water appears to be publishing false advertising in the form of affirmative, deceptive statements and presentation of information, and in its misrepresentation of ADA, CDC, and AAP positions on the safety of fluoride for infants.

Nursery Water mentions ADA’s support of water fluoridation multiple times in its online marketing materials, citing ADA positions to support the safety of fluoride in water for children, and making numerous mentions that Nursery water contains (or contains “up to”) the ADA’s “recommended” level of fluoride. Nursery Water references a 2006 ADA position paper in making these claims (ADA 2006). But instead of advocating for added fluoride in water for infants, ADA recommends against it in its 2006 position paper. ADA notes that while “the occasional use of water containing optimal levels of fluoride should not appreciably increase a child’s risk for fluorosis,” [emphasis added], “ready-to-feed formula is preferred,” since it typically contains no added fluoride, and that concentrated or powdered formula “can be mixed with water that is fluoride free” or that contains little to no fluoride, such as water that is “purified, demineralized, deionized, distilled, or reverse osmosis filtered water.” ADA does not recommend that infants drink water with added fluoride.

Likewise, Nursery Water notes in advertising materials that CDC “endorses” water fluoridation (www.nurserywater.com/nursery/fluoride.php), but fails to mention that CDC does not recommend that infants drink water with added fluoride, because of the risk of fluorosis (CDC 2007). CDC notes that while “mixing concentrate with fluoridated tap water on an occasional basis is unlikely to be of much consequence” [emphasis added], “parents and caregivers of infants fed primarily with formula from concentrate… can lessen [fluoride] exposure by mixing formula with low fluoride water most or all of the time,” such as bottled water known to be low in fluoride, including water labeled as “purified, deionized, demineralized, distilled, or prepared by reverse osmosis” (CDC 2007). CDC writes that:

  • “Infant formula manufacturers take steps to assure that infant formula contains low fluoride levels—the products themselves are not the issue. Although formula itself has low amounts of fluoride, when infant formula concentrate is mixed with fluoridated water and used as the primary source of nutrition, it may introduce fluoride at levels above the amount recommended to minimize the risk for fluorosis” (CDC 2007).
  • “Mixing concentrate with fluoridated tap water on an occasional basis is unlikely to be of much risk. However, when used consistently as the primary source of nutrition over longer periods of the first year, a child may receive enough fluoride to increase his/her chances of developing very mild or mild fluorosis” (CDC 2007).

CDC has found that 32 percent of children and young adults ages 6 to 19 have some degree of fluorosis (CDC 2005a,b). CDC does not recommend that infants drink water with added fluoride.

Nursery Water’s advertising claims that their product is “Made according to recommendations by the American Academy of Pediatrics (AAP)” (www.nurserywater.com/infants/bfeed.php), but the AAP takes the position that “Supplementary fluoride should not be provided during the first 6 months of life” (AAP 2005).

Clearly, the ADA, CDC, and AAP recognize the risk of enamel fluorosis in infants who are fed formula that is mixed with fluoridated water. These organizations advise that parents minimize their infants’ daily exposure to fluoride, while Nursery Water marketing materials clearly encourage the use of fluoride-supplemented bottled water for infants. Nursery Water’s misrepresentation of ADA, CDC, and AAP positions on its website may constitute affirmative, deceptive advertising.

False advertising: deceptive advertising that omits material facts likely to mislead consumers. FTC has also stated that in addition to affirmative deceptive statements, it will also consider deceptive advertising that omits material facts likely to mislead consumers. In assessing health claims, FTC defers to FDA expertise (FTC and FDA 1971). Nursery Water publishes advertising information on dental benefits and risks of fluoride for infants that omits material facts and could mislead parents about the benefits and risks of fluoride for infants. Most notably, Nursery Water fails to inform parents and caregivers about the increased risks for fluorosis faced by infants who are dosed with fluoride.

It is notable that Covington & Burling proposed an exclusion to dental health claims on fluoridated bottled water marketed to infants (Covington & Burling 2006b), and that FDA included this exclusion in its summary of the Health Claim Notification (FDA 2006). This exclusion is supported by the science on fluoride risks and benefits, none of which, to our knowledge, is cited in Nursery Water advertising materials.

Infants’ elevated risk for fluorosis. Nursery Water claims or implies in its marketing materials that the ADA, CDC, and AAP support the addition of fluoride to water consumed by infants. In fact, experts have taken the opposite position regarding the benefits of fluoride for infants than that represented in the companies’ advertising materials. While not placing the claim on the labeling, Nursery Water places it in their advertising materials, an apparent attempt to skirt the law and a violation of the FTC’s prohibition on the dissemination of false advertisements (21 USC §52).

Both ADA and 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 dark staining and, in severe cases, substantial corrosion of the enamel.

The development of permanent teeth begins at infancy with initial calcification of the first molars under the gum. Infants are particularly susceptible to fluorosis from fluoride exposure. Enamel fluorosis occurs when there is hypomineralization of tooth enamel; it results from excessive fluoride intake during tooth development. Infants are vulnerable to enamel fluorosis because of rapid tooth development during this critical period. Enamel fluorosis can affect both primary and permanent teeth. While most cases are considered mild in severity, the aesthetic effects that result include pitting, staining, and opacity of the enamel (Pizzo et al. 2007). While the mechanism of fluorosis development is not fully understood, it is thought that fluoride interferes with normal protein metabolism, leading to altered tooth structure (Marshall et al. 2004). Children remain at risk for fluorosis throughout childhood as tooth formation continues, though risks are particularly high during infancy.

In a recent report based on National Health and Nutrition Examination Survey (NHANES) results, 32% of children and adolescents aged 6 to 19 years were found to suffer from the condition (Beltran-Aguilar et al. 2005).

Recent reports in the peer-reviewed literature have highlighted the relationship between the development of enamel fluorosis and the use of fluoridated water for infants (Beltran-Aguilar et al. 2005, Levy 2003, Browne et a. 2005, Marshall et al. 2003, Warren and Levy 1999, Hong et al. 2006). As one example of findings from these studies, Hong et al. (2006) studied fluoride exposures of 579 children in Iowa, and found that fluoride exposures during the first year of life were the most strongly linked to the development of fluorosis of the two front teeth, followed by exposures during the second, third and fourth years of life.

Formula manufacturers voluntarily decreased the use of fluoride in their products in the 1970’s because of the risk of fluorosis from the use of their products. However, with the increasing popularity of powdered infant formulas, the use of fluoridated water to reconstitute these products has come under scrutiny. One recent study from scientists at the University of Iowa concluded, “Infants beverages, particularly infant formulas prepared with fluoridated water, can increase the risk of fluorosis” (Marshall et al. 2004).

Nursery Water fails to inform parents about infants’ risks for fluorosis, or that infants drinking Nursery Water’s bottled water can be exposed to fluoride above levels established by the Environmental Protection Agency to protect children from fluorosis. The EPA has recommended that to protect against dental fluorosis, infants be exposed to no more than 0.06 milligrams of fluoride per kilogram of body weight per day (0.06 mg/kg/d) (EPA 1999). EWG’s analyses show that a newborn would be exposed to fluoride above this limit by drinking just over one bottle of formula reconstituted with Nursery Water each day.

Our calculations show that a newborn of average weight (7.3 pounds) drinking just 12 ounces of powdered formula reconstituted with Nursery Water’s bottled water would be exposed to fluoride in excess of the EPA’s safe daily dose to protect infants from fluorosis (0.06 milligrams of fluoride per kilogram of body weight (EPA 1989), assuming Nursery Water’s published upper limit of 0.7 ppm added fluoride in the water (www.nurserywater.com) and 12% adjustment for solids content). The levels of fluoride added to water by Nursery Water would lead to many babies being exposed to fluoride above EPA’s safe dose beginning at birth and continuing throughout infancy.

Efficacy of fluoride to dental health from exposures during infancy. In addition to demonstrated elevated fluorosis risks associated with exposures during infancy, studies also raise serious questions about the efficacy of fluoride dosing in early life. The value of fluoride in maintaining dental health is clear, but some studies now demonstrate that fluoride may confer little to no resistance to cavities when dosing occurs in infancy, before the teeth erupt from the gum (Fejerskov 2004, Hellwing and Lennon 2004, Limeback 1999).

Studies demonstrate that fluoride’s primary action in cavity prevention derives from enhanced tooth mineralization after topical application (Featherstone 2000 & Fejerskov 2004). Fluoride’s antimicrobial action on the surface of the teeth is also thought to play a role. But fluoride that is swallowed and incorporated systemically into tooth enamel was not proven to have a significant effect in preventing cavities (Featherstone 1999). An increasing body of research supports the view that in developed countries with populations that practice good oral hygiene, fluoridated water may be unnecessary and, additionally, may present serious health risks (e.g., Pizzo et al. 2007, NRC 2006, Rocha-Amador et al. 2007, Wang et al. 2007).

Other potential health impacts of fluoride. As noted previously, potential health impacts from ingestion of fluoride extend beyond fluorosis to encompass other impacts as well. A March 2006 report from the National Academy of Sciences’ National Research Council (NRC 2006) identified fluoride as a potent hormone disruptor that may affect normal thyroid function. Fluoride's potential to impair thyroid function is most clearly illustrated by the fact that until the 1970s, European doctors used fluoride as a thyroid-suppressing medication for patients with hyperthyroidism. Infants are especially vulnerable to any disruption of thyroid function because adequate thyroid hormone levels are critical to normal growth and development.

The National Academy of Sciences’ (NAS) National Research Council (NRC) has raised further questions about additional risks fluoride poses during development based on studies demonstrating elevated rates of bone cancer (osteosarcoma), IQ reduction, thyroid disruption, and other impacts linked to fluoride exposure (NRC 2006). In particular, the NRC report cited concerns about the potential of fluoride to lower IQ, noting that the "consistency of study results appears significant enough to warrant additional research on the effects of fluoride on intelligence." Additional studies published since the NRC review provide further support for fluoride’s impacts on children’s IQ (e.g., Rocha-Amador et al. 2007, Wang et al. 2007). That NRC finding was echoed by a December 2006 study published in the prestigious peer-reviewed journal The Lancet that identified fluoride as an “emerging” neurotoxin (Grandjean and Landrigan 2006).

Recommendations. Because of the apparently intentional attempts to skirt FDA and FTCA law and the potentially significant adverse health effects to infants, we urge FDA and FTC to:

  • investigate expeditiously the improper use of health claims in advertising materials published by Nursery Water on the benefits of added fluoride in bottled water for infants;
  • enforce restrictions on such claims for bottled water marketed for infants;
  • release the names of the clients Covington & Burling was representing in its Health Claim Notification and all communications between the agencies and Covington & Burling regarding the health claim notification for fluoride;
  • enjoin the company from making further misleading health claims; and
  • pursue other appropriate legal remedies.

Nursery Water's materials appear to intentionally mislead consumers on the threat fluoride poses to infants and the positions of the Centers for Disease Control and Prevention, the American Dental Association, the American Academy of Pediatrics, the Environmental Protection Agency, and the National Research Council of the National Academy of Sciences, all of whom have recognized the unique risks fluoride exposures can pose during infancy. This appears to be an attempt to circumvent legal requirements to convince consumers to purchase their product without knowledge of the potential risks to infants.

Sincerely,

Anila Jacob, M.D., M.P.H.

Senior Scientist

Jane Houlihan

Vice President for Research

Cc:

Deborah Platt Majoras, Chair, Federal Trade Commission

Pamela Jones Harbour, Federal Trade Commission

Jon Leibowitz, Federal Trade Commission

William E. Kovacic, Federal Trade Commission

J. Thomas Rosch, Federal Trade Commission

ATTACHMENT

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