Fluoride supplements (drops, tablets, and lozenges) were introduced in the 1950s as a substitute for fluoridated water for children living in unfluoridated communities. Unlike dietary supplements, fluoride supplements cannot be purchased over the counter, but require a prescription from a dentist or a doctor. Further, unlike most other prescription drugs, however, fluoride supplements have never been approved as safe and effective by the Food and Drug Administration (FDA). Despite fifty years and countless prescriptions to millions of children, the FDA still considers fluoride supplements to be “unapproved new drugs.”
The use of fluoride supplements is premised on two outdated beliefs: (1) fluoride needs to be swallowed to be effective and (2) children in unfluoridated communities have a deficiency of fluoride intake. Modern research has invalidated both of these beliefs. Even some pro-fluoride dental researchers have begun calling for an end to fluoride supplements, and dental organizations throughout the western world have begun drastically revising their fluoride supplementation guidelines.
So what do you, as a parent, need to know about fluoride supplements today?
Fluoride supplements are no longer recommended for most children
In 1994, the American Dental Association, American Academy of Pediatrics, and American Academy of Pediatric Dentists significantly lowered their recommended dosage for fluoride supplements. Under the new guidelines, infants 0 to 6 months of age should receive no fluoride supplementation. More recently, in 2010, the ADA’s Council on Scientific Affairs announced its recommendation that “fluoride supplements should only be prescribed only for children who are at high risk of developing caries.” (Rozier 2010). Dental associations in other countries have made similar announcements. (Banting 1999). In Europe, “Most of the European scientific dental associations no longer recommend the use of fluoride supplements, such as fluoride tablets or drops, as a standard procedure in caries prevention.” (Zimmer 2003).
As discussed below, the waning enthusiasm for fluoride supplements by even the most ardent pro-fluoride organizations reflects the growing realization that (a) ingesting fluoride does little, if anything, to prevent tooth decay; (b) children in “unfluoridated” communities are now receiving fluoride from many other sources (toothpaste, etc), thus making “supplementation” unnecessary and harmful; and (c) children who use fluoride supplements are at very high risk of developing dental fluorosis of their permanent teeth.
Fluoride supplements are unnecessary
Fluoride supplements were developed in the 1950s based on the incorrect and outdated notions that (a) fluoride’s benefit to teeth comes from being swallowed during childhood, and that (b) children in unfluoridated communities have a deficiency of fluoride intake. (Burt 1999). Both of these premises have since been widely rejected. In the 1980s, dental researchers definitively established that fluoride’s primary benefit to teeth comes from direct topical contact with teeth, not from swallowing. And, in 1989, the National Academy of Sciences concluded that fluoride is not an “essential nutrient” for which there can be deficiency.
Further, even if ingesting fluoride were somehow necessary, the dental community now concedes that children in unfluoridated communities now receive fluoride from many other sources, such as fluoridated toothpaste, so there is no longer any “deficiency” to supplement. For example, according to the Journal of Public Health Dentistry: “Virtually all authors have noted that some children could ingest more fluoride from [toothpaste] alone than is recommended as a total daily fluoride ingestion.” (Levy 1999).
In the words of pro-fluoride dental researcher Brian Burt, “things have changed so much that the use of fluoride dietary supplements for young children now presents more problems than benefits.” (Burt 1999)
Fluoride supplements are ineffective
As even fluoride proponents now concede, the evidence that fluoride supplements reduces cavities is “poor,” “inconsistent,” and “weak.” (Ismail 2008; Riordan 1999). According to the pro-fluoride researcher Paul Riordan:
“The basis for the widespread acceptance of fluoride supplements in caries prevention is a large number of mostly small clinical trials in the late 1950’s and 1960’s. The early studies have been reviewed again recently in a series of publications and they have again been criticized. The criticisms are serious and virtually none of the early fluoride supplement studies would be published today, because of methodological and other shortcomings. They present conclusions that are not supported by their data or consistent with their designs.” (Riordan 1999).
While some modern studies have found marginal differences in tooth decay, other studies have found no benefit at all. (Kalsbeek 1992). Even if there is a minor benefit, “the benefits claimed for fluoride supplements are, in any case, available through regular toothbrushing with fluoride toothpaste and fairly minor and sensible lifestyle changes.” (Riordan 1999).
Fluoride supplements cause dental fluorosis
In contrast to the weak and inconsistent evidence of effectiveness, there is overwhelming evidence that fluoride supplements greatly increase the odds that a child will develop dental fluorosis on their permanent teeth. (Burt 1999; Ismail 1999; Riordan 1999). Dental fluorosis is a mineralization defect of the teeth caused by excessive fluoride intake during the tooth-forming years. In its mild forms, it presents as white specks and streaks on the teeth, while in its advanced forms it causes brown and black staining and erosion of the enamel. “The use of fluoride supplements increases the risk of developing dental fluorosis by at least two times.” (Ismail 1999). Thus, “supplement use by children younger than 5 years entails a risk of fluorosis which, at the community level, becomes a certainty.” (Riordan 1999). According to Burt, therefore, the case for eliminating fluoride supplements “is essentially a risk-benefit issue—fluoride has little preeruptive impact on caries prevention, but presents a clear risk of fluorosis.” (Burt 1999).
Fluoride supplements present other risks in addition to fluorosis
Fluoride supplements can cause other harm besides dental fluorosis. In some children, fluoride supplements have been found to cause allergic reactions, including gastrointestinal pain, nausea, skin rashes, and headaches. (Physician’s Desk Reference 1994; Shea 1967; Feltman 1961) In addition, children ingesting 1 mg tablets will experience daily spikes in their blood fluoride levels that exceed the blood fluoride levels (95 ppb) that increase blood glucose levels in both humans and animals. (Ekstrand 1983). The implications of this fact have yet to be considered by the dental community, but could be contributing to, or exacerbating, the development of childhood diabetes (a condition marked by chronically elevated glucose levels in the blood).
Some Dentists Prescribe Fluoride Supplements to Children in Fluoridated Areas
Although supplements were designed to be given to children living in non-fluoridated communities, studies have found that a sizable percentage of dentists do not consider the fluoride level in the child’s water supply before prescribing the supplement. (Narendran 2006; Ismail 1999). As a result, many children living in fluoridated communities have been simultaneously prescribed fluoride supplements.
In addition, although dental researchers implore dentists to consider other sources of fluoride that a child may be receiving (e.g., toothpaste), this rarely happens in practice. As a result, children who are inadvertently swallowing a prescription dose of fluoride through their toothpaste will still be prescribed a fluoride “supplement.” Such children are at high risk for advanced forms of dental fluorosis, particularly if they also happen to live in a fluoridated area.
- Banting DW. (1999). International fluoride supplement recommendations. Community Dent Oral Epidemiol. 27(1):57-61.
- Burt BA. (1999). The case for eliminating the use of dietary fluoride supplements for young children. J Public Health Dent. 59(4):269-74.
- Feltman R, Kosel G. (1961). Prenatal and postnatal ingestion of fluorides – Fourteen years of investigation – — Final report. Journal of Dental Medicine 16: 190-99.
- Ismail AI, Hasson H. (2008). Fluoride supplements, dental caries and fluorosis: a systematic review. J Am Dent Assoc. 139(11):1457-68.
- Ismail AI, Bandekar RR. (1999). Fluoride supplements and fluorosis: a meta-analysis. Community Dent Oral Epidemiol. 27(1):48-56.
- Levy SM, Guha-Chowdhury N. (1999). Total fluoride intake and implications for dietary fluoride supplementation. J Public Health Dent. 59(4):211-23.
- Kalsbeek H, et al. (1992). Use of fluoride tablets and effect on prevalence of dental caries and dental fluorosis. Community Dent Oral Epidemiol. 20(5):241-5.
- Narendran SN, et al. (2006). Fluoride knowledge and prescription practices among dentists. Journal of Dental Education 70(9): 956-64.
- Physician’s Desk Reference 1994, 48th Edition, p. 2335-36.
- Riordan PJ. (1999). Fluoride supplements for young children: an analysis of the literature focusing on benefits and risks. Community Dent Oral Epidemiol. 27(1):72-83.
- Rozier RG, et al. (2010). Evidence-based clinical recommendations on the prescription of dietary fluoride supplements for caries prevention: a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 141(12):1480-9.
- Zimmer S, et al. (2003). Recommendations for the use of fluoride in caries prevention. Oral Health Prev Dent. 1(1):45-51.
Kelly seeks ban on fluoride supplement
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.
Kelly calls Kids Fluoride Supplements "Fluorosis Risk" - Asks FDA to take action
Assemblyman John V. Kelly (R-36) today petitioned FDA Commissioner Jane Henney to take regulatory action against children's fluoride supplements. In his letter to FDA Commissioner Henney, Kelly wrote "the manufacturers of fluoride supplements have had fifty years to conduct clinical trials and toxicology studies to demonstrate the safety and effectiveness and submit them for FDA approval. They have not done so. Fifty years is a long time - even for the FDA".
FDA Attacks Prenatal Fluorides
October 24, 1966: The Food and Drug Administration last week moved to strike from the market fluoride-containing vitamin and mineral prescription preparations for prenatal use.
Physician's Desk Reference: Fluoride Hypersensitivity
The following are excerpts from various editions of the Physicians' Desk Reference (PDR). "In hypersensitive individuals, fluorides occasionally cause skin eruptions such as atopic dermatitis, eczema or urticaria. Gastric distress, headache and weakness have also been reported. These hypersensitivity reactions usually disappear promptly after discontinuation of the fluoride. In rare cases,
Allergy to Fluoride
Six children and one adult exhibited various allergic reactions after the use of toothpaste and vitaimin preparations containing fluoride. The following conditions were encountered: Urticaria, exfoliative dermatitis, atopic dermatitis, stomatitis, gastro-intestinal and respiratory allergy.
Prenatal and postnatal ingestion of fluorides - A progress report.
The cases described indicate that certain patients react unfavorably to fluoride therapy. Whether the fluorine acts as an allergen after short term use or whether the fluorine acts as an intoxicant after many months of use, is unknown and should be determined.