Dr. Richard Sauerheber
San Marcos, CA 92069
August 18, 2014
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Rockville, MD 20857
This letter is in support of the petition to ban the intentional infusion of fluorosilicic acid and sodium fluoride into public water supplies that is an attempt to prevent dental caries in humans (petition FDA2007-P-0346). It is necessary to call attention to the public information presented to consumers by manufacturers and promoters of ACT fluoride rinse in the context of fluoridated water consumption.
The manufacturer’s information is printed below and much of it has been spread nationally in television advertisements. Notice that the advertisement argues that drinking fluoridated water, in conjunction with twice daily ACT fluoride rinse and fluoridated toothpaste daily use, will not likely cause overexposure to fluoride. In contrast, the ad for ACT at Target stores states the rinse should not be used in areas with water fluoride at 0.7 ppm or higher. The claim the manufacturer is made without reference or proof of any kind, which constitutes misbranding of a drug. It implies that orally ingested fluoridated water is both harmless and effective, even when ingested in conjunction with daily use of both fluoridated topical pastes and daily fluoride rinses. The one correct statement that is made by the manufacturer is that fluoride is a drug.
Recall, while reading the claims below, that the FDA has never approved any fluoride compound for ingestion and correctly ruled that fluoride is a drug, not a mineral nutrient. Nevertheless the ACT rinses are made to be tasty, which encourages swallowing. The FDA allows use of sodium fluoride tablets for ingestion but only by prescription and only in regions where water fluoride is below 0.7 ppm. Nevertheless ACT use is promoted by the manufacturer even for fluoridated water regions. The claim interferes with the prescription process since both Luride and fluoridated water are intended for ingestion and fluoride from mouth rinses is partly assimilated. Significant amounts of fluoride are assimilated from rinses, particularly in children given tasty flavored liquids. Toothpaste fluoride designed not to be swallowed already accounts for 15% of fluoride in the bloodstream in fluoridated water regions (NRC, 2006). ACT rinses are made to be tasty, which makes it simpler for the average consumer to go ahead swallow some or much of the product. Flavors include bubble gum, berry, cinnamon, and mint. This proves beyond doubt these manufacturers are doing whatever it takes to sell materials, rather than carefully considering safety of consumers since ingested fluoride permanently incorporates into bone lifetime. Berry, cinnamon, and mint are recognized as foods to be swallowed. The manufacturer statement that ACT must not be swallowed provides cover for the manufacturer in cases of excess ingestion, but does not solve this fluoride ingestion problem.
Sadly, recent Federal court rulings have permitted pharmaceutical companies to provide information to physicians about unapproved uses for prescription drugs (Off-label squabble, San Diego Union Tribune, August 17, 2014, p. C1-4). The argument is that such companies have “free speech rights.” The FDA correctly opposes this ruling on the grounds that the mission of the FDA is to assure that drugs be used only when proven safe and effective in controlled clinical trials. Claiming effectiveness and safety without such trials is analogous to crying “Fire” in a crowded room and is not “free speech.” Fluoride rinses are being touted as able to reduce caries by “40% more than reductions caused by fluoridated toothpaste use alone.” This has not been verified in FDA approved clinical trials and is based on a single, old abstract (Heifitz, Jour. Dental Research 60, abstract 645, March, 1981). It may now be legal to make this abstract available to physicians and dentists for evaluation without FDA approval, but the court ruling does not allow such definitive claims of safety and effectiveness to be given to the general public. Manufacturers of ACT fluoride rinses now make such claims through public advertisements made by Walmart, Walgreen’s, and other retail outlets. Recall that the FDA asked Walgreen’s to stop claiming that fluoride mouthwash regenerates gum tissue. Walgreen’s complied and removed that product claim. Here with ACT, Walgreen’s advertisements also do not contain that claim, but that claim is made by the manufacturer in other advertisements without proof.
The ACT advertisement that 80% of children will get cavities by age 17 slams in the face against the idea that fluoridated water protects against caries. 72% of community water supplies in the U.S. have long been fluoridated. Most consumers in those districts also use fluoridated toothpaste, which its manufacturers also claim reduces dental caries from 20-40%. Pastes at 20-40%, rinses at 40%, and fluoridated water at 26% reductions add to near 100% or more! And yet caries are not near 0, but as stated 80% of children still get caries by age 17. The CDC website claiming 26% reduction in caries from fluoridated water consumption is:
Combining manufacturer, ADA, and CDC recommendations, a typical consumer intentionally places into the oral cavity each day about 75 mg fluoride from one tooth brushing, 2 mg from ACT fluoride rinse, and 0.02 mg in saliva produced daily from ingested fluoridated water. The first two are announced to produce a 60-80% reduction in caries after being expectorated, while fluoridated water with only 0.01% of the topical fluoride from the other sources, is argued to produce another 26% reduction. The mechanism for this massive reduction in caries from such a comparably miniscule amount and concentration of fluoride from drinking water is unexplained, and is not understood by promoters! The answer is that vast data prove that fluoridated water does not and has never reduced dental caries, as explained in previous letters (see Sutton, P., Fluoridation, the Greatest Fraud, 1986; Teotia and Teotia; Ziegelbecker; Connett, P., The Case Against Fluoridation, 2010; Yamouyiannis, J. Fluoride, the Aging Factor, 1985; among others), and any actual reductions were not due to fluoride ingestion rather than other factors.
Clearly the public is being duped with claims that ingested fluoride from water is effective. The claim is based on a 1939 correlation (which never implied causation) in a small sample. The idea took was accentuated by the uncontrolled Newburgh/Kingston fluoridation experiment in which missing teeth were scored as absence of cavities. We now know these missing teeth were caused by the adverse effect of blood fluoride in delaying tooth development. Please understand that this effect was so large that it was significant and detectable in fluoridated Newburgh, compared to non-fluoridated Kingston, even though the consumers did not volunteer to control diets, sugar consumption, brushing frequency, or daily water intake.
Fluoride cannot strengthen teeth, as claimed by the ACT manufacturer. A similar claim had been made for bone conversion to fluoroapatite through fluoride ingestion. Fluoridated bone is not strengthened, but was instead found in FDA-requested research to be weakened, especially at levels above 3,000 mg/kg (National Research Council, Fluoride in Drinking Water, 2006; Jour Env. Pub. Health 2014, article 439490). Fluoride cannot specifically strengthen teeth enamel either, because fluoride does not incorporate into the enamel matrix. Crystalline enamel is far too hard. We now know from scanning electron microscopy and X-ray crystallography studies (see petition) that topical fluoride does not enter enamel but instead merely forms calcium fluoride globules on teeth surfaces. These are easily washed away upon eating, and the topical fluoride is eventually all swallowed. 50% of ingested fluoride incorporates into bone permanently, whether from topical pastes, gels, rinses, or by systemic whole body fluoridation from treated drinking water. Fluoride sadly incorporates into dentin underlying teeth as an outgrowth of bone. Ironically, manufacturers of ACT claim that fluoride also strengthens teeth below the gumline where enamel is not present. But bone conversion to fluoroapatite is an abnormal, not a physiologic, process. Fluoride is not a normal component of the body and is not a normal constituent of blood. The notion that abnormal fluoroapatite is worthwhile in teeth because it is more resistant to acid degradation has been discredited in other studies. Caries are not caused by absence of fluoride. Good dental hygiene that prevents decay cannot have any “percent reduction” in decay (below zero) no matter how much fluoride is ingested or topically applied.
Water fluoride ingestion is known to produce 65% of the fluoride content of the blood in fluoridated regions, and fluoridated toothpaste use accounts for 15% of blood fluoride (NRC, 2006). Fluoride rinses will also significantly increase blood fluoride levels. The FDA has already approved fluoride toothpastes, gels, and rinses for topical use. A local dentist published that fluoride intake has no limit and should be added to our bread. It is very necessary for the FDA to now focus on halting false claims regarding whole body fluoridation of people through treatment of public water supplies with artificial fluoride compounds that are intended for ingestion without FDA approval.
In anticipation of help, we all thank you again,
Richard Sauerheber, Ph.D. Chemistry
The public advertisements for sales of ACT mouth rinses below were from:
ACT Fluoride Mouth Rinses.
Fluoride is vitally important for children as their teeth develop and as they get older because it helps stop cavities from forming by enhancing the strength of teeth. Proper daily use of ACT Fluoride Rinse is a great way for children to strengthen their teeth, help prevent cavities and reinforce good oral care habits.
Here’s a shocking fact – did you know that 80% of children will get a cavity by age 17?1“NIH Consensus Statement, Diagnosis and Management of Dental Caries Throughout Life” Vol. 18, Number 1, March 2001 Help your kids avoid this fate by encouraging a good oral care routine when they’re young. Incorporating ACT Fluoride Rinse into your child’s oral care routine can reduce their risk of cavities by up to 40% more than brushing with a fluoride toothpaste alone.2A Comparison of the Anticaries Effectiveness of Daily and Weekly Rinsing with Sodium Fluoride Solutions: Final Results After 3 Years’, Journal of Dental research, 60 (Special Issue A), Abstract 645 (March 1981)
ACT Fluoride Rinse is recommended for people over the age of 6.
Did you know? Most People Don’t Get Enough Fluoride. You never stop needing fluoride. The simple truth is that most people – kids and adults alike – don’t get enough. Consider the facts:
- 85% of all adults experience tooth decay.4Oral Health in America: a report of the U.S. Surgeon General, 2000:63, 74-94, 245.
Why do the larger sizes of ACT contain less fluoride?
- Fluoride is a regulated drug and, as such, the amount of fluoride sold to consumers in a single bottle is regulated for safety purposes. ACT 33.8oz bottles provide consumers with the maximum allowable fluoride concentration in an OTC rinse – 0.02% sodium fluoride, which can be used twice daily and provide all the benefits of fluoride.
If my town has fluoridated water, could my children get too much fluoride if they use ACT Fluoride Rinse?
- The chances are very unlikely. Given the relatively low concentration of fluoride in ACT products, and the fact that it’s not ingested, conditions associated with over-fluoridation such as fluorosis are not considered to be an issue. Please consult with your physician or dental professional about any health concerns you may have, as your physician is familiar with your children’s personal medical history.
Fluoride is a natural mineral. Fluoride applied topically for dental care is a drug. ACT rinse formulates fluoride at the maximum concentration allowed for this drug for safety reasons. The ACT rinse contains 0.02% (20 mg/100 g = 200 ppm) fluoride. 10 ml rinses held in the mouth for one full minute twice a day is recommended for kids over 6 (4 mg fluoride daily). Using ACT rinse in fluoridated water regions will not cause overexposure to fluoride. ACT is tasty.