THE DRINKING water system in the Philippines has no fluoride to prevent tooth decay.
Instead, fluoride is available is toothpaste and other oral health care products.
That said, it may interest you to know that the United States Food and Drug Administration (US FDA) announced last May that it will remove fluoride supplements from the market effective October 2025 – after a safety review is completed. The safety review applies to “ingestible fluoride prescription drug products” but does not cover toothpaste, mouth rinses, or other topical products containing fluoride.
“Ending the use of ingestible fluoride is long overdue,” said Robert F. Kennedy Jr. who heads the U.S. Department of Health and Human Services (HHS). “This decision brings us one step closer to delivering on President Trump’s promise to Make America Healthy Again.”
It’s a “a cart-before-the-horse” decision, said Dr. Peter J. Pitts, a former FDA associate commissioner and now the President of the Center for Medicine in the Public Interest which he founded. Shouldn’t the decision be made after the scientific review? he asked.
“Science evolves as both controlled clinical research and real-world evidence show us how to use health care technologies to better advance the human condition, he said in a press statement.
“Such a tool is fluoride,” he pointed out.
“Extensively studied over decades, fluoride has been scientifically validated for its effectiveness in reducing dental cavities, particularly in children. It is incorporated into municipal water supplies, toothpastes, mouth rinses, and dietary supplements. The benefits of fluoride writ large far outweigh its risks, but no health care intervention is ever 100 percent risk-free. It’s the FDA’s job to ensure the safety, efficacy, and quality of fluoride-containing drugs and supplements based on robust scientific analysis and regular post-marketing surveillance.”
He cited the American Dental Association which has said: “A review of the studies offered as referenced by HHS do not in fact demonstrate any harmful effects for the concentrations of fluoride prescribed by physicians and dentists.”
While it is uncommon, some drugs available by prescription are not FDA-approved for safety and efficacy, Dr. Pitts said, adding that often, these “unapproved” drugs are available with a prescription because they were available before current approval processes were in place. Many of these medications were on the market before 1962, when the US FDA first started requiring manufacturers to show that a new medication was safe and effective for its intended use, he said.
Prescription fluoride drops and tablets for ingestion were first marketed in the United States in the 1940s to prevent dental caries, or tooth decay, particularly in children who lived in areas with low or no water fluoridation.
These products are still prescribed today, but none have been reviewed and approved by the US FDA for safety, effectiveness, or quality, Dr. Pitts said. “Over the years, numerous medical and dental organizations in the United States have recommended the use of ingestible fluoride products for those for whom regular topical treatment is difficult to achieve and those for whom topical fluoride only is insufficient to avoid dental decay.”
These unapproved drugs present complex challenges for public health, especially for vulnerable populations like children, who are at greater risk for both the benefits and potential harms of fluoride exposure, he said.
“Formally withdrawing medical products requires a lengthy rulemaking process that can take years. It is likely that the FDA will ask manufacturers to voluntarily pull their products.”
We are sharing this information because you may be using “ingestible fluoride prescription drug products”. Just so you know.
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Dr. Joseph D. Lim, Ed. D., is the former Associate Dean of the College of Dentistry, University of the East; former Dean, College of Dentistry, National University; Past President and Honorary Fellow of the Asian Oral Implant Academy; Honorary Fellow of the Japan College of Oral Implantologists; Honorary Life Member of the Thai Association of Dental Implantology; and Founding Chairman of the Philippine College of Oral Implantologists. For questions on dental health, e-mail jdlim2008@gmail.com or text 0917-8591515.
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Dr. Kenneth Lester Lim, BS-MMG, DDM, MSc-OI, graduated Doctor of Dental Medicine, University of the Philippines, College of Dentistry, Manila, 2011; Bachelor of Science in Marketing Management, De la Salle University, Manila, 2002; and Master of Science (MSc.) in Oral Implantology, Goethe University, Frankfurt, Germany, 2019. He is an Associate Professor; Fellow, International Congress of Oral Implantologists; and Fellow, Philippine College of Oral Implantologists. For questions on dental health, e-mail limdentalcenter@gmail.com/PN
