These Fluoride Products Are The Latest To Be Targeted By RFK Jr. And The FDA
WASHINGTON (AP) — US health regulators announced an effort Tuesday to phase out ingestible fluoride supplements sometimes used to strengthen children's teeth, opening a new front in Health Secretary Robert F. Kennedy Jr.'s effort against a mainstay of dental care.
The Food and Drug Administration said it will conduct a scientific review of the children's products by late October with the aim of removing them from the market. Formally withdrawing medical products requires a lengthy rulemaking process that can take years. Instead, the FDA will ask manufacturers to voluntarily pull their products, according to an administration official.
Fluoride tablets and lozenges are sometimes recommended for children and teens at increased risk of tooth decay or cavities because of low fluoride in their local drinking water. Companies also sell drops for babies.
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FDA Commissioner Marty Makary said the products pose a risk when swallowed because they may interfere with healthy gut bacteria that are critical to digestion, immunity, and other key bodily functions. He also referenced studies showing possible associations between excess fluoride intake and other problems, including decreased IQ. Previous reviews by public health experts and dental professionals have not shown any serious health risks with the products.
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As state and local governments begin removing fluoride from their water, the need for supplemental fluoride is expected to grow.
Officials in Utah — the first US state to ban fluoride from drinking water — recently made fluoride supplements available without a prescription.
Fluoride strengthens teeth and reduces cavities by replacing minerals lost during normal wear and tear, according to the Centers for Disease Control and Prevention. In 1962, the agency set guidelines for how much should be added to water.
Kennedy, a former environmental lawyer, has called fluoride a 'dangerous neurotoxin' tied to a range of health dangers. Last month, he announced a task force to scrutinize fluoride's use, while at the same time saying he would order the CDC to stop recommending that it be added to tap water.
A report last year by the federal government's National Toxicology Program concluded that drinking water with more than twice the CDC's recommended level was associated with lower IQs in kids. The study was based on research conducted in Canada, China, India, Iran, Pakistan, and Mexico.
'Ending the use of ingestible fluoride is long overdue,' Kennedy said in a statement Tuesday. 'This decision brings us one step closer to delivering on President Trump's promise to Make America Healthy Again.'
An influential government health panel recommends fluoride supplements for children between the ages of six months and 5 years if they live in areas with low fluoridation levels. The US Preventative Services Task Forces judged the recommendation to have 'high certainty,' based on the available evidence.
A 2010 paper from the American Dental Association recommended supplemental fluoride for children up to 16 years old who are at high risk of cavities. The recommendation was based on a review of studies across different age groups. The most common side effect associated with the products is spotting or discoloration of the teeth, caused by extra fluoride.
The ADA did not immediately respond to a request for comment.
The FDA regulates most dental products, including fluoride-containing toothpastes, supplements, mouthwashes, and rinses. But in Tuesday's press release, the FDA said the ingestible products targeted by the agency have 'never been approved.' Its plan wouldn't affect toothpastes, mouthwash, or fluoride treatments used by adults or offered in dentists' offices.
In recent weeks, fluoride-containing products have increasingly been targeted with lawsuits and legal actions.
Texas Attorney General Ken Paxton announced an investigation early this month into the marketing of fluoride toothpastes by Colgate-Palmolive and Proctor and Gamble. A press release from his office described the companies' promotions as 'misleading, deceptive, and dangerous.'
This article originally appeared on HuffPost.
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Forward-looking statements can generally be identified by words such as 'potential,' 'can,' 'will,' 'may,' 'could,' 'trend,' 'potentially,' 'upcoming,' 'progression,' 'progress,' 'investigating,' 'investing,' 'look beyond,' or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Pluvicto, or regarding potential future revenues from Pluvicto. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Pluvicto will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Pluvicto will be commercially successful in the future. In particular, our expectations regarding Pluvicto could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References Data on file. Pluvicto [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc.; 2025. An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC (PSMAddition). identifier: NCT04720157. Updated March 5, 2025. Accessed June 2, 2025. Oing C, Bristow RG. Systemic treatment of metastatic hormone-sensitive prostate cancer—upfront triplet versus doublet combination therapy. ESMO Open 2023l doi: 10.1016/ Sartor O, J. de Bono KN, Chi K, et al. Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. NEJM 2021; doi: 10.1056/NEJMoa2107322. Morris M, Castellano D, Herrmann K, et al. 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial. The Lancet 2024; doi: 10.1016/S0140-6736(24)01653-2. University of Chicago Medicine. Lutetium-177 PSMA Therapy for Prostate Cancer (Pluvicto). Accessed June 18, 2024. Jadvar H. Targeted Radionuclide Therapy: An Evolution Toward Precision Cancer Treatment [published correction appears in AJR Am J Roentgenol. 2017 Oct;209(4):949. doi: 10.2214/AJR.17.18875]. AJR Am J Roentgenol. 2017;209(2):277-288. doi:10.2214/AJR.17.18264 Jurcic JG, Wong JYC, Knoc SJ, et al. Targeted radionuclide therapy. In: Tepper JE, Foote RE, Michalski JM, eds. Gunderson & Tepper's Clinical Radiation Oncology. 5th ed. Elsevier, Inc. 2021;71(3):209-249 # # # Novartis Media RelationsE-mail: Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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