FDA and RFK Jr. aim to remove fluoride supplements used to protect kids' teeth
WASHINGTON (AP) — U.S. health regulators announced plans Tuesday to phase out fluoride-containing 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 products by late October with the aim of removing them from the market. It was not immediately clear whether the agency planned to formally ban the supplements or simply request that companies withdraw them.
The products targeted by the FDA are sometimes recommended for children and teens who are at increased risk of tooth decay or cavities because of low fluoride in their local drinking water. They usually require a prescription from a pediatrician or dentist. Fluoride-based tablets and lozenges are designed to be chewed or swallowed. Companies also sell drops for babies and infants.
FDA Commissioner Marty Makary said the products pose a risk when swallowed by children 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.
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 U.S. 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 it.
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 U.S. Preventative Services Task Forces judged the recommendation to have 'high certainty' of benefit, 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 FDA regulates most dental products, including fluoride-containing toothpastes, supplements, mouthwashes and rinses.
In recent weeks those products have increasingly been targeted with lawsuits and legal actions.
Last week, Texas Attorney General Ken Paxton announced an investigation 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.'
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
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Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. In Europe, Opzelura® (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura. Opzelura and the Opzelura logo are registered trademarks of Incyte. IMPORTANT SAFETY INFORMATION OPZELURA is for use on the skin only. Do not use OPZELURA in your eyes, mouth, or vagina. OPZELURA may cause serious side effects, including: Serious Infections: OPZELURA contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. Some people have had serious infections of their lungs while taking OPZELURA. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with OPZELURA. OPZELURA should not be used in people with an active, serious infection, including localized infections. You should not start using OPZELURA if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) while using OPZELURA. Increased risk of death due to any reason (all causes): Increased risk of death has happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called JAK inhibitors by mouth. Cancer and immune system problems: OPZELURA may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers have happened in people taking a medicine in the class of medicines called JAK inhibitors by mouth. People taking JAK inhibitors by mouth have a higher risk of certain cancers including lymphoma and lung cancer, especially if they are a current or past smoker. Some people have had skin cancers while using OPZELURA. Your healthcare provider will regularly check your skin during your treatment with OPZELURA. Limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen. Increased risk of major cardiovascular events: Increased risk of major cardiovascular events such as heart attack, stroke, or death have happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors by mouth, especially in current or past smokers. Blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking OPZELURA. This may be life-threatening. Blood clots in the vein of the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a medicine in the class of medicines called JAK inhibitors by mouth. Low blood cell counts: OPZELURA may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If needed, your healthcare provider will do a blood test to check your blood cell counts during your treatment with OPZELURA and may stop your treatment if signs or symptoms of low blood cell counts happen. Cholesterol increases: Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high cholesterol or triglycerides. Before starting OPZELURA, tell your healthcare provider if you: have an infection, are being treated for one, or have had an infection that does not go away or keeps coming back have diabetes, chronic lung disease, HIV, or a weak immune system have TB or have been in close contact with someone with TB have had shingles (herpes zoster) have or have had hepatitis B or C live, have lived in, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or become more severe if you use OPZELURA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common. think you have an infection or have symptoms of an infection such as: fever, sweating, or chills, muscle aches, cough or shortness of breath, blood in your phlegm, weight loss, warm, red, or painful skin or sores on your body, diarrhea or stomach pain, burning when you urinate or urinating more often than usual, feeling very tired have ever had any type of cancer, or are a current or past smoker have had a heart attack, other heart problems, or a stroke have had blood clots in the veins of your legs or lungs in the past have high cholesterol or triglycerides have or have had low white or red blood cell counts are pregnant or plan to become pregnant. It is not known if OPZELURA will harm your unborn baby. There is a pregnancy exposure registry for individuals who use OPZELURA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become exposed to OPZELURA during pregnancy, you and your healthcare provider should report exposure to Incyte Corporation at 1-855-463-3463 or are breastfeeding or plan to breastfeed. It is not known if OPZELURA passes into your breast milk. Do not breastfeed during treatment with OPZELURA and for about 4 weeks after the last dose. After starting OPZELURA: Call your healthcare provider right away if you have any symptoms of an infection. OPZELURA can make you more likely to get infections or make worse any infections that you have. Get emergency help right away if you have any symptoms of a heart attack or stroke while using OPZELURA, including: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw, or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded weakness in one part or on one side of your body slurred speech Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with OPZELURA, including: swelling, pain, or tenderness in one or both legs, sudden, unexplained chest or upper back pain, or shortness of breath or difficulty breathing. Tell your healthcare provider right away if you develop or have worsening of any symptoms of low blood cell counts, such as: unusual bleeding, bruising, tiredness, shortness of breath, or fever. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of OPZELURA in people treated for atopic dermatitis include: common cold (nasopharyngitis), diarrhea, bronchitis, ear infection, increase in a type of white blood cell (eosinophil) count, hives, inflamed hair pores (folliculitis), swelling of the tonsils (tonsillitis), and runny nose (rhinorrhea). The most common side effects of OPZELURA in people treated for nonsegmental vitiligo include: acne at the application site, itching at the application site, common cold (nasopharyngitis), headache, urinary tract infection, redness at the application site, and fever. These are not all of the possible side effects of OPZELURA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463. Please see the Full Prescribing Information, including Boxed Warning, and Medication Guide for OPZELURA. INDICATIONS AND USAGE OPZELURA is a prescription medicine used on the skin (topical) for: short-term and non-continuous chronic treatment of mild to moderate eczema (atopic dermatitis) in non-immunocompromised adults and children 12 years of age and older whose disease is not well controlled with topical prescription therapies or when those therapies are not recommended the treatment of a type of vitiligo called nonsegmental vitiligo in adults and children 12 years of age and older The use of OPZELURA along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended. It is not known if OPZELURA is safe and effective in children less than 12 years of age with atopic dermatitis or nonsegmental vitiligo. About Incyte Dermatology Incyte's science-first approach and expertise in immunology has formed the foundation of the company. Today, we are building on this legacy as we discover and develop innovative dermatology treatments to bring solutions to patients in need. We strive to identify and develop therapies to modulate immune pathways driving uncontrolled inflammation. Specifically, our efforts in dermatology are focused on a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo, hidradenitis suppurativa, lichen sclerosus, and prurigo nodularis. To learn more, visit the Dermatology section of About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the potential for ruxolitinib cream to provide a successful treatment option for pediatric patients with AD; Incyte's plans to work with FDA; and Incyte's expectations with regard to the PDUFA date for its sNDA and regulatory approval, contain predictions, estimates, and other forward-looking statements. These forward-looking statements are based on our current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA and other regulatory agencies; the efficacy or safety of our products; the acceptance of our products in the marketplace; market competition; unexpected variations in the demand for our products and the products of our collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for our products; sales, marketing, manufacturing, and distribution requirements, including our ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional new products that become approved; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended March 31, 2025. We disclaim any intent or obligation to update these forward-looking statements. View source version on Contacts Media media@ Investors ir@ Error 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
