Fluoride Action Network

Acute Fluoride Toxicity from Toothpaste Ingestion

F.A.N. | March 2012 | By Michael Connett
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  • The Food & Drug Administration now requires that all fluoride toothpastes sold in the United States bear the following poison warning:

    “WARNING: Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a poison control center immediately.”

    The FDA warning is necessary because relatively small doses of fluoride can induce symptoms of acute fluoride toxicity (i.e., poisoning). Early symptoms of fluoride poisoning include gastrointestinal pain, nausea, vomiting, and headaches. The minimum dose that can produce these symptoms is estimated to be 0.1 to 0.3 mg/kg of fluoride (i.e., 0.1 to 0.3 milligrams of fluoride for every kilogram of bodyweight). A child weighing 10 kilograms, therefore, can suffer symptoms of acute toxicity by ingesting just 1 to 3 milligrams of fluoride in a single sitting.

    As demonstrated in the table, 1 to 3 mgs of fluoride is found in just 1 to 3 grams of toothpaste (less than 3% of the tube) — including toothpaste that is marketed specifically to children with bubble-gum and fruit flavors.

    Amount of Bubblegum-flavored “Colgate for Kids” Toothpaste
    Capable of Causing Acute Toxicity 
    Age of Child
    Average Weight*
    Milligrams of Fluoride
    Capable of Producing
    Symptoms
    Grams of Ingested Toothpaste

    Percent of Toothpaste
    Volume

    2 years
    ~12 kg
    1.2 – 3.6 mg
    1.1 – 3.3 g
    0.8 – 2.5%
    3 years
    ~15 kg
    1.5 – 4.5 mg
    1.4 – 4.1 g
    1.0 – 3.1%
    4 years
    ~16 kg
    1.6 – 4.8 mg
    1.5 – 4.4 g
    1.1 – 3.4%
    5 years
    ~ 18 kg
    1.8 – 5.4 mg
    1.6 – 4.9 g
    1.3 – 3.8%
    6 years
    ~20 kg
    2.0 – 6.0 mg
    1.8 – 5.5 g
    1.4 – 4.2%
    7 years
    ~22 kg
    2.2 – 6.6 mg
    2.0 – 6.0 g
    1.5 – 4.6%
    8 years
    ~25 kg
    2.5 – 7.5 mg
    2.3 – 6.8 g
    1.7 – 5.2%
    9 years
    ~28 kg
    2.8 – 8.4 mg
    2.5 – 7.6 g
    2.0 – 5.9%
    *Average weight data obtained here
    ** The fluoride concentration in Colgate for Kids toothpaste is 1,100 ppm. At 130 grams of paste in the average tube, this equals 143 milligrams of fluoride.

    Because the symptoms of acute fluoride toxicity mimic other, common ailments (e.g., upset stomach, nausea, flu), there are undoubtedly countless incidents of fluoride poisoning that routinely go undiagnosed. As noted in the Journal of Public Health Dentistry:

    “Estimating the incidence of toxic fluoride exposures nationwide also is complicated by the existence of biases. Parents or caregivers may not notice the symptoms associated with mild fluoride toxicity or may attribute them to colic or gastroenteritis, particularly if they did not see the child ingest fluoride. Similarly, because of the nonspecific nature of mild to moderate symptoms, a physician’s differential diagnosis is unlikely to include fluoride toxicity without a history of fluoride ingestion.”
    SOURCE: Shulman JD, Wells LM. (1997). Acute fluoride toxicity from ingesting home-use dental products in children, birth to 6 years of age. Journal of Public Health Dentistry 57: 150-8.

    Although many poisoning incidents go undiagnosed, the number of reports to Poison Control Centers in the U.S. has skyrocketed since the FDA issued its poison warning. Indeed, in the early 1990s (prior to the FDA warning), there were about 1,000 poisoning reports each year from fluoride toothpaste. Today, there are over 20,000 reports a year -- a 20-fold increase since the FDA added the warning.

    Reports to Poison Control Centers in U.S.
    Due to Excessive Ingestion of Fluoride Toothpastes

    Data from: Bronstein (2009, 2010) & Watson (2003)
    # Treated in
    Emergency Room
    Medical Outcome*
    Year Product # Reports None Minor Moderate Major Death
    2009 F Toothpaste 24,547 378 4,781 1,146 42 2 0
    2008 F Toothpaste 23,468 383 4,395 1,119 43 1 0
    2002 F Toothpaste 24,087 411 4,852 1,218 40 1 1
    Minor effect: Minimally bothersome signs or symptoms that generally resolved without residual disability or disfigurement (e.g. self-limiting gastrointestinal symptoms). Moderate effect: More pronounced or prolonged signs or symptoms, or more of a systemic nature than minor systems. While the symptoms are not life-threatening (e.g., disorientation or high fever that responds readily to treatment), some form of treatment is indicated. Major effect: Signs and symptoms that are life-threatening or result in significant residual disability or disfigurement. (Shulman and Wells 1997)

    SOURCES:

    Bronstein AC, et al. (2010). 2009 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS): 27th Annual Report. Clinical Toxicology 48:979-1178.

    Bronstein AC, et al. (2009). 2008 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS): 26th Annual Report. Clinical Toxicology 47:911-1084.

    Watson WA, et al. (2003). 2002 Annual Report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. American Journal of Emergency Medicine 21:353-421.

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    Reports to Poison Control Centers in U.S.
    Due to Excessive Ingestion of Fluoride Toothpaste (Pre-FDA Warning)

    Data from: Shulman and Wells (1997)
    # Treated in
    Emergency Room
    Medical Outcome*
    Year Product # Reports None Minor Moderate Major Death
    1989 Toothpaste 1,392 101 464 371 15 0 0
    1990 Toothpaste 1,379 107 468 329 7 0 0
    1991 Toothpaste 1,623 120 497 403 15 0 0
    1992 Toothpaste 2,331 141 700 497 17 1 0
    1993 Toothpaste 2,507 143 725 571 21 0 0
    1994 Toothpaste 3,369 166 852 800 19 1 0
    Minor effect: Minimally bothersome signs or symptoms that generally resolved without residual disability or disfigurement (e.g. self-limiting gastrointestinal symptoms). Moderate effect: More pronounced or prolonged signs or symptoms, or more of a systemic nature than minor systems. While the symptoms are not life-threatening (e.g., disorientation or high fever that responds readily to treatment), some form of treatment is indicated. Major effect: Signs and symptoms that are life-threatening or result in significant residual disability or disfigurement.
    ** With fluoride but without iron.
    SOURCE: Shulman JD, Wells LM. (1997). Acute fluoride toxicity from ingesting home-use dental products in children, birth to 6 years of age. Journal of Public Health Dentistry 57: 150-8.

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