Safety l Fluoridation Facts 55 A specific FDA regulation96 applies to “Anticaries Drug Products for Over-The-Counter Human Use” which provides the exact language for the warning label to be used on “fluoride dentifrice (gel, paste, and powder) products.” The regulation requires the following language appear on these products under the heading “Warning”: “Keep out of reach of children under 6 years of age. [highlighted in bold type] If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.”96 The over-the-counter (OTC) drugs listed in these regulations are generally recognized as safe and effective by the FDA.94 Fluoride toothpaste is just one of a long list of OTC products that carries a warning label. The over-the-counter (OTC) drugs listed in these regulations are generally recognized as safe and effective by the FDA. Fluoride toothpaste is just one of a long list of OTC products that carries a warning label. While the FDA has required such label language since 1997, the ADA has required manufacturers seeking the ADA Seal of Acceptance to place a label on fluoride toothpaste since 1991 to help ensure proper use and thereby reduce the risk of dental fluorosis. At that time, the ADA required the label to include: “Do not swallow. Use only a pea-sized amount for children under six. To prevent swallowing, children under six years of age should be supervised in the use of toothpaste.” Additionally, to ensure children’s safety, the ADA limits the total amount of fluoride allowed in any one tube of ADA-Accepted toothpaste. If a child were to ingest an entire tube of fluoride toothpaste at one time, the total fluoride content of a single tube is not enough to cause a fatal event. In fact, because of some of the (non-fluoride) additives in toothpaste, a child attempting to ingest a tube of toothpaste would most likely vomit before they could eat enough to become seriously ill. 31. Is fluoride, as provided by community water fluoridation, a toxic substance? Answer. No. Fluoride in water at the recommended level is not toxic according to the best available scientific evidence. Fact. Toxicity is related to dose. While large doses of fluoride could be toxic, it is important to recognize the difference between the effect of a massive dose of an extremely high level of fluoride versus the fluoride level currently recommended for public water systems. Like many common substances essential to life and good health — salt, iron, vitamins A and D, chlorine, oxygen and even water itself — fluoride can be toxic in massive quantities. Fluoride at the much lower recommended concentrations (0.7 mg/L) used in community water fluoridation is not harmful or toxic.16 Fluoride at the much lower recommended concentrations (0.7 mg/L) used in community water fluoridation is not harmful or toxic. The single dose (consumed all at one time) of fluoride that could cause acute fluoride toxicity is 5 mg/kg of body weight (11mg/kg of body weight of sodium fluoride).97 This dose is considered the probably toxic dose (PTD) which “is defined as the minimum dose that could cause serious or life- threatening systemic signs and symptoms and that should trigger immediate therapeutic intervention and hospitalization.”97 Acute fluoride toxicity occurring from the ingestion of optimally fluoridated water is impossible.97 With water fluoridated at 1 mg/L, an individual would need to drink five (5) liters of water for every kilogram of body weight. For example, for an adult male (155 pound/70.3 kilogram man), it would require that he consume more than 350 liters (nearly 93 gallons) of water at one time to reach an acute fluoride dose. With optimally fluoridated water now set at 0.7 mg/L, it would take almost 30% more, or nearly 120 gallons (more than 1,900 eight ounce glasses) of water at one time to reach the acute dose.