We are writing to request a clarification regarding two points of potentially misleading information which appeared in the article, "Are Our Patients Guzzling Too Much Fluoride?" (February 1997).
Specifically, we are referring to a statement which appeared in the article that "... even Procter & Gamble`s Crest `Sparkle` toothpaste for kids contains 1 gram of fluoride per ribbon of toothpaste." This isn`t correct. The amount of toothpaste commonly used by adults is a ribbon which weighs about one gram. A one-gram ribbon of Crest "Sparkle Fun" dentifrice contains approximately 0.0011 grams or 1.1 mg. of fluoride.
It is also important to note Crest`s recommended amount of dentifrice for use by children under six years of age is a pea-sized amount which corresponds to a ribbon weighing approximately 0.25 to 0.33 grams that would contain approximately 0.275 mg to 0.363 mg of fluoride.
Toothpastes intended for the prevention of dental caries are over-the-counter drugs that are regulated by the Food and Drug Administration (FDA). The specific regulations are described in the Final Monograph for Anticaries Drug Products for Over-the-Counter Human Use (21 CFR Parts 310, 355, and 369). These specify that all fluoride dentifrices must contain 850 to 1,150 parts per million (ppm) theoretical total fluorine. This requirement for dentifrices is 0.188 to 0.254 percent on a weight/weight basis. Crest toothpastes are formulated to contain 0.253 percent sodium fluoride and meets all other requiremens specificed in these regulations.
In addition to the error noted above, there is another statement on page 28 of the article which is misleading. The article states, "...it would be beneficial for manufacturers of dentifrices to add a warning on the label, stating the appropriate amount (of toothpaste) to use for children under six years of age."
In fact, toothpastes accepted by the American Dental Association, such as Kid`s Sparkle Fun Crest, have for several years included the following directions: "Use only a pea-sized amount for children under six."
In accordance with the Anticaries Monograph, the directions for regular Crest Cavity Protection and Tartar protection products now read as follows: "Children under six years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established." In addition, the statement, "do not swallow," is included on the directions of all versions of Crest sold in North America.
Thank you for the opportunity to clarify these facts for your readers.
Jerome A. Merski, PhD
Catherine Davis, PhD, RDH
Procter & Gamble
Editor`s Note: The article referred to above did not imply any product or manufacturer was providing unsafe levels of fluoride to our younger consumers. Instead, the authors advocated that dental hygienists need to actively monitor and prevent ingestion of excessive amounts of fluoride, particularly among younger patients. We contacted the authors and they acknowledged the error concerning 1.1 mg of fluoride in a ribbon. However, while they commended Procter & Gamble for advising consumers of a "pea-size" dosage, several packaging labels in the market do not advise patients in such a manner.