In the Federal Registry, Volume 52 (155):30089, August 12, 1987, the FDA changed the classification of dental mercury, a component part of mercury fillings, from the proposed Class II to Class I, stating, “…warnings under the misbranding provisions (21 U.S.C. 352) of the general controls of the act would warn dentists about the rare risk of allergic reactions among patients and the risk of toxicity to dental health professionals.” Arriving at its conclusion that the risk of allergic reaction was “rare,” the FDA relied on three (3) case reports, ignoring several other scientific studies clearly within the criteria set out in 21 C.F.R. 860.3, 860.7 for valid scientific evidence. These studies demonstrate that the risk of hypersensitivity (allergic) reaction to mercury effects at least five (5%) to eleven (11%) percent, and perhaps more, of those individuals receiving mercury fillings.
These studies present formidable scientific documentation that a very significant percentage of our population is at risk for hypersensitive reactions to mercury derived from dental amalgam.
Since August 12, 1987 most manufacturers have failed to warn of the risk of allergic reaction as required by 21 U.S.C. § 352 and the FDA has failed to force them to do so under 21 U.S.C. 334 and 21 C.F.R. § 800.55.
REFERENCE’S
[78] See, Djerassi, E., et al., (1969) The possibilities of allergic reactions from silver amalgam restorations. Int Dent J 19:481-488, attached hereto as Exhibit 117. (None of controls had allergy to dental amalgam. Of 180 subjects, 16.1 % exhibited an allergic response to amalgam and 11 % were allergic to mercury. Of the subjects who had amalgam fillings for up to five years, 5.8 percent showed positive reactions. For subjects who had amalgam fillings for more than five years, 22.52 % had positive reactions.)
[79] North American Contact Dermatitis Group, Epidemiology of Contact Dermatitis in North America, Arch Dermatol, vol. 108, (Oct.1973), attached hereto as Exhibit 118. (5.0% reacted to ammoniated Hg; 8.0% reacted to thimerosal a mercury containing preservative.)
[80] White, R.R., et al., (1976) Development of mercury hypersensitivity among dental students, J. Am Dent. Assoc. 92:1204-1207, attached hereto as Exhibit 119. (Authors patch-tested 396 dental students. Of those subjects having amalgam fillings for two years or less, 3.8 % had positive mercury patch tests, while 6.0% of those with amalgam fillings for more than five years were positive.)
[81] Miller, E.G., et al., (1987) Prevalence of mercury hypersensitivity in dental students. J. Prosthet. Dent. 58:235-237 (Exhibit 120) (Authors tested 171 dental students and found a greater correlation to the number of amalgam fillings subjects had than to the length of time the fillings were in place. The percentage of the subjects testing positive to mercury ranged from 26.9% to 38.7% by class.)
