MessageFrom: Weinstein, Les S Sent: Wednesday, August 07, 2002 11:44 AM To: Butler, Jennie C Subject: FW: Docket #01N0067- AGAINST FDA Proposal re Mercury Dental Fillings -----Original Message----- From: Johnson Drugs [mailto:johnsondru@broadviewnet.net] Sent: Wednesday, August 07, 2002 9:31 AM To: OMBUDSMAN@CDRH.FDA.GOV; DWF@CDRH.FDA.GOV; BES@CDRH.FDA.GOV; JMS@CDRH.FDA.GOV Cc: senator@kennedy.senate.gov; senator@john_kerry.senate.gov; info@healthytomorrow.org; public-access@epa.gov Subject: Docket #01N0067- AGAINST FDA Proposal re Mercury Dental Fillings RE: Docket #01N-0067 FDA Proposal FOR mercury dental fillings TO WHOM IT MAY CONCERN: Regarding the recent developments in the debate over mercury containing fillings, it is the position of the professional pharmacists and staff at Johnson Drugs, that the FDA’s position is CONTRARY to the good and safe practices of medicine as set by the FDA and is further CONTRARY to recent legislation/policies regarding mercury in the environment and in food. In the past year, the FDA has made bold statements about ending the use of mercury in childhood vaccinations (contact lenses and thermometers), and warnings to pregnant women about mercury in fish. The EPA also has policies that reduce mercury at its sources… treating dental fillings as HAZARDOUS WASTE. We have participated in the Massachusetts Mercury Thermometer Exchange. The most obvious flaw in the FDA’s position is the decision to use an advisory committee that met 7 years ago; long before recent FDA and other governmental regulations and policies were made. This has allowed the FDA to IGNORE these recent recommendations, policies and regulations and go forth in recommending the continued use of mercury amalgam dental filings. Peer reviewed studies (see Haley, Lorscheider, Vimy, Summers, Aposhian, Chang etc.), the Health Canada report (1996), as well as the manufacturer Dentsply (1997) recommend no mercury fillings in children, and go as far as CONDEMN their use. The American Pediatric Medical Assoc. position statement asks for its physicians to recommend mercury-free dentists to their patients. Announced in November of last year and widely publicized in dental journals, the Watson-Burton Bill (H.R. 4163) with its 6 co-sponsors would abolish mercury dental fillings altogether by 2007. This bill would give health warnings to all those considering mercury amalgam fillings and would immediately stop the use in children, pregnant women, and nursing mothers. The FDA, who is currently without a commissioner, has stated that during this transition period only those regulations requiring "urgency" should be acted upon. The only parties seeking urgency in this case are the ADA and the mercury manufacturers. This issue should wait for the appointment of a new commissioner and be re-reviewed by an advisory panel as soon as possible. Too much time has passed: new policies, discoveries, and regulations have been applied, and to say that mercury is safe as an amalgam filling would be MALPRACTICE. Mercury is UNSAFE, it is considered a hazardous waste and has been removed from products we use every day, as well as the environment we live in. It is treated as hazardous waste before and after it is used in your mouth. How can we be expected to believe that a hazardous waste is considered safe nowhere but in our mouths? We urge you, professionals and consumers alike, to make your opposition heard. Johnson Drugs 577 Main Street Waltham, MA 02452 Phone (781)893-3870 Fax (781)899-1172 info@johnsondrugs.com