Fluoride Action Network

Text of Email to Secretary Burwell & Administrator McCarthy

December 30th, 2014

Dear Secretary Burwell and Administrator McCarthy:

As we move into a new year, we believe the time has come for you to work together to establish a process to reach a joint position of HHS and EPA on federal fluoridation jurisdiction. In the email below, Steven Neugeboren, has indicated EPA willingness to participate in this process. I attach the 2-14-13 letter from Steven Neugeboren to Gerald Steel which provides the relevant EPA interpretations of the Safe Drinking Water Act (SDWA). Mr. Neugeboren is Associate General Counsel of the Water Law Office of EPA with responsibility to advise Administrator McCarthy regarding EPA’s interpretation of the SDWA. I also attach the 11-21-14 letter from Dr. Wanda Jones to Jill McElheney which quotes the relevant FDA interpretation on federal fluoridation jurisdiction. Dr. Jones is the Principal Deputy Assistant Secretary for Health in the Office of the Assistant Secretary for Health in the Office of the Secretary, HHS.

The said HHS 11-21-14 letter states, “FDA has determined that Congress did not intend for the FDA to regulate the addition of fluoride to public drinking water for dental caries prevention as a drug under the FD&C Act.” The FDA goes on to explain that it made this determination by interpreting the SDWA. The said EPA 2-14-13 letter states, “Under the Safe Drinking Water Act (SDWA), EPA is the lead federal agency with responsibility to regulate the safety of public water supplies. EPA does not have responsibility for substances added to water solely for preventative health care purposes, such as fluoride [except to establish and enforce MCLs].” The said EPA 2-14-13 letter continues, “The Department of Health and Human Services (HHS), acting through the FDA, remains responsible for regulating the addition of drugs to water supplies for health care purposes.”

On December 1, 2014, Gerald Steel emailed Appendices A, B, and C to FDA CDER Director Janet Woodcock, NIEHS Director Linda Birnbaum, Mr. Neugeboren, Administrator McCarthy and others. These three Appendices (with Appendix B updated) were originally attached to an 11-25-11 letter to former HHS Secretary Sebelius requesting classification of fluoridation products as drugs. Appendix B provides Gerald Steel’s legal analysis detailing why fluoridation products are drugs. Appendix C lists names and addresses of fluoridation product manufactures. Appendix A is from the NSF Fact Sheet on Fluoridation Chemicals. Please email geraldsteel@yahoo.com if you want a copy of these Appendices.

The FDA determination that it does not regulate fluoridation products is based on its interpretation of the SDWA. Its interpretation is inconsistent with the EPA interpretation of the SDWA. Under the law, the EPA interpretation of the SDWA must be accepted by HHS and FDA unless either can show it is inconsistent with statute. EPA’s position is that the SDWA does not affect HHS and FDA authority under the FD&C Act to regulate any substance (including fluoride) added to drinking water for preventative health care purposes.

Thank you for considering our requests and please keep us in the loop on actions taken. Have a happy and productive new year.

Gerald Steel, Attorney
7303 Young Rd. NW
Olympia WA 98502
Tel/Fax (360) 867-1166

Other Professional Signers

Paul Connett, PhD, Chemistry
Binghamton, NY

Bill Osmunson DDS, MPH
Neah Bay, WA

Jerry Hodges, Managing Agent
Mindbodyhealth LLC
Boulder, CO

Dr. Eloise Kailin M.D.
Sequim, WA

David Kennedy DDS
Past President
Fluoride Information Officer
International Academy of Oral Medicine and Toxicology
San Diego, CA

Hardy Limeback, PhD, Biochemistry, DDS
Toronto, Canada

Paul McKinney, PMP, CSM
Cedar Hill, TX

Lisa McLaurin, RN, CCRN
Certified Health Coach
Las Angeles, CA

Christopher Nidel, Attorney
Nidel Law, PLLC
Washington, DC

Richard Sauerheber, PhD, Chemistry
San Marcos, CA

Tom Theimer
Environmental Scientist
Dallas, TX

Concerned Citizen Signers

Jack Cook
Nashville, TN

Eve Elsbury

Regina Imburgia
Dallas, TX

Kimberly Kazaka
Dallas TX

Tony Shepherd

Organization Signers

King County Citizens Against Fluoridation
Washington non-profit public benefit corporation

Washington Action for Safe Water
Washington non-profit public benefit corporation

Clean Water California
nonprofit 501(c)(3) organization

Concerned Community Groups Across Canada to End Fluoridation

Fluoride Action North Texas
Community Organization

Hard Wired for Safety
Washington non-profit public benefit corporation

Protect the Peninsula’s Future
Washington non-profit public benefit corporation
Eloise Kailin, Corresponding Secretary