Letter to Senatators Kennedy and Dingell re: FDA Revitalization Act

7/30/07

The Honorable Edward M. Kennedy
Committee on Health, Education, Labor and Pensions
428 Dirksen Senate Office Building
Washington, DC 20510

The Honorable John D. Dingell
Committee on Energy and Commerce
2125 Rayburn House Office Building
Washington, DC 20515

Dear Messrs. Chairman,

The purpose of this letter is to alert Congress to the opportunity it has to protect the health of the American people by protecting a certain section in the "Food and Drug Administration (FDA) Revitalization Act" (S. 1082 and HR 2900), and overriding recent FDA Guidance threatening consumer access to natural therapies.

While the sponsors of the FDA Revitalization Act spoke on the Senate floor that the bill holds harmless natural supplements, Senator Durbin’s Food Title (VI) does include an explicit Section (608), “Rules of Construction,” authored by Senators Hatch and Harkin, protecting nutrients and natural supplements already regulated by the 1994 Dietary Supplement Health and Education Act (DSHEA). If Title VI is retained in the Conference Report for the underlying FDA bill, we respectfully request that Section 608 remain in the final bill. This is necessary as the FDA consistently interprets enactments contrary to clear Congressional intent that supplements are to be regulated like foods, not drugs.

This, however, is not the only problem facing consumers of Dietary Supplements. Recently FDA issued two draft Guidance’s: the so-called “CAM Products” (Docket No. 2006D-0480) and “Health Claims” (Docket No. 2007D-0125) that also impact DSHEA products. The first tries to create a new regulatory category – without Congressional approval while the second places a heavy burden on proof of health claims. The FDA Guidance’s could have dire and deadly health and freedom consequences since high potency nutrients are a well-demonstrated health protection strategy, which lowers morbidity, mortality and health costs. The undersigned organizations, representing in the aggregate millions of voters, are deeply concerned about the important health freedom assaults facing the people. We urge Congress to take immediate action to reverse these dangerous and potentially lethal regulations. One immediate step would be to adopt the Health Freedom Protection Act, HR 2117, mandating FDA approval of Health Claims that have scientific substantiation.

Signed,

Natural Solutions Foundation
Association of American Physicians and Surgeons
American Policy Center
Multiracial Activist
Republican Liberty Caucus
DownsizeDC.org, Inc.
U.S. Bill of Rights Foundation
Body Mind College, Inc.
Wahzee.com, Inc.
Body Mind Massage Clinic, Inc.
Medi-Key Transcription Service, Inc
The Prostate90 Foundation
Tanager Foundation,
Chemical Sensitivity Disorders Assocation
Asheville Homeless Network
Lotus Health & Wellness
Fellowship of Christian Love, Inc.
Pacific Green Party (Oregon)
Riverside Wellness Center
Gunderson Food Co-op
Global Consciousness Press, Inc.
The Schumacher Group
Blackstone Massage Therapy Center
Healing Traditions Inc.
Prosper Natural Sales
Allied Wellness Events
Michael Eidson Acupuncture and Wellness Center
Florida Breast Cancer Resource Network
AllSeasons Wellness
The Inner Center
NOW IF
Tree Sound Studios/TreeV Productions
Eyes Wide Open International
Kery Colvin Cleaning Services
Next Step Life coaching
Austin Kinesiology and Chriopractic Center
Bross, Inc.
Washington Rotary Club
Orange County Wellness Center
New England Holistic Chamber of Commerce
East Hawaii Island Volunteers Active in Disaster
Beyond Wheat Artisan Bakery
Good Energy Nautral Foods,llc
Center For Integrative Medicine
Natural Food Associates, Connecticut Chapter
Marian Center
Compromise Committee to SAVE our access to natural supplements
Natural Health Concepts
Foundation for the Advancement of Cancer Research
The Good Medicine Society
Celebrate Life
Healthy Heart Nutrition Store
Living Naturally
Unity of Louisville Church
Radiant Heart Healing Ministry
C & C HEATING & COOLING
Akasha Organics
Incredible New Technologies
Home Oriented Un-Schooling Experience in Montana
Helena Area Learning co-Opportunities
Unschooling-Spirituality
Spirituality, Unschooling & Beyond
Montanaunschoolers ·
Alternative Montana Unschoolers
Guaranteed Outcome Marketing, firm
Heart of Nature Apothecary
Yoga Source
Healing Leaves Ministry
Environmentally Friendly Options
New Beginnings ReeSearch
KE and Associates
Golden Flocks, INC
Aspen Chapter of the Weston A. Price Foundation
Informed Consent Town of Esopus
Creative Word Communications
A1 Health Depot LLC
Center for Homeopathy of Southern Vermont
American Standard Company
Riverhouse Holdings LLC
Candida Support Group
GRH, Inc
EARTHSONG
New Awakenings Community
Hermitage of St John the Baptiser
Motivational-Ink!
Pranic Healers of Portland, Oregon
Healing Touch Holistic Health
Cynthea's yoga mom's
The Learning Clinic
Health Marvels
Havetotalhealth
Blissentials
The Institute for Applied Sciences
Pathway to Wellness
Natural Food Associates (NFA)
Madhu Health Services, Inc
The Living Way
WOW Speaks Out
The Guerra Family
Esparza Enterprises
New Life Treatment Center
Heavenly Comforts
Communitas: A Center for Health and Transformation, LLC
Point of View Productions
Heritage Family Chiropractic
UNC Charlotte Small Business and Technology Development Center (SBTDC)
Bright Beginnings Family Services, Inc.
Maranatha Human Services, Inc.
PMG LLC
Arimathea Foundation
Alternative Medical Arts/docevaonline.com
Shepherd Valley Waldorf School
Occupational Therapy Associates
Walt's Photocopy Company
Mastery Consulting, LLC
The School of Complete Yoga
Trinity Wellness Institute
Marketing Visions Inc.
Senior Tax Advisors
Sacred Moments Ministry
Divine Feminine Institute
Talking Hearts
Grand Medicine
Hypnotherapy and Naturopathy Associates Inc.
Trinity Wellness Institute
Komyozan Dojo
Life in Balance
St. Louis Mannaplanners
Nutritional Pathways
OpenHouse Direct Inc
BellWether Group of 4Life Research
Aham Prema
The Whole Life Network, Inc
Healthy Solutions LLC
TLC Holistic Wellness PC
Nevada Holistic Chamber of Commerce
Program in Psychiatry and the Law, Department of Psychiatry, Beth Israel-Deaconess Medical Center, Harvard Medical School

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