Freedom of Choice in Medicine - The FDA versus First Amendment rights

One of the best overviews of what the FDA is up to, and what we must do to preserve our access to supplements and other health freedoms, is an article on the Life Extension site by William Falloon: http://www.lef.org/magazine/mag98/aug98_cover.html

For those interested in lobbying against further encroachments on our rapidly diminishing freedoms, the FDA will take e-mailed comments at FDADockets@bangate.fda.gov

Mail To:
Dockets Management Branch (HFA-305) Food and Drug Administration, Attn: Michael Friedman, MD Lead Deputy Commissioner 5630 Fishers Lane, Rm. 1061 Rockville, MD 20857 Fax: 301-827-6870

Dear Dr. Friedman:

I am writing to notify you that FDAÆs proposed rulemaking on structure function claims, 21 CFR part 101/Docket #98N-0044, is totally unacceptable to me as an American consumer of dietary supplements. Any final rule must reflect the true meaning and intent, mandated by Congress, of the Dietary Supplement Health and Education Act (DSHEA).

I support the FDA's effort to fully implement DSHEA as intended by Congress; however, I strongly object to the proposed regulations which:

1. Limit my access to (scientific) information about dietary supplements and health

2. Redefine disease restricting my ability to focus on preventive care and wellness.

It is extremely important to preserve Section 6 of DSHEA to allow for a robust flow of valuable health information in the marketplace. I want free access to available information about dietary supplements and health, and I want FDA to withdraw its proposal to redefine disease in a way that limits such health information. DSHEA allows products to make structure/function claims on the product labels. Redefining disease to nullify that part of DSHEA must be withdrawn.

Sincerely,

__________________________ (Sign here)

__________________________ (City and State)

FDA versus First Amendment Rights

"Freedom of the Press embraces the circulation of books as well as their publication." -- from Judge's ruling in Bantam Books v Sullivan [1963] FDA ATTEMPTS TO COMPEL DESTRUCTION OF BOOKS [On Natural Herbal Supplement Stevia]

DALLAS - May 26, 1998 -- In an unprecedented move, US Food and Drug Administration officials threatened legal action against Texas-based Stevita Co., Importers of the sweet-tasting herbal dietary supplement, stevia - for distributing books and literature about their product. The latest volley in a bitter battle has been fired at Texas-based Stevita Co. by federal Food and Drug Administration officials.

The FDA, an agency of the federal government, is responsible for upholding the US Constitution which guarantees freedom of speech and expression. This responsibility was drawn into question on May 19th when FDA Compliance Officer, James R. Lahar faxed a letter to Stevita Co. addressing the destruction of 2,500 books he deemed "offending," at a cost to the company well in excess of $10,000.

The letter further threatens that investigators will conduct a current inventory and "witness the destruction of the cookbooks, literature, and other publications for the purpose of verifying compliance" upon visiting Stevita Co. for a fourth time this year. One of three books in question is The Stevia Story - A tale of incredible sweetness & intrigue, by Linda Bonvie, Bill Bonvie and Donna Gates with Foreword by James S. Turner, Esq..

Ironically, Chapter Four of the book the FDA wants to destroy is titled: "What's wrong with the FDA?" An attempt to strong-arm critics into silence - similar to book burnings in Nazi Germany? Oscar Rodes, President of the Stevita Company said the FDA ordered the action because the books contain general information that include: history, usage's and scientific studies regarding stevia. Currently, Federal law requires stevia herbal products can only be marketed as dietary supplements without any mention of having sweetening power.
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The Stevia Story-A tale of incredible sweetness & intrigue by Linda Bonvie, Bill Bonvie and Donna Gates