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August 1998

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To The Honorable: ______________________________
United States House of Representatives
Washington, DC 20515

Dear Representative:

Simply changing "or" to "and" two times in the Federal Food, Drug, and Cosmetic Act (FD&C Act), and adding three words "other than food" in the appropriate places will greatly increase health freedom in the United States.

FIRST: The present definition of the term "drug" in the FD&C Act is so overly broad that it includes foods, herbs, and dietary supplements. The present flawed definition reads, "The term 'drug' means articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man...."

Congressman Ron Paul's simple 5-word bill would add three words-"other than food"-immediately following the word "articles," so it would read, "The term 'drug' means articles, other than food, intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man...."

Adding these three words would exempt all foods (which include herbs, vitamins and other dietary supplements) from being regulated as drugs by FDA. It would also prevent the FDA from banning true health claims for these food products simply because they have not been cleared as "drug" claims by FDA.

Scientific research in nutrition has been exploding in recent years, which shows that herbs and other dietary supplements are safe and effective in preventing and mitigating many diseases. However, the flawed definition of the term "drug" makes it a federal crime for the dietary supplement industry to give this true information to consumers as part of the label or labeling of herbs or dietary supplements.

Section 403 of FD&C Act protects consumers against false or misleading health claims for foods. It says: "Sec.403. A food shall be deemed to be misbranded if its labeling is false or misleading in any particular...." This gives the FDA tremendous authority in judging what is false or misleading labeling.

SECOND: Changing the "or" to an "and" will set a much higher and more fair standard that the FDA will have to meet before it can limit or ban the sale of herbs or dietary supplements by claiming they present an unreasonable "risk." The Paul amendment will require the FDA to prove the risk is both significant and unreasonable.

It is well known that the FDA has a long history of hostility against true health claims by the herbal and dietary supplement industry. Under present law, the FDA can easily charge that a targeted food, herb, or dietary supplement has health "risks" because there may indeed be risk to some sensitive or allergic persons from virtually every food, herb, or dietary supplement.

Signed: _____________________________________ Date:_____________
Address: ______________________________________________________
City/State/Zip: __________________________________________________

Provided by International Advocates for Health Freedom, 800-333-2553