|March 1998 |
Please Co-Sponsor The Consumer Health Free Speech Act (HR1077)
The Honorable ________________________
The Health Free Speech Act, recently introduced into the House by Rep. Ron Paul (R-Texas), is needed to preserve freedom of choice in health care in the United States. This will help Americans to learn about the scientific advances in nutrition occurring today by allowing truthful health claims for dietary supplements. The bill proposes the following changes:
FIRST: The present definition of the term "drug" in the Food, Drug & Cosmetic Act (FDCA) 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 would add the three words "other than food" immediately following the word "articles" so that 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 and other dietary supplements) from being regulated as drugs by the FDA. It also would prevent the FDA from banning truthful health claims based upon scientific evidence for these foods simply because they haven't been approved as "drugs" by the FDA.
Scientific research in nutrition has been exploding in recent years, showing that herbs and other dietary supplements are safe and effective in preventing many diseases. However, the flawed definition of the term "drug" makes it a federal crime for the dietary supplement industry to give this truthful information to consumers in labeling herbs or other dietary supplements.
SECOND: The Paul amendment (HR1077) will require the FDA, through a small word change, to prove that any risk is significant.
Section 403 of FDCA says: "A food shall be deemed to be misbranded if its labeling is false or misleading in any particular . . ."
Rep. Paul's amendment would change the "or" to an "and" ("is false and misleading"), setting a higher and fairer standard that the FDA must meet before limiting or banning the sale of herbs or other dietary supplements by claiming they present an unreasonable "risk."
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