Freedom of Health Information Act

Finally - here is a piece of proposed legislation with real teeth in it that won't produce wimpy or confusing results. We need your help to mail a copy of this proposal to your Congressman and Senator and ask them to sponsor this legislation - to end once and for all the Food and Drug Administration's censorship of information from the National Library of Medicine (NLM) and allow manufacturers of foods and dietary supplements to share with consumers expert opinion from the NLM on how food and dietary supplement may help prevent and mitigate disease. You can help by mailing a copy of this document to your elected leaders, health magazines and health freedom organizations today. Thank You - Conrad LeBeau

Congress having found that making scientific research available through the National Library of Medicine on how foods and dietary supplements derived from natural sources is beneficial in promoting health and well being, as well as in preventing and mitigating illness, amend the Food, Drug and Cosmetic Act (FDC ACT) and the Dietary Supplement Health and Education Act (DSHEA) to remove restrictions on commercial speech within the existing laws to facilitate the flow of health-related information to consumers and health care professionals:

To amend the FDC Act to redefine the definition of the word "drug" to exclude foods, herbs and dietary supplements

1. Under 21 USC Sec 321 Definitions; generally that define the term "drug" under 21 USC Sec 321(g)(1)(B) to insert the following words "(other than foods and dietary supplements derived from natural sources)" after the word "articles" and before the next word "intended."

2. Under 21 USC Sec 321 Definitions; generally that define the term "drug" under 21 USC Sec 321(g)(1)(C) to replace the words "other than foods" with the following words "(other than foods and dietary supplements derived from natural sources)" after the word "articles" and before the next word "intended."

3. USC Sec 321(g)(1)(D) To void and remove the subsection after (D) and before the next paragraph (2) in its entirety and replace it with the following: "articles that are patented or patentable or a component of any article specified in clause (A), (B) or (C).

Note: The intent here is to remove foods and natural dietary supplements from the category of "drugs" by definition and allow truthful and balanced scientific research to be used in the labeling and advertising of said products when such information informs consumers on how foods and nature-derived supplements can help promote general health and well being as well as prevent and mitigate illness.

To amend the FDC Act to redefine the meaning of the term "new drug" to exclude foods, herbs and dietary supplements

1. To amend 21 USCS Sec 321 (p)(1) of the Food and Drug Act and restrict the definition of "new drug" to "the invention of a person that is patented or patentable" which will then exclude foods and herbs from the definition as these are not patentable. After 21 USCS Sec 321 (p) The term "new drug" means - (1) is added after the words "Any drug" the following words "that has a new material composition or is an invention that is patented or patentable" and before (except a new animal drug or.........

To amend the Dietary Supplement Health and Education Act (DSHEA) and remove restrictions on commercial speech on the intended uses of foods and dietary supplements for preventing disease and for other purposes

1. To repeal the following sections of Public Law 103-417 of DSHEA: Sections 5 on Dietary Supplement Claims; Section 6. Statements of Nutritional Support; Section 7. Dietary Supplement Labeling and Nutrition Information Labeling; Sec. 9. Good Manufacturing Practices; Section 10 including the current GMP regulations now in effect made by the Secretary pursuant to these regulations; Conforming Amendments and Section 12. Commission on Dietary Supplements Labels.

2. To replace Section 5 of DSHEA with the following section: "Citations from scientific articles and expert opinion derived from the U.S. National Library of Medicine or directly from any peer reviewed medical journal may be used in the labeling of any food or dietary supplement providing that it is truthful, balanced and not misleading."

3. To replace Section 6 of DSHEA with the following: "The manufacturer of the dietary supplement has substantiation that such statement or statements is truthful and not misleading."

4. To replace Section 7 of DSHEA with the following; The following statement is required on the labeling of all foods and dietary supplements that are labeled with information that suggests an intended use for the prevention or treatment of disease: "The U.S. Government advises consumers to consult with a physician or health care professional before using foods or dietary supplements for the prevention, treatment or mitigation of disease."

Note: The current mandated disclaimer on dietary supplements is dishonest as it states that "This product is not intended to ....prevent or mitigate disease." Of course that is a lie. No one buys dietary supplements because the bottle is pretty and they don't know what else to do with their money. They buy supplements, at the minimum, to improve health and well being, feel better and to prevent disease. The disclaimer we propose here is honest and directs consumers to consult with their doctor. This disclaimer will also transfer the responsibility of how foods and dietary supplements are used to prevent or treat disease from the U.S. Food and Drug Administration to doctors and their patients where it rightfully belongs and to end the paternalistic role of the U.S. Government.

8. To replace Section 9 on Good Manufacturing Practices (GMP) with the following: 1. " "(A) The Good Manufacturing Practices for dietary supplements shall be same standards used for foods manufactured and shipped in interstate commerce. "

(B) "All supplements shall be labeled with a lot number or control number and a suggested expiration date. A sample of each batch produced with a label to properly identify the sample product shall be retained for one year past the expiration date or (best use by) date. A sample shall be available to the FDA for testing at any time upon the agency's written request."

(C) "Manufacturers shall keep a record of the sources of all ingredients used to make each product and of any changes in the manufacturing process or changes in the sources of ingredients used and the dates and lot number affected by these changes."

Note: The intent on Good Manufacturing Practices is to eliminate the excessive and burdensome regulatory red tape with repetitive testing and repetitive record keeping of the current FDA GMP regulations that violate the "Regulatory Procedures Act" and are causing severe economic hardship on small dietary supplement companies causing many to go out of business. Eliminating the cGMPs will allow the safety standards used for food that is already in effect to resume and requires no additonal legislation or rule makieng.

That's all folks!

This document was drafted by Conrad LeBeau on 4/20/11, was updated on Jan 20th 2012 and may be reprinted. 414-231-9817 This is also posted at lebeau books