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Life Extension Magazine

LE Magazine September 1995

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New Health Freedom Bill Introduced In Congress

On June 29, 1995, representatives Frank Pallone (D-NJ) and Dennis Hastert (R-IL) jointly introduced the Food and Dietary Supplement Consumer Information Act of 1995 (H.R.1951) in the US House of Representatives.

The purpose of this bill is:
"To amend the Federal Food, Drug, and Cosmetic Act to allow food and dietary supplement manufacturers to communicate truthful, nonmisleading information to consumers concerning the nutritional content and disease prevention benefits of their products, (and) to repeal or clarify rules enacted by the Dietary Supplement Health and Education Act of 1994."

Rep. Pallone was an original cosponsor of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Rep. Hastert was a cosponsor of DSHEA in the last Congress and serves as Chief Deputy Majority Whip and Vice Chairman of the Health Sub committee of the House Commerce Committee, both of which have primary jurisdiction over the U.S. Food And Drug Administration (FDA).

Both House members want to include the issue of the FDA's regulation of foods and supplements in the FDA reform debate and it is likely we will see Congressional hearings on the subject before the end of the year.

The new bill is cosponsored by Rep. Bill Richardson (D-NM), the House author of DSHEA; Rep. Peter DeFazio (D-OR), an early supporter of DSHEA and House author of The Access To Medical Treatments Act; and Rep. Dan Frisa (R-NY), who defeated Phil Schiliro, Administrative Assistant to Rep. Henry Waxman in last November's election for a Long Island, New York seat. Rep. Waxman is a longtime supporter of the FDA, whose power was reduced sharply when the Republicans gained control of the House.

Repairing Last Year's Bill

One of the purposes of H.R.1951 is to repair the flaws in the DSHEA, which, in its original version, would have allowed companies to make all truthful health claims about their products. This basic principle was watered down significantly in the legislative process that led to passage of the DSHLEA.

In addition to its clear-cut position on the right to make truthful health claims, the new bill prevents the FDA from classifying foods and dietary supplements as "drugs", and abolishes the recently created Presidential Commission on Dietary Supplement Labels, which was called for by the DSHLEA.

New U.S. Supreme Court Decision

According to Rep. Pallone, the reason the bill calls for the abolition of the Presidential Commission is a recent U.S. Supreme Court decision that eliminates the need for the Commission. In his speech before the House (when introducing the bill), Rep. Pallone said: "I think the philosophy and public policy objective concerning claims should be guided by the sage words of Justice Stevens who recently wrote in a landmark commercial speech case, Rubin vs Coors Brewing Co.

"'Any `interest` in restricting the flow of accurate information because of the perceived danger of that knowledge is anathema to the First Amendment; more speech and a better-informed citizenry are among the central goals of the Free Speech Clause. Accordingly, the Constitution is most skeptical of supposed state interests that seek to keep people in the dark for what the government believes to be their own good.'"

The Damage of FDA Censorship

In Rep. Pallone's speech before the House, he went to great lengths to explain the damage to the American people caused by FDA censorship of truthful health claims. As he put it:

"When we passed the Nutrition Labeling and Education Act in 1990 (NLEA), we authorized the FDA to pre-clear all health claims that a food or dietary ingredient could prevent a disease or health related condition. Congress wanted the FDA to allow such claims because of the overwhelming scientific evidence between disease and nutritional status. It also was allowed so that industry could better educate its customers regarding the benefits of their products. The FDA was given the discretion to use a standard that they called 'significant scientific agreement' to decide whether to approve a health claim. The record of the agency in this area has been a failure and should be reformed.

"When the NLEA was passed, the FDA was asked to evaluate nine health claims for foods and supplements. It approved only two for supplements; first was that calcium prevents osteoporosis and second, after initially rejecting the claim, that folic acid prevents neural tube birth defects for women of child bearing age. It also approved claims that antioxidant and fiber rich foods like fruits and vegetables could help prevent heart disease and cancer. It refused to approve the same claims for supplements of those dietary ingredients.

"The case of the Folic Acid health claim is most illustrative of the problem with the FDA being the censor of truthful, nonmisleading information and the terrible price our country pays for being kept in the dark. When NLEA was passed, the FDA was asked to evaluate a health claim for folic acid preventing certain birth defects. In November of 1991, the FDA denied the health claim, stating that there was no 'significant scientific agreement' to approve the claim. Subsequently in July of 1992, the US Public Health Service published an advisory asking all women of child bearing age to get adequate folic acid in their diets by foods or supplements to prevent these tragic birth defects.

"Public and scientific outrage finally forced the FDA to reverse itself in the fall of 1993 and the claim was approved. But what was most outrageous...was that the FDA testified in a Senate Labor and Human Resource Committee hearing in October 1993 that it had been aware of scientific data that folic acid could prevent these birth defects for ten years! They argued that, in their opinion, there was no 'significant scientific agreement' when the Nutrition Labeling and Education Act was first enacted in 1990 until the FDA reversed itself in the fall of 1993. In the interim, the American public was kept in the dark, and an estimated additional 2,000 children were born with birth defects that could have been prevented had the information been allowed to reach women in a responsible manner.

"For ten years when the first scientific data started coming in, women were not allowed to be told that Folic Acid might prevent neural tube birth defects. In this period of time, these tragic and irreversible birth defects struck approximately 20,000 babies. If any of my colleagues have ever seen a child born with anencephalopathy or spina bifida, then they know the pain and suffering these children and their parents face.

"These are children who are disabled, disfigured, and have short life spans. The costs to take care of these children run in the millions. Yet the information was out there that an adequate amount of folic acid had the potential to avert these birth defects. The risk to women of child bearing age who could have received this information was zero. The benefit potential was thousands of birth defects prevented. But American women were kept in the dark and we will never know precisely how many babies born with these defects could have been averted. We do know that this number reaches into the thousands.

"Now the same thing is happening with a class of nutrients called antioxidants which scientific research is showing huge potential in reducing or eliminating known risk factors for cancer and cardiovascular disease. As I introduce this legislation, I point out that in the June 21st edition of the Journal of the American Medical Association there was another study on Vitamin E and compelling evidence that it can reduce the risk of heart disease has been published.

"This is another study that adds to the overwhelming number of scientific studies that antioxidants have important contributions to make in the fight against degenerative diseases that are driving our health care costs into oblivion. And just a month ago, scientists confirmed that a mineral antioxidant, selenium, has the ability to protect the human immune system and minimize damage from viral infections. These studies promise innovation and cost effective treatments for people with viral illnesses. But such information will never reach the consumer in time under current FDA policies."


Why We Must Support This Bill

Because of the change in leadership in Congress, the chances of passing a fully intact health freedom bill, which guarantees your our rights to learn about and use the supplements of our choice, is very good this year, but only if we register our support for the bill with members of Congress.

Therefore, we urge you to contact your representatives in Congress immediately in order to urge them to become cosponsors of The Food and Dietary Supplement Consumer Act of 1995 (H.R.1951) and to help persuade their colleagues to support the bill.

Please call, write, and fax your support for this bill to your elected representatives now! If you do not have the phone number, fax number, and address or your representatives, just call the Capitol Switchboard at:

1-202-224-3121


Alternative Treatment Bill
Introduced In Congress

On July 13, 1995, Rep. Peter DeFazio (D-OR) introduced The Access To Medical Treatment Act (H.R.2019) in the U.S. House of Representatives. A companion bill will soon be introduced in The Senate by Sen. Tom Daschle (D-SD).

This bill would allow an individual to be treated by any health care practitioner who is legally authorized to provide health professional services in the State in which the services are provided, using any method of treatment the individual desires, as long as:

1. The treatment causes no serious harm other than reactions normally experienced with routinely used medical treatments for the same medical condition; and

2. The patient is fully informed about the treatment and its possible side effects.


Why This Bill Is Needed

The outrageous actions of the FDA against Dr. Burzynski and his patients, which is described in the lead article in this issue of the FDA Raid Report, make it very clear why we need legislation to protect our rights to have access to the medical treatments of our choice.

The FDA is doing everything it can to put Dr. Burzynski out of business, and perhaps behind bars, simply because he has dared to offer cancer patients an alternative to surgery, chemotherapy, and radiation-the three standard modes of treatment in the United States. The FDA is trying to destroy Dr. Burzynski, even though his antineoplaston treatment has been highly effective in treating some patients, and despite the fact that more Americans are afflicted with and dying of cancer today than ever before!

The Access To Medical Treatments Act does not alter the FDA's responsibility to approve treatments as safe and effective. It attempts to open up what is now a system that is closed to alternative treatments. The bill forbids claims by those offering alternative treatments to guard against "major marketing efforts" for non-FDA approved treatments.


Why We Should Support This Bill

We urge support for H.R.2019 because it gives Americans considerably more freedom than they have today regarding access to alternative treatments. It will be especially useful for patients who suffer from diseases considered "incurable" by mainstream medicine, who have no options other than to explore alternative treatments for their condition.

It will also be beneficial for alternative physicians such as Dr. Burzynski, who don't actively promote their services, and who would love to be left alone by the FDA's enforcement agents. The problem with the bill is that it is too restrictive on medical claims by alternative practitioners. Such restrictions could easily be used by the FDA-in direct contradiction to the wishes of Congress-to continue their illegal and immoral actions against alternative medicine.

We strongly recommend that you support this bill. Again, we urge you to phone, fax, and write your representatives in Congress in order to urge them to support The Access To Medical Treatment Act (H.R.2019). To find out how to contact members of Congress, just call the Capitol Switch board at:

1-202-224-3121


New First Amendment Lawsuit
Against The FDA

On June 30, 1995, the Nutritional Health Alliance (NHA) filed a lawsuit in Federal District Court for the Southern District of New York seeking a declaratory judgment that provisions of the Nutrition Labeling And Education Act (NLEA) and the U.S. Food And Drug Administration's (FDA) implementing regulations of that act are invalid under the first amendment to the U.S. Constitution to the extent that they constitute "prior restraint" of constitutionally protected speech.

The lawsuit, which was filed by the New York law firm of Bass & Ullman, attacks that portion of the NLEA which prohibits manufacturers and marketers of dietary supplements from using truthful, nonmisleading information to inform the public about the value of dietary supplements for the prevention of diseases and other health-related conditions.

According to NHA President Gerald Kessler, "the NHA has filed this case as part of its continuing campaign for health freedom and freedom of speech." Mr. Kessler further stated that: "We must continue the fight for the right of the dietary supplement industry to make truthful and non-misleading health claims and for the right of the American public to receive information which is crucial to their health and well-being."

This is the fourth first amendment lawsuit filed against the FDA that is now in the U.S. courts. A crucial hearing is scheduled before the U.S. Court of Appeals in San Francisco at 9 AM on August 15, 1995 with regard to the first amendment lawsuit filed against the FDA by Durk Pearson and Sandy Shaw. An in-depth report on these first amendment lawsuits will be carried in the next issue of LIFE EXTENSION MAGAZINE.