May 25, 1999, was a bluebird spring day. I was on the lawn in front of the nation’s Capitol, along with Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) and Congressman Peter DiFazio (D-Oregon). I had called a press conference to announce that I and three others had petitioned the Food and Drug Administration (FDA) for “permission” to use truthful health claims on the labels of nutritional supplements. But before I get into our specific requests, you need to know why I was there at that time.
This Battle Started Eight Years Ago
For over 25 years the FDA has prevented nutritional supplement manufacturers from telling you about the health benefits of their products. Incredibly, billions of bottles of supplements have been sold with no information at all on the labels explaining what the product is supposed to do. Because the label is “off limits” as a source of information about nutritional and herbal products, consumers must turn to books, newsletters, and the Internet. But that is going to change and change fast.
In January of this year, the Circuit Court of Appeals ruled that the FDA’s 25-year-old regime of censorship of the nutritional supplement industry was both illegal and a violation of the constitutional guarantee of free speech and press. The court ordered the FDA to allow health claims that had been submitted eight years ago by Durk Pearson and Sandy Shaw, long-time crusaders for freedom of speech on nutritional supplements, and which the FDA had categorically denied.
Now We’re Filing Four Claims
At the press conference we announced the addition of four more claims that the FDA must act upon in the next six months. According to Jonathan Emord, the attorney who brilliantly and successfully argued this case before the courts, this will be the first real test of the FDA’s willingness to adhere to the Court’s decision and act in the interests of confused consumers.
Let’s take a look at the four specific claims we filed and how they might affect your health.
Claim 1. Supplementary intake of folic acid, vitamin B6, and vitamin B12 may reduce the risk of cardiovascular disease. An estimated 30% of all heart attacks could be prevented with supplemental folic acid, vitamin B6 and vitamin B12. Research in support of this statistic has existed for well over a decade. Because of the FDA’s censorship of supplement manufacturers, many families who have lost a loved one to heart disease may understandably blame the FDA for their tragedy.
Claim 2. Daily use of saw palmetto extract may improve urine flow and reduce nocturia and voiding urgency associated with mild benign prostatic hyperplasia (BPH). BPH is such a common problem among men as they age that Representative DeFazio said in his statement to the press that this is the claim that might get the most attention from his colleagues in Congress, as they are “sitting around on their enlarged prostates.” Studies show that supplemental saw palmetto results in significant improvements in the majority of men suffering with BPH.
Claim 3. Psyllium seed husks used as a dietary fiber supplement may reduce the risk of heart disease. Psyllium fiber has been shown to reduce total cholesterol and LDL cholesterol levels. Elevated levels of both affect 60% of American adults and are significant markers of heart disease.
Claim 4. Supplemental vitamin E may help prevent cardiovascular disease. The therapeutic potential and health benefits of vitamin E have been recognized for over 50 years, and the body of supporting scientific research continues to grow. In one study of 2,000 people with heart disease, those taking supplemental vitamin E experienced a 75% reduction in heart attack incidence.
FDA Censorship Has Harmed Many Americans
Folks, we need to remember that this issue directly affects people’s lives. When a government agency is in violation of statutory law as well as the Constitution, the result is almost always disastrous for certain segments of the population. The FDA’s censorship of vital information on the specific benefits of nutritional supplements is nothing short of perverse, and many years of suppression have caused immeasurable suffering, countless deaths, and billions of dollars in preventable medical costs. Let me give you one graphic example.
As long ago as 1992, there was substantial scientific evidence to show that 400 mcg of folic acid per day could reduce the risk of neural tube birth defects, such as spina bifida and hydrocephalus, by as much as 50%. In fact, the Center for Disease Control and Prevention (CDC) published the following recommendation that year: “All women of childbearing age in the United States who are capable of becoming pregnant should consume .4 mg of folic acid per day for the purpose of reducing their risk of having a pregnancy affected with spina bifida or other neural tube defects.”
It Took Fours Years for Folic Acid Claims
Despite this recommendation, the FDA prohibited vitamin manufacturers from printing this claim on bottles of supplements containing folic acid. The agency finally reversed itself in 1996, relenting only under growing political pressure from Senator Orrin Hatch and Congressman Bill Richardson. However, during those four years, the FDA’s unreasonable refusal to permit this folic acid claim where it could do the most good contributed to an estimated 10,000 neural tube birth defects! Imagine, 10,000 children and their families suffer the consequences of these tragic birth defects, which could have been prevented had the FDA acted in a timely manner.
It gets even worse. The FDA actually squelched efforts of a state agency to improve the health of its citizens. The Texas Department of Public Health recognized in 1992 that in Cameron County, an impoverished rural county in southern Texas, the incidence of spina bifida and neural tube defects was quite high. They put together a program to disseminate information on the prevention of these birth defects and to supply folic acid to women at risk. Incredibly, the FDA intervened, and this very important program was delayed for four years.
Sen. Hatch Urged the FDA to Act Quickly
I was honored by the support and presence at the press conference of Senator Hatch and Senator Harkin. These two senators, Republican and Democrat respectively, have consistently supported freedom of speech and access to alternative health information and therapies.
In his statement to the press, Senator Hatch encouraged the FDA to act quickly on these petitions and not drag them through a bureaucratic maze. “I urge the agency not to fumble the ball by reverting to the obstructionist tactics the courts, consumers, and the Congress have squarely rejected. The public has come to expect more of its government.”
Other Speakers Called for Responsible FDA Action
Senator Harkin echoed these sentiments. “The Court of Appeals decision on January 15th was an important victory for consumers’ access to truthful and useful information. Now the FDA has the opportunity to show their commitment for consumer information in reviewing the four claims being submitted for review today. I join you in calling on the FDA to review those claims promptly and fairly. And ‘promptly’ does not mean a year or two, and ‘fairly’ does not mean entering it with a bias to say no. The FDA’s mission is to promote the public health. With these petitions you are giving them a chance to do their job. We’ll all be watching very closely.”
Representative DeFazio implored fairness on the part of the FDA. “We are here today to begin to turn the tide and say we are going to provide useful information. The FDA should go back and do what it’s supposed to do, which is regulate in the public interest–not in the interest of some certain special interest.”
You Have a Right to Truthful Information on Nutritional Supplements
The impunity with which governments can transgress human freedoms is precisely why we have a constitutional government. The Bill of Rights was written not to protect you from dishonest nutritional supplement retailers, but from the forces of government. The first amendment to the Constitution says that government shall make no law to abridge freedom of speech.
Yet the FDA instituted regulations that completely shut down speech on the value of nutritional supplements. Consequently, many intelligent people in our society still believe the nonsense that you can get all the nutrients you need for optimal health from diet alone. This is not to say that diet is an unimportant factor in health, but that the truth about the power of nutritional supplements has been rigidly and severely censored by the FDA.
Law Applies to Government Agencies, Too
When individuals in the private sector break the law and violate others’ constitutional rights, they are punished. When individuals cloaked in the mantle of “government bureaucrat” break the law, violate others’ constitutional rights and cause immeasurable damage in the lives of millions, they merely get some bad press. All of that is beginning to change, however, and I’ll keep you informed as to the progress of our petition through the bureaucratic labyrinth of the FDA.
Postscript: The FDA Finally Capitulates
Unbelievably, even the unanimous verdict from a U.S. court could not rein in this renegade agency, which has persisted in setting up roadblocks to thwart supplement manufacturers from simply stating on their labels what health conditions their products are for. After we submitted these label claims to the FDA for what should have been routine approval, they quibbled over one insignificant thing after another: Anything to subvert the process.
Well, we fought back. We hired crackerjack attorney Jonathan Emord to slap a lawsuit against the FDA to stop this nonsense, and in May 2001, the agency finally backed down! The agency decided to “reconsider its position” (legalese for “give up”) and agreed to a version of a label claim that is pretty close to the one we originally submitted and they subsequently disallowed. Supplement manufacturers may now put this label on products containing folic acid and vitamins B6 and B12:
As part of a well-balanced diet that is low in saturated fat and cholesterol, folic acid, vitamin B6 and vitamin B12 may reduce the risk of vascular disease.*
* FDA evaluated the above claim and found that while it is known that diets low in saturated fat and cholesterol reduce the risk of heart disease and other vascular diseases, the evidence in support of the above claim is inconclusive.
The Fight Isn’t Over Yet
The FDA’s capitulation is a victory for consumers and manufacturers alike. However, because the agency continues to drag its feet on other claims, we’re back in court again. These cases cost money, and the Whitaker Health Freedom Foundation is funding selected cases to the best of our ability.
We feel this is a worthy battle because as truthful, nonmisleading claims appear on other nutritional supplement labels, more and more Americans will learn about the health benefits of specific nutrients, and their health will be the better for it.
Modified from Health & Healing, July 1999, with permission from Phillips Health, LLC. © copyright 1999, Phillips Publishing, Inc. Photocopying, reproduction, or quotation strictly prohibited without written permission from the publisher. To subscribe to Health & Healing, call (800) 539-8219.