Attack on Dietary Supplements

The fact that pharmaceutical companies are one of the most wealthy and powerful industries in existence is allowing it to all but take over the regulations and laws surrounding medicine and drugs. Luckily for consumers, until now, drugs have been tested and evaluated differently than food, food ingredients, vitamins, and herbs. The use of alternative and herbal supplements is soaring, however, and this hits the pocketbooks of the drug companies directly - a reality that they do not like and will not tolerate. Now, due to pressure from the huge drug companies, the FDA is seeking to regulate herbs, vitamins, and all other dietary supplements as drugs. While this many not seem like an alarming change, those who understand the politics and wording of this proposed bill realize that it is likely to change health care for the worse.

Current law states that a food, food ingredient, or dietary supplement is safe to use unless proven otherwise. Under current regulations, it is up to the FDA to prove that a food or food ingredient is harmful. Meanwhile, according to drug safety law, the drug company is responsible for proving that the benefit of any particular drug outweighs the toxicity of it, and despite the fact that many FDA regulators have close ties to the drug industry, this is a lengthy, expensive, and corrupt process. A new bill, S1082, seeks to change the regulation laws for food, food ingredients, and dietary supplements, and will add them into the same category as drugs for safety review purposes. The Senate has passed this bill, and if it is passed by the House, our free access to vitamins, minerals, herbs, and other alternative therapies are in extreme danger.

If enacted, this bill will drastically change healthcare options for millions of consumers. Because the FDA and the multinational drug companies are intent on gaining a complete monopoly of healthcare choices, they are attempting to bring this legislation to the international community through trade agreements and international law.

Did you know that the calcium supplements you are taking could be whisked off the shelves? That the chamomile tea that you enjoy might be considered a narcotic substance? Perhaps the garlic that you buy so cheaply and freely in the supermarket will soon cost $50 a clove, once it is deemed a medicine.
The public is angry and has succeeded in slowing down S1082. Americans no longer trust the FDA, and because the wording in the bill leaves all dietary supplements at risk, the conscious public is concerned.

The attack on herbs and supplements has already started - the FDA has a long history of attacks on natural healers and herbal suppliers. One monumental case is the removal of Ephedra from store shelves. A recent Supreme Court case has allowed Ephedra, which has been used traditionally for thousands of years, to be legally removed from shelves by the FDA, despite the fact that there is no evidence of harm caused by low dose (normal) use. The FDA granted itself the authority to ban ephedrine by using drug-related risk/benefit analysis (the process by which drugs are approved, not herbs or food), and this sets the precedent to overturn what is currently the law. Kelly (name has been changed to protect her identity), a concerned citizen and member of the medical community, says, "The Ephedra case does make it more clear than almost any other example how the FDA is an arm of the pharmaceutical industry. The active ingredient in ephedra is chemically 100% equivalent to psedoephedrine, which is sold by pharmaceutical companies in dangeriously high doses (e.g. Claritin at 120mg). Yet in a low does form, like Nutracetical's Ephedra product, that was only 8mg, the FDA has now effectively banned the only safe dose of this chemical. To add insult to injury, in their risk benefit analysis, the FDA doesn't include the fact that Ephedra is extremely safe and effective for treating seasonal allergies. The reason they do not include benefits is because if a substance treats an illness (allergies) then it is by (their) definition a drug. The stupidest part is that this drug is already approved (otherwise you couldn't buy pseudoephedrine). But it is the natural delivery system and the fact that you do not need a pharmaceutical company to make it, that effectively has made our government ban it and use all their money and power to make sure everyone is totally brainwashed and confused regarding the facts of the matter." The Supreme Court is not interested in re-opening the Ephedra case, and as long as this case stands, the FDA has the legal precedent to do the same with any herb or vitamin it chooses. Ephedra was among the first, but surely it will not be the last.

It is the consumer who ultimately suffers. The FDA and the big pharmaceutical companies realize that there are many traditional herbs and remedies that will actually solve ones health woes instead of perpetually treating the symptoms, and they also know that consumers are beginning to wake up to this reality. The industry has no financial interest in herbs, botanicals, and supplements being available to the public, because this will mean an individual can choose to spend their money on a traditional remedy that will solve their problems without adding additional health concerns rather than on heavily toxic prescription drugs that will trap them in a constant cycle of medications and medical procedures.

The public must get involved. This bill has already passed the Senate, and we need to stand up for our rights for healthcare freedom. Send letters and emails to your Senators and Congressmen, and include Senators Hatch and Harkin (the original designers of the DHSEA) and Kennedy and Enzi (who claim they are not trying to regulate dietary supplements). The recommended letter follows:

HR 1561 (Senate bill S.1082) - Please Amend to Protect Dietary Supplements
Date
The Honorable (Representative or Senator First and Last Name)
Address

Dear Representative/Senator (Last Name);

The Senate has recently passed bill S1082, commonly known as the FDA Revitalization Act. I am concerned that the legislation, as currently written, opens the door for considerable regulatory confusion enabling the FDA to use this legislation to undermine my access to safe and effective dietary supplements. There must be no confusing the safety of drugs and the safety of food and food ingredients, which are governed by different laws. I am sure you and other members of Congress are not intending to create such concern among the 150 million Americans who rely on dietary supplements to assist their health, and this matter is easily corrected with the following amendment, which will not in any way stop the FDA from identifying truly contaminated food that pose a risk to human health.
Proposed amendment to S1082 and HR1561:

The bills are hereby amended to prohibit the Foundation or Institute from evaluating the health benefit or efficacy of foods, dietary ingredients, and dietary supplements and to limit review of foods, dietary ingredients and dietary supplements to a determination of whether they are safe. In assessing whether dietary ingredients and dietary supplements are safe, the Foundation or Institute shall not compare product risks with heath benefits or efficacy. Instead, the Foundation or Institute shall determine whether the product presents a significant risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are recommended or suggested in labeling, under ordinary conditions of use.

Please help preserve my rights and support this amendment.
Sincerely,
Your name here