FDA Regulating Herbs

by James Sloane

Once again the FDA is tying to overturn the Proxmire Vitamin Bill from 1962, which prohibits the FDA from regulating supplements as drugs. The FDA has tried numerous times though direct and manipulative methods. Several attempts were even made to hide their legislation within unrelated legislation, which would have given them the power to regulate supplements if the unrelated legislation had passed. Basically a Trojan horse method of trying to gain control.

This brings up some interesting questions. For instance, if the FDA considers herbs and supplements to be quackery, then why do they want to regulate these substances as drugs? Is it policy for the FDA to make prescription substances that they consider quackery? Of course it is not FDA policy, though it is done all the time. Take for instance the drug dextromethorphan (DM), which was shown in several studies dating back to the 1960s, to be no better than placebo. In fact, DM is only one of 710 drugs the FDA was ordered to remove from the market under court order in 1969. All 710 drugs were ordered to be removed because they were found to be either totally ineffective, or too dangerous for human use. Instead of removing these drugs as ordered to do by the court, the FDA instead found a loophole, and left all of these drugs on the market.

A large part of the problem is that numerous FDA officials own stock in the same pharmaceutical companies they oversee. In fact it has been reported for decades that over 150 FDA officials illegally own stock in these companies. Ownership of stock, by FDA officials, in pharmaceutical companies FDA officials oversee is a clear violation of insider trading laws. Furthermore, many FDA officials have gone to work, in high level positions, with these drug companies after helping to push the drug company’s drugs through the approval process. In other cases it was reported that drug companies gave FDA officials payoffs or gifts after the FDA officials pushed their drugs through the approval process, and when these FDA officials blocked the drug company’s competition. An excellent example is the generic drugscandal in which FDA officials were caught approving untested drugs in exchange for payoffs. Then the FDA harassed the drug company that tipped off the officials to the illegal activity of the FDA. More recently was the FDA’s approval of the drug Ketek. The FDA was fully aware that the drug company falsified the safety data of the drug before the drug was approved by the FDA. The FDA has refused to remove Ketek from the market despite 4 deaths and 12 reported dangerous reactions.

At the same time the FDA has tried to remove several herbs from the market that have not been proven to be dangerous or deadly, such as ephedra and chaparral. The FDA lied about deaths they claim were from ephedra, when in fact they were due to the pharmaceutical drug ephedrine HCl. The company Nutraceuticals took the FDA to court claiming the ban was illegal, and the FDA was court ordered to lift their ban. The FDA has remained in violation of this court order. Claims that chaparral could cause hepatitis lead the FDA to try and ban the sale of this herb as well. Although the FDA failed to disclose that the 13 isolated cases of hepatitis, attributed to chaparral ingestion, were in patients known to have pre-existing liver failure, and/or were taking pharmaceutical drugs well known to cause liver damage.

It is clear that the FDA is not there to protect the public, but rather to protect the profits of large corporations. Especially corporations in which the FDA officials have financial connections to, or are compensated from with gifts, jobs or payoffs. And this is not limited to drugs. Take for instance the sweetener aspartame (Equal, Nutrasweet). This highly toxic substance failed to pass the FDA approval process the first 4 times it was submitted. The fifth time it was pushed through by an FDA official who then went to work for the manufacturer in a high level position.

The FDA is supposed to regulate any drug on the market. Drugs are defined as any substance which treats, or mitigates a disease, or alters a body process. By definition this makes tobacco a drug. In fact, the tobacco industry deliberately manipulates nicotine levels within cigarettes to elicit a particular effect on the body. Additives are put in the tobacco to further increase these effects, by potentiating the effects of the nicotine, or by increasing its absorption. This clearly makes tobacco a drug, yet the FDA is not regulating it as a drug as they are supposed to.

So the question remains, can the FDA be trusted to regulate herbs and supplements when they cannot even properly regulate drug