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January, 2012, Vol. 12, Issue 01 >> Herbs/ Teas & Homeopathy

Do You Take Supplements? Kiss Them Goodbye

By Ralph Stephens, BS, LMT, NCBTMB

If you take or sell vitamins, minerals, herbs and other supplements, the Food & Drug Administration (FDA) has decided to protect you from yourself. They care so much about your health. NOT!

This is no joke. It is deadly serious. The FDA has found a loophole in the 1994 Dietary Supplement Health and Education Act (DSHEA). While supplements that existed at the time the law was passed were protected by law, the FDA was given the authority to regulate any new ingredients that were introduced after Oct. 15, 1994. What happened? At first, nothing. For 17 years, the FDA took no action. During that time, no one has been killed by a supplement ingredient. However, recently, the agency has drafted a proposal to regulate what it calls "new dietary ingredients." If this proposal is implemented, some of the most effective nutrients you take will be pulled from the market. Nutrients like resveratrol, ubiquinol CoQ10, bacopa, strontium and more.

Under the proposed new guidelines, the FDA can define almost anything as a "new dietary ingredient." For example:

If a supplement formula is changed to alter the ratio of ingredients, something like including more vitamin C for example, vitamin C becomes a new ingredient and must be proven safe.

If a probiotic yogurt formula now contains a strain of bacteria that was not found in yogurt 17 years ago it is new.

If a new manufacturing process is implemented the product is now new.

So what? Well, now manufacturers must prove any new ingredient "safe." How safe? According to the guidelines, many companies would have to conduct animal studies using a dosage that's 1,000 times the typical dose. I'm not kidding. A fish oil manufacturer would have to conduct a one-year study in which animals are force-fed the human equivalent of 240,000 milligrams of fish oil each and every day. Do you think this outrageous overdose might injure or kill its victim? Of course it could. And that would give the FDA all the excuse it needed to outlaw any product that contained it. Not to mention thousands of innocent animals abused and killed. Where is PETA on this?

It gets worse. One manufacturer cannot use another's research on the same product. Each manufacturer must conduct its own safety research, even if they both are using the same fish oil or vitamin C. And, remember, even with a mountain of successful research submitted, the FDA is not required to approve anything. A typical study, so called research, costs between $100,000 - $200,000 to perform. If a company has six products with six ingredients each, it would cost $3.6 - $7.2 million with no guarantee of approval, no matter how safe an ingredient is proven to be. There is no way most supplement companies could afford to do these ridiculous studies.

Supplements that have changed in any way since 1984 could be banned and pulled from the shelf by the FDA because they are not proven safe. According to the FDA, acetaminophen is proven safe, yet it kills hundreds of people a year. An FDA researcher estimated there may have been more than 27,000 deaths linked to the use of Vioxx before the FDA finally took the drug, which was proven "safe," off the market. No one has died from a food supplement, but they are not "safe" according to the FDA. See how much they care about your health?

If these rules are allowed to take effect, most food supplements will disappear from the market. Those that are proven "safe" will cost many times more than they do today. Homeopaths have spent millions trying to prove some of their remedies through "research." They have been successful and now the formerly cheap remedies are prohibitively expensive. Most manufacturers, especially the best ones which are smaller operations, will be put out of business and by the time the rules are changed, will be gone and unable to return, so their products will be lost, maybe forever. More job creation by the administration.

Are you concerned about this? Do you care? Not taking a stand is taking a stand. Not speaking out is speaking out. It will take an overwhelming outpouring of citizen response to the FDA, Congress and the White House.

Please, if you care at all - contact the people you do elect: your Congressman and your two U.S. Senators. They have the power to rein in the FDA and they have done so before — when enough voters complained. Please start complaining, loudly and regularly, until these rules are withdrawn or over-ridden by Congress. It is your health and freedom at stake. Even if you do not take supplements, please help defend and protect the rights of those who do.

To locate the contact information for all of your elected officials, visit To view the proposed rules and the contact information for the FDA representative, visit

Click here for more information about Ralph Stephens, BS, LMT, NCBTMB.


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