If I could spend a half-hour with each of you, I am convinced that you would want to take at least two or three dietary supplements that the FDA has either already tried to restrict, or will without passage of S. 784. Serenoa for the prostate and coenzyme Q10 for the heart are good examples.
In my medical practice in Massachusetts over the past 17 years, I have seen over 10,000 patients. It is clear that many people are willing and competent to make their own choices regarding health care, including dietary supplements. They are not being duped, but they know what is at stake, and they are willing to spend their own money, not federal or state money, for the right to improve their health and prevent disease. They will not be able to continue to do this without the passage of this bill, which I strongly support.
Some of my colleagues and various researchers have also expressed similar sentiments, and I would like to report some of these to you. For example, Gladys Block, PhD, has made the following points:
1. The evidence of a beneficial role for [antioxidant] nutrients is extraordinarily extensive.
2. Many Americans are not consuming even minimal, let alone excessive, amounts of nutrients.
3. There is no evidence that supplement users neglect their diet or other health care-quite the contrary.
4. The evidence of benefit is increasing explosively, and conclusions formed a decade ago are insufficient to inform us.
5. FDA's role in protecting public health would be much more valuable if focused on ensuring quality of supplements and providing consumers with information.
In the reviews of the Serenoa repens extract studies published by the FDA in New Developments, of March 5, 1990, they gave their reasoning for not allowing claims for prostate improvement. Although they admitted that there was "statistically significant" improvement, they considered it not to be "clinically significant," even though it was better in all parameters than the drug that they did approve. The drug is potentially dangerous, and women who may get pregnant who are partners of men taking the drug are cautioned to avoid exposure to this partner's semen and to avoid handling the crushed tablets of the drug. It also has other side effects (impotence, decreased libido, ejaculation dysfunction). There are no known side effects from the herbal product.
The FDA does not consider only the value and safety of dietary supplements in deciding what to approve. It has other motives, including "...what steps are necessary to ensure that the existence of dietary supplements on the market does not act as a disincentive for drug development." Also, Deputy Commissioner for Policy David Adams said that the establishment of a separate regulatory category for supplements "...could undercut the exclusivity rights enjoyed by the holders of approved drug applications."
In a letter to the New York Times, September 8, 1992, Dr. Bernard Rimland said "...Dr. Kessler tells us that the FDA doesn't want to block the sale of vitamins. All we have to do is convince him and his fellow bureaucrats that they have been wrong for many decades in saying that vitamins are useless. Just provide the FDA with the evidence that will make them change their minds and they will let us buy all the vitamins we want. Fat chance! The FDA's stonewalling of any and all evidence favoring the use of vitamins is legendary. We could more easily convince a shark to become a vegetarian."
The evidence does not support the FDA claims that nutrients, including amino acids, are in any way a significant risk. These baseless claims mislead Congress and the public and make it dangerous to give such regulatory power to the FDA.
In case there is doubt about the regulatory intentions of the FDA, let me include some quotes from FDA officials pinpointing their position:
From the Task Force Report on Dietary Supplements:
"...the task force recommends that the agency adopt a 'Dietary Supplement Limit' which would be the maximum daily intake of a given vitamin or mineral that the agency deems safe" - e.g., "the highest RDA levels listed by the National Academy of Sciences." "The Agency should take regulatory action against those supplements that exceed the above guidelines as 'unsafe food additives'...."
"Amino acids should be regulated as drugs."
"If a potency is listed on the label for any non-essential substance (a dietary supplement for which there is no RDA) action would be taken against those products."
One has to question the rationale behind the FDA's proposal to redefine amino acids as "drugs." Using such an approach should suggest that sugar (sucrose) refined from beets or sugar cane, a food extraction product, should be regulated as a "drug." In fact, sugar in the American diet poses far more risks than amino acids.
Here is the text of what I wrote to the committee after the hearings were over, for inclusion in the official Congressional record of the hearings:
During the testimony at this hearing of Dr. David Kessler, Commissioner of the Food and Drug Administration, he made a number of misleading and false statements and a number of confusing points. I addressed some of those points in my testimony, but due to a lack of time I did not address all of them, nor did I respond adequately to reflect my concerns.
First of all on the issue of the safety of nutrients. The FDA has asked that dietary supplements meet the same standards of safety as OTC [over-the-counter] drugs. Using their own data and according to all the records of the American Association of Poison Control Centers, dietary supplements are 2550 times safer than OTC drugs.
Dr. Kessler said that there was potential toxicity from chromium, folic acid, gamma-linolenic acid (GLA) and
l-tryptophan. I am sure that he feels there is a problem with other nutrients in spite of their long record of safety based on animal and human studies and traditional use. If Dr. Kessler feels there is a risk, he can avoid taking these products, but only if he can reasonably prove a risk should the FDA be allowed to remove these from the market.
I would like to state categorically that there is no known risk from the ingestion of any of the above products at anywhere near the amounts that are typically used. In fact, you would probably have to take enough GLA-containing oil to get obese from the calories before it would do any other harm. No one is recommending such high doses.
Folic acid does not cause any side effects. What Dr. Kessler calls a side effect, the masking of the anemia that is an early sign of a B12 deficiency, is actually a therapeutic benefit. However, I recognize that a B12 deficiency, if prolonged, may lead to peripheral neuropathy, but this is not a side effect of the folic acid. There are now easy ways to measure B12 in the blood, so a physician would not have any difficulty in recognizing a deficiency. You might argue that you need to see a physician to determine this even if people are taking folic acid on their own. However, that is moot, because a person would need a physician to recognize the anemia also. Although the dispute revolves around the dose of 400 to 1000 micrograms (mcg), folic acid is safe at doses measured in milligrams (mg). I have seen no side effects in patients taking up to 100 mg (100,000 mcg). This dose has been used to treat gout, because, as a xanthine oxidase inhibitor, folate works like the drug allopurinol. Inhibition of xanthine oxidase may also reduce the risk of heart disease.
Chromium is a perfectly safe nutrient that can lower cholesterol and help to regulate insulin, thus improving sugar control in diabetics and hypoglycemics. Doses that I have recommended, again with no clinical or laboratory signs of toxicity, range up to 1000 micrograms. It is safer than the drugs that are approved to lower cholesterol (e.g., lovastatin), and they have side effects such that their effect on mortality is neutral or negative.
Lovastatin actually inhibits the production of another substance, coenzyme Q10, which is very important for a healthy heart, immune function and energy production. Since coenzyme Q10 protects against heart disease, there is theoretical evidence, and also clinical studies, showing that this is a risk of taking the drug. And, as an aside, coenzyme Q10 is a substance that the Texas Department of Health, following FDA's lead, tried to remove from the health food stores in Texas.
The case of l-tryptophan deserves more comment. Dr. Kessler repeated in his testimony the claim that "they" were not sure that the eosinophilia myalgia syndrome (EMS) was due only to a contaminant. As I stated in my testimony, the New England Journal of Medicine and the Journal of the AMA both concluded that it was from a contaminant back in 1990. In the past month there have been two reports, one from the CDC by Robert Hill published in the Journal of Contaminants and Environmental Toxicology and one from Dr. Cluew, a professor at George Washington University, reported at a rheumatology meeting. They both concluded that the EMS was the result of a contaminant and not
If the FDA and Dr. Kessler do not know the older literature on the subject and they do not know the more recent literature on the subject, they are the wrong agency or the wrong personnel to be involved with the enforcement of dietary supplement regulations. There are many other reasons that I have come to this conclusion. Either we change the agency, change the personnel or specifically limit their power with strict Congressional guidelines such as mandated in S. 784.
Dr. Kessler also revealed his true intentions inadvertently when he stated that FDA was within the law to regulate dietary supplement products that were mixtures as food additives. There is no scientific rationale for removing two safe products from the market if they happen to be mixed together, just because you have the legal authority to do so. Some products are better when they are mixed, such as GLA and vitamin E. The product lasts longer on the shelf without oxidizing because of the presence of the vitamin E. Sometimes mixtures are cheaper and sometimes they are more effective. The FDA attitude is to blow up Mount McKinley because it's there! There is no reason to expect that the FDA, with its current personnel make-up and level of authority, will suddenly start to treat dietary supplements more equitably than they have for decades.
Dr. Kessler left the impression that all the bottles of products that he displayed, in his grandstanding gesture, were labeled with false claims. He presented only one that had a false claim on the label. (No one at the hearing actually examined the label, but I have no doubt that there are occasional false claims, which generally are not a great risk to the public health.) Most of those products were properly labeled, but FDA agents were able to cajole someone at a health food store to suggest to them that the product would be useful for a specific health problem. The manufacturers or distributors are inapppropriately being held liable for the actions of retail clerks. If a clerk in a market said to take prunes for constipation, that would be an unsubstantiated health claim according to the FDA, and they could have put a box of prunes on the table with all those bottles.
When confronted with the toxicity of FDA-approved drugs, which kill so many people annually, Dr. Kessler replied with his "canned" comment that "half of our drugs are derived from plants." This is a clear misrepresentation and designed to mislead. Many pharmaceuticals are plant extracts that have been significantly altered so that they can be patented, and this alteration usually increases their toxicity. Also, many of them are synthetic analogs of plant products, not the plants themselves. You might as well say that they are made from carbon, nitrogen and oxygen, which we encounter every day! Further, many of the most widely used and most expensive drugs are totally synthetic and have nothing to do with plants. Anti-ulcer drugs, anti-inflammatory drugs, anti-anxiety drugs, newer cardiac drugs and antihyper-tensives are not plant products. They cost many Americans lots of money and have numerous side effects. They are necessary for many patients but are widely overused. This is partly because physicians have no access, in the normal course of their work, to the information about dietary supplements that should be disseminated widely. This would lessen the need for drugs and enhance the health of all Americans, while reducing the medical care crisis that we are now facing.