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Comments on the Dietary Label Committee & It's Report
The Dietary Supplement Label Committee Report
The Committee on Dietary Supplement Labels (CDSL) sent out a draft of their report to people who had presented testimony requesting comments.
The final report, which is very similar to the draft, is available on line here.
What follows are the written comments that I submitted.
July 26, 1997
Office of Disease Prevention and Health Promotion
Subject: Comments on the Draft of the Committee on Dietary Supplement Labels Report
Drug & Medical Claims Versus Nutritional & Health Claims
The major focus of your report is on health and nutritional claims made in marketing dietary supplements. This is not something that concerns me a lot. What does concern me is the big marketing campaign aimed at convincing people that natural is safe and synthetic is dangerous.
I am also very concerned by the fraudulent drug claims being made for both useless and harmful substances and by the promotion and sale of dangerous substances such as ephedra, thyroid hormone and colloidal silver and gold as safe, effective, natural remedies.
I am not concerned about peas and carrots or rosemary for remembrance. I am very disturbed about the fact that stores across America are stocked with mislabeled products and people like medical doctors, chiropractors, naturopaths and acupuncturists, to name a few, are prescribing and selling unapproved remedies, some known to be dangerous, for which they are making drug claims.
People who prescribe drugs should never be allowed to sell them. It doesn't take a rocket scientist to see the abuse this invites.
Safety & Adverse Reactions
There could very well be an untested product just as lethal as cigarettes on the shelf of a store near you. Your report calls for government, industry, and consumer groups to monitor products already marketed for adverse reactions. You know that with some products these may not show up until the next generation (thalidomide) and with others they can take decades to occur (cigarettes). By the time the harm caused is discovered the damage has already been done to large numbers of people.
Such risks are acceptable when dealing with a fatal illness such as AIDS or incurable cancer. They are not acceptable when treating a healthy child or pregnant woman to "boost their immune systems" and to protect them from colds and flu.
The Colloidal Silver (CSP) Scam
I presented a file about an inch thick to you, the FDA, and the FTC regarding the fraudulent marketing of colloidal silver (CSP). The file documented the fact that I had been disfigured by nose drops prescribed for me by a physician about forty years ago. The drops contained silver and turned my skin gray.
The condition, argyria, is well-documented in the medical literature. All the evidence indicates that CSP is at best useless and at worst harmful and that it is snake oil and an 80-year old-scam.
I included fraudulent ads and articles presently circulating touting CSP as a safe, all-natural antibiotic that treats and prevents 650 different diseases including acne, AIDS and cancer with promoters claiming that silver is an essential mineral and that even a trace amount in the body keeps people from getting sick. They quoted turn-of-the-century quacks pretending that they were researchers living today, misquoted reputable authors and published anecdotes selectively chosen to sell CSP. Many of the products were labeled pre-1938 OTCs.
In October 1996 the FDA published a proposed rule in the Federal Register stating that CSP is not a pre-1938 OTC (Attachment 1).
If manufacturers want to make drug claims for it they will have to apply to have it approved as a new OTC. The FDA has seen no evidence that CSP is safe and effective. They know it can cause argyria. CSP is still being sold. You can buy a machine to make your own (Attachment 2). The same promotional material is still out there making the same drug claims. (Check the Internet.) But now instead of being sold as a pre-1938 OTC, it is sold as a "dietary supplement" (Attachment 3).
Council for Responsible Nutrition
When the FDA published the proposed rule, they requested comments. One received from John N. Hathcock, Ph.D. from the Council for Responsible Nutrition explicitly states that, "In any further publication or communication on this topic, FDA should explicitly state that this rulemaking does not apply to dietary supplements." (read his letter) (Attachment 4).
Dr. Hathcock doesn't present any evidence indicating that CSP is safe or that it offers any nutritional or health benefits. Why in the world would he want to make sure that his industry is guaranteed the legal right to sell a product that is at best useless and at worst harmful?
Perhaps Dr. Annette Dickinson, your committee member from the Council for Responsible Nutrition, can answer this question. She was present at the subcommittee that I addressed at your October 1996 meeting in Washington, D.C. She saw my pile of evidence and heard me say that the FDA had proposed the rule telling manufacturers that they could not sell CSP as a drug.
I added that that wouldn't stop them from selling it as a dietary supplement, though. If she knew that I was wrong, that silver is really an essential mineral beneficial to human health, why didn't she have her group present their evidence to the FDA?
You state several times in the draft of your report that, "The Commission considers it axiomatic that all marketed dietary supplements should be safe." How can Dr. Dickinson say that when the group she represents is expressly requesting the FDA to grant them the legal right to sell a product as a dietary supplement which has no known benefits and which has been proven to be harmful?
I think that the name Council for Responsible Nutrition is very misleading. It sounds like a public interest group, not an industry trade association.
Controlled Studies
Because of its antiviral properties, CSP is presently being aggressively marketed as a drug to people who are HIV positive (Deborah Orr & Clara Lawhead, both of whom have presented you with testimony). If anyone has evidence that CSP will prevent or cure AIDS, I will be the first to endorse it. Given the choice between being a gray person and dying of HIV, most people would choose to be gray.
The Silver Institute (Attachment 5) wants the government to study the drug value of silver. There is a man on the Internet selling equipment to make your own CSP with. (Attachment 2) He sells his generator for $99 and claims that you can manufacturer your own CSP with it at a cost of eight cents an ounce.
While we do not know the dose of silver that causes argyria, we do have a good idea about the dose that causes other toxic effects. So why haven't CSP manufacturers and silver producers done controlled studies with AIDS patients?
It would be so easy, safe and cheap. All they would have to do is set up two matched groups of patients on the same drug protocols with one group receiving CSP and the other a placebo.
Is this type of pre-marketing study too much for the American public to require of a drug or dietary supplement manufacturer?
The Scientific Method
The Scientific Method is one of the greatest contributions ever made to civilization. It is responsible for creating societies such as those of the U.S. and Europe in which people live longer and enjoy better health than their grandparents ever dreamed possible.
DHSEA has presented us with the antithesis of the scientific method. It has taken experimentation out of the labs and into the living rooms of America where the results are completely useless and invalid because the studies are uncontrolled.
DSHEA has opened the door to the quacks and begged them to come in. They have done so in droves. Instead of studying first and marketing second, the way reputable scientists who truly care about health and truth do, they market first and are pitching the next miracle cure by the time the studies come out showing that what they were really promoting was snake oil.
This is a terrible waste of time and resources and offers false hope to desperate people. The dietary supplement industry is just as bad as the tobacco industry ever was. It must be regulated like every other industry. The public must be protected from fraud and dangerous products (Attachment 6).
Dietary supplements should have to be approved before they are marketed by scientists from a government agency such as FDA, scientists without a vested interest like Dr. Hathcock.
DSHEA was passed behind closed doors by the dietary supplement industry. The public still doesn't know that it exists. When they find out that there are unregulated products on the shelves of their "health food" stores and pharmacies, they are furious.
Biased Makeup of Your Committee
Your committee is biased in favor of industry. You don't have one member who is a consumer representative or one member who is the victim of dietary supplement fraud. (When I was injured by silver, it was sold as a drug. Today it is sold as a dietary supplement. It was snake oil then. It is snake oil now.)
Out of a committee of seven, three (Dickinson, McCaleb, and Podesta) represent the dietary supplement industry. Nesheim and Kumanyika represent academia and nutrition scientists. Gilhooley represents law enforcement and government.
Dr. Farnsworth represents academia and the science of pharmacology, specifically pharmacognosy. I have also seen his name on the masthead of the magazine Veggie Life (Attachment 7). Since that magazine promotes dietary supplements, I now wonder about Dr. Farnsworth's objectivity on the subject. Until I saw his name in Veggie Times, I had thought that he was the best qualified of your members.
In addition to consumer advocates and victims, I believe that your committee should have included more representatives from public health, law enforcement, and pharmacology. As I said above, my concern is with unapproved drugs and toxins not fruits, vegetables, or spices.
Conclusion
Please let me know which legislative body is going to review your report and when they are going to meet. Tell them that I want to speak to them. I want them to know that the American people have no idea that there are unregulated products sold in the United States today. When they find out they are furious.
DSHEA must be repealed. The only ones who benefit from it are those in the dietary supplement industry and they have proven that they are as bad as the tobacco companies. If they are left unregulated, someday they will be just as powerful as the tobacco lobby used to be.
Thank you.
Rosemary Jacobs |
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