Additional Comments on the Dietary Label Committee & It's Report

When the committee reviewed the comments at the final meeting in Reston, Virginia on August 13-14, 1997, Dr. Nesheim, a food scientist, noted that a colleague of his at Cornell thought that there should be a statement included noting that most people get all the nutrients they need from foods. Dr. Dickinson of the trade association CRN exclaimed in horror that that just is not true.

Dr. Fisher, the moderator from HHS, brought up three of my comments. First, he mentioned what I had said about the fact that just because adverse reactions have not been reported doesn't prove that supplements are safe. Dr. Farnsworth responded that you cannot prove that something is not unsafe by which I think he meant that no one can accurately determine that a particular substance will never prove to be harmful.

For example, with water the best you can do is say that it has been used by everyone from time immemorial without any evidence of its causing harm to those ingesting it. That does not, however, show that it cannot at some future date harm someone.

(Theoretically, this is a valid logical argument, but it is pretty irrelevant in the real world or the world of science where you would have to begin by defining what you meant by water. Water containing parasites, toxins and pathogens commonly caused serious illness before the advent of good sanitation. In the real world and the world of science, you speak of very specific substances as well as of probabilities rather than of absolutes.)

Dr. Fisher told Dr. Farnsworth that my point was valid. It is something that is not just used when discussing supplements . It is considered when evaluating all new ingredients being considered for consumption such as food additives. I think it is also ordinarily considered when evaluating old substances that will be consumed in new forms or in increased amounts.

Next Dr. Fisher noted my comment about situations in which a substance such as colloidal silver is not permitted to be sold as a drug because the FDA has no evidence that it is efficacious for anything and does have a lot of evidence that it is dangerous.

In spite of this colloidal silver can and is being sold as a supplement.

Mr. McCaleb and Dr. Dickinson, representatives of the supplement industry, said that they didn't want to get into that. Dr. Kumanyika, a food scientist, stated that the committee could not deal with things on an individual basis adding that all rules of government don't always agree. McCaleb and Dickinson agreed.

Third, Dr. Fisher brought up my comment about there being no evidence that supplements are safe for pregnant or lactating women. Mr. McCaleb, without referring to me by name, stated that botanicals have been used for years and that the person who made the comment, me, offered no proof that they caused adverse reactions in fetuses.

He told Dr. Fisher that warning labels against use in pregnancy and during lactation are not needed since botanicals are foods. He vehemently insisted that herbs are safe in spite of all the evidence presented to the contrary.

(URL Chinese Patent Medicines to be posted)
(URL Chris' story to be posted)

When Dr. Fisher asked about the adverse reactions reported to FDA, McCaleb dismissed them as unsubstantiated reports and hearsay. Dr. Farnsworth agreed with all that McCaleb said on the subject.

Actually, in Chapter 3, heading #3 "Safety of Botanicals" on p.21 of the hardcopy edition of the Commission's final report it states that:

"The Commission recognizes that most botanical products taken as dietary supplements in the United States are safe when used as directed on labels. There are relatively few reports in the scientific literature that indicate potential or actual toxicity following the use of these products."

The citation given for this information is an article by Dr. Farnsworth that appeared in "Herbalgram" 29:36AH in 1993. "Herbalgram" is not a peer-reviewed medical journal. It is a magazine published by the Americal Botanical Council (ABC) and the Herb Research Foundation (HRF), organizations that promote botanical drugs. Mr. McCaleb is technical editor to "Herbalgram" and the president of HRF. Dr. Farnsworth is a trustee of ABC, a contributing editor to "Herbalgram" and also associated with HRF.

When the meeting broke for lunch, I visited the Barnes & Noble bookstore across the plaza and started pulling the books on herbs. I checked what they said about those that I know are toxic.

In Michael Castleman's HEALING HERBS, Bantam edition, August 1995, p.421, with the voices of McCaleb and Farnsworth still ringing in my ears proclaiming that, "Herbs are safe and do not require a warning label for pregnant and lactating women", I read to my horror that, "Though small amounts of pennyroyal oil can be fatal, the oil is a superconcentrated extract of the herb. Drinking a few cups of pennyroyal infusion poses no hazard. University of Illinois pharmacognosist Norman Farnsworth, Ph.D. estimates it would take 75 gallons of strong pennyroyal infusion to approach a toxic dose of pennyroyal oil."

I knew that there were reports in the literature of serious problems including deaths from pennyroyal and that the Doctor Farnsworth quoted by Castleman was the very same Dr. Farnsworth who I had just heard proclaim that, "Herbs are safe." The same one whose article in "Herbalgram" was cited in the draft of the Commission's report as showing that "most botanical products taken as dietary supplements in the United States are safe when used as directed on labels."

(URL on pennyroyal to be posed)

I went home and sent the following comment to the committee:

August 17,1997

To the Committee on Dietary Supplement Labels:

If I had realized that Mr. McCaleb would dismiss my comments about the possibility of adverse reactions on fetuses caused by pregnant women ingesting dietary supplements on the grounds that I failed to produce documentation of such occurrences, I would have looked for the evidence.

Obviously, I believe that this is a very reasonable concern without documentation. The point being that until lab experiments or large-scale epidemiological studies are done on each dietary supplement to be marketed, we just don't know if they are safe or not.

Also I had gotten the impression that your committee thought that the documentation I presented on the colloidal silver scam was far too much. Something about shelf heaven and the inverse relationship between the number of pages in a report and the number of people who will read it. In my very cursory review of the written testimony presented to your committee the only documentation, besides my own, that I noticed was from Deborah Orr.

I find it very ironic that Mr. McCaleb, the representative of an industry that tells outright lies to sell products and continually makes outrageous claims without any documentation whatsoever (check with the FTC and attorneys general if you need verification), would dismiss my comment on the grounds that I had no documentation.

Enclosed are copies of statements by Varro Tyler and Allison McCutcheon on the safety of herbs in children and nursing mothers. I do not consider this evidence, but I will try to contact both scientists and see if they can provide anything specifically relating to adverse reactions of botanicals on fetuses.

As for Mr. McCaleb's contention that botanicals have been used for thousands of years without adverse reactions, where is his documentation?

How does he know that the ginseng sold in a bottle at my local health food store is the same ginseng that a man in China took 2000 years ago? And what would have been the average life expectancy of the man consuming that substance way back then?

If he had been smoking cigarettes exactly the same as those sold in a convenience store near you, would he have lived long enough to develop lung cancer?

Enclosed are a few things that I pulled off the Net on this issue.

Chris Grell and I are forming a group of victims of health fraud. Perhaps one of the first things we should do is commission a group of reputable Chinese doctors and scientists to do a scientific paper on this very topic.

Mr. McCaleb, please hold yourself and your industry to the same level of proof that you ask of me and mainstream scientists. I have no problem with you and the Commission saying that botanicals have been used for thousands of years and that you are not aware of any serious problems with them.

I have a big problem with you and the Commission declaring them safe and effective without presenting proof. The Norwegian term, non-proven therapies - NPTs, is far more accurate and truthful.

Also, I have no problem with someone selling a substance such as colloidal silver (CSP) as a dietary supplement even when it is not considered safe and effective as an OTC. I have a big problem with someone selling a product as a dietary supplement when all the proof indicates that it is at best useless and at worst harmful. This may be the letter of DSHEA, I really doubt that it is what the legislature intended. The very term dietary supplement implies some type of health benefit.

I don't believe that you ever directly addressed hormones. Would you like the name of a doctor in Vermont who can document an adverse reaction to a thyroid hormone prescribed and sold to a pregnant woman by a chiropractor? In Canada hormones such as melatonin are classified as drugs and cannot be sold off the shelf.

I haven't checked the medical literature on adverse reactions due to hormones and don't intend to. I suspect that if you had had physicians not connected to the dietary supplement industry on your Committee that they would documented some for you.

Perhaps the simplest most equitable solution to this problem would be to permit manufacturers of unregulated substances to put anything they want on their labels as long as they preface it with, "We believe that studies have shown that..." and add in prominent letters, "Unregulated substance. Non-proven therapy. Take at your own risk."

Rosemary Jacobs

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