Note: This long letter was written to Jonathan Collin, MD, Editor of the Townsend Letter for Doctors and Patients, in response to an editorial of his which differs from my views. Collin reprinted William Campbell Douglass' article which Nature's Way had threatened to sue him over. Collin reprinted the Douglass article without realizing that Nature's Way had threatened to sue. In the Feb/March issue of the Townsend Letter, Collin opened up the debate on Codex by printing his editorial, Douglass' retraction of his Codex article, a statement about Codex by Citizens for Health, a PR statement by Nature's Way, and an article of mine (for balance).
It is clear to me that Collin, and his readers needed some additional information in order to understand the current health freedom battle clearly, and to really understand why we need to pass HR 2868. If you agree with the views expressed in this letter, please fax or email your own letter in to the Editor of the Townsend Letter. If you would like a copy of the Feb/March issue of the Townsend Letter, call them at 360-385-0699 or email them at firstname.lastname@example.org
19 Feb 1998
To The Editor
The Townsend Letter for Doctors and Patients
Thank you for opening up a debate on the Codex International Threat to Health Freedom, and the dire need to pass HR 2868, the Consumer Health Free Speech Act! (Special Report from the Front Lines- pp.159-162 Feb/March '98) New threats to health freedom described here amply illustrate the need to move beyond internecine warfare because we're all in the same boat.
Will "Roll Up" Roll Over Health Freedom???
Foods are NOT DRUGS
A substance isn't transformed into a drug just because it has therapeutic properties. A drug should only be defined on a basis of safety according to the nature of the substance based on its toxicology, carcinogenicity, mutagenicity, and taratogenicity. If a substance has therapeutic qualities, that by itself does not make the substance a "drug."
Rather than find in favor of the so called "significant scientific agreement" standard which the FDA uses to arbitrarily block the making of true claims on dietary supplements, and rather than recommend the creation of an unlevel playing field by advocating the creation of an herbal advisory panel at FDA to rule on OTC drug claims, the Commission on Dietary Supplement Labels should have defined what kinds and combination of studies validate claims on a basis of significant scientific evidence. This is because in the Supreme Court decision of Daubert v Merrill Dow, (which occurred on June 28, 1993 AFTER passage of NLEA), the "significant scientific agreement" standard was overturned. Daubert replaced significant scientific agreement with the Federal Rules of Evidence for admitting scientific testimony in a federal trial.
"Roll up" is occurring within the dietary supplement industry, as pharmaceutical interests buy their way in. GNC has formed an unholy joint venture with Monsanto, makers of aspartame, bovine growth hormone, and genetically engineered food. Bayer and Boerhinger Ingleheim are referring to herbs as "green pharmaceuticals" and phytopharmaceutical manufacturers are increasingly becoming targets for acquisition by multinational giants. While there is nothing illegal about Nature's Way's partnership with Madaus and Schwabe, it bears scrutiny, especially if they should continue failing to back HR 2868, the Consumer Health Free Speech Act which would relevel the playing field by removing food from the drug definition, allowing therapeutic claims to be made, as long as they're true, without forcing a company to go through the expense of complying with a lot of red tape.
Currently Ron Paul's bill has 3 cosponsors (DeFazio, Stump, and Pallone) and enjoys bipartisan support. Loren Israelson, Nature's Way's attorney has expressed the concern that unless "significant" and "unreasonable" are defined in HR 2868, an undefined term in a statute is left open to interpretation by case law, confusion, delay, and little or no progress to advance the solution. Perhaps we can all work together to draft a Senate companion bill which defines these terms.
Following are a number of points which underscore the current threat to health freedom, and the need to back HR 2868. A rising tide raises all boats. Any company or organization which doesn't support HR 2868 in light of the following information cannot claim to be fighting for health freedom, regardless of anything they may have done in the past:
EMORD LOSES FIRST AMENDMENT DECISION
On January 12, 1998, Judge Gladys Kessler ruled against attorney Jonathan Emord's first amendment lawsuit, declaring that the FDA's Final Rules did not violate the NLEA, APA, first amendment or fifth amendment. She also ruled in favor of upholding the FDA's so called "significant scientific agreement" standard, which the agency arbitrarily uses to block the making of truthful claims. There is a need to frame an appeal well enough to put this issue before the US Supreme Court.The series of cases including Coors and 44Liquermart seem to go in the direction of an endpoint that commercial speech is congruent with free speech as long as it is truthful and nonmisleading and validated by the best available science. Milt Bass has another first amendment suit currently in the US Court of Appeals.Since there is never any guarantee of winning in the courts, we must also try to pass legislation to achieve the same end result, which is where HR 2868 comes in.
WHAT PHARMAPRINT HAS TO SAY ABOUT SELLING HERBS AS DRUGS:
PharmaPrint, Inc. (traded on the Nasdaq stock exchange as PPRT) has BIG plans to patent all of our favorite herbs, and license pharmaceutical companies to use their patented technology.PharmaPrint has the direct backing of the WHO. To prove that a global move is afoot to steal our herbs, check out what PharmaPrint has to say on their website:
"Botanicals Offer Low Cost and Reduced Risk in Developing Drugs Pharmaprinting of a botanical drug costs approximately $500,000 and can be performed in about 6 months. It includes validating manufacturing under GMP guidelines and filing for patent protection. Phase I/II clinical trials takes an additional 18 months to complete at a cost of about $1.5 million. This is followed by Phase III trials that take 2-3 years at an estimated cost of $5 - $20 million. These figures are in sharp contrast to the estimated average cost of $230 million over a period of 12 years that is needed to complete development of a drug from the drug discovery stage to commercialization. In addition to the major cost advantage of drugs made from botanical sources, there also is a greater likelihood of success in clinical trials because they have already shown evidence of therapeutic efficacy in humans prior to initiating formal clinical studies."
FDA TOBACCO REGS PROVIDES FDA NEW WAY TO ATTACK SUPPLEMENTS
The FDA's recent tobacco regulations were discussed by Ellen J. Flannery,Esq. of Covington & Burling on December 9, 1997 at the Food and Drug Law Annual Meeting in Washington D.C. We are at risk. There is a very real need to get the food exemption into the drug definition because the FDA can now use the tobacco rule to go after intended use in other areas such as herbs, and other dietary supplements. HR 2868, the Consumer Health Free Speech Act puts the food exemption into the drug definition. We must all work together to pass it, and if there is a need to make some changes to improve the bill, that can be done in a Senate companion bill.
FDA ANPR THREATENS TO HARMONIZE REGS WITH CODEX STANDARDS
Contrary to your assertion that "the information about CODEX being a conspiracy to outlaw supplement manufacture is largely fabrication," on July 7, 1997, our criminal FDA announced in an Advanced Notice of Proposed Rulemaking published in the Federal Register, Volume 62, #129 pp.36243-36248 that "by sleight of hand, they intend to give the Codex Alimentarius Commission even more power over the health and welfare of the American public than even the most expansive interpretation of our obligations under current international law would warrant." (Suzanne Harris,JD, of the Law Loft in comments submitted to the FDA on behalf of the Life Extension Foundation, and the National Health Federation.)
In their ANPR, FDA has announced their intention to move through what Harris accurately describes as a "quasi legal covering system" to harmonize their regulations with emerging Codex standards despite the extreme differences in their mission statement and that of the Codex Alimentarius Commission, and despite their constitutional obligations to the American people. (I discussed this in my "Special Report from the Front Lines" at the bottom of p.160 in your Feb/March issue. I also handed copies of this ANPR, along with Harris' comments to the FDA regarding it, to every member of the Senate Labor Committee during my successful campaign to get dietary supplements exempted from the harmonization language in the FDA Reform Bill. Candace Campbell of the American Preventive Medical Assn. provided a succinct discussion of my legislative victory with the FDA Reform bill in her Director's Report in the Feb/March issue of TL for D&P which you published on p. 164-165.
Sources on Capital Hill have informed me that efforts will be made to repeal my amendment in upcoming legislation. Language to accomplish this could be neatly tucked away in some piece of legislation as thick as a phone book with no one even noticing its existence, much in the same way that no one would have known about the July 7 ANPR re Codex harmonization if Will Dailey, Suzanne and I hadn't noticed it.
NEVER FORGET WHAT DYKSTRA SAID
Far too many people forget where we were in the recent past, and as such have difficulty seeing what we need to do now in order to keep protecting our access to natural products.
The infamous words of Gary J. Dykstra, Assistant Commissioner of Regulatory Affairs come immediately to mind. After the passage of the Nutrition Labeling and Education Act of 1990, Dykstra issued the infamous report bearing his name in which he stated: "The use of dietary supplements must not be allowed to serve as a disincentive to new drug development." Dykstra's Advance Notice of Proposed Rulemaking was nearly identical to today's German Codex proposal, and the same market forces were behind it. We have returned..... to 1991.....
In 1991 I wanted to meet with Dykstra to try to get the comments period extended on his ANPR since the government printing office had only issued about 200 copies of it, and huge numbers of people wanted to read it and send in comments, but as usual, they weren't allowing enough time. I was able to get one of the few available copies, and did my best to sound the alarm, going on Gary Null's radio show and others to try to rally people, but the clock was ticking.... Dykstra was willing to meet with me because I had testified at a public hearing that the FDA was required by law to hold after passage of NLEA. The hearing was held in Masur Auditorium of NIH on August 29, 1991 and it ran all day, with opposing forces squaring off on the dietary supplement issue. The FDA was trying hard to demonize the whole industry, using the tryptophan issue as a vehicle.
When Dykstra met with me, he brought 15 other FDA staff to the meeting with him, and they were very hostile. They did not extend the comments period as requested, and their notice in the Federal Register about what transpired at our meeting (which they were required by law to write) was heavily slanted against everything I had to say about the need for an extension, and on their ANPR in general.
Today, unless we can pass HR 2868, the FDA threatens to use the new Tobacco rule against us as a way to harmonize their regs with emerging Codex standards. With the threatened ban on B-6 above 10 mg in England, we run the risk of losing England as an ally against the German Codex proposal, because if MAFF can get away with banning B-6 to 10 mg, they could similarly restrict ANY nutrient to equally untherapeutic dosage levels.
SOME CORRECTIONS ON YOUR EDITORIAL:
In your editorial you made a couple of errors. I am not the "head" of Life Extension Foundation, (p.13) they are a client of mine, and Saul Kent is their President.. I am the founder and President of International Advocates for Health Freedom, which you inaccurately referred to on p.159 as "International ASSOCIATES for Health Freedom.
Life Extension Foundation, is the largest organization in the world devoted to alternative gerontological research. Saul Kent and Bill Faloon have the honor of being the President and Vice President of LEF. In addition to having the intestinal fortitude necessary to go out on a limb to be the first to market the nutrients melatonin, DHEA, and Co Enzyme Q10 in the United States, LEF is the first organization in the 88 year history of the FDA to survive a criminal indictment.
After 11 years of wasting taxpayers money, three years ago all 56 trumped up charges which had been filed against Saul and Bill were dropped by the criminal FDA, which lacked the courage to put them on trial, because they knew we would dismember them in court. About the best they could do was to sick ABC's Day One on us, but even that backfired, because the public could see through the spin control and they joined us en masse.The war cost the Foundation in excess of $1.3 million, and if we had lost, you can rest assured that we would have no health freedom in this country today. The April issue of Life Extension Magazine contains an article titled "Achieving Enhanced Quality Control" which covers the extensive measures taken at Prolongevity (LEF's house brand) to not only provide state of the art quality control, but to share their quality control protocols with the rest of the industry. LEF isn't opposed to good quality control, but they do oppose the creation of an unlevel playing field because it would hurt the industry and consumers.
While working as the Political Coordinator of LEF, I worked with a team of people for several months to create the world's only FDA Holocaust Museum, to meticulously document the numerous ways in which the FDA is engaging in genocide against the American people. When the Museum was located in Dania, FL, it had a large neon sign that was visible at night to passengers in airplanes landing at Ft.Lauderdale International Airport. Today, the museum exhibits are located at the new LEF world headquarters in Ft.Lauderdale, FL. To read the complete story about LEF's Victory Over the FDA, please visit http://www.lef.org/cgi-local/shop.pl/page=victory.htm/SID=1550224382
The way forward is self evident: we must define the terms "significant" and "unreasonable" because as Loren Israelson correctly states, an undefined term in a statute is left open to interpretation by case law, and confusion, dispute, delay, and little or no progress to advance the problem to solution. But we can work together to define these terms, and in doing so prevent future FDA deceptions of the public such as occurred with the fraudulent ban on tryptophan, the safe serotonin precursor, contrasted with the dangerous serotonin drugs Prozac and fen-phen. (A more current example of where these definitions would be helpful is with the ongoing battle to defend access to ephedra where our opponents hypocritically attack a safe herb, while the REAL killers, the pseudoephedrine products, are commonly available to any 7 year old with some loose change in any supermarket.
Tylenol went back on the market when FDA knew there was no more cyanide adulteration, so when Centers for Disease Control identified "Peake-E" as the contaminant in the Showa Denko tryptophan, and when Christopher Caston, MD of Spartenburg S.C. patented a nutritional protocol (which includes pharmaceutical grade l-tryptophan) that successfully reverses the eosinophilia myalgia syndrome caused by the contaminated tryptophan, why didn't the FDA allow tryptophan back on the market???
What the so called "Commission on Dietary Supplement Labels" should have done, (rather than recommend the formation of a botanical review board at FDA to review OTC drug claims for herbs) was to generate a definition for "significant scientific evidence" since so called "significant scientific agreement" has already been overturned by the Supreme Court as illegal in the Daubert v. Merrill Dow decision. (As discussed in IAHF's comments submitted to the CDSL, they also should have discussed Emord's split label/gradation of claims suggestion.
In addition, CDSL should have payed especially close attention to Harris's comments on how shifting products across the line from food to drug plunges us down a very slippery slope in light of emerging international law, vis a vis the fact that as FOODS, we can prevent foreign embargos against our products using the SPS agreement in GATT as a shield. (There is a very real problem posed to consumers the minute we get out from under the protection afforded by the SPS agreement and our favorite products start being regulated instead under the far more stringent TBT agreement wherein as drugs, they are much more tightly regulated on a basis of risk/benefit analysis.
After rigorous study of what is unfolding at the international level, including sneaking in to the WHO's last meeting in Geneva regarding TBT, Harris emphatically warns us that it is utterly imperative to keep these products classed as foods. (To hear what Harris has to say about this, order the tapes of the Third Public Forum for Health Freedom of the Health Action Network Society in Vancouver, BC, Canada at 604-435-0512. On the same tape hear HPB defector Dr. Michelle Brill Edwards discuss the rampant corruption within the HPB, and how they are attempting to orchestrate the complete destruction of the natural products industry. Also hear despicable regulator Micheline Ho of the HPB present their biased viewpoint to learn first hand about the sort of spin control used by regulators in their efforts to deceive the consuming public.)
If consumers and industry can come together behind this HR 2868, work together to draft a stronger Senate companion bill with some needed definitions to guard against attacks through case law and bury the hatchets, but not in each others skulls, we may be able to keep defending health freedom.
It is my fervant hope that the truth revealed here will assist us all to move beyond this internecine warfare in order to very clearly see the way forward, by rooting ourselves to the solid principle that foods are not, and never will be "drugs." Please assist us in the passage of HR 2868. IAHF is not the enemy, the enemy is ICDRA: the International Council of Drug Regulating Authorities, a UN entity under which the FDA,HPB,MCA,MCC,TGA,PSD, and other rogue miscreants gather, ostensibly for the betterment of mankind.
If we don't pass HR 2868, the FDA will use the tobacco rule to attack all supplements based on their intended use along with their stated intention to harmonize their regs with emerging Codex standards to severely limit our access to dietary supplements. With moves already afoot to try to repeal my amendment of the FDA Reform Bill which kept our food and drug laws from being harmonized with those of the EU, we can't be too careful.
John C. Hammell, President and Founder,
International Advocates for Health Freedom
2411 Monroe St. Hollywood, FL 33020 USA
800-333-2553, 954-929-2905, fax 954-929-0507,
1. (In Daubert, the general acceptance standard was overturned. "General acceptance" is an analogy for "significant scientific agreement." The "general acceptance" test was based on the 1923 Frye v US case [54 App D.C. 46:F 1013, ALR 145
2. Are Nutraceuticals The Future Of Food? By Kathleen Spiessbach 1/30/98 (Reuters) http://www.pnc.com.au/~cafmr/hammell/world/gnc.html
3. Germany Moves to the Forefront of the European Herbal Medicine Industry by Robert Yuan, Ph.D. and Jorg Grunwald, Ph.D. (Genetic Engineering News, April 15, 1997) http://www.pnc.com.au/~cafmr/hammell/world/herb-eu.txt
4. Download bill text from http://thomas.loc.gov/cgi-bin/query/z?c105:H.R.2868: Download formletter from http://www.pnc.com.au/~cafmr/hammell/s830vict.html
5. Durk Pearson and Sandy Shaw, ET AL, v Donna Schalala, Secretary, US Dept of Health and Human Services, ET. AL Civil Action No. 95-1865 Filed 1/12/98
6. PharmaPrint's site: http://www.mhmeyerson.com/research/abt/abt00002.htm
7. FDA Tobacco Regulations:
(A) Proposed Rule and Jurisdictional Analysis 60 Fed. Reg. 41314, 41453 (August 11, 1995),
(B) Final Rule and Jurisdictional Determination: 61 Fed. Reg. 44396, 44619 (August 28, 1996),
(C) Coyne Beahm, Inc. vs FDA, 996 F.Supp. 1374 (M.D.N.C. 1997)
(D) Brown and Williamson Tobacco Corp. v. FDA No.97-1604 (4th Cir. Appeal Pending)
8. Ellen J. Flannery, Esq. Covington and Burling 202-662-6000
9. Contact Suzanne Harris of the Law Loft via 816-576-7800
10. Dept of Health and Human Services Public Meeting: Dietary Supplements Docket # 91N-0256 8/29/91
11. See the UK Section of the IAHF website for info on MAFF's efforts to ban B-6, as well as what people have been doing to fight back.
12. Life Extension Foundation 800-841-5433, 954-766-8433 Call for free magazine. www.lef.org, email@example.com
If you call them to get a free magazine, be sure to tell them you heard of them through IAHF. I receive commissions when people join LEF through me, or buy products from them.
13. See Emord's website www.emord.com
14. For a copy of Suzanne Harris' comments to CDSL re their draft report http://www.pnc.com.au/~cafmr/hammell/cdsl-su2.html