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NATURE's WAY's SPIN CONTROL REFUTED

A response to Ken Murdock, Chairman, and Gary Hume, President/CEO

By John C. Hammell, Founder, International Advocates for Health Freedom


While he should be working overtime to amend the harmonization language in the FDA Reform Bill (S.830) which threatens to merge American food and drug law with the European Union's (where dietary supplements are regulated as drugs, and access is becoming increasingly restricted), Ken Murdock of Nature's Way is circulating a document critical of my views towards his company and about my views on the Codex issue (!)

Could this be because there is language in S.830 that allows a single stakeholder to introduce a dietary supplement into the market as a drug upon the filing of an application which is deemed approved with the classification picked by the stakeholder unless the FDA reacts within a short time? Could it be because if American food and drug law is harmonized to that of the EU, it would give European phytopharmaceutical manufacturers (such as Madaus and Schwabe) a competitive advantage in the American marketplace where supplement manufacturers would be put out of business?

Could the timing of this attack be calculated to divert attention from these issues just in time to get this kind of legislation through? Murdock's comments can be found on Nature's Way's website at http://www.naturesway.com/naturesway/response.html, and in Citizens for Health's website. I wrote this rebuttal so that people can draw their own conclusions about the ongoing battle for health freedom, and the degree to which Nature's Way has, or has not actually been looking out for the interests of consumers.

POINTS TO PONDER

  1. Nature's Way advocates expanding the OTC drug category to include herbs when therapeutic claims are made that go beyond structure function claims. Is it legal for the Commission to make this recommendation? From a standpoint of emerging international law, will it help American business interests if the we blur the line between foods and drugs? Shouldn't consumers and American manufacturers protest this? Are we REALLY protected by DSHEA?
  2. Murdock-Madaus-Schwabe is a joint venture between Nature's Way; Madaus AG of Cologne, Germany; and Dr. Willmar Schwabe GmbH& Co. of Karlsruhe, Germany. Madaus and Schwabe are phytopharmaceutical companies, and in their own website, Nature's Way announces that they are an over-the-counter drug licensed manufacturing facility.
  3. Consider that Nature's Way is a member of NNFA, which actively blocked the introduction of a Senate Companion bill to HR 1951: The Food and Dietary Consumer Information Act of 1995, which would have curbed the worst excesses of the Dietary Supplement Health and Education Act of 1994. It would have stopped the FDA from turning dietary supplements into drugs, it would have allowed us to make truthful health claims on dietary supplements, and it would have codified a Supreme Court decision favoring free speech to stop FDA from arbitrarily blocking health claims. Moreover, it would have repealed the health claims section of the Dietary Supplement Health and Education Act of 1994, including the section which established the Presidential Commission on Dietary Supplement Labels, (through which Nature's Way is currently pushing to create an OTC drug category.)
  4. Consider the fact that Madaus AG is conducting a $385,000 controlled clinical trial at Bastyr University in Seattle on echinacea in order to sell it as a drug. This appears like another move by a pharmaceutical company to do preliminary work to classify herbs as drugs. (Natural Health Merchandizer, April p.10)
  5. An Herb Survey on p.24 of the October issue of Whole Foods states that "echinacea tops the list of best selling herbs for the third straight year." This fact provides incentive for Madaus to invest in the controlled clinical trial, given that the ability to make therapeutic claims would give them a market advantage over echinacea sold as a dietary supplement.
  6. Consider the fact that Nature's Way is a member of the Utah Natural Product Alliance, which, along with NNFA, and AHPA presented a signed statement to the Commission on Dietary Supplement Labels at their Baltimore meeting advocating expansion of the OTC drug category to include herbs and botanicals.
  7. Consider the fact that Nature's Way's house counsel, Loren Israelson, in his capacity as executive director of the Utah Natural Products Alliance spoke at the Drug Information Association's Thirty Third Annual Meeting in Montreal on June 26, 1997 on the topics of "Developing an Authoritative Reference Standard for Therapeutic Botanicals" and on "The Emerging Classification Hierarchy for Heterogenous Botanicals- From Food to Ethical Drugs."
  8. Consider the fact that Nature's Way's house counsel, Loren Israelson, signed as co-counsel on the European-American Phytomedicine's Coalition petition to turn a list of specified botanicals into OTC drugs. The EAPC is a coalition of manufacturers of phytomedicines operating in France, Germany, the Netherlands, the United Kingdom, and the United States.

EMORD CHALLENGES COMMISSIONS MOVE TO EXPAND OTC DRUG CATEGORY TO INCLUDE HERBS

I'd like to direct your attention to the website of attorney Jonathan Emord (http://www.emord.com). There, at http://www.emord.com/dietary.htm, you will find a legal brief filed on behalf of:

AMERICAN PREVENTIVE MEDICAL ASSOCIATION;
NATIONAL HEALTH FEDERATION;
TRACE MINERALS RESEARCH, L.L.C.;
HEALTHY DIRECTIONS, INC.;
MEDITREND, INC. DBA PROGENA PROFESSIONAL FORMULATIONS;
PURE ENCAPSULATIONS, INC.;
JULIAN M. WHITAKER, M.D.;
CHARLES B. SIMONE, M.D., M.MS.;
HARRY G. PREUSS, M.D., F.A.C.N.;
SHARI LIEBERMAN, PH.D., C.N.S.;
DURK PEARSON AND SANDY SHAW

The brief was filed as comments to the Presidentially Appointed Commission on Dietary Supplement Labels and the joint commenters have thrown down the gauntlet against the Commission which, in their draft report, far exceeded their statutory authority under the Dietary Supplement Health and Education Act of 1994, by (among many other things) illegally advocating the expansion of the OTC drug category to include herbs.

Nature's Way wants the OTC drug category expanded to include herbs, and so do their partners, Madaus AG and Schwabe, two of Europe's largest phytopharmaceutical companies.How many NNFA, UNPA, and AHPA companies have formed offshore alliances in an effort to get close to sources of money and patents in an effort to "GATT proof" themselves? We may never know. Are the smaller members of these trade association aware of the harm that result to their business if we allow the line between food and drugs to be blurred? As will be discussed below, this push for an expansion of the OTC category creates a blurring of the lines between foods and drugs which is not in the best interests of American consumers, or of American business, and is worthy of very close scrutiny.

DSHEA- WHO IS PROTECTED, & WHAT REALLY HAPPENED?

Many Americans remember the "Save Our Supplements" campaign paid for by Nature's Way, as well as the drive to pass the Dietary Supplement Health and Education Act of 1994, (DSHEA) and the ubiquitous brochures, ads, and pitches for money from Citizens for Health (CFH), attempting to motivate one and all to line up behind the drive to pass legislation protecting our access to dietary supplements and herbs. Is DSHEA really protecting us? [detailed analysis of DSHEA below.]

THE MECHANISMS OF DECEPTION

Repressive guidelines have already been implemented in countries like Finland and Norway where vitamins have extremely limited availability, are very expensive and can only be sold at RDA dosages. For example, Ron Birckhead reports from Norway that a bottle of vitamin C, sold at the maximum legal dosage level of 200 mgs, costs the equivalent of over $100./ bottle. No one in Germany can get vitamin E at 800 IU potency without a prescription. Anyone shipping vitamin E at 800 I.U. from another country to a friend or relative will have the supplement either returned or destroyed.

DSHEA created the illusion that what happened in the Nordic countries and Germany will not happen in the US, however DSHEA is giving both Americans and Canadians (whose proposed so called "third category" is patterned after it) false hope, because according to the Food and Drug Administration (FDA), international harmonization with the Codex standards is the goal of the U.S.A. The FDA's intentions are clearly spelled out in their Internet web site:

"FDA plans to amend its regulations and procedures for consideration of standards adopted by Codex. This action is being taken to provide for the systematic review of Codex standards in order to enhance consumer protection, promote international harmonization and fulfil the obligations of the United States under international agreements."
(http://www.fda.gov/ola/319.htm)

Also, in the Federal Register, the FDA published an Advanced Noticed of Proposed Rulemaking titled "Consideration of Codex Alimentarius Standards" (62 FR 36243, July 7, 1997) Docket No. 97-N0218, RIN 0910-ZA01. How many Americans have read this? I have, and so have respected scientists and vitamin manufacturers Durk Pearson and Sandy Shaw who have drafted extensive comments which warn the FDA to keep their hands off our supplements! Comments are due on October 6. (Pearson and Shaw's comments will be posted in the IAHF website.)

DSHEA- THE BIG LIE EXPOSED

Murdock truthfully asserts that Nature's Way heavily funded the drive to pass the legislation DSHEA, but WHOSE VICTORY WAS IT????

Three "Trojan Horses" were installed into DSHEA, which give us far less protection than most people think they have. They were designed by Congressman Waxman (and apparently by large vitamin companies that "negotiated" with FDA as a win-win) to regain the upper hand at a future time, after the public was lulled into a false sense of security. (If this were not true, why would NNFA make the effort they made to block the introduction of a Senate companion bill to HR 1951, which would have allowed us to make therapeutic claims on dietary supplements?)

The 3 Trojan Horses were:

(I) SIGNIFICANT SCIENTIFIC AGREEMENT

This so called "standard" is not defined, and can't be defined, it is a tautology-- but thats fine with the FDA because they were given it under DSHEA, and they arbitrarily use it to block any truthful claim, at any time, regardless of how much scientific evidence backs it. FDA used "significant scientific agreement" to block the claim that folic acid prevents neural tube defects, despite the fact that this claim had already been approved by the US Public Health Service two years before. (FDA's food dragging caused 7,500 children to be born with Spina Bifida, a horrible crippling birth defect. It is estimated that 50% of these cases could have been prevented, if FDA had approved the claim in a timely fashion so that women could have learned about folic acid's protective benefits, at the point of sale, from the label.

(II) FDA GIVEN RIGHT TO DRAFT NEW GMPs : HAACP REGS THREATEN ALL BUT THE LARGEST VITAMIN AND HERB COMPANIES

DSHEA handed the FDA a huge weapon to use against the dietary supplement industry. They were given the right to draft new Good Manufacturing Practice Regulations for the whole industry, and as I write this they are in the process of drafting these regulations which will clearly favor the larger vitamin companies, while many smaller companies whose quality control has been excellent, won't be able to afford to deal with the bureaucratic red tape.

Murdock makes the following misleading statement about GMPs in his rebuttal to me: "The Facts Are: DSHEA permits FDA to establish Good Manufacturing Practices (GMPs) for dietary supplements based on food GMPs. This was explicitly put into DSHEA to prevent FDA from proposing any type of drug-related GMPs for dietary supplements. Apparently Mr.Hammell does not know that vitamins, minerals, and herbs have been regulated under food GMPs for the past 40 years."

Of course I know that supplements have been under food GMPs for many years, but they have NOT been under HAACP regulations, and this is what FDA now intends to shove down our throuts as a result of the weapon handed to them through DSHEA! What you need to examine here are how high the FDA is setting the hurdles when it comes to being able to comply with the GMPs, and who will be able to clear the HAACP hurdles? Will small to mid sized companies be able to afford the cost of compliance? Nature's Way may clear these hurdles, but what about the small companies?

In his comments to the Commission on Dietary Supplement Labels at http://www.emord.com/proposed.htm, attorney Jonathan Emord discusses HAACP regulations as being necessary for both the food and pharmaceutical industries (where they are used), but states when applied to the dietary supplement industry, which has a history of being far safer than either the food, or pharmaceutical industries, HAACP constitutes gross bureaucratic overkill.(In Emord's comments below, proposed "CGMPs" are "current good manufacturing practices" (HAACP regs) especially note his 5th and 6th points:

"The Joint Commenters oppose adoption of the proposed CGMPs for the following reasons, explained in detail herein: (1) the dietary supplement market is far safer than the food and drug markets, militating against reliance on CGMPs in the former; (2) brand name recognition, private certification, and products liability already provide safety and quality assurance in the dietary supplement market; (3) the proposed CGMPs are a disproportionate response to a market in which safety is the norm and harm occurs in extremely rare, isolated, readily identifiable instances; (4) existing FDA adulteration and misbranding regulations and state and local health regulations provide adequate protection for the public; **(5) the proposed CGMPs will benefit large dietary supplement companies and harm small ones by substantially increasing costs of production (and imposing a disproportionate burden upon them); **(6) the proposed CGMPs will increase the cost of dietary supplements and substantially reduce innovation to the detriment of consumers without increasing relative dietary supplement safety and quality; (7) the "one-size-fits-all approach" of the proposed CGMPs lacks scientific and economic merit given the extraordinary diversity of ingredients and forms of dietary supplements in the market; (8) the proposed CGMPs suffer from fatal ambiguities that provide inadequate guidance to agency inspectors and invite arbitrary and capricious enforcement; (9) the agency lacks resources necessary to enforce the proposed CGMPs adequately; (10) the proposed CGMPs will not affect those few who currently violate the law by producing adulterated and misbranded products; and (11) the Dietary Supplement Health and Education Act (DSHEA) creates a presumption in favor of the safety of dietary supplements and precludes adoption of procedures requiring manufacturers to prove safety in the absence of evidence of harm."

Klaire Laboratories of San Marcos, CA is the first vitamin company in the world to manufacture hypoallergenic vitamins for people with chemical sensitivities and food allergies. They are a small company, but their quality control is second to none. Is it fair that FDA is going to be forcing them to hire a lot of new employees that they may not be able to afford, just to be able to deal with the unnecessary red tape imposed by HACCP regulations? A lot of good companies are about to be driven out of business by this red tape. Nature's Way may have won here, but consumers and small vitamin and herb companies have clearly lost.

Emord clearly illustrates that HACCP regulations will favor large vitamin companies (such as Nature's Way) over smaller companies that will have difficulty absorbing the costs. He also clearly demonstrates that HACCP regs are not necessary for the dietary supplement industry, which is much safer than BOTH the food and pharmaceutical industries.

(III)THE COMMISSION ON DIETARY SUPPLEMENT LABELS
THE BIGGEST TROJAN HORSE INSIDE DSHEA- EXPOSED BY EMORD and HARRIS

This was the biggest Trojan Horse of all inserted into DSHEA. The Commission was charged with examining ways for consumers to have access to a greater volume of health information at the point of sale, through labels and labeling. Attorney Jonathan Emord submitted comments to the Commission in the form of a legal brief in an effort to hold their feet to the fire. (See www.emord.com) Emord stated in his comments that the Commission failed to properly discharge their duties, and stated that entire sections of their draft report would have to undergo radical change, (including the part about expanding the OTC drug category to include herbs) because the Commission has grossly exceeded its statutory authority. Emord went on to state that any FDA rulemaking, or legislative efforts based on the Commission's report as it existed in draft form, would be illegal.

The Commission was stacked against consumers, who had no representation on it at all. The executive director, Ken Fisher, Ph.D., has worked at FASEB his whole career. Most of the work FASEB does is subcontracting for the FDA, right there inside the beltway. They might as well be part of FDA, and Fisher was tracked right in to the FDA's agenda as he oversaw the drafting of the Commission's report. Sadly, he wasn't the only plant. Another was Margaret Gilhooley, a former FDA attorney who currently teaches law at Seton Hall University. Consumers had zero representation on the Commission.

Emord states that the Commission totally failed to address the problem of FDA prior restraint against the making of truthful claims, such as the example provided above regarding folic acid. Since the Commission upheld the so called "Significant Scientific Agreement" standard, consumers STILL aren't being protected as FDA can arbitrarily block access to lifesaving information.

Emord put forth a solution: have a split label in which the FDA can state what they want on half, and the manufacturer can make their validated claim on the other half. Emord envisioned a 5 tiered gradation of claims, with 1-3 having increasingly more validating evidence in the form of peer reviewed studies, with a #4 claim being FDA approved, and a #5 claim being approved by some other governmental, or educational body such as the US Public Health Service, or a University.

WHAT NATURE's WAY SHOULD BE DOING

Rather than push for the expansion of the OTC category to include herbs, I wish Nature's Way (and all 4 vitamin trade associations) would put their energies directly behind CONSUMERS by directly supporting the First Amendment Suit against the FDA which has been filed by Emord and Associates. When we win this suit, FDA won't be able to stop us from making therapeutic claims on dietary supplements.

The firm has filed suit on behalf of Durk Pearson, Sandy Shaw, the American Preventive Medical Association, and the National Health Federation against the Food and Drug Administration challenging final regulations promulgated under the Nutritional Labeling and Education Act that impose a blanket ban against health claims on labels and in labeling of dietary supplements and that prohibit the communication of truthful and nonmisleading health information on the benefits of antioxidant vitamins and omega-3 fatty acids. The case is pending for decision before the Hon. Judge Gladys Kessler of the United States District Court for the District of Columbia. Information about this lawsuit can be found at http://www.emord.com/lawsuits.htm#LS.

HARRIS EXPLAINS HOW THE EXPANSION OF THE OTC DRUG CATEGORY WILL HURT AMERICAN CONSUMERS AND SMALL MANUFACTURERS UNDER EMERGING INTERNATIONAL LAW

In my website at http://www.iahf.com/cdsl-su2.html you will find the Law Loft's comments to the Commission which examines from a standpoint of emerging international how a pharmaceutical takeover is being fostered by expanding the OTC drug category to include herbs.

People had better look at the European Commission's Discussion Paper "Addition of Vitamins and Minerals to Foods and Food Supplements" on which the comments period ended September 30, 1997. Suzanne Harris explains:

"So far, since the promulgation of EEC 65/65, dietary supplements have technically fallen within the classification of drugs in the EU since they have preventive and therapeutic effects. Moreover, EU law supersedes the laws of the individual countries that are members of the EU. In other words, the nations that are members of the EU are free to promulgate their own laws on particular subjects unless and until the EU issues a "directive" on the topic and removes the right of the individual counties to legislate for themselves in that particular area.

"In an increasingly global marketplace, what happens in any large market like the EU is of interest because it has commercial implications for our own companies and indirectly for our own ability to access dietary supplements. If European products can monopolize the European marketplace because dietary supplements are classified as drugs, obviously our companies lose market access.

"Conversely, as the EU products enter the US market as drugs, the EU products will be better able to compete here than domestic products because as drugs, they will be labeled with preventive and therapeutic use indications. (While this process is not complete, it is definitely happening. The European-American Phytomedicines Coalition has already petitioned the FDA for OTC drug status for European products, and the Commission on Dietary Supplement Labels will be recommending the expansion of the OTC drug category as a result." (See comments submitted on August 4, 1997 by the European-American Phytomedicines Coalition to the Commission on Dietary Supplement Labels. Comments were filed by their multinational law firm: Akin, Gump, Strauss, Hauer, and Feld, L.L.P. 133 New Hampshire Ave. N.W., Ste. 400, Washington DC 20036, 202-887-4000. They won't say who their clients are, but its not too hard to guess.)

IMPLICATIONS OF THE SPS and TBT AGREEMENTS

Harris explains that under NAFTA and GATT, foods are regulated under the "SPS" (Sanitary/Phytosanitary Measures) agreement, while drugs are regulated under the "TBT" (Technical Barriers on Trade) agreement. How is this significant? In international trade, risk/benefit analysis is used in evaluating products for safety. Much more stringent criteria are used to evaluate drugs, under the TBT agreement, than are used to evaluate foods under the SPS agreement.

Harris argues that OTC drug products with the ability to make therapeutic claims, will put smaller competitors (who can't afford to go through the OTC drug approval process), at a competitive disadvantage, eventually driving them out of business. This would also be hastened by small companies difficulties affording the cost of compliance with the new HACCP GMP regulations. How would the surviving companies (selling OTC drugs) fare in the international market, compared with how they'd do if their products were classified in the USA as foods?

By shifting products from the food category to the drug category, American companies lose protections that we would otherwise have in a trade dispute if another country attempted to block us from importing products to their country. If a product is being sold as a food, and another country, where the same product is regulated as a drug tries to block it from being shipped into the country, the American company could presently go before the Dispute Settlement Body of the World Trade Organization, and argue that the blockade is unscientific on a basis of risk benefit analysis under SPS. However, if the same herb product were a drug in the US, and another country tried to blockade it, they would have an easier time before the dispute settlement body because under TBT, the criteria for risk/benefit analysis is much stricter.

Thus, from a standpoint of American business interests in making international sales, it is to our advantage to keep herbs classed as foods. This is also to the consumer's advantage, because more companies can afford to compete in the marketplace, while only a few will be able to afford the cost of making OTC drug claims- and they would enjoy a competitive advantage, driving many smaller companies out of business- to the detriment of consumers.

Is Nature's Way hoping we won't see this?

For the full text of Harris's comments to the Commission:
http://www.iahf.com/cdsl-su2.html

RONA REPORTS ON PHARMACEUTICAL FRONT GROUP IN CANADA

In an article published in the Fall/Winter issue of The International Council of Health Freedom newsletter (ICAHF 5580 La Jolla Blvd, B429, La Jolla, CA 92307) Zoltan Rona, MD reports the following from Canada:

"In an article published by Dr. Robert Yuan and Dr. Jorg Grunwald (Genetic Engineering News, April 15, 1997), it is clear that a strong connection exists between pharmaceutical firms and the leading members of the Canadian Coalition for Health Freedom.

"Until recently, there has been much less interest in the much smaller US market. However, the optimistic projections for a future US market have led two German companies, Schwabe, and Madaus, to establish a joint venture in the United States called Nature's Way. The scientific data and manufacturing quality associated with German herbal products makes it likely that more American companies will enter into alliances, mergers and acquisitions with their German counterparts as this industry continues to grow." (More on this Genetic Engineering News Article Below.) [Note: Citizens for Health and CCHF are both funded by Nature's Way. Just as CFH is pushing for OTC drugs, CCHF is pushing for them north of the border.]

ARTICLE IN GENETIC ENGINEERING NEWS CHALLENGES MURDOCK'S VIEWS

Murdock attempts to disavow my view that there appears to be a German conspiracy to make all herbs into drugs stating that "The herbs that Madaus and Schwabe research and partner on with Nature's Way are sold in the U.S. as dietary supplements not drugs. In fact, both companies value the unique U.S. opportunity created through the passage of DSHEA which allows for their products to be freely sold with non therapeutic, structure function claims."

This may be true, but I suspect strongly that Murdock-Madaus-Schwabe (Nature's Way) is far more interested in profiting from the OTC drug market that they are pushing so hard to create. Many smaller herb companies will not be able to afford going through the OTC drug approval process, which would put them at a competitive disadvantage in the marketplace because they can't make therapeutic claims.

In the April 15, 1997 issue of Genetic Engineering News, in an article titled "Germany Moves to the Forefront of the European Herbal Medicine Industry" after citing figures which estimate the North American market in herbal products to be $1.6 Billion, (compared with a 7 Billion dollar European market) it states "Until recently, there has been much less interest in the much smaller US market. However, the optimistic projections for a future U.S. herbal medicine market have led the two major German companies, Schwabe and Madaus to establish a joint venture called Nature's Way in the U.S. Other companies like Lichtwer Pharma (a member of the Boerhinger Ingleheim Group) have subsidieries in the U.S. The scientific data and the manufacturing quality associated with German herbal products makes it likely that more American companies will enter into alliances, mergers and acquisitions with their German counterparts as this industry continues to grow."

The same Genetic Engineering News article discusses the meteoric popularity of Gingko Biloba, and St.John's Wort and says "Such developments have attracted the attention of major European multinationals- and include companies such as Boerhinger Ingleheim, Boerhinger Manaheim, and Bayer, that see the potential of what are called 'green pharmaceuticals.'

"Bayer's strategy was to jointly market their existing pharmaceutical antidepressant alongside their herbal counterpart, thus giving the physician the option of treating mild depression with botanical products (with few side effects) and severe depression with chemical products. The herbal product was obtained through collaboration with Zeller AG, which has a long history of collaboration with Ciba-Geigy (now Novartis). This pattern, in which major multinationals own or have strategic alliances with herbal medicine companies is likely to grow along with the market sector."

BAD NEWS FROM SOUTH AFRICA

In phone conversations with health freedom activist Stuart Thomson from South Africa, of PHARMAPACT (People's Health Alliance Rejecting Medical Authoritarianism Prejudice and Conspiratorial Tyranny) I'm finding that an identical front group to CFH has also been operating there. Thomson reported this on p.6 of the ICHF newsletter:

"Last November the Medicines Control Council declared its intention to regulate all natural health substances as medicines, its latest strategy to extend its oppressive jurisidiction over proactive means to natural health.

"Collaborating closely are most of the larger natural pharmaceutical companies dominating the Health Products Association in an effort to regain market dominance lost to increasing post-sanctions local and international competition."

"Nauseatingly, this is being passed off as being the result of democratic and representative negotiations with all roleplayers, whereas, in reality, pseudo-democratic structures dominated by financially and power-play vested, rather than consumer interests are being appended to a flawed regulatory system which will serve to increasingly erode consumer choice as restrictions limit the field to only the most affluent players."

Thomson has issued a constitutional challenge to the S.African government and is fighting the MCC in the courts to defend consumer access to supplements. (Stuart Thomson, PHARMAPACT, P.O. Box 247, Knysna, 6570, South Africa, Tel and Fax:(to call from N.America) 0112744577695. An article by Thomson will appear in an upcoming issue of Life Extension Magazine, which Murdock so desperately tries to discredit.

ROLL UP- IT HAPPENED IN THE AUTO INDUSTRY, IT HAPPENED IN THE PIZZA INDUSTRY, AND NOW ITS HAPPENING WITHIN THE DIETARY SUPPLEMENT INDUSTRY, BUT DOES IT HELP CONSUMERS WHEN MONOPOLIES FORM?

Is Murdock telling the truth when he asserts that Madaus and Schwabe value the opportunity for their products to be freely sold with non therapeutic, structure function claims?

MAYBE- but I suspect this to be a smokescreen. I suspect strongly that they put a much higher value on the chance to sell their products as OTC drugs where the profits would be considerably higher, and which would give them a competitive advantage over smaller companies that won't be able to afford the expenses involved with OTC drug approval. The April '97 issue of Natural Health Merchandizer reports on p.10 that Madaus AG is funding a $385,000 controlled clinical trial on echinacea at Bastyr University on echinacea, which Whole Foods magazine reports is the largest selling herb on the American market. While it is true that consumers can benefit from such research, it is also clear that Murdock-Madaus-Schwabe have designs on this market, and consumers will have to pay much more if they monopolize its sale.

If the price were right would Murdock-Madaus-Schwabe sell out to a multinational giant such as Boerhinger Ingleheim, Bayer, Hoechst, or Novartis? Dr. Rona reports that Quest Vitamins in Canada sold out to Boerhinger Ingleheim, and with roll up obviously occurring within the dietary supplement industry as pharmaceutical giants eyeball the entire industry trying to figure out how to deal with the thorn in their side, consumers can't be too careful.

PHARMAPRINT INC. SEEKS TO PATENT AND MONOPOLIZE HERBS

Murdock asserts that "Many overseas companies have been selling herbs in the U.S. as dietary supplements which may be regulated as drugs or traditional medicines in their own or other countries. There is no conspiracy to make all herbs into drugs."

Hmmm. Oh, really? Maybe this is why PharmaPrint, Inc. of Irvine California (traded on NASDAQ as PPRT) announced via PR Newswire on December 4, 1996 that the World Health Organization Collaborating Centre for Drug Monitoring announced "a global standardization program and a new technology that world health experts expect to bring effective herbal medicines into modern medical science."

The article goes on to state: "At a briefing here today, the WHO group announced a new technology called PharmaPrinting, which produces pharmaceutical versions of herbal medicines that previously could not be standardized, patented, clinically tested, approved by government agencies, prescribed by doctors nor reimbursed by governments or insurance companies."

So, Murdock says there is no conspiracy to make all herbs into drugs? PharmaPrint sure wants to try! They are traded on the NASDAQ stock exchange as PPRT, and seem bent on trying to improve on God with the stated intention of going right down the list of the world's most popular herbs and turning them all into "drugs," and they have the open backing of the (so called) World Health Organization, which is dominated by pharmaceutical interests and which jointly administers the Codex Alimentarius Commission (along with the Food and Agriculture Organization of the United Nations.)

The world's first IND has been filed by PharmaPrint Inc. on an herb- on Saw Palmetto - go to http://biz.yahoo.com/bw/97/08/05/pprt_y000_1.html to read the gory details on how PharmaPrint intends to "rake it in." The article begins as follows:

"Tuesday August 5 10:01 AM EDT
Company Press Release
PharmaPrint Submits With FDA Its First IND for an Herbal Pharmaceutical
IRVINE, Calif.--(BUSINESS WIRE)--Aug. 5, 1997--
Goal Is 11 Submissions For Pharmaceuticals Addressing Markets Estimated At $19 Billion

PharmaPrint Inc. (NASDAQ:PPRT) Tuesday announced it has submitted its first Investigational New Drug (IND) application with the FDA.

The company also announced its goal to submit approximately one IND per quarter during the next three years.

If the clinical trials associated with these submissions are permitted by the FDA and if they perform as expected by PharmaPrint, they could result in important new, natural pharmaceuticals addressing worldwide markets aggregating to more than $19 billion.

These potential new pharmaceuticals employ PharmaPrint's proprietary technology that, for the first time, makes possible standardization of multimolecule herbal medicines necessary for clinical testing, FDA review and third-party reimbursement. If approved, some of these new pharmaceuticals are expected to be available by prescription and others are expected to be available over the counter."

Phase II Drug Trials for Saw Palmetto were announced at http://biz.yahoo.com/bw/97/09/08/pprt_y0022_1.html PharmaPrint announced that "if a New Drug Application for a pharmaceutical derived from Saw Palmetto is approved the Company estimates the Pharmaceutical would capture a meaningful share of the current $1.3 billion global market for other pharmaceuticals that address symptoms associated with benign prostate hypertrophy."

After PharmaPrint spends millions to run Saw Palmetto through FDA's so called "approval process" in order to make the claim that it can be used to successfully treat benign prostate hypertrophy, how likely is it that they will feel comfortable with Saw Palmetto remaining on the market as a dietary supplement? Huge numbers of people world wide are using saw palmetto extract successfully to treat benign prostate hypertrophy. Should we REALLY have to jump through the regulators hoops in order to make therapeutic claims? Murdock thinks so, while attorney Jonathan Emord does not. Emord feels that we have a constitutional right to make truthful statements right now about these products, and he intends to take his case all the way to the Supreme Court.

With PharmaPrint loudly announcing its intention to license other pharmaceutical companies to use its patented technology, "roll up" can be expected to occur within the dietary supplement industry, and (UNLESS WE STOP IT) it will happen to the detriment of consumer as the resulting monopolies drive prices out of sight.

NATURE'S WAY FAVORS CANADIAN DRUG IDENTIFICATION NUMBERING SYSTEM- WOULD THEY WANT THIS SYSTEM IN THE UNITED STATES?

Murdock has openly stated to Marilyn Nelson of Freedom of Choice in Health Care in Toronto that he favors the Drug Identification Number classification system used in Canada because it "allows us to make claims." This system is hated by Canadian consumers and small manufacturers because it has driven up prices, and has driven a lot of small companies out of business.

(If Murdock favors DIN numbers in Canada, would anything stop him from pushing a similar system here? Are FOODS, "DRUGS"? Wasn't the idea of DSHEA supposed to be to keep dietary supplements and herbs classified as FOODS???)

CITIZENS FOR HEALTH CODEX "BACKGROUNDER" TOO SIMPLISTIC

In their "CODEX Alimentarius Commission BACKGROUNDER," Citizens for Health states that "the Codex Committee on Nutrition and Foods for Special Dietary Uses (CNFSDU) is charged with looking only at essential nutrients- several dozen essential vitamins and minerals such as vitamin C, E, calcium, etc. that are found in foods. The CAC doe not yet address the broad category of dietary supplements, which includes amino acids, concentrates, metabolites, and hundreds of other non-essential nutrients but potentially harmful ingredients. Herbs and botanicals will not be discussed by the CFNSDU. While there was some debate within the CNFSDU as to expanding the scope of their work to include herbs, such action was rejected by the NFSDU at the 1996 meeting in which Citizen's representatives participated."

While this is true, it is misleading because incomplete information is selectively being provided by which to assess this issue. For one thing, the only reason the Commission abandoned its plan to expand the scope of their work to include herbs was that massive grass roots pressure, especially in Canada, opposed this expansion. I generated the awareness of the Canadian proposal to create a special "panel of experts" which would have created a negative, or "no trade" list of herbs through public speaking I did in Canada, as well as through extensive networking with Canadians by phone, fax, and email. The Reform Party in Canada gained official opposition status through a good showing at the polls, in no small part due to my efforts to educate Grant Hill, a member of Parliament, whose party embraced the health freedom issue.

Regarding other dietary supplements beyond vitamins and minerals, you can't view the work of the Codex Commission in isolation. You must take a macro view of the pharmaceutical industry's takeover campaign or you won't understand it. While considering the work of the Commission, you must simultaneously consider EEC 65/65,(which classified foods as drugs in the EU), the European Commission's Discussion Draft titled "Addition of Vitamins and Minerals to Foods and Food Supplements" (which is being used to influence an EU wide vote on this issue in order to finalize things).

You must also view these events against the backdrop of the Commission on Dietary Supplement Labels final report (which has yet to be issued, but which pushes for the expansion of the OTC drug category.)

You can't ignore the Mutual Recognition Agreement between the USA and EU with its sectoral annexes covering GMP's for drugs and for food products. These MRA annexes empower European inspectors to act on behalf of FDA and vice versa. It is clearly the intent to harmonize, that is to make the US and EU food and drug law the same all across the board. (See the Agreement on Mutual Recognition Between the United States of America and the European Union at http://www.ustr.gov.index.html)

From this detailed analysis of the international campaign by the pharmaceutical industry to take over the dietary supplement industry, we can clearly see that Citizens for Health's analysis is too simplistic, but perhaps there is a reason it is. No one knows which companies are members of the European-American Phytomedicine's Coalition. All we know is that they filed comments to the Commission on Dietary Supplement Labels through a multinational law firm which has a Washington office, and we see from Harris' analysis that it would give German pharmaceutical companies such as Madaus, and Schwabe (and partner Murdock in the US) a competitive advantage in the American market if they could create an OTC drug category for herbs and botanicals.

IS MURDOCK CORRECT?

Murdock claims "We have no idea what "hand in glove" deal Mr. Hammell refers to. Nature's Way has no contact with HPB and certainly has not been working with the FDA. However, we have spent tremendous time and resources on passage and implementation of DSHEA, which was strongly opposed by FDA. It is unjust that our company, which sponsored and paid for the SOS Campaign (Save Our Supplements), spent countless hours on DSHEA, and gave generously to small retail groups and citizen groups which supported the passage of DSHEA, is not being singled out in such a malicious manner."

(Just exactly WHO is being protected by DSHEA? It helps the large vitamin and herb companies such as Nature's Way, but does it help small companies, and does it REALLY help consumers? From the analysis provided here, we hope you can now see a more complete picture.)

IS AMERICAN SOVEREIGNTY THREATENED BY HARMONIZATION EFFORTS?

The Genetic Engineering news article certainly does indicate that some German companies have a very strong interest in entering the N.American market, and so does Madaus funding of the controlled clinical trial on echinacea, which the October 1997 issue of Whole Foods magazine lists on p.24 as being the number one selling herb, with 11.93 % of sales in 1997. How many American herb companies could currently afford to enter the OTC drug market?

Consumers don't benefit when monopolies take over the dietary supplement and herb industries. Consumers benefit when there is healthy competition in the marketplace, and small companies aren't driven out of business by HACCP GMP regulations, and by foreign phytopharmaceutical companies wading into our market. DSHEA was not a victory for consumers, but it was a victory for those companies who can afford the cost of compliance with HACCP regulations, and who can afford to enter the OTC drug market. Some of these companies may survive despite PharmaPrint's efforts to patent herbs and to sell their patented technology to large pharmaceutical companies.

As Bayer, Hoechst, BASF, Rhone-Polenc and push to dominate this market, and as American food and drug laws are harmonized with the European Union's, will the German's eventually succeed in passing their draconian Codex proposal to restrict supplement levels to untherapeutic doses?

Is American sovereignty threatened by efforts to harmonize our laws with the EU? At http://www.thewinds.org/archive/government/eobf6-97.html you can download Parts one and two of an interesting article titled "Executive Orders: Bonfire for the Constitution" Quoting from the beginning of the article:

"On June 3, 1994, President Clinton signed Executive Order #12919 gathering together into a single document all the power and authority of a multitude of executive orders issued by preceeding presidents from John Kennedy on. Recent examination of this Executive Order has brought to light that the consolidation of previous presidential orders deliver unprecedented authority into the hands of the Chief Executive that exceed those powers granted him under the US Constitution.

Incorporated under the aegis of President Clinton's EO #12919 are powers originally claimed by President Kennedy in a series of Executive Orders signed into "law" in February of 1962 which, if invoked, would virtually suspend the greater portion of liberties guaranteed by the United States Constitution."

Will consumers be able to keep America from "harmonizing" its laws with the EU? Will Americans be able to stop this country from being forced into a world government run from Brussels? Will Americans continue having access to high potency vitamins and a wide range of affordable dietary supplements, or will our health freedom be destroyed like Finland's or Norway's? Time will tell. It is my hope that American consumers will wake up, and begin by getting the House companion bill to S.830 amended so that this "harmonization" process can at least have some citizen and congressional oversight.


John C. Hammell, legislative advocate
International Advocates for Health Freedom
2411 Monroe St. Hollywood, FL 33020 USA
jham@concentric.net
www.iahf.com
fax on demand 954-927-8795
fax 954-929-0507, 954-929-2905, 800-333-2553
(donations needed)