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LIST: Ed Fry, Distributor for NOW Foods has done a terrific job here of responding to a poorly written editorial in the Townsend Letter for Doctors which was writtin by Editor Jonathan Collin, MD. I hope Dr. Collin pays close attention to what Ed is saying here, because he has his fingers on the pulse of what is happening in this industry more than anyone I know.

NOW Foods is a company that has truly conscientious people, including Ed working for them, and this fact is reflected by this well researched letter which provides more information on what is really happening right now in the supplement industry than anything I've seen in a long time.

From: Edward Fry
To: John Hammell jham@iahf.com
Subject: Response to Townsend Letter editorial Editor:
Date: Thu, 09 Dec 1999 12:26:39 -0800

Reading the editorial "Vitamins Inc. Cartel" was like reading the Swiftian "modest proposal" to eat our young as a means of resolving human population pressures. The editorial, however, lacked Swift's irony and wit, and certainly didn't read like satire.

The editor should travel to Germany to regard the kind of regulatory environment he seems to invite, one on bended knee to huge pharmaceutical interests. Since shortly after World War ll, big drug companies there have functioned as self-serving dictatorships.

By 1951 officers of defunct I.G. Farbin were returned to public life to run Farbin's daughter companies Bayer, BASF, and Hoechst for the good of the German economy. In 1946 these men had been convicted by the Nuremberg tribunal for crimes against humanity, but by ‘51 they were released in the name of fiscal expediency. For more on this visit Linus Pauling's cohort, Matthias Rath, M.D. at web site http://www.rath.nl/.

Why mention this? Because consumer access to a whole array of nutrients to which Americans have free access is verboten in Germany and much of the world. A basic nutrient we take completely for granted, like vitamin C, is available only in very restricted doses without prescription. Ditto the B vitamins. Most of Europe has followed the example of its most powerful economy and created similar regulations. This, of course, has all been done in the interest of "public safety," with Norway trumping even the "cautious" Germans, by forbidding vitamin C in any dosage form (C powder is still permitted as a food preservative) without a prescription.

Such regulation means that big drug companies have complete control of the nutrient market there, from production of basic raw materials to the marketing of finished consumer goods. The net effect is a limited supply of products and drug-like prices. Remember, we don't have socialized medicine to subsidize the cost of drugs and drug-defined products, as Europeans do. Reflecting the sentiments of former FDA officer, Gary Dykstra, drug companies abroad have assured that dietary supplements do not act as a "disincentive for the development of new drugs," (where the SERIOUS profits are).

"What's this got to do with us?" you ask. This couldn't happen here. You believe that? Read the National Academy of Sciences risk assessment proposal for nutrients http://www.nas.edu/, ordered and presented by the FDA with the assent of members of the U.S. vitamin industry at Codex Alimentarius meetings in, where else, Germany. These negotiations, under the auspices of the World Health Organization (WHO)/ Food and Agriculture Organization (FAO) of the U.N., are intended to set international standards to facilitate "free trade".

Guess who oversees, interprets, and enforces all this? None other than the WTO, with its vaunted Dispute Settlement Body, acting as the final arbiter. And guess who influences which way the WTO and DSB blow? No one in the public knows for sure, but based on past decisions, it would appear the biggest money blows strongest. Citizens and workers of the first and third worlds, and just about no person in any given community, standing on any given piece of earth, appears to count for much.

Why are key representatives of the vitamin industry giving their approval to a document that would limit the prescriptionless dosage level of niacin to 35 mg. (the "Lowest Observable Adverse Event Level" [LOAEL], thus averting dreaded, harmless skin flushing)? Key industry trade group officials say it's "the best science we have." This approach of evaluating nutrient safety was modeled on the way EPA evaluates toxics, and was dreamed up by a guy named John Hathcock, a former FDA employee, who now works for the Council for Responsible Nutrition. CRN was founded by long time members of the vitamin industry in the 70s, like Bill Thompson, who felt good science should be the foundation for the vitamin business. CRN's membership today is dominated by BIG drug companies.

Vitamin company people who "represent" the trade at Codex negotiations have no voting power. Only the FDA, as the sole U.S. government representative, votes. Members of industry are there to offer perspectives, and the prevailing view is that the NAS/ FDA Risk Assessment document has the best chance of mollifying the "international community," influenced and exemplified by the German position.

Why are vitamin big wigs all of a sudden so cozy with a position embraced by the FDA? As a thirty year worker in the vitamin industry, as distinguished from an owner or corporate executive, my view is that many supplement company owners and operators are poised to sell-out to really big corporate movers and shakers, which just so happen to be big drug companies. Corporate power and money are more despotic than ever before here in the take-over 90s. One might be considered crazy not to sell-out.

The Skolnick family walked away with $425 million in cash by selling Solgar to American Home Products/ Wyeth Ayerst division. There Solgar becomes a relatively small, but strategically valuable brand next to Centrum®, Premarin®, and part of a group whose sister division is chemical/ genetic ag giant, American Cyanamid. [The foregoing a matter of public record, and is not libelous.]

A commitment to optimizing human nutrition is fanciful or naive to cynics. The fact is, though the vitamin industry was once the target of big money-inspired regulatory assaults, it now sags under the weight of big corporate money. If you can't beat ‘em down, buy ‘em up.

If big money wins the battle of who makes consumer supplement products and how they are regulated, be prepared to witness a grinding down of products available without prescription, and watch for price escalation that makes today's "blue sky-profit" gimmickry look amateurish .
_____________________________

Additional Responses to the Editorial:

1) Nobody sane or honest is running "to Congress to ask that labeling requirements on vitamin products should be given free reign [sic]". Virtually every reputable vitamin company is complying with the latest FDA regulations. Those who believe otherwise need only speak with the companies spending millions of dollars to reformat labels to comply with FDA regs governing what can be stated on labels and how.

2) Despite what the editorial implies: the FDA has the power (without reasonable cause) to keep even safe products off the market , such is the scope of their authority. Free form, synthesized l-tryptophan is daily administered in significant doses to infants and the infirm in the form infant formula and parenteral feeding preparations. Yet, tryptophan is deemed dangerous, and is forbidden as a supplement for healthy adults, as a result of the Showa Denko fiasco. Tryptophan, a serotonin precursor, was safely used for two decades. In a sudden shift, it began to be made by a novel means by the company known to have caused the Minamata Bay disaster. Why did this not make it a target for more scrupulous inspection by the FDA at its port of entry? And how serendipitous for the maker of Prozac®, a serotonin reuptake inhibitor, was the coincidental introduction of Prozac® with the permanent removal of tryptophan from the market, thus eliminating a potential "competitor" that had been selling at an estimated value of $150 million annually .

3) Instead of directing garbled allegations at "proprietary vitamin manufacturers," a clear expression of outrage for admitted drug corporation perpetrations of conspiracy and price fixing would have been welcomed. The conspiracy to raise, fix, and control prices of vitamin raw materials compromised the health of countless people, particularly those requiring, but least able to afford, vitamin enriched foods and supplements. For nine years consumers AND consumer product manufacturers were defrauded and overcharged, yet the editorial somehow refers to the fact of raw material production by huge drug conglomerates as a basis for more stringently regulating smaller consumer product companies.

4) Should mislabeled, fraudulent, and potentially harmful products be removed from the market? Absolutely. Are regs in place that would sanction such enforcement? Yes, indeed. Yet, FDA too often behaves like a traffic cop at an intersection tallying, instead of ticketing, red light runners in order to build a case for more autocratic powers. FDA appears to have spent admittedly limited resources on media releases lamenting its lack of authority. It has sponsored studies by the private National Academy of Sciences, and traveled abroad to Codex meetings as the U.S.' sole, unelected voting representative, for the establishment TRADE standards and policies. In this latter role the FDA should be present in an advisory capacity to assure no weakening of its mission to protect the nation's food and drug supply. Its mission is NOT to facilitate "harmonization" of U.S. regulations to international TRADE standards.

5) If the editorial seeks to seriously discuss the corrupting influence of profit, it might better discuss the harmful activity begat by prodigious drug profits, which can be calculated in hundreds or thousands of percentage points, rather than the double digits of supplements. It might note that drug corporations are large enough to manipulate the crafting of the very regulations that govern their operation, the very laws that affect their ability to cross international boundaries with minimal regulatory interference (just enough to keep small, upstart competitors from emerging). It might mention that drugs have historically generated the greatest profits of any industry, an industry quietly acknowledged by its very administerers and proponents to kill over 100,000 U.S. citizens annually.

6) Would it be better to regulate supplements as drugs? Better for whom? By published, conservative estimates over 100,000 Americans die annually from appropriately prescribed and properly administered drugs ( drugs that ostensibly have been determined to be safe and efficacious). This is the equivalent of a 747 crashing every day, or of the deaths from two Vietnams every year. This figure doesn't include errors in prescription or administration leading to death. How would such a system assure greater integrity and safety of supplements, which today, with the exception of accidental iron over dosage, harm virtually no one?

7) No rational or honest purveyor of vitamins argues for freedom from regulation on the basis that nutrients are "natural". Someone with but a modest knowledge of the value of dietary supplements would argue instead that supplements, and the physiological molecules they contain, are safer by orders of magnitude than xenomolecular, pharmaceutical agents. Because supplements are also safer than the U.S. food supply, they , therefore, require less stringent regulations.

8) The remark that "ascorbic acid supplements are synthetic" could readily be interpreted by uninformed readers to mean that such supplements are made from petrochemicals or contain the kind of artificial (xeno-) molecules found in patent pharmaceuticals. While it is demonstrably true that co-nutrients found with vitamin C in nature contribute to ascorbate's value, only a fool or charlatan would argue that the vitamin C in oranges is chemically superior to the identical compound synthesized from sugar (food), which is how organisms biosynthesize it.

9) The editorial confused and failed to distinguish commonly marketed forms of natural (food) source beta carotene and vitamin E from the chemical versions of those nutrients manufactured by big drug companies. Natural beta carotene is always derived (commonly from micro-algae) amidst an array of other, natural, physiologically useful carotenoids. Natural source, vegetable oil derived, d- form vitamin E is chemically distinct from the synthetic dl- form, which does not exist in nature. There is ample evidence that chemically derived and isolated b-carotene and synthesized dl- vitamin E, act differently in vivo and are inferior to natural (food) source forms.

10) The muddled syntax and logic of the end of the editorial make it difficult to determine just how the editor justifies his intent that supplements be further policed. It's suggested that makers of pricey and profitable faux drugs (i.e., "so-called immune supporting agents") should be reined in for insisting that their products are natural. It is never made clear why natural molecules that are derived or processed from various sources by large concerns, and then "peddled as natural" require more regulation.

The final admonition is that vitamins, if adulterated, would seem to be in need of regulation. Again, the FDA can yank an adulterated product from the market in a heart beat. However, the implication that inexpensive readily translates to adulterated is not borne out by studies. There have been a number of different independent trials that have demonstrated that inexpensive supplements are no more likely to be deficient or adulterated than higher priced brands.

It's not difficult to identify dietary supplement makers who have mimic the profit strategies of drug makers, by wherever possible patenting ingredients, processing methods or uses. To maximize profits many have adopted the practice of developing formulations with suggestive, trademarked names, and grabbed a share of the kind of proprietary advantage and profits for which drug companies are famous. Is this praiseworthy? No, but if fraud or malfeasance is alleged, regulatory remedies presently exist. The FDA (or FTC) has but to enforce, instead of stumping for expanded powers. Beware revolving-door, large industry/ government bureaucrats concluding people need their protection.

Lastly, a tip from a long time vitamin insider: the fifty year standard in the industry has been the 100% mark-up. A manufacturer sells a product that costs $10 for $20 to a retailer. The retailer sells it for $40. A perusal of financial web sites shows that many name brand vitamin manufacturers are sticking with this this profit structure.

There have emerged manufacturing companies and retailers, however, that have determined that the market is now large enough to rely on velocity and volume of sales for bottom line growth. These companies are satisfied with quick nickels in place of slow dimes, i.e., food profit margins. There are reputable brands and retailers today selling vitamins at a 30 to 35% profit margin, not the traditional 50 to 70%. Price alone is not a test of quality.

If one buys a clearly labeled product from a company recognizable as being big enough to have a stake in doing things correctly and avoiding litigation, one should conclude their low-priced product to be what it says it is.

If such a company offers a product represented to be the product desired at an attractive price, it should be considered. Companies that have abandoned boutique profit margins, can and do give solid quality and value for the money. For companies that might be stupid enough to cheat, an approach that appears to preserve consumer access, while offering greater quality assurance than a drug oriented, drug influenced government bureaucracy, is that of the Dietary Supplement Quality Initiative. Everyone and, please, mister Editor, check out http://www.dsqi.org/.

Edward Fry Independent Representative NOW Foods

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IAHF:(International Advocates for Health Freedom) PO Box 625 Floyd, Virginia,24091, USA 800-333-2553, overseas: 540-745-6534, 540-745-6535 fax, http://www.iahf.com email: jham@iahf.com

Help Get a Codex Oversight Hearing:
Call Beth Clay at 202-225-5074

House Government Reform and Oversight Committee- See Codex Oversight Section of IAHF website for more info.

If You Belong to NNFA- Ask Them Why They Oppose Having a Codex Oversight Hearing, and Ask Why They Don't Enforce Article 14.3 in their Bylaws: (Conflict of Interest)

Ask why they don't kick Warner Lambert and the rest of the drug cartel OUT of NNFA!

Ask Why they endorse the NAS paper "A Risk Assessment Model For Establishing Upper Levels for Nutrients" when it is being used illegally by the FDA to break past the consumer generated impasse at Codex. [See Codex Oversight Section http://www.iahf.com]

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