Dave Hartley Still-Point Healing Services Web Page: http://www.ioa.com/home/davehart
-----Original Message----- From: [email protected] [SMTP:[email protected]] Sent: Friday, June 12, 1998 12:04 PM To: [email protected] Subject: FDA attack of product names that imply a therapeutic use John Hammel ([email protected]) sent to PLANETNEWS: IAHF Distribution List USA: WE ARE UNDER ATTACK!!! At the end of this front page NY Times article I have enclosed a form letter for use in deluging the FDA during their comments period on the proposed rule which would seriously limit structure function claims, as well as attack product names that imply a therapeutic use. ***TO DO: Download this NY Times article and my letter to your word processor and print them out. Deliver copies to all the health food stores in your area with instructions for them to bagstuff them. ***We MUST bury FDA with comments by the end of the deadline on August 27! Forward this to more people. Anyone can be on the iahf email list by sending email with the word "add" in the subject line. June 10, 1998, Wednesday FRONT PAGE: NEW YORK TIMES Section: National Desk DRUG REGULATORS MAKE PUSH TO REIGN IN HERBAL REMEDIES By SHERYL GAY STOLBERG Here at the base of the Rocky Mountains, in a region that is the heart of the nation's herbal and vitamin industry, a stainless steel contraption was hard at work on a recent morning, spitting out clear plastic capsules at the rate of 90,000 an hour. Each contained precisely 600 milligrams of a fine, brick-colored powder that Federal health officials are trying to ban. The powder, a pulverized strain of rice fermented with red yeast, is imported from China, where it has been consumed for 2,000 years, as an herbal remedy (it is thought to improve blood flow) and a food (it spices up tofu and makes a tasty marinade for duck and pork.) Then five years ago, William McGlashan Jr., a young California venture capitalist, learned that scientists in Beijing were studying red yeast rice for another reason: it seemed to lower cholesterol. Today, Pharmanex, Mr. McGlashan's company, sells the encapsulated red powder under the trade name Cholestin in 37,000 American stores,from health food outlets to the giant Wal-Mart chain. Mr. McGlashan calls Cholestin a dietary supplement. Officials at the Food and Drug Administration call it something else: an illegal, unapproved drug. On June 15, in the gray stone Federal courthouse in Salt Lake City, United States District Judge Dale A. Kimball will be asked to determine who is correct. The case is being watched as a pivotal battle between the agency, which is chafing at a 1994 law that left it almost powerless to regulate vitamins and herbal products, and the dietary supplement industry, which has been growing wildly since the law was passed. At issue is not whether Cholestin is dangerous; no one argues that it is. Rather, the agency contends that Cholestin has crossed the increasingly murky boundary that separates dietary supplements from drugs, because it contains an ingredient, lovastatin, that is the key component of a cholesterol-lowering drug. Pharmanex says the lovastatin occurs naturally in the rice and that Cholestin is more akin to a food than to a drug. The outcome of the case could be reflected in the medicine and kitchen cabinets of millions of American consumers, including many doctors and scientists, who have come to believe that ginkgo, echinacea and St. John's wort, among other natural remedies, are as important to good health as aspirin and antibiotics. Aside from the turf battle between the supplement industry and regulators, the dispute raises crucial questions: Is there a distinction between these herbal products, which may contain naturally occurring chemicals as potent as those in any drug, and the drugs themselves? Must products like Cholestin be subjected to the rigorous testing that drugs undergo? "You see more and more dietary supplements sold right next to duct and it is now trying to ban Cholestin. Agency officials say the 1994 law, restrictive though it is, gives them the authority to take Cholestin off the market, because it bars companies from bringing dietary supplements to market if they contain the same active ingredients as previously approved drugs. In passing the Dietary Supplement Health and Education Act, Mr. Schultz says, Congress did not intend for companies to skirt the drug-approval process by selling medicines under the guise of dietary supplements. Lawyers for Pharmanex, however, contend that Cholestin falls squarely within the intent of the 1994 law. "This product was specifically developed to be a dietary supplement," said Daniel Kracov, a company lawyer. "What the F.D.A. objects to is the fact that this product has a drug substance in it, in their view. You may object to that, but our response is: If you don't have a safety issue,don't go after these products." Whatever the outcome, Dr. David A. Kessler, the former Commissioner of Food and Drugs, says the agency's action will hardly make a dent in the rampant proliferation of herbal remedies that he says are ineffective at best and unsafe at worst. "Just walk into your pharmacy; it's out of control," said Dr. Kessler, who waged a bitter, unsuccessful battle against the 1994 law as commissioner. "Efficacy is now defined as what sells off the shelves. The agency is powerless." While the law was a disaster for regulators, it was a windfall for makers of dietary supplements and vitamins. After the act was adopted, annual sales of dietary supplements in the United States skyrocketed, jumping to nearly $12 billion last year from more than $8 billion in 1994,according to the Nutrition Business Journal, a trade publication. So furious has the growth been that one analyst, Matthew Patsky of the Boston-based investment banking firm of Adams, Harkness & Hill,said some of the biggest pharmaceutical companies were planning to sell their own herbal products. That worries Mr. Schultz, the F.D.A. deputy commissioner for policy. "If companies that would have tested their products and sold them as drugs are now going to not test them and sell them as dietary supplements," he said, "then we have lost information about the safety and efficacy of those products." Among the law's beneficiaries was Mr. McGlashan, a 34-year-old Stanford University business school graduate who studied Chinese history.With the aging of baby boomers, Mr.McGlashan saw a growing demand for natural medicines the Chinese have used for centuries. Mr. McGlashan says he had a vision for his business; he wanted to apply "pharmaceutical rigors" to the dietary supplement industry, using research to persuade consumers that Eastern therapies worked. In early 1994, he met Michael Chang, a former pharmaceutical industry researcher who had set up a plant to produce herbal medicines in Huzhou,China, near Shanghai. Dr. Chang scoured Chinese research for promising herbal products, identifying 5,000; the list was narrowed to 30. By early 1995, Pharmanex was born, with headquarters in SimiValley, Calif. Red yeast rice, called hong qu, was one its most promising projects. "We know hong qu has been used for centuries, but we don't know why it lowers cholesterol," Dr. Chang said. "We need to find out." The 1994 law, Mr. McGlashan said, made it worth investing in science. The company introduced Cholestin at the end of 1996, after nearly three years of study. Most recently,Pharmanex enlisted Dr. David Heber, director of the Center for Human Nutrition at the University of California at Los Angeles, to study the effects of Cholestin in adults with moderately elevated cholesterol. The study, financed by Pharmanex, compared the cholesterol levels of 42 adults who took 2.5 grams of Cholestin every day for three months with the levels in 41 adults who were given placebos. Dr. Heber said the total cholesterol counts of those who took the supplement dropped, on average, from 250 to 210. Dr. Heber dismisses the contention that red yeast rice is a drug; instead he calls it "a functional food." The same cholesterol-lowering ingredient in lovastatin, he notes, occurs in even higher concentrations in oyster mushrooms, commonly used in Asian cooking. And nobody, he said, is trying to ban mushrooms. However, Dr. Richard A. Friedman, director of psychopharmacology at New York Hospital-Cornell Medical Center, contends the current distinction between dietary supplements and drugs is based on semantics, not biology, and that both should be carefully regulated. "If there is a biologically active component in the supplement, to say it is not a drug is illogical because it will have a similar effect," he said.Companies like Pharmanex, he added, "want to be able to implant the idea in the public that the drug is medically beneficial" without the rigorous research. That kind of science, Mr. McGlashan admits, would cost far too much for a small company like his. Yet with a decent body of research behind Cholestin, he said, he at one time envisioned himself becoming the F.D.A.'s model for good behavior. Instead, he received a visit from F.D.A. investigators last year; the agency had received complaints that Cholestin contained lovastatin, both from a pharmacist and from Merck and Company, which makes Mevacor, the cholestorol-lowering drug, known generically as lovastatin. Shortly thereafter, Federal authorities impounded ten tons of red yeast rice. Then on May 20, the F.D.A. notified Mr. McGlashan that it considered Cholestin illegal, a move that led the company to ask for a hearing before Judge Kimball. "This case is going to determine the extent to which companies can imitate prescription drugs," said Mr. Schultz of the F.D.A., "and avoid the approval process." But Mr. McGlashan contends that the dispute is an economic one. Cholestin, he said, is intended for use by people who are too healthy for Mevacor. Merck, he contends, is trying to push Cholestin off the shelves- a charge denied by Jan Weiner, a company spokeswoman. While the court case is pending, Mr. McGlashan said, sales of Cholestin are booming. Even his mother called, he said, asking, "How am I supposed to get my Cholestin?" For now, Mr. McGlashan has no answer. Standing outside the low-pressure room where the encapsulating machine was spinning, a lab coat covering his royal blue shirt and Hermes tie, he looked a little wistful. The fine red powder being packed into the capsules, he said, was the last of his supply. ------------------------------------------------------------------------------------------------- FIRST AMENDMENT ALERT! COMMENTS DUE AT FDA BY AUGUST 27,1998 [Docket No. 98N-0044] RIN 0910-AA59 Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body; Proposed Rule and Dietary Supplements: Comments on Report of the Commission on Dietary Supplement Labels; Notice Submit written comments to: Dockets Management Branch (HFA-305) FDA 200 C. St. SW, Washington DC 20204, 202-205-4697 or send them to LEF Box 229120, Hollywood, FL 33022 Dept IAHF To Whom it May Concern at FDA: A Supreme Court decision on June 28, 1993 renders your proposed rule to limit manufacturers ability to properly inform the American public on the health benefits of dietary supplements utterly and completely illegal. (It puts Section 403 (r)(6) of the Food, Drug, and Cosmetic Act pertaining to structure-function claims in question, and it means that the so called Commission on Dietary Supplement Labels (whose advice you were following when you drafted your proposed rule) has utterly and completely ignored the Supreme Court Decision of Daubert v. Merrill Dow. (We hereby put you on notice that the Supreme Court is the highest court in America, and the Commission on Dietary Supplement Labels (CDSL), Congress, and the FDA are required by law to not only be aware of their decisions, but to abide by them when proposing new regulations such as this.) Under Daubert, the "General Acceptance Test" (an equivalent phrase to significant scientific agreement) was replaced by the Federal Rules of Evidence for admitting scientific testimony at a Federal Trial. As a Federal Agency FDA ought to formulate its proposed rules in accordance with this decision, but has failed to. Given the Daubert decision, rather than find in favor of the so called "significant scientific agreement" standard, what CDSL should have done as to define what kinds and combinations of studies validate claims based on significant scientific evidence. Rather than recommend arbitrary and capricious limits on health information provided at the point of sale through labels and labeling of dietary supplements, CDSL should have recommended the adoption of the "gradation of claims" proposal recommended in comments to the CDSL by Durk Pearson and Sandy Shaw, Jonathan Emord and Associates, International Advocates for Health Freedom, and many others. This proposal allowed for a gradation of claims, depending on the amount of evidence supporting them, and the consumer can then be in a position to make their own decisions- but you have no legal right to withhold truthful information, and your proposal severely BLOCKS our access to information that we need in order to make better health choices for ourselves and our families. In your proposed rule you say that it would be illegal to suggest anything but drugs to reduce nausea associated with chemotherapy. This is arbitrary and capricious. What about ginger to reduce nausea? What about co-enzyme Q-10 and vitamin E to reduce chemotherapy-induced heart muscle damage; melatonin to reduce chemotherapy-induced immune system damage; and n-acetyl-cysteine to reduce chemotherapy induced liver damage?? Since you are ruling it "illegal" to use the words "protects against cancer", you will also consider it "illegal" to use the words "protects against heart attacks." This means folic acid can be promoted to "lower homocysteine levels" but it would be "Illegal" to say that folic acid "protects against heart attacks" even though The New England Journal of Medicine (April 9, 1998) recommends the use of folic acid to lower heart attack risk (!!!) Since when did the FDA become the sole repository of truth? In light of the fact that your proposed rule is of questionable legality in view of the Daubert decision, I hereby call for its immediate withdrawal, and demand that my Congressman address this outrage by cosponsoring HR 2868 The Consumer Health Free Speech Act, which removes food from the current, overly broad statutory definition of drug. This will allow us to make therapeutic claims on dietary supplements, something which you have no legal right to block with this proposed rule. Now that I have appraised you of the Daubert decision, please let me know precisely how you intend to artfully dodge the law by utterly ignoring it? (cc to my Senators and Congressman) Signed:________________________________________ Date: _______________ Address:______________________________________________________________ City:___________________________________ State:____________ Zip:___________ Provided by International Advocates for Health Freedom www.iahf.com, [email protected], fax 954-929-0507, 800-333-2553 ****************************************** Donations Needed- Need Help to Keep Helper On International Advocates for Health Freedom John C. Hammell, Legislative Advocate 2411 Monroe St. Hollywood, FL 33020 USA 800-333-2553, 954-929-2905, FAX 954-929-0507, [email protected] http://www.iahf.com HERBS ARE _NOT_ DRUGS! HELP PASS HR 2868 THE CONSUMER HEALTH FREE SPEECH ACT!!! -- The silver-list is a moderated forum for discussion of colloidal silver. To join or quit silver-list or silver-digest send an e-mail message to: [email protected] -or- [email protected] with the word subscribe or unsubscribe in the subject: line. 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