Supplement Consumers World Wide: PLEASE pay VERY close attention to the US FDA's BAN on Cholestin, a dietary supplement derived from Chinese red rice yeast which effectively lowers cholesterol.
Cholestin is manufactured by a company called Pharmanex. Pharmaceutical Giant MERCK has lobbied the FDA arguing that the product is a "drug" because it contains a naturally occurring substance that is similar to, but distinct from the drug lovastatin (which is marketed by Merck as "Mevacor.") (In addition to the substance which is similar to lovastatin, the red rice yeast also contains nine other active ingredients which undoubtedly make it synergistically much SAFER than Mevacor.)
Long time foe of the dietary supplement industry Bruce Silverglade of so called "Center for Science in the Public Interest" (an inside the beltway shill group for pharmaceutical interests) was quoted in the May 21st Washington Post as saying "What this case stands for is the proposition that just because a substance occurs naturally in the food supply doesn't necessarily make it a dietary supplement." "The distinction is important" says Silverglade. "Products like lovastatin treat dangerous conditions that should be monitored by medical professionals" says Silverglade. (When Silverglade makes THIS kind of statement, we had BETTER be ON GUARD! This guy has a LONG history of attacking dietary supplements as a stooge for the FDA, and he is ALWAYS widely quoted by the mass media. I've been battling Silverglade and so called "Center for Science in the Public Interest" since 1989, and have always thought they had a particularly Orwellian name.)
Bill McGlashon, president of Pharmanex told the Washington Times that the FDA is doing the bidding of the pharmaceutical industry, and in particular lovastatin maker Merck, which has been asking the FDA to take action. "The reason this whole thing began is because of Merck. Its REAL CLEAR what this is about," McGlashan said.
Pharmanex, makers of Cholestin is contesting FDA's action, and a hearing is scheduled for sometime this month (June) in Utah. I will be monitoring this VERY closely, and need YOUR help to do so.
FDA isn't requiring Pharmanex to remove the product from store shelves, but they have banned ADVERTISING for the product and are currently BARRING FUTURE IMPORTS OF THE CHINESE RED RICE YEAST EXTRACT because it competes with the sale of MEVACOR. Not even the FDA disputes the fact that Cholestin is safe, or that it effectively reduces cholesterol (!!) FDA's action against Cholestin occurred on May 20, and was announced the next day in the Washington Post, New York Times, and other papers. FDA is using cholestin as a test case in a campaign to attack ALL dietary supplements based on intended use!! If they beat Pharmanex in court, what will be NEXT???
Will Silverglade start suggesting OTHER targets for them to go after? I use the amino acid tyrosine as a natural anti depressant. Will some pharmaceutical antidepressant manufacturer request that the FDA ban it because it can be used to treat a medical condition which Silverglade feels "should only be dealt with by a trained medical professional?" (Make your own mental checklist of the supplements YOU take, and what Silverglade might say about THEM.) If you own a health food store, or are a manufacturer and belong to NNFA, UNPA, AHPA, or CRN CALL YOUR TRADE ASSOCIATIONS AND _DEMAND_ to know what they are doing to encourage a FLOOD of comments on this before August 27!
(The same goes for people doing network marketing: Call the front office of Enrich, Nature's Sunshine, Amway, etc, and DEMAND to know what they are doing- and if NECESSARY lobby them through the most powerful people in your organization. I am sick unto DEATH of network marketing companies which seem so DEATHLY afraid of driving away potential distributors that they often seem very disinclined to encourage this sort of grass roots action. They ALWAYS seem to have CLUELESS LAWYERS who collect a FAT paycheck, while not even REMOTELY being able to take a MACRO view of any of this. There tends to be a very DANGEROUS corporate ethic within multi level companies (and the industry on a whole) of not wanting to "alienate" the FDA, or of not wanting to "alienate" NNFA. If you have a huge downline, please take MY lead if the lawyers at your company start dragging their feet on this! Now is NOT the time for ANY of us to sit on our hands!
The FDA has strategically timed their current comments period on structure-function claims to end on August 27 (the end of the summer, when the largest possible number of people are on vacation and Congress is not in session, and the DEEPER we get into the summer, the HARDER it is for me to move ANYONE to action..... so I NEED YOUR HELP!
(We are once again battling FDA Standard Operating Procedure, remember the comments period on the Final Report of the Commission on Dietary Supplement Labels which ALSO ended at the end of August last year? I never take a vacation in August, because the FDA does this EVERY YEAR! They were prepared to take a HUGE BITE out of us, and we only slowed them down a little when we FLOODED them with comments last year. Some of you I'm sure remember this.
The June '98 issue of Natural Foods Merchandizer includes a poorly written article which does virtually nothing to facilitate the making of comments, and fails to discuss FDA's latest attack from an International context (which would assist the public and industry in assessing the URGENCY we currently face with ESCOP and CODEX breathing down our necks!!)
Most health food store owners receive Natural Foods Merchandizer, but there is very little in the article that would move these busy people to bother taking any action to alert their customers to the comments period. FDA is clearly attempting to usher in the Australian listings system through the herbal door-- they're heating things up once more over Cholestin-- in an effort to develop a test case against us, but your health food store isn't up in arms about this due to the degree NNFA and AHPA are currently being influenced by companies which are sleeping with the regulators.
I am going to need a LOT help from multilevel companies, anyone who can put me on the air, and by dedicated people who can assist me in rapidly spreading this mssg by any available means to do just 3 simple things before FDA's comments period ends on August 27:
1. Massively disseminate the attached comments period form letter to friends, neighbors, co-workers, health food stores, alternative doctors offices, and in addition to flooding it into the FDA,
2. Request that your health food store pressure NNFA into mounting a serious campaign over this. Your pressure in this regard is ESSENTIAL. Also, INSIST to the storekeeper of your local health food store that he should QUIT NNFA if they don't start endorsing HR 2868. Even though this session of Congress is rapidly drawing to a close-- and we don't have time to so much as force a Hearing for this badly needed bill, we will obviously be forced to get the bill reintroduced in the next Congress- so the effort to educate Congress to the DIRE NEED for this bill remains.
Be sure to send a donation to Congressman Ron Paul, sponsor of HR 2868- he takes ZERO donations from the multinationals, and is one of the very FEW Congressmen we can trust. There hasn't been a man like him in Congress since the beginnings of this country. Both the Republicans and Democrats want to drive him from office because he is a Libertarian and refuses to kowtow to the DRUG TRUST.It took COURAGE for Ron to sponsor HR 2868. We BADLY NEED Ron Paul to get reelected! http://www.self-gov.org/ronpaul.html
Even when a bill doesn't move rapidly, just the ACT of getting a congressman to cosponsor a bill like HR 2868 serves as at least SOME deterrant to the FDA and FDA apologists such as Silverglade who are trying to maneuver in a political environment- so please don't EVER think your efforts to help me keep the wolf from the door are wasted! Less than 5% of all bills that are introduced get signed into law, but we HAVE to take a stand on what we believe in, because the other side has their antennae out there, and BELIEVE ME, they MONITOR the progress of bills that would work against their vested interests, and HR 2868 can be a SERIOUS thorn in their side if we use it as a basis of educating our elected officials. (If you aren't familiar with the bill see the IAHF website.)
3. To assist you in grasping the URGENCY of our present situation, it is vitally important that more people visit the IAHF website in order to take a MACRO view of what we are facing in America, by gaining sufficient awareness to be able to SEE the pharmaceutical takeover pattern! It is VITALLY important that more people join this email list, and that you continue making donations to assist IAHF so that we can be in YOUR corner the way we need to be. A pivotal health freedom battle is currently raging in S.Africa. It is essential that you pay attention world wide because unless more people can come to SEE the international PATTERNS of Pharmaceutical/Regulatory SUPPRESSION of natural products, FDA and their fellow regulators world wide will soon be CARVING US UP LIKE A CHRISTMAS TURKEY.
Form Letters Follow: Use them as PHONE SCRIPTS to call Congress via US Capital Switchboard at 202-225-3121. The toll free numbers to the Switchboard are frequently disconnected because they are paid for by private groups which absorb enormous phone bills til they can't keep it up, so I hesitate to give out any more 800 numbers for the switchboard unless also accompanied by this 202 number. The last 800 number to the switchboard that I was giving out is no longer good. Does anyone know a current 800# for the Switchboard?
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 Acceptence 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 "signficant scientific agreement" standard, what CDSL should have done as to define what kinds and combinations of studies validate claims based on signficant 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, 2411 Monroe
St.Hollywood, FL 33020 www.iahf.com, jham@iahf.com, fax 954-929-0507, 800-333-2553
To The Honorable______________________________
United States House of Representatives
Washington,DC 20515
Dear Representative_______________________________,
Simply changing "or" to "and" two times in the Federal Food, Drug, and Cosmetic Act (FD&C Act), and adding three words "other than food" in the appropriate places will greatly increase health freedom in the United States.
FIRST: The present definition of the term "DRUG" in the FD&C Act is so overly-broad that it includes foods, herbs, and dietary supplements. The present flawed definition reads: "The term 'drug' means articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man..."
Congressman Ron Paul's simple 5 word bill would add three words "other than food" immediately following the word "articles" so it would read:
"The term 'drug' means articles, other than food, intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man..."
Adding these three words would exempt all foods (which include herbs and other dietary supplements) from being regulated as drugs by FDA. It would also prevent FDA from banning true health claims for these food products simply because they have not been cleared as "drug" claims by FDA.
Excellent scientific research in nutrition has been exploding in recent years which shows that herbs and other dietary supplements are safe and incredibly effective in preventing and mitigating many diseases. However,the flawed definition of the term 'drug' makes it a federal crime for the dietary supplement industry to give this true information to consumers as part of the label or labeling of herbs or dietary supplements.
Section 403 of FD&C Act protects consumers against false or misleading health claims for foods. It says: "Sec.403. A food shall be deemed to be misbranded if its labeling is false or misleading in any particular..."
This gives FDA tremendous authority over false or misleading labeling.
Second: By changing the "or" to an "and" it will set a much higher and more fair standard that FDA must meet before it can limit or ban the sale of herbs or dietary supplements by claiming they present an unreasonable"risk".
The Paul amendment will require the FDA to prove the risk is both significant AND unreasonable.
It is well known that FDA has a long history of hostility against true
health claims by the herb and dietary supplement industry. Under present
law, FDA can easily charge that a targeted food, herb, or dietary supplement
has a risk because there is admittedly a risk to some sensitive or allergic
persons from virtually every food, herb, or dietary supplement.
Name: ______________________________________ Date: _________________
Address: ___________________________________________________________
City: ________________________ State: __________________ Zip: ___________
Info provided by International Advocates for Health Freedom www.iahf.com, jham@iahf.com 800-333-2553
Will small to midsized dietary supplement companies and consumers survive the ongoing FDA/pharmaceutical alliance to drive you out of business by blocking your ability to compete in the marketplace with pharmaceutical companies? On April 24, 1998 the FDA issued a press release titled "FDA Proposes Rules to Make Claims for Dietary Supplements More Informative, Reliable and Uniform." The proposed rules will define the permitted and unpermitted label claims for dietary supplements, and clearly fosters pharmaceutical dominance of the natural products industry.
This week the FDA will be publishing an Advanced Notice of Proposed Rulemaking (ANPR) in the Federal Register, (which I'll send to you) and we will have 120 days, until August 22, to flood them with comments in opposition to their proposed rule.
We must view this ANPR in the context of the European-American Phytomedicines Coalition's efforts to push for the creation of a botanical review board at FDA. (Below we name EAPC's membership as it existed in '95)
The FDA states that the ANPR "will not affect the availability of these products or consumers access to them." I will demonstrate that this is a lie!
We will also be forced to work very hard to pass HR 2868, the Consumer Health Free Speech Act, (which removes food from the overly broad statutory definition of "drug" to allow therapeutic claims to be made on dietary supplements as long as they're true) or be faced with a very unlevel playing field favoring pharmaceutical interests as the hurdles are raised to full ISO pharmaceutical standards, much as they are in Europe where the same bottle of saw palmetto extract which costs $15. in the USA costs $49 abroad.
The FDA's ANPR can't be viewed in isolation if it is to be properly understood. I'm telling you this now because European American Phytomedicine Coalition influenced propaganda published in supplement industry publications and newsletters will undoubtedly attempt to mislead you. Big bucks are at stake, and some in our midst appear to have sold out. Some companies in our midst could survive a move to full ISO pharmaceutical GMPs, and are licensed by the FDA right now to manufacture OTC drugs... but are YOU?????
Dovetailing with this, sometime in May, the US-EC Mutual Recognition
Agreement which will harmonize pharmaceutical GMPs is scheduled to be signed.
In the EC, dietary supplements are regulated as "drugs" and we must inform
Congress that dietary supplements and herbs must be specifically exempted
from the harmonization language of this MRA. The press release on this
MRA can be viewed at <www.eudra.org/emea.html > (This MRA would undermine
the successful effort spearheaded by IAHF last October to get dietary supplements
exempted from the harmonization language in the FDA Modernization Act of
1997 aka the "FDA Reform Bill" The American Preventive Medical Assn. presented
IAHF with an award for our efforts on Capital Hill which led to that victory,
but will it stand??)
The FDA's release, (which follows my report), was issued in response to recommendations from the Commission on Dietary Supplement Labels, and proposes to define certain permitted and prohibited types of labeling claims for dietary supplements. Their proposal defines "the criteria for the structure-function claims that DSHEA permits and the disease claims that it prohibits, and provides examples from both categories." "The proposal also describes various means- such as product names, vignettes, graphics and citations- by which a dietary supplement could make or imply a disease claim prohibited under DSHEA." (This threatens to force many label changes on products currently carrying names that imply therapeutic claims, but is this FAIR, and should we TAKE IT?)
(The full FDA press release follows my statement, along with a form letter to pass HR 2868 as a means of countering FDA's effort to create an unlevel playing field. The bill and additional info can be viewed at <www.iahf.com/usa/index.html#hr2868>
HR 2868 removes food from the overly broad statutory definition of "drug."
It will allow any company to exercise their first amendment right to make
a therapeutic claim on a dietary supplement as long as its true. The EAPC
doesn't want you to be able to do this, because they want to grab market
share.)
Although there are some members on both the NNFA and Citizens for Health's boards who know the truth, are GENUINE health freedom fighters, and who are for HR 2868, their hands are tied and your help is needed so that they can ACT in your behalf! They need to hear YOUR support for this bill, or they will be BLOCKED from defending your rights!
You won't currently learn the truth about what is going on through either NNFA or Citizens for Health due to the influence of the European American Phytomedicines Coalition on their boards. This powerful pharmaceutical coalition has been suppressing the truth, and they've been engaging in massive spin control against my message, exerting considerable influence over numerous industry publications.
The EAPC which has influence within these Boards consists of Boerhinger
Ingleheim (Germany), Murdock-Madaus-Schwabe (Germany-USA), Lichtwer Pharma
GmbH (Germany), Lichtwer US (USA), Bioforce (Netherlands, Switzerland,
USA), Pharmaton S.A. (Switzerland), Indena (Inverni Della Beffa, S.p.A.-
Italy),R.P. Scherer (USA and UK),Sunsource Health Products, Botanicare
Products, RP Scherer (UK-USA), Institut Henri Beaufour (France), and the
Utah Natural Products Alliance (Loren Israelson). This information was
taken from comments submitted by the EAPC to the FDA in '95, and they may
have grown in size since then.
To better understand the threat posed by FDA's press release it is necessary to visit the ESCOP/BIOMED websites, which can both be reached through Phytonet at <www.exeter.ac.uk/phytonet/welcome.html>These programs are funded by the EU, (read "Drug Trust"), and they state that their mission is to "harmonize the laws throughout the EU and the world" with regards to the regulation of herbal products. They brazenly state their intention to force the world to adopt full ISO (pharmaceutical) GMP standards (which many quality companies can't afford, can you?????)
It is noteworthy that the only two manufacturing members of the BIOMED scientific committee are Madaus AG, and Schwabe. These are Nature's Ways German partners and Murdock-Madaus-Schwabe are in the EAPC).
Along with this, be aware that the US Patent Office has been violating international law by issuing a growing number of use patents on dietary supplements and herbs. The government of India recently challenged an illegal patent that was awarded by the US Patent Office to the University of Mississippi on Turmeric for the treatment of wound healing. (Turmeric has been used for this purpose for thousands of years, so this is hardly a novel "invention" (!)
Pharma Print Inc. of Irvine CA is currently in Phase 2 Controlled Clinical Trials to evaluate saw palmetto in the treatment of enlarged prostate glands.
If FDA approves their Saw Palmetto for this use, they will be the only
company allowed to make this claim, which is unfair to us all! Pharma Print
(traded on NASDAQ as PPRT) has announced big plans to patent the worlds
most popular herbs and to license major pharmaceutical companies to use
their patented technology which can measure all the active constituents
in a herb for standardization purposes. (Is "standardization" REALLY an
improvement on the synergistic combination of active ingredients present
in any quality whole herbal formula? While it may insure batch to batch
consistency for SOME ingredients, does it insure that quality herbs went
into the product in the first place? Are a lot of high quality companies
which don't sell standardized products about to be driven out of the market?
If you still need some more convincing as to what is going on, download "The European Phytomedicines Market: Figures, Trends, Analysis" by Jorg Grunwald, Ph.D. who is the Director, Medical-Scientific Department, Lichtwer Pharma GmbH, Berlin, Germany. He outlines the whole takeover very matter of factly as if he considers it to be a "done deal." The article can be downloaded from <www.healthy.net/Library/jou.../1995/Summer/features/phytomed.htm>
In his article, Grunwald provides us with a "Table 6: Acquisitions of
Phytomedicine Companies by Multinational Pharmaceutical Companies"
| Multinational Pharmaceutical Firm | Phytomedicine Company |
| American Home Products | Dr.Much (Germany) |
| Boerhinger Ingleheim | Pharmaton (Switzerland), Quest (Canada) |
| Boots | Kanold (Germany) |
| Bausch and Lomb | Dr.Mann (Germany) |
| Fujisawa | Klinge (Germany) |
| Johnson &Johnson/Merck | Woelm Pharma (Germany) |
| Pfizer | Mack (Germany) |
| Rhone Poulenc Rohrer | Natterman (Germany) |
| Sanofi | Plant Organ (Germany) |
| Searle | Heumann (Germany) |
| SmithKline Beecham | Fink (Germany) |
| Solvay | Kali Chemie |
| Discussed/Rejected: | |
| Sandoz | Madaus (Germany) |
The recent pharmaceutical efforts to dominate our industry began in Norway in the late 1980's when they harmonized their regulations to highly restrictive WHO guidelines which limit dietary supplements to only very low doses, slight multiples above RDA, while anything not having an RDA must be approved and listed as a "medicine" (for which you pay through the nose, IF what you want is even available.)
This so called "listing system" first appeared in Norway not long after ESCOP held its first meeting in Cologne Germany on June 18, 1989. It then spread throughout Europe, and to Australia (the first country to develop computer software to facilitate the registration process). To some degree the Australian listings system has been brought into Canada (in the form of Drug Identification Numbers) and now they are attempting to con them into bringing in the computer software which would lock them more firmly into the clutches of the multinational pharmaceutical companies such as Boerhinger Ingleheim, which is now referring to herbs as "green pharmaceuticals".
The same thing is also happening in New Zealand and S.Africa. (See the IAHF website). In Europe, the only countries still holding out are the UK and Holland, but pressure is being exerted there to force them into compliance with EEC 65/65, the European Commission Directive by which all dietary supplements are regulated as "drugs". (See the IAHF website.)
What we are seeing now through FDA's ANPR is an effort to force us to
harmonize our laws with the European Unions where dietary supplements are
regulated as drugs. Already, members of the American Herbal Products Assn
are being subjected to EAPM propaganda through the last issue of the AHPA
REPORT which extolls the (alleged) virtues of the Canadian DIN registration
system, and of the European system. The EAPM is hard at work on both sides
of the border, doing their best to influence the NNFA in the USA and the
CHFA in Canada. Now that you know who they are, it shouldn't be too hard
to see the writing on the wall if you don't take action NOW!
If you are a member of NNFA, or Citizens for Health, it is IMPERATIVE that you demand that their boards get behind HR 2868, the Consumer Health Free Speech Act. Please use the enclosed form letter as a guide to write your own letters for mailing, emailing and faxing to Congress. (All of this can also be downloaded off the IAHF website at www.iahf.org.) Please take this information to your health food store and show it to the manager. Tell him you insist that he take action, and that he inform NNFA and Citizens for Health that he wants these organizations endorse HR 2868,and actively work towards its passage! (If you are the manager of a store and need to talk with me, please call!)
Any member of Congress can be reached through the US Capital Switchboard at 202-225-3121. When you call, insist on two things: 1) That he cosponsor HR 2868 The Consumer Health Free Speech Act, and 2) also insist that dietary supplements be specifically exempted from the harmonization language in the US-EC Mutual Recognition Agreement Sectoral Annex for Good
Manufacturing Practices before the USTR/FDA signs the agreement in May.
Toll free numbers to the US Capital Switchboard are paid for by private entities and often change, but I will try to keep a current toll free number on my answering machine to reach the Capital Switchboard and on my website. The writing is on the wall. If we fail to take decisive action NOW, we will lose access to many herbs and other dietary supplements as pharmaceutical giants make their move to dominate our industry. What has happened already in Norway, and Australia, (and which is happening in Canada) could EASILY happen here, and WILL happen if we take this threat lightly.
IAHF will also send you the ANPR in the Federal Register as soon as it appears this week. Please email us if you would like to assist with the campaign to pass HR 2868 into law, and please visit the IAHF website for additional information on the international battle for health freedom. Codex isn't the only thing we are fighting now. Since we succeeded in getting herbs removed from the Codex deliberations via political pressure put on Chretien in Canada, ESCOP/BIOMED and ongoing harmonization present an equally large threat.
Badly needed donations can be sent to: IAHF 2411 Monroe St. Hollywood, FL 33020. My part time helper and I can be reached via www.iahf.com, email to jham@iahf.com, 800-333-2553, fax 954-929-0507
Form letter for HR 2868, and a copy of FDA's Press Release of April 24, '98:
CONSUMER HEALTH FREE SPEECH ACT
H.R.2868 NEEDS YOU AS A CO-SPONSOR!
To The Honorable______________________________
United States House of Representatives
Washington,DC 20515
Dear Representative_______________________________,
Simply changing "or" to "and" two times in the Federal Food, Drug, and Cosmetic Act (FD&C Act), and adding three words "other than food" in the appropriate places will greatly increase health freedom in the United States.
FIRST: The present definition of the term "DRUG" in the FD&C Act is so overly-broad that it includes foods, herbs, and dietary supplements. The present flawed definition reads: "The term 'drug' means articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man..."
Congressman Ron Paul's simple 5 word bill would add three words "other than food" immediately following the word "articles" so it would read:
"The term 'drug' means articles, other than food, intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man..."
Adding these three words would exempt all foods (which include herbs and other dietary supplements) from being regulated as drugs by FDA. It would also prevent FDA from banning true health claims for these food products simply because they have not been cleared as "drug" claims by FDA.
Excellent scientific research in nutrition has been exploding in recent years which shows that herbs and other dietary supplements are safe and incredibly effective in preventing and mitigating many diseases. However, the flawed definition of the term 'drug' makes it a federal crime for the dietary supplement industry to give this true information to consumers as part of the label or labeling of herbs or dietary supplements.
Section 403 of FD&C Act protects consumers against false or misleading health claims for foods. It says:"Sec.403. A food shall be deemed to be misbranded if its labeling is false or misleading in any particular..." This gives FDA tremendous authority over false or misleading labeling.
Second: By changing the "or" to an "and" it will set a much higher and more fair standard that FDA must meet before it can limit or ban the sale of herbs or dietary supplements by claiming they present an unreasonable "risk".
The Paul amendment will require the FDA to prove the risk is both significant AND unreasonable.
It is well known that FDA has a long history of hostility against true health claims by the herb and dietary supplement industry. Under present law, FDA can easily charge that a targeted food, herb, or dietary supplement has a risk because there is admittedly a risk to some sensitive or allergic persons from virtually every food, herb, or dietary supplement.
Name_________________________________
Date________________
Address_________________________________________________
City____________________________________State_______Zip______________
Information provided courtesy IAHF, John C. Hammell, legislative advocate
2411 Monroe St. Hollywood, Florida (33020) America
800-333-2553, fax 954-929-0507
www.iahf.com, jham@iahf.com
(Downloaded from www.fda.gov/bbs/topics/NEWS/NEW00637.html) This press
release will be followed sometime this week by an ANPR published in the
Federal Register, which I will forward to you, along with additional comments)
In response to recommendations made by the Commission on Dietary Supplement Labels, the Food and Drug Administration today proposed rules to give consumers better information about dietary supplements by making the labeling of these products more reliable and uniform. The proposal, which defines certain permitted and prohibited types of labeling claims for dietary supplements, will not affect the availability of these products or consumers' access to them.
In addition to the new proposal, the FDA today is also responding to the report of the Commission on Dietary Supplement Labels. (Separate fact sheets on the new proposal and the response to the Commission report are attached.) The Commission was an independent panel of experts mandated by the Dietary Supplement Health and Education Act of 1994 (DSHEA) and appointed by President Clinton to study and make recommendations on the regulation of label claims and statements for dietary supplements, including procedures for evaluation of such claims.
Under DSHEA, dietary supplements may carry "structure/function" claims -- claims that a product may affect the structure or functioning of the body -- but not claims that they can treat, diagnose, cure or prevent a disease.
Today's proposal defines the criteria for the structure/function claims that DSHEA permits and the disease claims that it prohibits, and provides examples for both categories.
The law allows, without FDA's authorization, claims that are truthful and not misleading about the effect of a dietary supplement on the structure or function of the body for maintenance of good health and nutrition. Under the proposal, such permissible structure/function claims can state, for example, that the product "promotes regularity," "helps maintain cardiovascular health," or "supports the immune system."
The proposal also identifies many types of so-called "disease claims" that are prohibited under DSHEA. In general, these claims state or imply benefits for a disease, which the proposal in part defines as any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, or system of the body that is manifested by a characteristic set of signs or symptoms. Under the proposal, dietary supplements that expressly or implicitly claim to diagnose, treat, prevent or cure a disease continue to be regarded as drugs, and have to meet the safety and effectiveness standards for drugs under the Food Drug and Cosmetic Act (FDCA). Examples of such prohibited disease claims for a dietary supplement include "protects against cancer," "treats hot flashes," and "reduces nausea associated with chemotherapy."
The proposal also describes various means -- such as product names, vignettes, graphics and citations -- by which a dietary supplement could make or imply a disease claim prohibited under DSHEA.
"Consumers want access to dietary supplements, but also need reliable information about the products they are consuming," said William Schultz, FDA's Deputy Commissioner for Policy. "By clarifying for manufactures what types of claims can and cannot be made on a dietary supplement label, this new proposal helps consumers make more informed and wiser choices."
Today's proposal and FDA's response to the Commission's report will be published next week in the Federal Register. The agency welcomes written comments and recommendations on the proposed criteria and other aspects of the proposal, and will accept such communication for the next 120 days. The agency will also accept written comments on its response to the Commission on Dietary Supplement Labels. All comments should be addressed to:
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WASHINGTON (Reuters) - The Food and Drug Administration (FDA) proposed new rules Friday that it said would make labeling clearer on herbs and supplements.
Under the proposals, manufacturers will be able to claim that supplements "promote regularity" or have other general benefits, but will not be able to make specific health claims, such as "cures cancer".
Claims that are truthful and not misleading will be allowed without the maker having to seek FDA authorization.
Under the proposal, such permissible claims can state, for example, that the product "promotes regularity," "helps maintain cardiovascular health," or "supports the immune system," the FDA said in a statement.
"Under the proposal, dietary supplements that expressly or implicitly claim to diagnose, treat, prevent or cure a disease continue to be regarded as drugs, and have to meet the safety and effectiveness standards for drugs under the Food Drug and Cosmetic Act (FDCA)," the statement added.
Examples of such prohibited disease claims for a dietary supplement include "protects against cancer," "treats hot flashes," and "reduces nausea associated with chemotherapy."
The proposal, which is open for public comment for four months, describes in detail how a product might make such prohibited claims, such as by using a certain name, graphics or "citations" .
"Consumers want access to dietary supplements, but also need reliable information about the products they are consuming," William Schultz, the FDA's Deputy Commissioner for Policy, said in the statement.
"By clarifying for manufacturers what types of claims can and cannot be made on a dietary supplement label, this new proposal helps consumers make more informed and wiser choices."
The proposals were written by an independent panel of experts called for under the Dietary Supplement Health and Education Act of 1984 (DSHEA) and appointed by President Clinton to make recommendations on the regulation of label claims and statements for dietary supplements.
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Friday April 24 11:34 PM EDT