Political Action Alerts
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Legislative Update - May 2004
compiled by Marc Sklar, L.Ac.
AHPA Writes "Open Letter" to Consumer Reports
The American Herbal Products Association (AHPA) has published an open letter to the editor of Consumer Reports magazine, in response to an article titled "Dangerous Supplements: Still at Large" in the May issue of that publication. The full text of the letter is printed below for review and comment.
* * * *
April 28, 2004
Letters to the Editor
101 Truman Avenue
Yonkers, NY 10703-1057
An article in the current (May 2004) issue of Consumer Reports titled Dangerous Supplements: Still at Large identifies ten herbal ingredients or constituents as too dangerous to be on the market. While some of the information provided in this article is accurate, much of it is exaggerated and some is false.
The American Herbal Products Association (AHPA) has no disagreement with Consumer Reports advice to avoid internal consumption of four of the identified herbal substances. The safety concerns associated with aristolochic acid, for example, are sufficiently well established to support removal from the market of any product containing herbs in which this compound occurs.
The article fails to report, however, that products that contain aristolochic acid are illegal. Contrary to the statement that until very recently the U.S. Food and Drug Administration (FDA) had not managed to remove a single dietary supplement from the market for safety reasons, FDA has used its current regulatory authority to identify products containing aristolochic acid as adulterated and adulterated products are illegal products. This was not news to AHPA when FDA took this action in 2000, and AHPA had provided information to its members regarding the potential substitution of species of aristolochia as early as 1997.
Similarly, AHPA agrees that comfrey should not be an ingredient in any dietary supplement unless the potentially toxic compound that naturally occurs in this plant is first removed. This has been our formal position since 1996, which was five years before FDA acted, again by identifying comfrey as adulterated. Both FDA and the Federal Trade Commission have since acted, under their existing authority, to remove from the market products containing comfrey.
Also, the herb germander has no legitimate place in the market, but it is disingenuous of Consumer Reports to fail to disclose that the company that was identified as offering this plant for sale also warns consumers not to use the herb without the advice of a healthcare practitioner and any knowledgeable practitioner (even if they have not subscribed to the magazine) will warn against its use.
In addition, AHPA and its members are aware of the concerns associated with oral consumption of pennyroyal oil, and have recommended that pennyroyal herb not be used by pregnant women. The dangers identified in the article for pennyroyal oil are not, however, necessarily relevant to the herbal products that were identified in the article.
At the other extreme, AHPA strongly contests the listing of skullcap as presenting a danger of abnormal liver function or damage. The only suggestion of such a danger was associated with an incident of misidentification of skullcap in a product that, in fact, contained germander and did not contain skullcap.
With regard to the other five herbs listed in this article, the evidence on each of these suggests that consumers who choose to use these products should be provided with information to assist them in making such choices. AHPA recommends, for example, that kava products bear a serious warning statement about the potential risk of liver toxicity that has been identified by FDA as rare. Though chaparral is not broadly sold, AHPA recommends that all such products also inform consumers of potential liver risks, even though such risks are based on similarly rare reports of side effects. In addition, many products that contain bitter orange caution consumers to consult with a healthcare practitioner prior to use. E
ach of these five herbs can be used with respect and with knowledge but that is true with every herb that is available as a dietary supplement. Respectful and informed use, however, is far from Consumer Reports advice to avoid all use of these herbs.
Michael McGuffin, President
American Herbal Products Association
Federal Acupuncture Coverage Act of 2003
HR 1477, sponsored by Congress Member Maurice Hinchey of New York, and co-sponsored by 42 other Congressional Representatives, would provide coverage for qualified acupuncture services under MediCare Part B and Federal Employees Health Benefits (FEHB) program.
This is the sixth incarnation of this legislation. Bills expire at the end of each Congressional Session, which last two years. The current 2003-2004 Session version of this Bill has been numbered HR 1477. As with previous versions of the legislation, this Bill is being held in committee, waiting for enough demand to move it. Specifically, we need one hundred co-sponsors to get the bill heard in committee.
CAOMA has been an active advocate for this important piece of legislation for years. As a result of our grass roots lobbying, nearly twenty Congressional Representatives from California have signed the bill as co-sponsors, making up the majority of support. We now have more cosponsors than the bill has ever had. CAOMA has expanded its attention nationwide, and is hoping that this is the year that we get 100 sponsors and this bill will move out of Committee. Simultaneously, we are actively working to get an identical bill introduced in the Senate.
· For more information on this issue please visit the Council of Acupuncture and Oriental Medicine Associations at www.acucouncil.org and The Acupuncture and Oriental Medicine National Coalition at http://www.aomnc.com/.
California Workers Compensation Reform
· Link to PDF full copy of bill http://www.leginfo.ca.gov/pub/bill/sen/sb_0851-0900/sb_899_bill_20040419_chaptered.pdf
· Summary of Reform - http://www.dir.ca.gov/chswc/SB899summary.html
Changes in the
2004 Workers Compensation System
Dear CSOMA Members and Colleagues:
May 5, 2004
SB 899: Workers Compensation
Legislative Impact on Acupuncture and Oriental Medicine
April 19, 2004: Chaptered by Secretary of State.
April 19, 2004: Approved by Governor.
April 16, 2004: Enrolled: To Governor at 12:30 p.m.
Greetings CSOMA Members and Colleagues:
I would like to clarify my last alert pertaining to the changes in the Official Medical Fee Schedule that seems to have caused a lot of confusion. Unfortunately it didnt take the powers that be long at all to get a new fee schedule up and running. As it is now, the fee for elecro-acupuncture was reduced to $70.11 and acupuncture to $52.00. I'm sorry that this caused some confusion.
Taking effect immediately, SB899 was signed into law by Governor Arnold Schwarzenegger on April 19, 2004. It changes the Workers Compensation system as it pertains to acupuncturists. Ill try to map out some of the pertinent changes as they relate to our profession.
· Firstly, we werent taken out as physicians as we had feared. Nor was the language changed from cure or relieve to cure and relieve. Labor Code (LC) 4600 is pretty clear in its intent to keep us in the system.
· LC 4600 also refers to Section 5307.27, which hasnt been written yet, and may alter the treatment guidelines that are currently in use by the American College of Occupational and Environmental Medicine (ACOEM).
· These new guidelines are to be in place by January 1 st of 2005. However, the ACOEMs guidelines have already begun to prevent and/or delay treatment authorization.
· In LC 4616(d), initiating in January 2005, employers are to create medical provider networks (MPN) to provide treatment to all injured workers. The MPN must include all types of physicians and in numbers great enough to adequately treat injury. After the first visit to the employers physician, the employee may choose to be treated by any other physician in the network, including acupuncturists (4616.3 (b)).
· Out of network referrals are only allowed if there are no qualified physicians in the network. If the employee is not satisfied with the physicians diagnosis or treatment plan, he or she may choose another. If the employee is still dissatisfied, he or she may choose yet another treating physician. If there is still dispute, the worker may request independent medical review (IMR) from a medical doctor or osteopath assigned by the Administrative Director.
· The IMR physician will conduct a physical exam and/or review clinical records at the employers discretion (LC 4616.4(e)). If the IMR agrees with the injured worker, he or she is entitled to pursue treatment from any physician, in or out of network. The new law does not mention what happens if the IMR agrees with the insurer, although the employee may still request opinions of other physicians in-network.
· Should the employer fail to create a MPN, the employee may choose a treating physician of his/her choice after 30 days as stated in the previous Workers Compensation Laws.
· Another item that didnt change is our QME status (you can access more information about QME/AME procedures in LC4602).
· What did change is our right to be pre-designated as personal physician to the injured worker (LC 4600 (d)(2)(A)). Chiropractors and acupuncturists can no longer be pre-designated.
· Per LC 5402, an employer, from the first day after an employee reports an injury, must provide appropriate medical treatment up to $10,000.00 or until liability for the claim is accepted or rejected.
· Our biggest hurdle, after rebutting the ACOEM guidelines is to ensure that we are included in the Administrative Directors guidelines pursuant to LC5307.27 as mentioned above. These guidelines for treatment of typical work injuries need to be created by our profession.
This is the initial review of the bill. If you find any items that we have not addressed, or matters where you are seeking additional clarification, please send your emails (please no phone calls) to firstname.lastname@example.org, as written communication allows us to ascertain the specific nature of your request.
We would like to thank Fred Lerner and Brian Fennen for their input in interpreting this bill.
CSOMA will be releasing a follow-up News Alert within two weeks from the dated date of this release. Should you have questions regarding this update, please address your queries to: email@example.com.
You can reference the full text of SB899 at www.leginfo.ca.gov.
Ephedra/ Ban Xia Ban
FOR IMMEDIATE RELEASE
April 12, 2004 Media Inquiries: 301-436-2335
Consumer Inquiries: 888-INFO-FDA
FDA Announces Rule Prohibiting Sale of Dietary Supplements Containing Ephedrine Alkaloids Effective April 12
The Food and Drug Administration (FDA) announced today that the final rule on dietary supplements containing ephedrine alkaloids is effective immediately. The rule, which was published on February 11, 2004 in the Federal Register, declares dietary supplements containing ephedrine alkaloids (ephedra) adulterated because such supplements present an unreasonable risk of illness or injury.
Two manufacturers had asked the United States District Court in New Jersey to enter a temporary injunction to prohibit FDA from enforcing the rule. However, the court ruled today that it would not immediately stay the rule. The court ordered the parties to submit additional briefs so that it may decide whether to permanently stay the rule.
"We will take appropriate enforcement actions if needed to stop manufacturers from illegally selling and distributing dietary supplements containing ephedra alkaloids," Health and Human Services Secretary Tommy G. Thompson said. "These products pose unacceptable health risks, and any consumers who are still using them should stop immediately."
On December 30, 2003, FDA issued over 60 letters to manufacturers notifying them of our intent to publish the rule as well as a consumer alert warning the public of the dangers of ephedra and asking that they stop taking these products immediately.
Dietary supplements containing ephedrine alkaloids have been shown to pose a real risk to health, said Dr. Lester M. Crawford, Acting FDA Commissioner. The court's decision today makes clear that these dietary supplements may not be lawfully marketed while the matter remains under review by the Court.
FDA plans to step up Internet surveillance to determine whether anyone, including the original 60 + targeted firms, is continuing to actively promote and sell these products.
FDA has already seen progress in its regulatory efforts, as a majority of the manufacturers to whom letters were sent have ceased selling dietary supplements containing ephedrine alkaloids.
For more information go to: http://www.fda.gov/oc/initiatives/ephedra/february2004/
· Summary of the final rule
Dietary Supplements Containing Ephedrine Alkaloids
Final Rule Summary
The Food and Drug Administration (FDA) is issuing a final regulation declaring dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because these dietary supplements present an unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in labeling, under ordinary conditions of use. Most dietary supplements containing ephedrine alkaloids are used for weight loss or enhancement of athletic performance.
We have concluded that dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death, and that these risks are unreasonable in light of any benefits that may result from the use of these products. This action is taken under the Dietary Supplement Health and Education Act of 1994 (DSHEA) which amended the FD&C Act.
DSHEA grants FDA the authority to take action against a dietary supplement under certain circumstances, including when the product presents a significant risk, an unreasonable risk, or an imminent hazard, does not comply with good manufacturing practices, or makes an unsubstantiated structure-function claim. The final regulation that FDA is issuing today applies the unreasonable risk standard to dietary supplements containing ephedrine alkaloids.
Standard for Determination
· Section 402(f)(1)(A)of the FD&C Act requires evidence of "significant or unreasonable risk" of illness or injury. There is no requirement that there be evidence that the product has caused actual harm to specific individuals, only that scientific evidence supports the existence of sufficient risk.
· FDA's burden of proof for "unreasonable risk" is met when a product's risks outweigh its benefits in light of the claims and directions for use in the product's labeling or, if the labeling is silent, under ordinary conditions of use.
· "Unreasonable risk," represents a relative weighing of the product's known and reasonably likely risks against its known and reasonably likely benefits.
· In considering whether dietary supplements containing ephedrine alkaloids present an unreasonable risk, FDA considered evidence from three principal sources: (1) The well-known, scientifically established pharmacology of ephedrine alkaloids; (2) peer-reviewed scientific literature on the effects of ephedrine alkaloids; and (3) the adverse events (including published case reports) reported to have occurred following consumption of dietary supplements containing ephedrine alkaloids.
· In evaluating whether dietary supplements containing ephedrine alkaloids present an unreasonable risk, we looked at the seriousness of the risks and the quality and persuasiveness of the totality of the evidence to support the presence of those risks. We then weighed the risks against the importance of the benefits and the quality and persuasiveness of the totality of the evidence to support the existence of those benefits. We gave more weight to benefits that improve health outcomes, especially in the long term, than to benefits that are temporary or rely on subjective measures such as feeling or looking better.
· FDA considered studies using closely related products, as it is appropriate to consider the safety of closely related products, such as those with the same active ingredient (e.g., synthetic ephedrine products) or closely related ingredients (such as other sympathomimetics). We would expect that dietary supplements containing ephedrine alkaloids will exhibit pharmacological effects similar to those other products and, therefore, pose similar risks.
· Based on the best available scientific data and the known pharmacology of ephedrine alkaloids and other sympathomimetics, dietary supplements containing ephedrine alkaloids pose short-term and long-term risks.
· This is clearest in long-term use, where increased blood pressure in any population will clearly increase the risk of serious adverse events, such as stroke, heart attack, and death. There is also evidence of increased risk of serious adverse events from shorter term use in patients with heart failure or underlying coronary artery disease.
· Ephedrine alkaloids are members of a large family of sympathomimetic compounds. These compounds increase blood pressure and heart rate.
· Such sympathomimetic effects raise three concerns:
o they can induce cardiac arrhythmias in susceptible people, such as those with underlying coronary artery disease
o increased mortality has been observed in patients with congestive heart failure who were treated with sympathomimetic drugs; studies that showed these adverse effects occurred in about 3 months of product use.
o Elevated blood pressure.
Peer-reviewed scientific literature on ephedra's safety and effectiveness
· The evidence shows that there is an increase in blood pressure attributable to ephedrine alkaloids. A relative increase in blood pressure in any population, even individuals with "normal" blood pressure, will increase the risk of heart attack, stroke, and death in that population. Many individuals are unaware that they have coronary artery disease or early heart failure because these conditions may not cause prominent symptoms until later in the course of these conditions.
· Approximately one in four adults has high blood pressure. Of those with high blood pressure, 31 percent are unaware that they have it. The extremely high prevalence of diagnosed and undiagnosed hypertension in the United States population, and the likelihood that blood pressure in obese patients is already elevated, make the effects of great concern.
· The published controlled studies of the use of ephedrine alkaloid products for weight loss cannot establish the safety profile of dietary supplements containing ephedrine alkaloids because many of the most serious risks, such as strokes or heart attacks (consequences of elevated blood pressure), arrhythmias, or worsened heart failure would not have been detected in the trials because of the design limitations of these trials. These limitations also impact certain conclusions attributed to these trials.
· Based on clinical data, the ephedrine alkaloids present in dietary supplements would be expected to have the same or similar effects as other sympathomimetics on heart rate and blood pressure. Controlled clinical trials using products containing ephedrine alkaloids confirm their typical sympathomimetic effects. These studies show a blood pressure effect from ephedrine itself, independent of any additional effect from caffeine.
· There is evidence from peer-reviewed scientific literature that a wide range of drugs with sympathomimetic activity have adverse effects (increased mortality due to heart failure and sudden death) in patients studied with congestive heart failure. These effects have been seen in relatively short-term studies. Similarly, there are studies that document that people with coronary artery disease are more susceptible to the well-known pro-arrhythmic effects of sympathomimetics. The occurrence of such an arrhythmic event is not one that requires prolonged exposure but would represent a risk associated with each use, including the first.
Adverse Event Reports
· The adverse event reports are not dispositive of a determination of unreasonable risk and our determination did not depend on them. However, the types of adverse events reported are consistent with the risks expected from the known pharmacology of these products and the findings described in clinical studies.
· AERs may raise concerns about a product, as well as buttress a finding that a particular dietary supplement represents an unreasonable risk based on other types of evidence. This is particularly true with dietary supplements containing ephedrine alkaloids because of the disproportionate number of adverse event reports we have received for these supplements as compared to other supplement products. The importance of the AERs for dietary supplements containing ephedrine alkaloids is that they support the clinical and scientific evidence of the risks of these products.
· Although there is no required reporting of AERs to us for dietary supplements, including those containing ephedrine alkaloids, FDA, and others, have reviewed and analyzed thousands of AERs in depth to ensure that all relevant evidence has been considered.
· Despite the limitations of such AERs, a detailed review of the AERs submitted to us for dietary supplements containing ephedrine alkaloids and comparison of those AERs to scientific data about the pharmacology of these substances establishes that the AERs are consistent with the known and expected pharmacological effects of these products considered. FDA has received approximately 2,200 AERs submitted directly to us and was provided approximately 16,000 reports from call records submitted by Metabolife International, one of the largest distributors of dietary supplements containing ephedrine alkaloids.
Multiple studies demonstrate that dietary supplements containing ephedrine alkaloids, like other sympathomimetics, raise blood pressure and increase heart rate. These products expose users to several risks, including the consequences of a sustained increase in blood pressure (e.g. serious illnesses or injuries including stroke and heart attack that can result in death). There is also a risk of increased morbidity and mortality from worsened heart failure and pro-arrhythmic effects. Although the pro-arrhythmic effects of these products typically occur only in susceptible individuals, the long-term risks from elevated blood pressure can occur even in nonsusceptible, healthy individuals.
These risks are not outweighed by the known or reasonable likely benefits of dietary supplements containing ephedrine alkaloids. These products do not provide a meaningful health benefit. The best clinical evidence for a benefit is for weight loss, but even there the evidence supports only a modest short-term weight loss insufficient to positively affect cardiovascular risk factors or health conditions associated with being overweight or obese. Other possible benefits, such as enhanced athletic performance, enhanced energy, or a feeling of alertness, lack scientific support and/or they would provide only temporary benefits that are trivial in comparison to the risks.
· Link to Final Rule - http://www.fda.gov/OHRMS/DOCKETS/98fr/1995n-0304-nfr0001.pdf
NOMAA & ACAOM
The National Oriental Medicine Accreditation Agency (NOMAA) and The Accreditation Commission for Acupuncture and Oriental Medicine (ACAOM) are both creating standards for entry level Doctorate program for Oriental Medicine. If you would like more information about this new development and how these two organizations are establishing these standards please visit the links below.
Senate bill 722 and other federally proposed bills
Congress Increasingly Active on Herbs and Dietary Supplements: Durbins Bill Intends to Clamp Down on Supplement Safety while Hatch and Harkin Propose More Funding for FDA Enforcement of DSHEA
HerbalGram. 2004;61:56-59 © American Botanical Council
by Mark Blumenthal
The year 2003 witnessed an increasing level of involvement by the U.S. Congress in matters dealing with the regulation, quality, safety and claims for herbs and other dietary supplements. In March 2003, Sen. Richard Durbin (D-IL) introduced the Dietary Supplement Safety Act (S. 722) into the U.S. Senate proposing significant changes to the regulation of herb and dietary supplements. In July, the House Committee on Energy and Commerce held a two-day hearing on safety issues related to the controversial herb ephedra (Ephedra sinica Stapf, Ephedraceae). In July, Senators Tom Harkin (D-IA) and Orrin Hatch (R-UT) introduced the DSHEA Full Implementation and Enforcement Act of 2003 (S. 1538), to promote full enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Then, in October Rep. Susan Davis (D-CA) introduced the Dietary Supplement Access and Awareness Act (HR 3377) which proposes to prohibit "high-risk" supplements to minors and other restrictions on supplements. In November, an amendment was attached to the Agriculture Bill that would grant the U.S. Food and Drug Administration (FDA) $1 million in additional funding to enforce existing provisions of DSHEA, including $500,000 for enforcement of provisions related to ephedra. Four other bills have implications for herbs and other supplements (Table 1).
At the close of Congress in December, these bills were still "on the table," although it is possible that they will be amended or given another designator number when Congress reconvenes in January 2004. The following is a brief summary of each bill and their potential impact on the herb and dietary supplement industry.
Table 1: Bills in Congress Relating to Dietary Supplements
Dietary Supplement Safety Act (S 722)
DSHEA Full Implementation and Enforcement Act (S 1538)
Dietary Supplement Access & Awareness Act (HR 3377)
Amendments to Agriculture Bill for $1.25 million to FDA for DS enforcement
The Dietary Supplement Information Act (HR 724)
The Access to Medical Treatment Act (HR 2085, S 1410)
The Dietary Supplement Tax Fairness Act (HR 2627)
The Anabolic Steroid Control Act of 2003 (S 1780) Primary Sponsor(s)
Davis, Waxman, Dingell
Durbin, Harkin, Hatch
Burton, Pallone, Paul
Biden, Grassley, Harkin, Hatch
Dietary Supplement Safety Act
Among numerous other provisions Sen. Durbins bill (S. 722) would require FDA pre-approval for any substance in a supplement that meets the proposed definition of "stimulant" (see Table 2). It would also require mandatory adverse event reporting for serious adverse events and a FDA review and audit of such events. A serious adverse dietary supplement experience, as defined by the Act, means an experience that results in (1) death; (2) a life-threatening condition; (3) inpatient hospitalization or prolonged hospitalization; (4) a persistent or significant disability or incapacity; (5) a congenital anomaly, birth defect, or other effect regarding pregnancy, including premature labor or low birth weight; or (6) requires medical or surgical intervention to prevent one of the outcomes described above.1
S. 722 is primarily a response to mounting concerns in Congress and elsewhere over the safety of ephedra as well as other controversial ingredients that have been misrepresented and sold as dietary supplements (e.g., androstenedione, a.k.a. andro).
In his press release announcing the submission of the bill, Sen. Durbin said, "A small number of products primarily stimulants and steroids masquerading as herbal compounds have proven lethal to consumers. My bill provides that before you can sell these high-risk products, you must prove they are safe. This bill will save lives and restore Americas confidence in the use of dietary supplements."2
However, some herb industry leaders are not so sure. "By requiring that all stimulants, except conventional foods such as coffee, tea, etc. as well as OTC drugs containing caffeine, be subjected to FDA pre-market approval procedures, interpretation of this provision suggests that even green tea (Camellia sinensis (L.) Kuntze, Theaceae) dried extract in dietary supplement dosage forms would be subject to FDA pre-market approval a scenario which is both absurd and entirely unnecessary," Loren D. Israelsen, executive director of the Utah Natural Products Alliance (UNPA), a trade group representing large supplement manufacturers, primarily in Utah, wrote to the author on Jan. 6, 2004.
In an email sent in July 2003 to UNPA stakeholders, Israelsen claims that the provisions in S. 722 are "a dramatic and punitive attempt to rewrite DSHEA and impose unnecessary and impractical requirements on many safe and useful supplements.
In particular, the bill proposes what appears to be extraordinarily burdensome requirement for adverse event reporting, which has no precedent under food or drug law. Not only is this requirement punitive but it would subject virtually every supplement company to tremendous economic and legal liability in trying to comply with these proposed provisions."3
In an open letter, constitutional attorney Jonathan Emord called S. 722 "redundant." He wrote, "FDA already has the authority conveyed by SB 722. Indeed, FDA has the authority to remove, seize, condemn and destroy products that are misbranded, adulterated or otherwise present an unreasonable risk of harm to the public. Under DSHEA, a manufacturer cannot market a dietary supplement unless it is safe; if FDA determines that the product or an ingredient in the product is unsafe, it has statutory authority to remove it from the market. Further, FDA has statutory authority to regulate the types of ingredients that can be included in dietary supplements. Finally, the proposed current good manufacturing practices will become final rules in the not too distant future. Those regulations grant FDA broad authority and will address any outstanding safety issues in connection with dietary supplements."4
Predictably, S. 722 is being opposed by industry trade groups American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), the National Nutritional Foods Association (NNFA), UNPA, as well as some major supplement manufacturers all of whom have joined a coalition to work in Congress to oppose S. 722 and S. 3377 and support S. 1538. The newly formed Coalition to Preserve DSHEA (CPD) is being run chiefly by large supplement companies, with trade organizations as nonvoting members. CPD reportedly will be spending funds on specific, earmarked projects but will have no ongoing infrastructure and no administrative overhead, according to NNFA Executive Director/CEO David Seckman.5
Table 2. Summary of the Proposed Dietary Supplement Safety Act (S 722)1,14
1. Adverse Event Reports (AERs). All serious adverse experiences with dietary supplement (DS) are to be investigated and reported to FDA within 15 days. FDA will conduct a clinical evaluation of each serious AER. All DS manufacturers must annually submit a report to the FDA with respect to all AERs received by the company.
Sources of AERs can include the following: direct from consumers plus any other means (i.e., information without regard to the source, foreign or domestic, derived from these sources: commercial marketing experience, post-marketing investigations, post-marketing surveillance, clinical studies, case reports in the medical literature, and unpublished scientific papers, presumably those in possession of the company, that is, those that the company may have sponsored but not published).
2. Post-market Surveillance. The Department of Health and Human Services (HHS) and/or the FDA may order a company to conduct post-market surveillance if they determine there is a reasonable possibility that a use or expected use of a DS by a significant number of consumers may result in serious adverse experiences.
3. Safety reviews for possibly dangerous DS. A clinical evaluation by FDA on one or more serious AERs may indicate that a DS or a dietary ingredient (DI) appears to present a significant or unreasonable risk of illness. HHS/FDA may require manufacturers of the DS or DI to submit to FDA data demonstrating that the DS or DI is safe in order for the DS/DI to remain on the market.
4. Approval/disapproval of continued marketing. As soon as practicable, FDA shall review the data and determine if the DS is safe and if continued marketing is approved, or, whether the DS is unsafe and continued marketing is disapproved.
5. Stimulants. The newly proposed definition of stimulant is a DI that has a stimulant effect on the cardiovascular system or the central nervous system of a human by any means, including speeding metabolism, increasing heart rate, constricting blood vessels, and/or causing the body to release adrenaline.
6. Pre-market approval for stimulants. No one shall sell a DS containing a stimulant unless an FDA approval of that DS is in effect. FDA shall approve applications for pre-market approval for a stimulant DS if the manufacturer demonstrates the DS is safe under ordinary or frequent conditions of use. In the case of a combination of stimulants in a DS, FDA shall consider the interaction of the various stimulants to assess and conclude a safety determination. This law does not affect caffeine used as a food or a drug. The provisions in this section will take effect 2 years after the date of enactment of the act.
7. Steroid Precursors. Section 201 of the Food, Drug and Cosmetic Act would be amended to read, Other than tobacco or a product that bears or contains an anabolic steroid (including a substance that is chemically or pharmacologically related to testosterone but not including an estrogen, progestin or corticosteroid.) That is, the definition of dietary supplement would automatically preclude tobacco (as is currently the case in DSHEA) plus anything that would be interpreted as an anabolic steroid, which is defined as Anything that promotes muscle growth or is advertised or used to promote muscle growth. Such products would be subject to regulation under the Controlled Substances Act.
DSHEA Full Implementation and Enforcement Act of 2003
On July 31, Senators Harkin and Hatch, the principle sponsors of DSHEA (with former Rep. Bill Richardson [D-NM]), introduced the DSHEA Full Implementation and Enforcement Act of 2003 (S. 1538) (Table 3).6 The bill is a response to concerns expressed by industry associations that many of the problems with dietary supplements heralded by the media and highlighted in congressional hearings are the result of FDAs inadequate enforcement of DSHEA. According to the NNFAs Seckman, S. 1538 is basically a funding bill for 2004.5 The proposed law would increase funding to the FDA to more fully enforce the provisions of DSHEA ($20 million for fiscal year 2005, growing up to $65 million in 2008). S. 1538 also proposes $30 million in funding in 2004 for the Office of Dietary Supplements (ODS) at the National Institutes of Health, an agency created by DSHEA "for expanded research and development of consumer information on dietary supplements" and "such sums as may be necessary for each of the fiscal years 2005 through 2008." The bill also proposes that the Secretary of the U.S. Department of Health and Human Services submit to Congress an annual "Accountability Report on the Regulation of Dietary Supplements," which would require that FDA provide Congress with a detailed accounting of its activities and resources spent in the area of regulating dietary supplements (DS).
Table 3. Summary of DSHEA Full Implementation and Enforcement Act of 2003 (S 1538)5,14
1. Increased funding for FDA to implement DSHEA:
Additional $20 million in fiscal year 2004, growing to $65 million in 2008.
2. Increased funding for Office of Dietary Supplements (ODS) for research and consumer education on dietary supplements.
Additional $30 million in 2004 with further monies incrementally until 2008.
3. The Secretary of HHS will submit to Congress an annual Accountability Report on the Regulation of Dietary Supplements, which will include the following provisions on the implementation and enforcement of DSHEA:|
1) The total funding and number of full-time equivalent personnel in the FDA dedicated to:
a) dietary supplement (DS) regulation over the prior fiscal year.
b) administering adverse event reports (AERs) as they relate to DS regulation over the prior fiscal year.
c) enforcement of DS labeling and claims requirements over the prior fiscal year and an explanation of their activities.
d) good manufacturing practice (GMP) inspections of DS manufacturers over the prior fiscal year and an explanation of their activities.
2) The number of GMP inspections of DS manufacturers by the FDA over the prior fiscal year and a summary of the results.
3) The number of new ingredient reviews and safety reviews related to DS and the results of those reviews.
4) An explanation of all enforcement actions taken by the FDA and HHS related to dietary supplements over the prior fiscal year, including the number and type of actions.
5) The number of DS claims for which the FDA requested substantiation from the manufacturer over the prior fiscal year, and the agencys response.
6) The number of DS claims determined to be false, misleading, or nonsubstantiated by the FDA over the prior fiscal year.
7) The research and consumer education activities supported by the ODS.
8) Any recommendations for administrative or legislative actions regarding the regulation of DS.
9) Any other information regarding the regulation of DS determined appropriate by the Secretary of HHS or the Commissioner of FDA.
Dietary Supplement Access and Awareness Act
On October 28, Rep. Susan Davis introduced the Dietary Supplement Access and Awareness Act (HR 3377), which, among other provisions, would prohibit the sale of DS to minors under the age of 18 if such supplements were deemed by the FDA to pose a significant risk to minors (Table 4).7 The bill is co-sponsored by Representatives John Dingell (D-MI) and Henry Waxman (D-CA), two powerful representatives who have long held critical views of the supplement industry. The bill proposes to classify DS into two categories those that are nutritionally based conventional supplements like vitamins and minerals and those others that are not normally associated with nutrition (e.g., herbals). The proposed act would deal with the latter category, not vitamins and minerals. In one of the most controversial provisions, the bill would require that manufacturing companies submit adverse event reports received for all supplements containing herbs, amino acids and other related ingredients two times annually to the FDA. Industry leaders characterize this part of the bill as burdensome, unreasonable, and unprecedented, particularly with respect to requirements for the pharmaceutical industry.
In a bulletin to AHPA members, AHPA President Michael McGuffin wrote, "AHPA has long stated its belief that submission of serious adverse event reports should be mandatory for supplements, but it appears as if this bill fails to provide the protections to industry that are established by law for adverse event submissions by drug companies. Also, the idea of a product registration is one that may deserve discussion and cost evaluation, but Representative Davis should first explain why the proposed semi-annual burden for supplements should exceed the annual burden for drugs. In addition, the subjective nature of FDA decision making for each of their proposed new authorities must be challenged."8
The bill was referred to the House Committee on Energy and Commerce, chaired by Rep. Billy Tauzin (R-LA), who held the hearing on ephedra in July, and who later said his vote for DSHEA in 1994 was an error.
Table 4. Summary of Dietary Supplement Access and Awareness Act (HR 3377)6,14
1. Applies only to herbs, amino acids, and other ingredients described in DSHEA as dietary substance(s) used by man to supplement the diet by increasing the total dietary intake; vitamins and minerals excluded.
2. All manufacturers and processors of these dietary supplements must provide to FDA, and update every 6 months, the following:
a) a list of all products;
b) labeling for each product;
c) a listing of all major ingredients ... including active ingredients, as applicable;
d) at the discretion of FDA, a quantitative listing of all ingredients;
3. Manufacturers and distributors of these products, unless specifically waived by FDA, must report serious adverse events to FDA within 15 days of receipt, to investigate any such reports, and to maintain certain records;
4. FDA would have new authority to order a manufacturer to conduct post-market surveillance of supplements for which there is a reasonable possibility...[of] serious adverse health consequences;
5. FDA would have new authority to require a manufacturer to demonstrate safety of a supplement if the agency has reasonable grounds for believing that the supplement presents a significant or unreasonable risk of illness or injury or is an imminent hazard to public health or safety;
6. FDA would have new authority to establish criteria for determining that a supplement may pose a significant risk to minors and for deeming the act of selling such product to minors as misbranding.
7. The bill would provide funding to educate health professionals on reporting adverse health experiences associated with DS to FDA and to educate consumers about informing health professionals on the DS and drugs they take.
8. The bill would also change the Food, Drug and Cosmetic Act, as amended by DSHEA, which states that the burden of proof is on the federal government to demonstrate that a supplement is adulterated or unsafe.
Other bills introduced into Congress in 2003 may directly or indirectly affect herbs and other dietary supplements. Most of these bills are in committee and have an uncertain fate at this time.
The Dietary Supplement Information Act (HR 724). This bill was also introduced on February 12 by Rep. Davis. It intends to require registration of all dietary supplement products with FDA, establish an AER system requiring annual reporting of minor AER, establish broad inspection authority by FDA of supplement companies records, and require the 1-800-MEDWATCH phone number be placed on all supplement labels (a move previously required by the State of Texas for all ephedra products marketed in that state).9 The reporting of minor AERs is currently a requirement for new drugs only, and is not required for over-the-counter drugs, and, reportedly this bill would not guarantee dietary supplement manufacturers the protections that current federal regulations give to pharmaceutical companies with similar obligations. The bill has no co-sponsors and has been referred to the House Committee on Energy and Commerce.10
The Access to Medical Treatment Act (HR 2085 & S 1410). These bills have been introduced in the House by Rep. Peter DeFazio (D-OR) on May 1411 and the Senate by Sen. Harkin on July 15.12 If passed, the legislation would allow treatment by a licensed healthcare practitioner using any medical modality that the patient requests, including a treatment that is not approved, certified, or licensed. It would require a practitioner administering such treatment to report both the adverse and positive effects observed while administering an unconventional medical treatment for a life-threatening medical condition. The House bill currently has four co-sponsors and has been referred to the Committee on Energy and Commerce; the Senate version also has four co-sponsors and has been referred to the Committee on Health, Education, Labor and Pensions.
The Dietary Supplement Tax Fairness Act (HR 2627) was introduced on June 26 by Representatives Dan Burton (R-IN), Frank Pallone (D-NJ), and Ron Paul (R-TX). The bill would amend the Internal Revenue Code to treat amounts paid for foods for special dietary use, dietary supplements, and medical foods as medical expenses for purposes of the medical expense deduction. It currently has three co-sponsors and has been referred to the Committee on Ways and Means.13
The Anabolic Steroid Control Act of 2003 (S 1780) was introduced October 23 by Senators Joseph Biden (D-DE) and Hatch.14 The bill applies to substances that, once ingested, metabolize into anabolic steroids and "would amend the Controlled Substances Act to clarify the definition of anabolic steroids and to provide for research and education activities relating to steroids and steroid precursors." The intent of the bill is to treat the hormone androstenedione (andro) and similar chemicals as controlled substances. While this might appear to be a relatively simple issue on the surface, the question that arises for herbs is whether an herbal material containing natural sterols and related compounds might be inappropriately relegated to the status of controlled substances. The bill has three co-sponsors and is currently referred to the Judiciary committee. The bill appears to be strongly supported by a large coalition of medical and sports organizations concerned about the availability of dietary supplements containing anabolic steroid precursors and ephedra.
At this time it is not clear which of these bills, if any, will prevail in the ensuing political process that has the inevitable effect of subtly and often significantly changing the intentions of the initial sponsors of the bills. Sen. Durbin has indicated that he is not interested in accepting any significant changes or compromises to his bill and would rather reintroduce it in the new session of Congress, which started this year. As for the future of the Hatch-Harkin bill, a step in its intended direction has already taken place: On November 6, Senators Harkin and Hatch, with the support of Sen. Durbin, were successful in getting a rider added to the Agriculture Bill in which $1 million in new funding was appropriated to FDA for enforcement of DSHEA. As a compromise to enlist the support of other members, another provision sponsored by Sen. Durbin, and co-sponsored by Harkin and Hatch, was attached to the bill providing for an additional $250,000 to be earmarked for FDA enforcement actions related directly to ephedra.
Regardless of the outcomes of the legislative process, it is quite clear that powerful forces are converging with the intention of changing the way dietary supplements, particularly herbs, are regulated. One group wants to see full enforcement of the existing regulations while the other wants to seriously amend the existing regulatory landscape. If either or both prevail, the future of herbal regulation will definitely be different from the experiences of the past decade.
1. 108th Congress. US Senate. Dietary Supplement Safety Act of 2003 (S 722). Mar. 26, 2003. Available online: <http://thomas.loc.gov>.
2. Durbin R. Durbin moves to prevent sale of dangerous dietary supplements like ephedra: bill would require manufacturers to prove stimulants are safe prior to sale, would no longer allow steroids to be considered dietary supplements, and would bolster FDAs enforcement authority [press release]. Mar. 26, 2003. Available online: <http://durbin.senate.gov/~durbin/new2001/press/2003/03/2003328821.html>.
3. Israelsen LD. Email to author, July 2003.
4. Emord J. Dietary Supplement Safety Act of 2003 [letter], undated.
5. Seckman D. Personal communication to author, Dec. 15, 2003.
6. 108th Congress. US Senate. DSHEA Full Implementation and Enforcement Act of 2003 (S 1538). July 31, 2003. Available online: <http://thomas.loc.gov>.
7. 108th Congress. US House of Representatives. Dietary Supplement Access and Awareness Act (HR 3377). Oct. 28, 2003. Available online: <http://thomas.loc.gov>.
8. AHPA Update. Waxman/Dingell/Davis introduce new supplement bill legislation: targets herbs and other non-nutritive ingredients. Silver Spring, MD: American Herbal Products Association. October 31, 2003.
9. 108th Congress. US House of Representatives. Dietary Supplement Information Act (HR724). Feb. 12, 2003. Available online: <http://thomas.loc.gov>.
10. Anon. 2003 the year in review: regulations and legislation. The AHPA Report. Jan. 2004.
11. 108th Congress. US House of Representatives (HR 2085). Access to Medical Treatment Act. May 14, 2003. Available online: <http://thomas.loc.gov>.
12. 108th Congress. US Senate. Access to Medical Treatment Act (S 1410). July 15, 2003. <http://thomas.loc.gov>.
13. 108th Congress. US House of Representatives. The Dietary Supplement Tax Fairness Act (HR 2627). June 26, 2003. Available online: <http://thomas.loc.gov>.
14. 108th Congress. US Senate. Anabolic Steroid Control Act of 2003 (S 1780). Oct. 23, 2003. Available online: <http://thomas.loc.gov>.
15. Israelsen LD. DSHEA 10 years later. What happened? Las Vegas, NV: National Nutritional Foods Association Annual Convention; July 2003.
American Botanical Council, 6200 Manor Rd, Austin, TX 78723
Phone: (512) 926-4900 | Fax: (512) 926-2345
Email: firstname.lastname@example.org | URL: http://www.herbalgram.org
An Urgent Call to Action:
Your Right to Use Nutritional Supplements Is in Jeopardy
SPECIAL SUPPLEMENT TO:
Dr. Julian Whitaker's - Health & Healing - September, 2003
We need to take action and we need to take action now. There is a movement in Congress to restrict your freedom to use nutritional supplements, destroy the nutritional supplement industry and, in the process, endanger your health.
Here is the problem. Reacting to the hysteria over ephedra, Richard J. Durbin (D-IL) brought forth Senate Bill 722, cosponsored by Hillary Clinton (D-NY), Dianne Feinstein (D-CA) and Charles Schumer (D-NY), which gives unprecedented power to the FDA to remove nutritional supplements from the market. Here's how.
A Bill With Chilling Implications
The bill calls for a reporting system for adverse reactions to nutritional supplements. The FDA is empowered to act on a single adverse reaction report and immediately take the product off the market while it is being investigated. In addition, it could force the manufacturer to undergo prohibitively costly safety analyses of the product, similar to what is required for new drugs.
Here's a scenario; Mrs. Jones in Somewhere, USA, is taking a supplement containing vitamin C. One afternoon she has some diarrhea. She faints, falls in her bathroom, hits her head and is hospitalized with a head injury. Believe it or not, an adverse reaction could be pinned on vitamin C. Based upon this single event, the FDA could, at its discretion, move to restrict sales of vitamin C throughout the entire country until an investigation proves that vitamin C did not cause Mrs. Jones' problems.
Don't Believe the Smoke Screen of "Safety"
The bill also gives the FDA license to require supplement manufacturers to submit safety information that would cost hundreds of millions of dollars, patterned on regulations required for new drugs. This is absurd. New drugs need rigorous safety testing because they are compounds that have never been ingested by human beings. The ubiquitous use and long history of safety of nutritional supplements is apparently irrelevant to the sponsors of this bill.
The nutritional supplement industry arguably has the best product safety record of any industry in the country. According to Congressman Dan Burton (R-IN), a maximum of 16 deaths were attributed to a nutritional supplement last year. (Excessive doses of ephedra were the suspect in the majority of these cases and the supplement link was definitively proven in only a few of them.) Meanwhile, the FDA turns a blind eye to the 106,000 deaths from adverse effects of prescription drugs and the tens of thousands of deaths from aspirin and other over-the-counter drugs that occur every year.
This isn't about safety. It's about control.
This bill is a good example of government irrationality and it Will harm you.
According to a 2002 report by Washington, DC based Council for Responsible Nutrition (CRN), the use of antioxidants, folic acid, calcium, zinc and other nutritional supplements could reduce the incidence of neural tube birth defects by 70 percent, hip fractures by at least 20 percent and sick days caused by infectious diseases by 50 percent. Heart disease, stroke, cataracts, macular degeneration, some types of cancer; nutritional supplements have been shown to prevent or delay all these conditions and others. Furthermore, CRN reports that by delaying the onset of cardiovascular disease, stroke and hip fracture alone, nutritional therapies could potentially save $89 billion a year in healthcare costs!
Yet S.B. 722 would empower the FDA to dismantle the supplement industry and prevent you from receiving the many benefits that only nutritional supplements can deliver.
You Can Make a Difference
The only way to stop this bill is for us to flood our elected representatives with so many emails, faxes and phone calls that they will be forced to say no to the powerful interests that are behind this movement.
Don't underestimate the power of such a grass-roots movement. Ten years ago, Health & Healing readers were instrumental in rallying the passing of the Dietary Supplement Health and Education Act (DSHEA). Millions of letters were written to our representatives and senators in support of this legislation. It generated more letters than any other issue in US history. Because of DSHEA, which reduced the FDA's power to block the production, sale, and use of natural substances, we have free access to herbs, amino acids, vitamins, minerals and other nutritional supplements.
The Bad Old Days
Some of you might remember the pre-DSHEA days when the FDA was completely out of control. They raided the offices of nutritional physicians like Jonathan Wright, MD, of Kent, WA - at gunpoint! They barged into manufacturing facilities and seized natural substances such as stevia and GLA. They authorized the removal of coenzyme Q-10 and other supplements from health food stores, claiming they were "illegal." They refused to allow any information on nutritional supplement labels that would help consumers make informed choices. They mandated that many supplements now sold over the counter require a prescription, making them more expensive and less accessible. This is the kind of tyranny we experienced then and if you think this kind of stuff couldn't happen again, you're wrong.
A Power Grab by the FDA
You may have read in the press that we need new laws because there is no regulation of nutritional supplements. This is simply not true. DSHEA gives the FDA tremendous regulatory power and, in fact, it already has the power to pull any supplement it feels is unsafe off the market.
Yet because DSHEA also gives supplement manufacturers some autonomy, the FDA has attempted to circumvent it from day one. This agency fought hard against the passage of DSHEA ten years ago and, in a thinly veiled attempt to get rid of or amend it, has refused to act responsibly within its confines ever since.
Send a Message and Tell a Friend
Time is of the essence. S.B. 722 has recently been referred to committee and may be tagged onto the Agriculture Appropriations Bill. We can and must act quickly to stop this legislation.
What can you do? Send a message to your senators today asking them to vote against S.B. 722. If you've already done so, do it again. Tell your friends about this threat and encourage them to take action as well. If each one of you could commit to generating just a handful of emails, faxes or phone calls, over a million messages would descend upon Washington. You may not realize how powerful a grassroots campaign like this can be, but our elected officials cannot ignore something of this magnitude.
How to Contact Your Senators
The easiest way to let your senators know what you think about SB.722 is to visit NNFA's website (http://capwiz.com/nnfa/S722.html). All you have to do is type in your zip code and it will address a message to both of your senators, allow you to personalize it if desired, then send it by e-mail or print it out for faxing.
If you don't have access to a computer, write a short letter identifying the bill and your position on it. Address it to The Honorable (senator's name), United States Senate, Washington, DC 20510. You may also call your senators' offices. You'll likely speak with staff members, but your message will still be heard. Let them know who you are, ask them to vote against S. 722 and be prepared to tell them why.
The US Capitol switchboard number is (202) 224-3121. Look in the phone book for your senators' local office numbers. Staffers can give you your senators' fax numbers, as well as other contact information.
To your health and freedom,
Julian Whitaker, MD
WHO and EU codex on supplements
· Link to full WHO and EU Codex Alimentarius Proposal:
What is Codex Alimentarius ?
Codex Alimentarius means "food code" and is the compilation of all the Standards, Codes of Practice, Guidelines and Recommendations of the Codex Alimentarius Commission. The Codex Alimentarius Commission (Codex) is the highest international body on food standards. The Commission is a subsidiary body of the UN Food and Agriculture Organization (FAO) and the World Health Organization (WHO).
The Codex system was set up to protect the health of consumers, ensure fair practices in international food trade and to coordinate all international food standards work. International food trade is currently valued at more than US$ 400 billion annually. Universally uniform food standards have the advantage that they protect consumers from unsafe food and allow food producers, processors and traders to have access to markets by breaking down artificial non-tariff barriers to trade. Codex standards are based on sound science and are accepted as the benchmarks against which national food measures and regulations are evaluated within the Uruguay Round Trade Agreements.
The significance of the food code for consumer health protection was underscored in 1985 by the United Nations Resolution 39/85, whereby guidelines were adopted on consumer protection policies. The guidelines advise that "Governments should take into account the need of all consumers for food security and should support and, as far as possible, adopt standards from the ... Codex Alimentarius".
In November 1961, the Eleventh FAO Conference passed a resolution to set up the Codex Alimentarius Commission. In May 1963, the Sixteenth World Health Assembly adopted the statutes of the Codex Alimentarius Commission.
The Codex Alimentarius Commission is an intergovernmental body and is open to all countries that are members and associate members of the FAO and the WHO. The Commission currently has 165 member countries, representing more than 98 percent of the world's population. It meets every two years. Country delegations often include representatives of industry, consumers' organizations and academic institutes, in addition to representatives of government. A number of international non-governmental organizations also attend as observers.
One of the principal purposes of Codex is the preparation of food standards. Codex adopts international recommended standards, guidelines and codes of practice after thorough consideration by all Codex member countries. The Codex Alimentarius contains more than 200 standards. There are general standards or recommendations for: food labeling; food additives; contaminants; methods of analysis and sampling; food hygiene; nutrition and foods for special dietary uses; food import and export inspection and certification systems; residues of veterinary drugs in foods; and pesticide residues in foods.
An increasing number of countries are aligning their national food standards, or parts of them with those of the Codex. This is particularly so in the case of additives, contaminants and residues. The World Trade Organization (WTO) Agreements on the Application of Sanitary and Phytosanitary Measures (SPS) and on Technical Barriers to Trade (TBT) encourage the international harmonization of food standards on the basis of Codex standards.
Food can be subject to harmful contamination. Pathogenic bacteria and other food contaminants can cause acute or chronic health problems. Outbreaks of food borne illness can also damage trade and tourism, and lead to loss of earnings and employment. Prevention of food contamination is the best approach and the Codex Alimentarius has established international codes of practice on food hygiene and other guidelines for good food production and handling practices.
The work of the Codex Commission goes beyond means of removing trade barriers. It also encourages countries to adopt ethical practices. The Code of Ethics for International Trade in Food, for example, calls on parties to stop dumping poor-quality or unsafe food on to international markets.
Many countries need FAO/WHO advice and recommendations about the risks that can be caused by chemicals that become, intentionally or unintentionally, part of foods. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) advises the Codex Commission on food additives, contaminants and residues of veterinary drugs. JECFA establishes the amount of an additive that can be ingested on a daily basis, even for a lifetime, without significant risk. JECFA is independent of the Commission. It has examined more than 700 chemicals as well as 25 contaminants. JECFA members are selected from the scientific community. They must be impartial and work as individuals and not as representatives of their governments or institutions. Another group of scientists (Joint FAO/WHO Meeting on Pesticide Residues) advises the Commission on pesticide residues.
The Secretary of the Codex Alimentarius Commission is a senior FAO official. The Codex Secretariat has six full-time food standards officers based at FAO's headquarters.
Alliance for Natural Foods (ANH) RELEASE: Legal update April 2004
Read on for a summary by ANH Legal Director of the ANH legal challenge to the EU Food Supplements Directive
ANH LEGAL CHALLENGE TO THE EU FOOD SUPPLEMENTS DIRECTIVE
The Food Supplements Directive (FSD) was widely promoted (and thus supported) as a measure, designed to distinguish food supplements from drugs and harmonize their EU legal treatment, facilitating their free movement between EU Member States.
This is a laudable aim for promotion of trade between Member States, in view of the great disparities between EU countries as to how food supplements are classified and regulated. Unfortunately as the Directive turned out; it actually has the opposite effect for innovative advanced bioavailable nutrients; many of which are at risk of being banned.
· Restricted List of allowable nutrients
The FSD creates a list of permitted ingredients (initially only applying to vitamins and minerals) for food supplements and mandates all Member States to permit the sale of these across the EU from 1 August 2003 at the latest.
However all nutrients not on this positive list will be banned right across the EU from 1 August 2005 at the latest, unless a detailed Dossier in respect of each nutrient (at an estimated cost of £80,000-£250,000 per ingredient for which safety data is not readily available) evidencing their safety is submitted by the Member State to the EU Commission not later than 12 July 2005. This is despite the fact that previously they may have been permitted under one or more Member States regulations.
The effect of the Directive will be to ban about 300 of the 420 or so forms of vitamins and minerals present in around 5000 products currently on the UK market, many of which are sold in high street health food stores. The ban will have a similar effect on products in such countries as Sweden, the Netherlands and Ireland, which also have advanced markets for food supplements.
· Restricted Potency for allowable nutrients
The potency of food supplements comprised of nutrients, which are on the positive list, will also be limited, as the FSD stipulates these nutrients will be subject to maximum permitted amounts taking into account upper safe levels (established by scientific risk assessment and intake of vitamins and minerals from other dietary sources).
In summary, the FSD will ban high potency, organic / food state bioavailable vitamins and minerals, irrespective of the fact that they have been on sale in EU Member States as food for many years.
Initially the FSD will apply only to vitamins and minerals but by 12 July 2007 (if not before) it requires the EU Commission to make proposals for a similar regime for all other nutrients or substances with a nutritional or physiological effect.
Thus the FSD provides a legislative model for all food supplements mandating a narrow (positive) list of allowed nutrients and a limited potency.
The Directive is presented as the first part of a plan for the comprehensive regulation of food supplements at the EU level and all the indications are that once this model is in place in the EU it will be exported worldwide via Codex Alimentarius.
After detailed analysis, the Alliance for Natural Health (ANH) concluded that the most effective option now left for the protection of the continued supply of safe, natural and effective advanced food supplements in the EU was to challenge the FSD ban on non positive list nutrients, in the Courts. It is not seeking to overturn the FSD as a whole but only the prohibition against sale of any non positive list goods (the ban) in Member States which might otherwise allow their sale.
To that end, with specialist EU law barristers, it commenced legal proceedings in October 2003 and in brief, the latest position is as follows:
The legal challenge is viable (successful Reference to ECJ)
On 30 January 2004, Mr. Justice Richards, a High Court Judge, (expert in EU law) granted ANH permission for judicial review of the FSD and made a Reference to the European Court of Justice in Luxembourg.
For for further details on the legal action, including outline of grounds of challenge and need for action, please download complete 2-page Legal Executive Summary (April 2004) from Key Documents area on homepage of website.
David C. Hinde
Alliance for Natural Health
Tel: +44 (0) 207 738 1640
ANH PRESS RELEASE: Victory in Court!
Alliance for Natural Health obtains reference to European court on food supplements ban
ALLIANCE FOR NATURAL HEALTH
OBTAINS REFERENCE TO EUROPEAN COURT
ON FOOD SUPPLEMENTS BAN
An English High Court judge ruled yesterday that the legislative powers of the European Commission should be examined by the European Court of Justice in Luxembourg.
Separate landmark cases brought by the Alliance for Natural Health and two UK industry associations were successful both in getting permission for Judicial Review and obtaining a reference to the European Court of Justice in their challenge to the legality of the Food Supplements Directive ban on nutrients.
Mr. Justice Richards gave decisive judgment yesterday afternoon after having examined the voluminous evidence filed and considered detailed legal arguments. He emphasized that the reference to the European Court should be made without delay given that the ban proposed by Brussels legislators takes effect from 1 August 2005.
Up to 5000 vitamin and mineral products in the UK alone will be lost, negatively impacting manufacturers, retailers, practitioners and consumers reliant on these products across Europe.
Industry and complementary health organizations around Europe are hopeful that the European Court of Justice will give its ruling prior to the imposition of the ban next year.
David Hinde, Solicitor and Legal Director of the Alliance for Natural Health says:
This is a test case on the proper scope of the legislative powers of the Community Legislator over member states and has far reaching implications for health as well as freedom of choice.
Other countries like the UK with advanced markets for supplements such as Sweden, Ireland and the Netherlands all stand to benefit if ANHs arguments are accepted by the European Court.
Dr Robert Verkerk, Executive Director of the Alliance for Natural Health says: This court decision is a victory for millions of consumers of advanced food supplements, many of whom have found good health using nutrition as a central approach. We are hopeful that the Court in Luxembourg will invalidate the unnecessary ban on the wide range of perfectly safe natural, food-derived ingredients which comprise most of the advanced food supplements. The proposed ban is wholly unnecessary and works counter to health policy where nutrition is increasingly seen as a key way forward.
CONTACT DETAILS for further information:
Dr Robert Verkerk
Tel: 01252 371 275 (general enquiries)
Tel: 0771 484 7225 (direct)
David C. Hinde LLB
Alliance For Natural Health
Cell: +44 (0) 7958 548 186
FDA manufacturing rules
FDA Proposes Manufacturing and Labeling Standards for all Dietary Supplements
March 7, 2003
The Food and Drug Administration (FDA) today took action to help Americans get accurately labeled and properly manufactured dietary supplements, through its Proposed Rule for Dietary Supplement Current Good Manufacturing Practices (CGMPs). FDA is submitting this proposed rule as part of the agencys ongoing effort to help Americans take more control over their own health.
FDAs Proposed Rule for Dietary Supplement Labeling and Manufacturing Standards
This proposed rule would establish the standards necessary to ensure that dietary supplements and dietary ingredients are not adulterated with contaminants or impurities and are labeled to accurately reflect the active ingredients and other ingredients in the product.
Specifically this proposal would:
· Require the use of new industry-wide standards in the manufacturing, packing, and holding of dietary supplements, thus reducing risks associated with dietary supplements that are contaminated with harmful or undesirable substances such as pesticides, heavy metals, or other impurities or are not properly labeled to accurately describe what they contain.
· Ensure that the identity, purity, quality, strength, and composition of dietary supplements are accurately reflected on the product label, which would be a significant step in assuring consumers they are purchasing the type and amount of ingredients declared.
Science-Based Consumer Protection
Previously, dietary supplements have not been subject to mandatory standards for manufacturing or labeling. Congress gave FDA the authority to develop and implement CGMPs as part of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
The proposed rule addresses the quality of manufacturing processes for dietary supplements, and the accurate listing of supplement ingredients. It does not limit consumers' access to dietary supplements, or address the safety of their ingredients, or their effects on health when proper manufacturing techniques are used. Rather, the proposed rule creates a level playing field for the industry by ensuring that every firm uses high-quality manufacturing procedures and uses the same rules for describing their ingredients.
In December, FDA issued a report on its new policies for taking legal action against dietary supplements that make misleading health claims. Last week, to address concerns about the safety of ephedra, FDA announced a proposed warning label, issued warning letters on certain ephedra marketing practices, and announced a public comment period regarding potential further restrictions on ephedra products.
Under DSHEA, dietary supplement manufacturers have an essential responsibility to substantiate the safety of the dietary ingredients they use in manufacturing a product. Manufacturers are also responsible for determining that any representations or claims made about their products are substantiated by adequate evidence to show that they are not false or misleading. With this proposed rule, FDA will have the authority to determine standards that firms should apply in production and labeling.
· The proposed CGMPs provide much-needed requirements in these areas:
o Design and construction of physical plants,
o Quality control procedures,
o Testing of final product or incoming and in-process materials
o Handling consumer complaints, and
o Maintaining records to demonstrate compliance with these regulations.
· Since 1993, FDA has received about 7000 dietary supplement-related voluntary adverse event reports. Below is a breakout of adverse event reports over the past four years:
o Year 2002: 1,214 adverse event reports
o Year 2001: 553 adverse event reports
o Year 2000: 500 adverse event reports
o Year 1999: 528 adverse event reports
· Many of these adverse events may be related to misbranding or adulteration. In recent years, analyses of dietary supplements by a private sector laboratory suggest that a substantial number of dietary supplement products analyzed may not contain the amounts of dietary ingredients as reflected on the products labeling.
· In addition, dietary supplements have been recalled because of microbiological, pesticide, and heavy metal contamination adulteration that might be prevented through a uniform set of manufacturing requirements.
· Examples of product quality problems that the proposed rule would help prevent are:
o dietary supplements that contain much more than listed on the label and may be harmful
o dietary supplements that contain less ingredients than listed on the label
o wrong ingredient,
o drug contaminant,
o other contaminant (e.g., bacteria, pesticide, glass, lead),
o foreign material in a dietary supplement container,
o improper packaging, and
FDA To Implement DSHEA Enforcement Plan
5/1/2004 4:30:05 PM
In the wake of its April ban on ephedra, the U.S. Food and Drug Administration is implementing a science-based plan to better enforce the Dietary Supplement Health and Education Act and ensure that dangerous supplements are more quickly removed from the market, said FDA Acting Commissioner Lester Crawford.
The agency's new approach to DSHEA enforcement includes evaluating available pharmacology, published literature, evidence-based reviews and adverse-event informationthe same methods used to justify the ephedra ban.
Supplements the FDA is said to be currently researching include kava, usnic acid and pyrrolizidine alkaloids.
Representatives from the supplements industry, including the Council for Responsible Nutrition, applauded the FDA's actions.
"Laws that sit on the books unenforced are no laws at all," said Loren Israelsen, executive director of the Utah Natural Products Alliance. "What was envisioned in 1994 [when Congress passed DSHEA] was proper enforcement. That's good for everybody and doesn't undermine DSHEA."
Israelsen did, however, question why the FDA is outlining a science-based plan now.
"This is what they should have been doing all along. Whether it's lack of money, lack of will, it appeared the agency was unwilling to enforce the law. It now appears the mindset has changed."
In an April 19 speech before industry groups, Crawford said, "
We have seen over the last 10 years a huge growth in the dietary supplements industry.
We have become increasingly aware of the potential health problems some of these products pose."
Israelsen also expressed concern about how the DSHEA enforcement will be enacted. "Will it be an internal process where the industry will find out through trade and consumer publications? We want appropriate scientific and safety standards."
Crawford announced that the FDA will provide more information on its DSHEA enforcement plan during the next several months.
The agency is also developing supplements industry regulations for good manufacturing practices, and label guidelines addressing structure/function claims.
Ephedra and Ban Xia Bans
What follows are updates on the ephedra and
ban xia bans, including phone numbers and sample letters towards the
bottom of the page. If you are a member of the public or new to this issue, read this page first.
[04/09/04] [03/25/04] [What You Need To Do] [Sample Letter]
April 13, 2004
Apr. 12 has come and gone and the judge in
N.J. didn't save our bacon. Neither has AHPA. Below is an email I
received at my request from Richard Frieburg in Florida. The following
email gives information on initiating a suite against the FDA. I
believe that only such a legal challenge is going to work with the FDA.
According to Richard, the law firm mentioned would probably charge an
initial retainer of $2K, and the suit is likely to cost about $20K.
Here's what Honora and I propose:
1. We form a separate trade association of
Chinese medical suppliers and herb manufacturers, importers, and
distributors outside of AHPA. AHPA's great, but they have their own
conflict of interests. Honora and I believe we need an association that
is totally, 100% devoted to our interests. We tried this once before
and failed, but now we have a real issue to coalesce around.
2. Each member firm chips in a portion of the
initial retainer on a sliding scale based on last year's gross sales
with a promise to similarly split the eventual cost of litigation.
3. We either hire the law firm recommended by
Richard or some other firm with a proven track record against the FDA
ASAP and get this litigation going.
Honora and I would be willing to do a certain
amount of the organization and logistics of getting this off the
ground. However, if someone else wants to take responsibility, and then
really does follow through, no problem. We're not attached to the
process, only the results.
The ball's in your court. What do you say?
Also, who else should we be reaching out to?
Honora & Bob
Bob The FDA is a federal agency and therefore
comes under the Executive branch of government. Within the executive
branch.......code/rule making which the Ephedra ban rule is, is called
Administrative Code Rule which MUST follow the laws of rule making
along with DSHEA and coupled with Food, Drug & Cosmetic Act. The
APA law is called the federal Administrative Procedures Act. The
complaint which is brought is called an Administrative Petition
(complaint) and is heard/adjudicated by a federal Administrative Law
Judge very similar to the judicial court system. It is called an
Administrative Hearing similar to the judicial court system in that
administrative law uses much of the Rules of Civil Procedure with
exceptions that can be tricky. And if one loses in Administrative Court
there is always Judicial Court as the next remedy which follows. Often
if one tries to sue in judicial court first it can be thrown out since
the petitioner has not exhausted all the administrative remedies. I
will send you an example of MY Admnistrative Petition when I challenged
the Florida Department of Health/Board of Acupuncture last year (8/03)
and successfully won the case (10/03) without ever hiring a lawyer. Not
something that I would do or recommend anyone else trying especially on
a federal level. I will send you the Florida Administrative Law Judge's
Final Order in my case. This way you can SEE what these challenges look
like in real life and what kinds of charges can be made. Much of which
is technical - some of which is practical. The lawfirm is Ben Kay
Associates - telephone number is 941-955-2248 and ask for Paul
Reinhardt. Actually Paul is in Tallahassee today and tomorrow as will
I......so reach him on his cell at 941-718-0825 and discuss with him.
If you call sometime tomorrow - I wil be with him. RRegards,Richard In
a message dated 4/12/04 5:52:59 PM Eastern Daylight Time,
Could you please send me the information again
on the law firm you recommended and the exact name of the kind of suit
you are recommending we bring?
April 9, 2004
Greetings Friends and Colleagues:
On March 24, 2004, I emailed this "Call to
Action" Alert, providing an update on the FDA Ephedra Ban. While we
have received significant response confirming that the practitioner
community has written their federal representatives (congressional
& senate), it is important that we keep the pressure on in
Washington. Following, you will find the background information
necessary to understand, respond and take action.
On February 11, 2004, The Food and Drug
Administration issued a 263-page final ruling that prohibited the sale
of dietary supplements containing ephedrine alkaloids. They cited that
these supplements present an "unreasonable risk of illness or injury"
to the general public. The complete 263-page rule was published in the
Federal Register Feb. 11, and becomes effective April 12, 2004, sixty
days from the date of publication. Important links regarding the ruling
from the FDA website follow.
Questions and Answers about FDA's Actions on
Dietary Supplements Containing Ephedrine Alkaloids
Federal Register - Final Rule
Final Rule Summary
FDA Press Release - Dated: February 6, 2004
Section IIIB “What Products are Covered” of
the ruling states: “Several Ephedra species (including those known as
“ma huang”) have a long history of use in traditional Asian medicine.
These products are beyond the scope of this rule because they are not
marketed as dietary supplements.”
Section VB5 “Scientific Evaluation: What are
the Known and Reasonably Likely Risks presented by Dietary Supplements
containing Ephedrine Alkaloids?: Traditional Asian Medicine” continues
with a response to some public comments: “This final rule does not
affect the use of Ephedra preparations in traditional Asian medicine,
although we considered the comments’ views and information on the use
of Ephedra in traditional Asian medicine in the context of their
possible relevance to the risks of dietary supplements containing
ephedrine alkaloids. This rule applies only to products regulated as
dietary supplements (See 62 FR 30678 at 30691). Traditional Asian
medicine practitioners do not typically use products marketed as
However, it was through CSOMA member John
Chen’s analysis of the FDA ban that he was able to clarify the
ambiguities of this ruling to the extent that the CSOMA board concluded
a very real threat does exist. Dr. Chen’s March 11, 2004 letter to the
TCM community states:
In follow-up discussions with John Chen and
Gene Bruno, President, of the AAOM, CSOMA has pledged Board support to
their ongoing discussions with the FDA on behalf of the profession. We
feel that it has been the result of the effective work of the AAOM that
has warranted the current “exemptions” that appear to have been
afforded to the traditional Asian medical practitioners community. To
that extent, this represents a “Call to Action” for our members to
initiate a campaign to inform our federal representatives
(congressional & senate) of our need for continued access to these
potentially banned herbs. When writing, please indicate the following:
We ask that letters be addressed to your
federal congressional and senate representatives as well as FDA
representatives [see John Chen’s “Call to Action” addendum] and that a
copy be sent to CSOMA’s office at email@example.com, or by fax
to: 916-455-0356. The input received from members, peers, and
colleagues will be combined and provided to Dr. Chen, the AAOM, and the
American Herbal Products Association.
The need for unification in addressing this
issue cannot be stressed strongly enough as there must be “one voice”
that represents the profession with the FDA. To that extent, CSOMA
recommends that all state associations to reach out to their
memberships in doing what they can to support the AAOM’s efforts on
this important issue.
We also feel it is important to inform our
membership of the efforts of the American Herbal Product’s Association
in submitting a March 12, 2004 Petition for Reconsideration and
Petition for stay of Action to the FDA, Docket No. 1995N-0304. CSOMA
was unable to take a formal position on this petition due to the timing
of the petition. CSOMA will remain in contact with members of the
American Herbal Products association and will provide updates on the
status of their petition.
We ask your assistance in supporting this
effort by emailing your responses to firstname.lastname@example.org with a
subject of Response to Ephedra Ban, or you may fax your responses to
Howard Kong, MS, LAC, President
CSOMA Board of Directors
Thursday, March 25, 2004
Practitioner Call to Action on Ephedra Ban
Requested by the Chinese herbal medicine
manufacturer group, Blue Poppy Enterprises is passing on this
information to all practitioners, students and doctors of Chinese
medicine to ask for your participation in this action. Act now and send
the attached letter as soon as possible (the FDA rule goes into effect
on April 12) to your Government Representatives regarding the loss of
the Ephedra (ma huang) and Pinellia (ban xia) herbs in use in
Traditional Chinese Medicine.
The ruling by the FDA, which states "This
final rule does not affect the use of Ephedra preparations in
traditional Asian Medicine. This rule applies only to products
regulated as dietary supplements. Traditional Asian medicine
practitioners do not typically use products marketed as dietary
supplements" is very confusing. While it may seem that practitioners of
Chinese medicine are exempt from the FDA ban, in point of fact, all the
prepared medicines that practitioners of Chinese medicine use are
labeled as dietary supplements. This means that the access to Ephedra
and Pinellia will in effect be denied for practitioners using prepared
herbal formulas that contain these two substances. In fact, some
companies manufacturing herbal formulas have already taken these two
herbs out of their formulas.
Review of the safety, benefits, or traditional
uses of Pinellia rhizome (ban xia or Pinellia ternatae) has not been
conducted. Considering the very low level of ephedrine alkaloids in
this herb, the appropriateness of the ban on this herb should be
questioned. In fact, unprepared Ban Xia has 0.00344% or 34 PPM of
ephedrine alkaloids and prepared Ban Xia has ND (non-detectable) at a
testing limit of 3PPM. FDA cites significant Adverse Event Reports for
the herb Ephedra but none were related to any product sold to or by
professional practitioners. No Adverse Event Reports at all have been
associated with Pinellia (Ban Xia). Please note that licensed health
practitioner products which contain Ma Huang exceeds 325 products and
licensed health practitioner products which contain Ban Xia exceeds 950
The Ruling, as interpreted by law firms
specializing in FDA matters (not corporate attorneys), is confusing as
to which "traditional Chinese herbal products" may be exempted by
licensed health practitioners.
What needs to be done?
Practitioners should email/mail your Senators and Congressman
concerning the FDA Final Rule, which will become effective 4/12/04 and
will ban the use of ephedrine alkaloids (i.e., Ma Huang and Ban Xia).
For a list of the government representatives
in your area, please access:
The following is a partial list of FDA
Mark McClellan, MD
Wayne Amchin, Ephedra contact
Center for Food Safety and Applied Nutrition (HFS-007)
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857
Example of letter to be
sent: (cut and paste it)
I am a Licensed Acupuncturist in your voting
district and would like to voice my opinion regarding the final FDA
ruling declaring Dietary Supplements containing Ephedrine alkaloids
adulterated. The FDA has banned the use of Ephedra (Ma Huang) and
Pinellia (Ban Xia) because they contain ephedrine alkaloids. There are
no Adverse Event Reports regarding the herbs Ephedra (Ma Huang) and
Pinellia (Ban Xia), from a practitioner-restricted product. In other
words, the FDA has not followed due process with this herb.
I use Ephedra (Ma Huang) occasionally and
Pinellia (Ban Xia) regularly in my practice and these herbs are
administered safely according to my extensive traditional Chinese
herbal training and national certification. Please communicate to FDA
on my behalf. I would like to request that this recent ban be revised,
to allow access to dietary supplements that contain ephedrine alkaloids
in my practice, for use in traditional formulas and for traditional
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