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Submitted by Robert Felt on May 2, 2007 - 2:13pm.
The innumerable, often-forwarded emails and list service postings discussing the FDA Guidance on complementary and alternative medical products have slowed down, perhaps reaching a saturation point. It may then be that this is a time for a more detailed and less "excited" look at this issue. (I have posted a copy of the Guidance here should you wish to read it for yourselves.) These communications have ranged from rather strident yahoogroups postings suggesting that the F.D.A. is planning on imposing the E.U .Codex in the U.S. to the more measured response from the A.A.A.O.M. Writing for the A.A.A.O.M. President Leslie McGee states:
The FDA has written a document entitled "Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the FDA " This draft guidance seeks to clarify when a CAM product is subject to regulation under the Federal Food, Drug, and Cosmetic Act (called "the Act") or the Public Health Service Act (called the "PHS Act").
The AAAOM has asked several of our expert analysts to review this draft guidance. Based on these reviews, our conclusion is that this document simply reiterates the current regulatory status of CAM products, including herbs. This document contains no new proposed regulations or principles. We see no language that attempts to redefine herbs as drugs or that proposes any new regulation of herbal medicine. 
I agree with the A.A.A.O.M., although I do see language that could be used to "redefine herbs as drugs;" however, as Ms. McGee notes, that language has been in place for some time. The realistic dangers to our access to Chinese medicinals and formulas are not so much the Codex Alimentarius but the potentials introduced by our own actions, and the actions of supplement manufactures. To understand this, it is first important to look at the realities of F.D.A. regulation. In the United States herbs (I'm accepting the misnomer here, we are actually talking about all medicinal substances, not just the herbaceous ones) are "dietary supplements," like vitamins and minerals. Dietary supplements are regulated by the Dietary Supplement Health and Education Act (DSHEA) of 1994. An FDA explanation of the act can be found here. The main points are summarized thus:
The DSHEA established a formal definition of "dietary supplement" using several criteria. A dietary supplement:
- is a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.
- is intended for ingestion in pill, capsule, tablet, or liquid form.
- is not represented for use as a conventional food or as the sole item of a meal or diet.
- is labeled as a "dietary supplement."
- includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the Secretary of Health and Human Services waives this provision). 
There's no question that Chinese prepared formulas and individual medicinals are and have been imported, manufactured and sold under the definitions of DSHEA. What then has caused the excitement around this issue?
Man the Barricades Codex is Coming, Codex is Coming!
One of the primary sources of the furor is the notion that "Codex" (i.e.: Codex Alimentarius) is an imminent threat to the availability of dietary supplements in the U.S. An example of this notion may be found here . These pronouncements have included requests for donations, sites to provide comment to the F.D.A., and, in my opinion, inflated notions of the likely outcomes. Again, it is important to have a clear sense of what Codex Alimentarius does.
The potential for Codex specifications to impact the use of dietary supplements in U.S. is through the notion of a trade barrier. If, for example, the U.S. were to adopt standards for a dietary supplement that were in excess (more restrictive) of those in the Codex Alimentarius, a member of the World Trade Organization would have a right to demand that the U.S., as a fellow member of the W.T.O., provide scientific evidence supporting this greater restriction. Absent that evidence, the U.S. standard could be ruled restrictive to trade and sanctions could be levied against the U.S. Sanctions, by themselves, would not necessarily change U.S. standards because the U.S. could decide to simply absorb any sanctions imposed by the W.T.O., typically as an import duty. A sanction would not necessarily fall on the substance challenged. In effect, DSHEA protects the lower U.S. standards for dietary supplements. Since the products of a W.T.O. member state can be sold in the U.S. if it is produced to an applicable Codex standard that is more restrictive than the related DSHEA standard, there is effectively no impetus for Codex-controlled manufacturers to bring a complaint to the W.T.O. Regardless of the on-line warnings, the international agreements involved contain no mechanism by which the U.S. can be forced to adopt the Codex Alimentarius.
What will be the ultimate ramifications of the Codex Draft Guidelines on U.S. dietary supplement law? No one can predict with certainty what the actual impact will be. The legal reality is that the passage of the Codex Draft Guidelines in July 2005 will not immediately change U.S. law, regardless of what some of the "alarmist" emails proclaim. Your right to purchase and sell supplements will not be taken away by the Codex guidelines come July 2005. Notwithstanding these immediate legal realities, the Codex Draft Guidelines still warrant your close attention. Whether the FDA attempts to issue regulations similar to Codex standards, whether certain members of Congress use the Codex guidelines as rallying points in an attempt to harmonize U.S. law with international standards and diminish DSHEA, or whether action takes place in the WTO to impose sanctions on the United States, remains unknown. Unfortunately, the "alarmist" emails declaring the end of DSHEA have a negative effect for those fighting against Codex standards. Instead of rallying support for opposition to the Codex Draft Guidelines, these emails diminish the credibility of the people who have raised rational and valid concerns about the possible threats to the U.S. dietary supplement community. It is important that the U.S. dietary supplement community be aware of the facts surrounding the Codex Draft Guidelines and rally in an informed, rational manner so that members of Congress, the FDA, and other influential groups are aware that the changes suggested by the Codex Draft Guidelines are not justified, warranted or wanted by the majority of the U.S. dietary supplement community. The ramifications of the Codex Draft Guidelines will continue to be one of the "hot" topics and an issue that requires reasoned discussion and action.
Clearly, Attorney Procnow was correct that the March 2005 Codex did not result in any change of the U.S. law. It is also clear that his advice regarding the "alarmist emails" was well considered as we are again responding to them two years after the Codex Guidelines were promulgated. Importantly, his warning makes plain where the dangers actually lay: Congressional action harmonizing U.S. Law with the Codex standards. In other words, what we have to fear is not Codex, but actions from within the Chinese medicine community, or others, that inspire conformity to Codex Alimentarius, more restrictive legislation, or a more restrictive interpretation of DSHEA..
What are the Clear and Present Dangers?
Basically, we need to be concerned about anything that brings medicinals and formulas into the public eye as a danger to the health of the general population. Consider, for example, the current case of melamine contaminated pet (and possibly human) foods imported from China. The public outcry has lead to the creation of a new FDA position with considerable power over what can and cannot be imported.. If the damage done by weight loss formulas that were never part of the C.M. formulary is heavy-handed restriction on Ma Huang, just imagine what would follow revelations of a pollution-laden or contaminated medicinal. Of course, there's nothing we can do about this sort of attention except to thank our importers for their diligence in assuring the purity of the medicinals we use. Yet, we also require due diligence of manufacturers on whom we depend for these products. Bill Mosca, L.Ac. of C.S.O.M.A. makes the salient point:
In my view, the far greater threats to our continued access to traditional herbs are the misuse of herbal isolates by supplement manufacturers. By extracting and concentrating "active ingredients" from herbs, these manufacturers expose us to overregulation by FDA.
One only needs to look as far as the FDA actions against Ma Huang in recent years to see the effects of this. I'm not aware of a single major adverse event associated with the appropriate traditional useof Ma Huang. However, the extraction of ephedrine alkaloids from this herb and its use in weight loss supplements has killed people.
Without any effective regulatory mechanism for distinguishing between traditional use of the whole herb and the extractive use in supplements, FDA has little choice but to issue wholesale bans on the herb in all forms.
Synephrine alkaloid containing herbs such as Zhi Shi may be next on the FDA chopping block due to extraction, isolation, and misuse in weight loss supplements.
Let's work to address the most pressing and real issues with herb and supplement regulation in the U.S. and not get distracted by lesser threats.
Here we see, similar to Attorney Procnow's warning, that we need to concentrate our attention on the present threats and not be distracted by "codex is coming" hyperbole. So, how do we avoid the blunt instrument of FDA prohibition? In some regards, there's not much we can do. As with Ma Huang, we cannot keep people from diving into the traditional literature, making assumptions and producing products of, or including, herbal isolates with effects and dangers not present with the traditional medicinal. It seems to me self-defeating for any C.M. practitioner to buy, sell or offer their patients these products. C.M. web and print publishers should certainly refuse to accept advertising in their periodicals and clinicians should certainly let anyone who advertises and, or, sells such products know of their disapproval. We can be rigorously pro-active in informing the public that these products are not based on, or justified by, Chinese clinical experience. Ideally, we would find a way to control explicit claims of efficacy based in Chinese medical experience such that unethical producers would be unable to associate their products with Chinese medicine simply because they misuse a traditional ingredient. But, frankly, this would likely require convincing the F.D.A. that there should be a category for traditional forms and uses. Unfortunately, the risks in the political realm are both difficult to anticipate and to counter.
There are risks can we do something about. There is a clue in the F.D.A. Guidance document itself:
To illustrate how these definitions might apply, consider an herbal product that is intended to treat arthritis in humans. The herbal product, which would be a "biologically based practice" insofar as CAM domains are concerned, would be a "drug" under section 201 (g)(l)(B) of the Act because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (arthritis) in man. The same herbal product would also be a "new drug" under section 201 (p)(l) of the Act unless it is generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. "New drug" status triggers the Act's requirements for premarket review and approval by FDA. (Emphasis added)
What this illustration from the FDA Guidance document tell us, in a nut shell, is that a herbal product that intends to treat a human ailment recognized by biomedicine (arthritis) will trigger definition as a drug, and the new drug protocols, unless generally recognized by experts to be effective for the disease claimed. On the one hand, this suggests that expert testimony could result in acceptance. However, as Emmanuel Segmen, who has long participated in medicinal importation and has followed the development of the current regulatory environment states:
I agree that the following passage [posted above] provides a possible way out of the New Drug category if they really mean to let "experts" qualify herbs as drugs which are safe and effective. Once an herb or an herbal formula triggers the New Drug status, you lose it completely since it can be neither a regular drug nor a dietary supplement. This is where lobbying and legislation comes in. Back in 1994 Sun Tien and others ponied-up some hundreds of thousands of dollars and got things done in California. The next step at the federal level did not take place. So that's where things are at now.
The question becomes, what are the chances that testimony by experts acceptable to the FDA could actually keep the new drug regulations from being imposed? Personally, I do not put a lot of store in this possibility. The FDA's relationship with "Big Pharma," particularly under this administration, and that "Almost every doctor in the country has some type of relationship with pharmaceutical manufactures, whose clear goal is to influence physicians to prescribe the company's newest, most expensive drugs'' does not suggest much chance that the expert testimony route will accomplish much. Again, in Emmanuel Segmen's words:
No matter what the new "guidance" might promise from the word of "experts," it's my own firm belief and contention that the treatment protocols of CM be applied to the treatment of CM patterns ... and nothing else. There can be "parallel practice," but any given practice has to maintain the integrity of it's principles. For the moment, I can't see any way around this. And probably, it's wise not to try to "go around".
Here, Emmanuel strikes the critical note. Whenever and wherever someone steps outside the context of Chinese medicine, whether it is in the creation of a commercial weight loss product, or the making of claims to a "biologically based practice" in the treatment of biometrically defined diseases, we add another layer of risk. Thus, I cringe more than a little when I read a clinician's post stating:
I believe that a STRONG, concerted effort on our part is necessary to assure the continued existence of TCM as we know it. We are doctors and we should say so. Our pharmacoepia is comprised of herbal medicines that treat disease and we should say so. We should not have to hide behind TCM diagnosis jargon in order to avoid notice.
Admittedly, the term "TCM diagnosis jargon" hits a loudly discordant note for me because it is so blatant an expression of the idea that Chinese medicine's underlying observed-pattern logic is nothing more than just so much "jargon" to be replaced by the "real" biomedical diseases that doctors treat. While it is broadly believed that "labeling" in FDA terms refers only to what is printed on the container, note well that the language of the FDA illustration shown above does not only mention labeling but also "intent." The existence of a literature which far too often describes the function of medicinals and formulas in biomedical terms, eliminates or simplifies signs, symptoms and conditions that are "too Chinese," seems to me a rather good way to show intent. I do not believe that the presence of public claims that Chinese medicinals and formulas treat human disease, rather than provide the general well-being associated with dietary supplements, has yet caused the F.D.A. to trigger new drug protocols. However, in my opinion, it would be unwise to assume that it never will. In fact, this week Senators Kennedy and Enzi introduced Senate bill S1082 which reportedly will increase the F.D.A.'s powers to remove products from the market as well as increase its financial ties to the pharmaceutical industry.
In sum then, the A.A.A.O.M. hits the right note in saying that there is nothing new in this Guidance document. A lot of what has been published is off the mark in this regard. However, that does not mean that there is no danger. Some of those dangers we can do nothing about, for example, the misbehavior of manufactures. Others, like the Kennedy/Enzi Bill may demand political action. But we can do most for ourselves is to, as Emmanuel Segmen so aptly states, maintain the integrity of our principles.
 Leslie McGee, RN, LAc, DiplAc, President, American Association of Acupuncture
and Oriental Medicine, email of April 24
 Personal email correspondence with Emmanuel Segmen.
 Email correspondence with the author.
 Anne Underwood, Newsweek On-line, April 15, 2007
Please note, this is a complex bill that I have not analyzed in any rigorous way.