The State of Florida vs. the FDA: An Infringement on the Practice of Medicine

I recently made a presentation before the Florida Board of Acupuncture on behalf of the Florida Association of Oriental Medicine (FAOM) and as a faculty member given authority to speak for the Florida College of Integrative Medicine. This article seeks to further the argument made then to this wider audience of our profession.

The issue raised before the board was whether there is a state's right issue respecting the impairment of the delivery of health care services by providers of acupuncture and Oriental medicine in the state of Florida, due to the inappropriate application of federal regulatory rules by the Food and Drug Administration against herbal and homeopathic remedies, most notably those addressed last April by an FDA ruling regarding ma huang and ban xia, and more currently, animal products via the misapplication of the Convention on the International Trade of Endangered Species (CITES) and the Dietary Supplement Health and Education Act (DSHEA).

Documentation supportive of this argument was submitted with material from the American Herbal Products Association, the American Association of Oriental Medicine, the National Acupuncture and Oriental Medicine Alliance, and other agencies. The board intends to review the argument presented, and assess whether the issue is as pervasive as I had argued. The board counsel agreed with the legal argument made and added that the issue is political and turns on whether the state would advance the issue once the argument is presented to the state's Office of the Attorney General via the Secretary of the Department of Health.

The issue herein is to promote a wider dialogue, be a catalyst and causative of action taken elsewhere on this state's right issue, and direct all effort to support the American Herbal Products Association as the group that has been and is taking on the issue. We should support members of this trade association and make it known to the ownership through our purchases.

In Florida, the two guiding rules that augment Florida statutes are:

• 64B1-4.004 Herbal Therapies. Herbal therapy means the use, prescription, recommendation, and administration of herbal therapy/phytotherapy, which consists of plant, animal, and/or mineral substances and shall include all homeopathic preparations to promote, maintain and restore health and to prevent disease.
• 64B1-4.009 Dietary Guidelines. Dietary guidelines shall include nutritional counseling as used in acupuncture and oriental medicine and the administration, prescription, and/or recommendation of nutritional supplements to promote, maintain, and restore health and to prevent disease.

As Oriental medicine has attained greater presence in the delivery of efficacious health care service with protocols and medicines that do not carry with them the significance of adverse affects, we suffer the consequences of the political umbrella of the wider medical community, which perceives a market threat and therefore seeks to diminish our presence and usurp our protocols by a leveraged presence via the FDA, control of research, lobbying by the AMA, lobbying by varied state medical associations, and the media, with its promulgation of misinformation driven on the element of fear over this or that remedy that is advanced as causative of some "alleged" harm.

Sen. Richard Durbin, the Democratic senator from Illinois, had introduced legislation that would grant FDA broad, new authorities over dietary supplements. The so-called Dietary Supplement Safety Act (S. 722) would establish new rules for dietary supplements, but not for drugs, so that a single report of a serious adverse event could result in a demand by FDA for a dietary supplement to be removed from the market.

The American Medical Association (AMA), located in Chicago, has a standing policy to amend DSHEA. In 1998, the AMA adopted Policy H-150.954, which urges Congress to modify DSHEA so that all dietary supplements , including those already on the market, are required to undergo approval by the Food and Drug Administration (FDA) .

Consumers Union, the publisher of Consumer Reports, is actively working to support Sen. Durbin's legislation with a coordinated "grassroots" project. With a call to urge stricter FDA oversight of dietary supplements , this organization is encouraging its readers to contact the U.S. Congress with a message to reform DSHEA and protect consumers.

The perception of FAOM and that of the Florida College of Integrative Medicine is that we, as a profession, in the fulfillment of our goal of delivering our services and practice of medicine to the satisfaction of the public interest, must assure the proper interpretation of our medicines as herbs and not as a pharmacological assessment. This circumstance of inappropriate interpretation of our internal medicine lies within our folder for our failing at an earlier time to adequately demonstrate their proper and scientific interpretative profile in a manner that agencies of government may properly understand.

This has led to the more current additional and compounding infringement of the delivery of health care to the public by the inappropriate application of CITES (the Convention on International Trade in Endangered Species of Wild Fauna and Flora, www.cites.org), an international agreement between governments. Its aim is to ensure that international trade in specimens of wild animals and plants does not threaten their survival. The result is that the FDA is overreaching its authority and banning the importation of other animal and plant products.

Shipments with tian ma are held up with the assertion that it is an endangered species on the CITES list; however, though an orchid, it is on the "exception" list. We have also had scenarios in which shipments with animal products are held up with the assertion that they are new dietary ingredients (NDIs) and are without adequate information to warrant their safe use.

Upon challenge, these shipments are released. "Upon challenge" means months of delay and chasing the tail of the tiger. The practice of medicine is being impaired; public health is being jeopardized. The issue is a state's right matter respecting the practice of medicine, and we need to further this argument in each state.

Animal Ingredients That Are Not "New Dietary Ingredients"

The American Herbal Products Association states, "Numerous AHPA members that market dietary supplements that contain herbal and other botanical dietary ingredients also market dietary supplements that contain dietary ingredients that consist of various parts of several animal species. Some of these consist of ingredients that are commonly referred to as 'glandulars' and that are processed from various animal organs, such as heart, kidney, liver, etc. Others are animal ingredients that have long been associated with, and used along with, traditional Asian herbal ingredients. All of these animal ingredients fit into the broad group of dietary ingredients described in 21 U.S.C. 321(ff)(1)(E), that is, 'a dietary substance for use by man to supplement the diet by increasing the total dietary intake.'"

The use of animal-source dietary ingredients certainly predates DSHEA and is not unknown to FDA; in fact, FDA has specifically recognized the presence of these ingredients in the food supply. Even before DSHEA was passed, FDA's Dietary Supplement Task Force acknowledged the use in supplements of "animal extracts."¹ In addition, in implementing the food facility registration requirements established by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the agency developed a food facility registration form that requires the registrant to disclose, among other things, the general product categories, including categories for food for human consumption, that are applicable to the facility. One of the human food categories identified on the registration form is "dietary supplements," and an "optional selection" that is placed as a subdivision of dietary supplements is "animal by-products and extracts."

It is AHPA's belief and position that quite a number of glandular and traditional Asian animal ingredients were marketed in the United States prior to Oct. 15, 1994 and are therefore excluded from the statutory definition of "new dietary ingredient." In addition, AHPA is aware that there is significant evidence, in the form of dated catalogues and other dated marketing documents, that many of these animal ingredients were offered for sale in the United States prior to Oct. 15, 1994.

It has come to AHPA's attention that FDA has on several occasions detained dietary supplements prior to importation that contain animal ingredients, particularly traditional Asian animal ingredients that were marketed in the United States before Oct. 15, 1994, and that are therefore not NDIs. In recording these detentions. FDA's compliance officers have cited violation of the Federal Food, Drug, and Cosmetic Act, section 402(f)(1)(B) (21 U.S.C. 342(f)(1)(B)), and stated that the product "appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury." In other words, the FDA compliance officers are holding ingredients that are not NDIs accountable to a regulation from which these ingredients are specifically exempt.

As a direct comment to this docket, AHPA believes that any animal ingredient, including glandular ingredients and traditional Asian animal ingredients, that was offered for sale in the United States before Oct. 15, 1994 is exempt from the statutory definition of "new dietary ingredient." In addition, AHPA hereby requests that FDA act promptly to correct the erroneous detentions of animal ingredients described above, at every point of import, by clearly communicating to all compliance officers that the statutory requirements for new dietary ingredients do not apply to ingredients that are not NDIs.

Our materia medica is the heart and soul of our practice, which we must rise to defend by firstly an action of estoppels and secondly a plan that generates a mechanism of proper profiling of our materia medica so that agencies of government may better reflect their responsibilities of protection of the public through appropriate regulation of medicine while not infringing on the practice of medicine.

Under DSHEA, the FDA may remove a dietary supplement from the market if it presents a significant or unreasonable risk of illness or injury when used according to its labeling or under ordinary conditions of use. FDA's final regulation presents a framework for applying this unique statutory standard.

A summary of the FDA's Final Rule on ephedrine alkaloids can be found at www.fda.gov/oc/initiatives/ephedra/february2004/finalsummary.html. The AHPA submitted a petition, which was joined by the National Acupuncture and Oriental Medicine Alliance, seeking a clarification of the ruling respecting the professional use of traditional formulas, on March 16, 2004, which stated in part:

"The petition for reconsideration specifically requested that FDA 'recognize that dietary supplements that contain ephedrine alkaloids do not present an unreasonable risk of illness or injury under conditions of use that include formulation as a traditional Asian herbal formula or as a traditional Ayurvedic herbal formula, and that are for dispensing by a licensed health care practitioner within the practitioner's scope of practice and in a manner consistent with traditional practice.'

"The Final Rule, as published by the agency on Feb. 11, 2004 and due to become effective on April 12th, determined that all dietary supplements that contain ephedrine alkaloids present an unreasonable risk and are therefore adulterated. At the same time, in the preamble of the Feb. 11th Federal Register, the agency made numerous comments to the effect that the final rule would not apply to 'traditional Asian medicines' that contain ephedrine alkaloids and that the rule 'does not change how these products are regulated.'"

As primary health care providers, licensed in the state of Florida to practice Oriental medicine, we are impaired in its full faith and delivery and set forth the following tenets applicable and supportive of our argument: that we are doctors of Oriental medicine; that we are trained in herbal medicine; that the FDA's ban of ephedra as a "dietary supplement" and pinellia is on the basis of their ephedrine alkaloids; that this mechanism of assessment is pharmacological and not an appropriate means of interpreting herbal medicine; that there has never been an adverse report arising from its "prescribed" use by a doctor of Oriental medicine; that the continued inappropriate application of CITES and the DSHEA against plant and animal products is patently obstructive to the practice of medicine and inconsistent with the applied rules; and that the implementation of these bans poses harm to the public by depriving them of the benefit of these herbs and animal products when prescribed by a trained doctor of Oriental medicine.

We use these herbs extensively in our practice, as they are found in numerous formulae, and have never noted an adverse affect. I am requesting that communication be tendered to the FDA by way of the state's Office of the Attorney General on our professional behalf seeking a clarification of this ruling that would allow appropriately licensed practitioners access to dietary supplements that contain ephedrine alkaloids and those plant and animal products that are not subject to CITES nor DSHEA constraints for use in traditional formulas.

Reference

1. Dykstra G, et al. (U.S. Food and Drug Administration). Dietary Supplements Task Force Final Report, May 1992, p. 1.