AAOM Strategy on Protecting Herbal Medicines

[Guest guest]

AAOM Strategy on Protecting Herbal Medicines

 

 

 

The goal of the American Association of Oriental Medicine is that Chinese

medicine

 

herbal formulas, including those containing ephedra, continue to be available

to practitioners and their patients.

 

 

 

FDA’s final regulation finding dietary supplements containing ephedrine

alkaloids to be adulterated says it does not affect the use of ephedra

preparations

in traditional Asian medicines. This direct, unambiguous statement supports

our goals. Indeed, this is the very result recommended by the AAOM in response

to the FDA’s earlier request for comments. AAOM considers this a positive

development and recognition that the FDA is aware of the needs of our medicine.

The regulation also says that products typically used by Asian medicine

practitioners are not marketed as dietary supplements. This statement leaves an

important question unanswered. This question is not limited to formulas

containing

ephedrine alkaloids. It is broader than that. It affects all traditional Asian

herbal formulas. The unanswered question is, in FDA’s view, “just what is

the

Food, Drug and Cosmetic Act status of traditional Asian medicine herbal

formulas?â€

 

 

 

We have requested clarification from FDA consistent with our long-term goal

of assuring a continued supply of traditional Asian medicine herbal formulas to

our practitioners and their

 

patients. The AAOM expects this process, at a minimum, will lead to a better

understanding of FDA’s position on the issue, and beyond that, hopefully, lead

to the development of a position

 

satisfactory to FDA and consistent with our goals. We recognize that any

solution may require legislation. If this is the case, we believe our chances

are

enhanced if the legislation has FDA’s support. We realize that this may not be

possible. We recognize the litigation is an option, but consider litigation

to be a last resort, because of the cost, the timeline, the uncertainty of the

results and its incompatibility with the pursuit of a negotiated solution. The

AAOM is looking for accommodation and believe we can find it.

 

 

 

The AAOM recognizes that others in the community may feel differently and we

respect their beliefs. If practitioners want to be pro-active, they can write

their congressperson and ask for help in convincing the FDA to clarify this

issue. The AAOM will be patient, persistent and flexible, as befits our

tradition. There will be rocks in our path. Like flowing water, we will move

around

them. The FDA says it is not changing the way Asian medicine herbal formulas are

regulated. Asian medicine herbal formulas have been sold without disruptive

Federal intrusion for a long time, with certain exceptions. We have seen no

hard evidence that this policy is about to change. The exceptions in the past

were instances where FDA perceived safety issues. The AAOM also has ideas on how

safety concerns might be better addressed in the future, which we intend to

share with FDA at the appropriate moment.

 

 

 

What Practitioners Can Do

 

Many practitioners have been contacting the AAOM to ask what they can do as

individuals to help protect our access and use of herbs. The AAOM encourages

practitioners to take the following actions which can lead to an actual,

productive result:

 

As you are aware, a recent FDA regulation bans the use of ephedrine alkaloids

in dietary supplements but specifically says in the preamble to the rule that

this does ban not apply to ephedra preparations in traditional Asian medicine

.. Placing this assurance in the preamble has caused confusion among suppliers

of Chinese medicine herbal formulas about the legality of their products

which merits immediate clarification.

 

Here Is What You Can DO: You are a licensed practitioner who votes in the

legislator's district.

 

• Ask the legislator to contact the FDA and insist on an amendment to the

ephedrine alkaloid regulation.

 

• Explain to the legislator that the exemption for traditional Asian medicine

needs to be added in the text of the rule.

 

•Since the preamble to the rule does state that the ban on ephedrine

alkaloids does not apply to Chinese medicine herbal formulas, by placing this

statement into the actual rule will help clarify any confusion.

 

These products have a centuries old history of benign and effective use by

practitioners of Chinese medicine. This clarification is essential to assure

the continued supply of these products to practitioners and their patients.

 

How to make contact: One of the best ways to make contact is by written

letter, but certainly an e-mail version is fine. Some of you who have a

relationship with your legislator may also want to speak with her/him

personally.

Nevertheless, having a written copy of your request is important. Keep your

letter

simple, and to the point.

 

Very Important: Send a copy of your letter or e-mail to AAOM headquarters.

This way we can compile a file of hundreds of letters that will give us more

leverage with the FDA.

 

 

Gene Bruno

AAOM President