What ELSE can be done to PROTECT Our Access to Herbs

[Guest guest]

Attilio

 

All should be at least clear that although these activities may be

helpful.............they are NOT the way of real LEGAL challenge as to the FDAs

promulgation of this rule. In other words they carry NO weight of the law.

 

The strongest activity is for someone/entity (preferably one of the effected

herbal companies) to file a REAL Administrative Law challenge against the rule.

 

What AHPA filed is NOT an Administrative Law challenge. It was filed through

the voluntary public comment process and does NOT hold the strength of a legal

challenge.

 

The difference is further seen in that the AHPAs request goes to the FDA for

their decision on whether or not they wish to consider a 'stay' or to

'reconsider' the arguments. Would you trust your future on the FDA? It is as

foolish

as going before one's enemy and asking them for permission as to what armaments

you might use in battle.

 

The REAL administrative law challenge goes before a REAL federal

Administrative Law JUDGE via a special hearing process and ultimately the case

is decided

based upon many facts and factors including but not limited to whether or not

the FDA over stepped their legal boundaires, whether or not their so-called

research was proper, whether or not even their arhuments leading them to the

final rule was sound in law, etc.

 

This public comment process is simply asking the FDA to listen and usually

utilizied before the final rule is published.......the second is to take it to a

Judge for a legal decision based upon a proper CHALLENGE against the

invalidity of the rule.

 

Richard

 

 

 

 

of In a message dated 3/26/2004 8:17:52 AM Eastern Standard Time,

attiliodalberto writes:

Taken from the AAOM newsletter dated 25/03/04

 

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 ban does 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 with your Senator or Representative

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.

 

We are providing you with a link to the United State House of

Representatives and the United State Senate. Click on one of the

links below and you will be directed to the main web site of either

the Senate of House of Representatives. From the U.S. Senate web

site, you will be able to select your state. From the U.S. house of

Representatives web site, you will need to enter your zip code.

 

http://www.senate.gov/

 

http://www.house.gov/

 

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.

 

 

Attilio