JADE ACUPUNCTURE/ Herbal Regulations Proposed

Please be aware that the following developments will impact your ability to provide herbs to your patients.
This proposal is also attempting reduce the difference between the way that drugs and dietary supplements are regulated.
OM practitioners and their patients need to take action now with their legislators.

AHPA Update
American Herbal Product Association
September 25, 2003
Rally on Capitol Hill Set for October 21
AHPA Members and Practitioners are Urged to Attend

Critics of DSHEA on the move.

Do you know that Senator Richard Durbin, the Democratic Senator fromIllinois, has introduced legislation that would grant FDA broad, newauthorities over dietary supplements? The so-called Dietary SupplementSafety Act (S. 722) would establish new rules for dietary supplementsbut not for drugs so that a single report of a serious adverse eventcould result in a demand by FDA for a dietary supplement to be removedfrom the market.

Do you know that the American Medical Association (AMA), located inChicago, Illinois, has a standing policy to amend DSHEA? In 1998, theAMA adopted its Policy H-150.954, which urges Congress to modify DSHEAso that all dietary supplements, including those already on the market,be required to undergo approval by the Food and Drug Administration(FDA).

Do you know that Consumers Union, the published of Consumer Reports, isactively working to support Senator Durbin’s legislation with acoordinated “grassroots project? With a call to “urge stricter FDAoversight of dietary supplements, this organization is encouraging itsreaders to contact the U.S. Congress with a message to reform DSHEA andprotect consumers.

Senators Harkin, Hatch focus on FDA accountability.
But you should also know that Senators Tom Harkin (D-IA) and Orrin Hatch(R-UT) have introduced a bill that would provide additional funding forFDA to enforce the current dietary supplement law. Finding that FDA hasnot adequately used its authority to enforce DSHEA, the DSHEA FullImplementation and Enforcement Act(S. 1538) would increase FDA fundingfor regulation of dietary supplements and would require that the agencysubmit an annual accountability report to the U.S. Congress on theagency’s enforcement of DSHEA.

Now is the time to act.
Our critics and others who believe that there should be little, if any,difference between the way that drugs and dietary supplements areregulated, are lining up. They are organized and focused, they haveestablished their goals and are actively implementing their strategies.At the same time, our champions continue to address the real issue which is thefailure of the federal regulatory agency to adequately enforce the law.

The herbal and dietary supplement industry must be at least as wellorganized and active as our critics.We must support our Congressionalallies and build new alliances. We must Get Out the Vote, beginningwith our own, to send a clear message of support for S. 1538 andopposition to S. 722.

What you can do.
1. Rally on Capitol Hill set for October 21.
In cooperation with otherindustry organizations, AHPA is co-sponsoring a Lobby Day inWashington, DC. This event, scheduled for October 21, 2003, will createa real opportunity for you to meet personally with key members ofCongress and their staff to educate them about your stake in keepingdietary supplements on the market. There is no cost to attendees and allyour meetings are prearranged for you. For more information and toregister for the Rally on Capitol Hill, visit the AHPA website athttp://www.ahpa.org/rally.pdf or call (301) 588-1171 x106.

2. Write to the Senate and House of Representatives.
No message is more important to an elected officeholder than one received from someone who votes in their state or district. If you can not get to Washington, DC on October 21, you should contact your Congress members in writing. A pre-scripted letter (subject to your modifications) is posted at the end of this alert. Direct email access to your Congressional representatives can be accessed at http://www.congress.org/congressorg/

3. Forward this message to others.
You and your company have relationships with your vendors, your customers, and possibly your customer's customers to whom you should communicate the message that NOW is the time to act. The more voices that Congress hears whether in person on October 21, or in writing, by telephone, or by email, the more clearly they will hear this important message in support of S. 1538 and in opposition to S. 722.

To Use This Suggested Letter.
Go to http://www.congress.org/congressorg/, then simply insert your zip code (preferable zip + 4) and hit go. Follow the instructions (click “email” and then click “Compose Your Own letter”) to send 3 separate emails: one to each of your two senators and one to your representative. Then insert this prescripted message or your own letter and send.

Subject: Support S. 1538 and Oppose S. 722
As your constituent, I urge you to support a very important bill from Senators Tom Harkin and Orrin Hatch, the DSHEA Full Implementation and Enforcement Act of 2003 (S. 1538). This bill will give the Food and Drug Administration the resources it needs to enforce the current law, the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Even though the two most recent FDA commissioners have said that they have the power to ensure dietary supplements are safe for American consumers, the agency has also expressed concern that it doesn't have enough funding to enforce the current law. S. 1538 will provide funding that is consistent with FDA’s needs and will also require the agency to file annual reports to Congress about how DSHEA is being implemented and enforced.

Please support Senators Harkin and Hatch in their efforts to pass this bill and please also consider becoming a co-sponsor.

At the same time that I am requesting your support for S. 1538, I urge you to oppose S. 722, the so-called Dietary Supplement Safety Act, introduced by Senator Richard Durbin. Despite its title, this bill provides no more consumer protection than DSHEA if it were properly enforced. It does, however, contain new and discretionary enforcement powers that would significantly undermine many of the freedoms that American consumers of dietary supplements - like myself, my employees and my customers - hold dear.

S. 722 would also establish a regulatory scheme that subjects nearly all vitamins, minerals, herbal products and other supplements to a level of scrutiny that is both unwarranted and unnecessary. Products that have been used safely and beneficially for many years would be subject to clinical evaluation using standards that are at the complete discretion of the FDA.

Instead of changing a good law, Congress should help FDA do a better job enforcing DSHEA by providing the resources the agency needs to make full use of its existing and adequate authority.

In closing, I ask you support the S. 1538 to help FDA fully implement and enforce DSHEA. I also ask that you oppose the extreme and unnecessary legislation proposed in S. 722.

I look forward to hearing your thoughts on this important matter.