Fwd: Botanical & Supplement Proposed Regulations

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> info

> Wed Oct 01, 2003 11:23:03 AM US/Pacific

>

> Botanical & Supplement Proposed Regulations

>

>

> Dear Practitioners,

> 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.

> Thank you,

> Bill Egloff

> President, Crane Herb Company

> Co-Chair, AHPA's Chinese Herbal Product Committee

>

>

>

>

> 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 from

> Illinois, has 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.

>

> Do you know that the American Medical Association (AMA), located in

> Chicago, Illinois, has a standing policy to amend DSHEA? In 1998, the

> AMA adopted its Policy H-150.954, which urges Congress to modify DSHEA

> so 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, is

> actively working to support Senator Durbinís legislation with a

> coordinated ìgrassroots project? With a call to ìurge 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.

>

> 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 for

> FDA to enforce the current dietary supplement law. Finding that FDA has

> not adequately used its authority to enforce DSHEA, the DSHEA Full

> Implementation and Enforcement Act(S. 1538) would increase FDA funding

> for regulation of dietary supplements and would require that the agency

> submit an annual accountability report to the U.S. Congress on the

> agencyís 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 are

> regulated, are lining up. They are organized and focused, they have

> established their goals and are actively implementing their strategies.

> At the same time, our champions continue to address the real issue which

> is the

> failure of the federal regulatory agency to adequately enforce the law.

>

> The herbal and dietary supplement industry must be at least as well

> organized and active as our critics. We must support our Congressional

> allies and build new alliances. We must Get Out the Vote, beginning

> with our own, to send a clear message of support for S. 1538 and

> opposition to S. 722.

>

> What you can do.

> 1. Rally on Capitol Hill set for October 21. In cooperation with other

> industry organizations, AHPA is co-sponsoring a Lobby Day in

> Washington, DC. This event, scheduled for October 21, 2003, will create

> a real opportunity for you to meet personally with key members of

> Congress and their staff to educate them about your stake in keeping

> dietary supplements on the market. There is no cost to attendees and all

> your meetings are prearranged for you. For more information and to

> register for the Rally on Capitol Hill, visit the AHPA website at

> http://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

> ìemailî and then click ìCompose Your Own letterî) 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.

> ---------

>

> 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 FDAís 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.

>

>

>

>

>

 

Chinese Herbs

 

 

" Great spirits have always found violent opposition from mediocre minds " --

Albert Einstein