Impending Legal Situation, Forewarded from Crane Herbs

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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 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.

 

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 agency'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

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.

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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.

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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.