Building Support for: " The CODEX Guidelines Vitamins and Minerals
Rejection and Dietary Supplement International Protection Act of 2009 "

 

Contact: Beth Clay, Senior Vice President, Capitol Strategy Consultants

Click here for more information on Beth Clay

 (E-Mail: bclay@dc-strategy.com) (Fax: 202-318-7557)

1. The legislation which will have the following short title: "The Dietary Supplement
International Protection Act of 2009"

2. Review Conducted - I conducted an extensive review of US laws and regulations and
international agreements was conducted.. I found a pathway through which we can
address the CODEX matter effectively and without risking an opening up of the current
law. (There is always concern when we address dietary supplement issues that our
opponents would use that as a vehicle to undermine the Dietary Supplement Health and
Education Act of 1994 (DSHEA) or the Proxmire Amendment of 1976.

3. Legislation Drafted with a team of experts, (with Clinton Ray Miller ) 

4. Legislation Presented to Key Congressional Supporters: On Monday, February 2, I
delivered this draft legislation to key staff in the offices of Congresswoman Diane
Watson (D-CA) and Congressman Dan Burton (R-IN) for their consideration. There was
a positive expression of interest. Staff have submitted it to the Congressional Legislative
Counsel where it will be officially drafted and any legal questions clarified. Once this is
done, Representatives Watson and Burton will determine if they choose to be original
co-sponsors of the bill and let us know. I am in regular contact with both offices. By
utilizing two recognized friends of the supplement industry, who have come together in
years past on non-partisan issues like this, we build a framework from which we can be
successful. Legislative Counsel may turn this around in a few days or may take a number
or weeks. (This is out of anyone's control and depends entirely on their work load.
 

5. Build support through grassroots campaign: Using the highly successful Clinton Ray
Miller Model, we have drafted (attached) a two page letter for distribution to colleagues
and to send in to you our member of the House of Representatives. (We will do the same
thing in the Senate a little later.) Further Action Steps: 1. Send the letter to your
Representative. (If you don't know who this is, or their fax/address, visit www.house.gov
on the top left corner is a 'look up your representative' mechanism in which you insert
your zip code.. 2. Call the legislators office and ask to speak to the staff person who
handles the health issues (typically known as the Health Legislative Assistant). Get their
name and if possible their email address. Tell them about the letter, inquire about the
Representative's position, ask for support. Please send me an email with a confirmation
of who you talked to and their email, and any position taken so I can follow up in person
and keep track of whose been contacted.

6. What the Proposed Legislation does:

A. The first section of the Bill is Congressional "findings". The official reason
for this area is to provide opinions from Congress that will be used in the interpretation of
the law itself. The unofficial reason is to provide some framework for anyone picking
up the bill with no background in the topic. In this section we have proposed a validation
of the value of supplements and health freedom and a background of how Congress has
responded to the draconian practices of the FDA in the past. We address the consumer's
concern about the potential that international guidelines may lead to reduced access to
supplements in the future. We identify the technical correction that needs to occur and
state that the 2005 Guidelines on Vitamins and Minerals are rejected by the United
States. Additionally, we put forward the recommendation that all US delegates earnest
promote current US law regarding supplements when in international forums.
B. The next par t of the draft legislation has 3 parts:

1. No official within the Executive Branch, (The Secretaries of Health and Human
Services or Agriculture, the FDA Commissioner, etc.) are barred from
promoting, adopting or harmonizing any provision of any international guideline
or policy that would modify or supersede any existing laws on dietary
supplements such as DSHEA and Proxmire, unless the Congress passes
legislation to made the change.
2. Officially rejects the 2005 CODEX Guidelines for Vitamins and Mineral Food
Supplements and bars government officials from promoting them.
3. Requires our government representative in international forums to energetically
promote the principals of existing U.S. law.

 C. We conclude the proposed legislation by requesting more transparency at CODEX
and requiring the US CODEX office to take verbatim transcripts and posted on the web
within 30 days of a meeting. We require an annual report to Congress on the CODEX
activities including the stage of implementation or rejection of international food
standards.

7. Why are we doing this? In 1997, Congress passed language in the Food and Drug
Administration Modernization Act (FDAMA) that forbid any harmonization of
regulations affecting dietary supplements. However, the FDA has failed to modify their
Code of Federal Regulations that define how they respond to all CODEX standards. In
their regulations it states they have to either 'accept', 'accept with change' or 'reject'.
Because the loop has not been closed here, we are offering what is essence a 'technical
amendment' to enforce a decision that Congress made in 1997. We further are inserting
Congress into the review process on CODEX. Also, because we have not as a country
officially rejected the 2005 Guidelines, we are putting forward an official rejection.