Victory in The Senate

We usually publish our newsletter on Tuesday. We held it overnight in order to report on the outcome of the Senate HELP Committee’s “FDA Food Safety Modernization Act” (Food Safety) mark up hearing. This hearing would decide whether to amend the dangerous Codex provision.  The decision would have a momentous impact on the future of dietary supplements.

During the past few weeks, we met with most HELP Committee Senate offices to discuss our concerns and request an amendment to the Codex language in the Food Safety bill.   Why were we so concerned?  Because the original legislative language appeared to commit the US to the concept of harmonization of our food and supplement safety laws with a global standard. This global standard in turn is very likely to reflect European standards which are extremely hostile to dietary supplements.

Thanks to the amendment, the bill no longer requires the development of a plan “to harmonize requirements under the Codex Alimentarius”. Now the bill calls for a plan   “on whether and how to harmonize requirements under the Codex Alimentarius" (§306, p. 116).

As will be evident, we have not succeeded in eliminating the Codex provision entirely. This is because the Senate wants to keep open the option of adopting some Codex rules while protecting dietary supplements from the harsh European regime. The language of the amendment means that we will have to remain very vigilant and probably refight the same battle over again in the future. But at least the US has avoided committing itself to the concept of Codex harmonization. And this is a very important legislative victory.

US law on dietary supplements is currently governed by The Dietary Supplement Health and Education Act (DSHEA). Senators Harkin and Hatch, strong supporters of natural health and the use of supplements, have assured us that asking the FDA to review Codex standards will not be allowed to threaten DSHEA. This is vital of course because of the FDA’s well known hostility to dietary supplements.

In his opening remarks in the mark up, Senator Harkin, chair of the HELP Committee,  emphasized this message of protecting DSHEA.  As the Senate moves forward with the legislation, Senators Harkin and Hatch have also promised to see what else can be done to make absolutely clear that none of its provisions will impact our access to high quality, potent dietary supplements.

There is more good news. The Senate Food Safety bill has eliminated many of the provisions in the House bill that most troubled us.   However, we can’t forget that after the Senate passes it’s version of the Food Safety bill, the House and Senate will go to conference. There they will work behind closed doors to combine the Senate and House versions of the bill.  This means that the worst provisions of the House bill could return.

Perhaps the most troubling aspect of the House bill is the increase in jail sentences (from three to ten years) and fines (to $100,000 for individuals and $7.5 million for corporations) for "adulterating" or "misbranding" food or supplements.  If a food or supplement company cites scientific, peer-reviewed studies in support of a health benefit of a product, this would be deemed by the FDA to be misbranding and could trigger the penalties.  Likewise, as defined in the current Good Manufacturing Practices, even minor paperwork violations could, per the FDA, represent adulteration and lead to draconian fines or jail sentences. These penalties are particularly worrying because of the FDA’s well established record of intimidation and legal harassment of innocent parties. It often seems that the FDA’s primary concern is to protect drugs from competition. Drug companies of course pay a significant portion of the FDA’s salaries.

The House bill also imposes new fees on food operations of all sizes,  from the very smallest to the largest; imposes record keeping, hazard analysis, food safety plans, and more on farms as well as businesses, small and large; gives the FDA control of farming standards and practices, despite the Agency’s ignorance of these matters; permits the FDA to conduct random, warrantless searches; and ignores the recommendations of a government report on the failings of the FDA and the urgent need for reform at the Agency.

We will continue to work with members of Congress to ensure that the final version of the Food Safety bill does not compromise your access to healthy, natural and sustainable healthcare options, including high quality food and food supplements.

We’ll keep you updated!

November 18, 2009