As we enter the Obama era today, NutraIngredients-USA.com examines the likely effects of the much-awaited Congressional shift on the functional foods and dietary supplements industries. According to industry veteran Loren Israelsen, the road ahead could be less than positive – especially for supplements. Despite a very severe financial crisis and economic recession, there is a palpable sense of hopefulness that he will re-establish America as a global partner that listens, cooperates and understands the role of government to act as a protector and conservator of natural resources, and as a sensible regulator that protects consumers’ interests while not stifling business growth and opportunity. Big job. But first, let’s take a look at the truly big picture. President Obama inherits: A deep recession; a jobless rate that will likely climb into the double digits; an auto industry on life support; a massive federal deficit that will push past $2 trillion; banking and retail industries that teeter on the edge; and a tremendous urgency to address and repair Medicare, Medicaid and, most important, America’s healthcare system. Against this backdrop, the dietary supplement and functional food industry is a minnow in a sea of sharks. Notwithstanding, there are big issues awaiting us. In this article, we will look at some of the players on the supplement/functional food chess board. The White House chess board The Secretary of Health and Human Services will be Tom Daschle – former majority leader of the Senate and author of a book titled ‘Critical: What We Can Do About the Health-Care Crisis’. Widely seen as a good choice, Secretary Daschle’s biggest challenge will be entitlement programs: Medicare, Medicaid and Social Security. He will also have to deal with rebuilding a dispirited and ‘broken’ FDA that has been heavily criticized for approving new prescription drugs only to have them withdrawn from market for safety problems, bungling the management of food safety, and losing many of their best and brightest employees who grew weary over the political meddling of the past White House. Joining Secretary Daschle is Bill Corr, Deputy Secretary of HHS and a former staff member to Congressman Henry Waxman. Another name to remember is Mark Childress who has been named HHS Chief of Staff. Mr Childress was formerly of Senator Kennedy’s staff and not a friend to the supplement industry. Finally, another former Waxman staffer, Phil Schillero, has been named White House Legislative Director. We will return to Congressman Waxman shortly. The Senate threat to DSHEA The two key players to follow will be Senator Richard Durbin, Senior Senator of Illinois and No. 2 Democrat in the Senate, and Chairman Henry Waxman of the House Energy and Commerce Committee. Senator Richard Durbin was one of the first important political figures to endorse Senator Obama and has become a trusted friend, confidant and advisor. Senator Durbin is the most vocal critic of DSHEA in the US Congress.
Herein lies the greatest threat to DSHEA – not an open legislative challenge of current law but rather a quiet discussion between the President and a key advisor that would both set a tone and create the pathway to change DSHEA or grant FDA new authority that could have the effect of limiting access to dietary supplements. Then we have Chairman Henry Waxman, also a vocal critic of supplements in the Congress and now Chairman of the most powerful committee in the House (Energy and Commerce) which has direct jurisdiction over FDA. Many of the key White House and HHS appointments noted above have worked for Chairman Waxman, thus creating a fraternity of experienced and now very influential policy makers who have both motive and means to take up the issue of how supplements should be regulated. Again, there are many other pressing issues that demand first attention, but we are now on notice that a battle once won may not be over yet. Principle piece of the puzzle That position will truly determine the political zeitgeist for the supplement and functional food world for years to come. If I had to list a few flashpoint issues that will likely arise in the coming months, they would include: · The use of stimulants in foods and supplements. How should they be regulated? · The role of supplements in the military. · A crack-down on imported drugs and dietary ingredients that contain undeclared spiked pharmaceuticals. · The need to ‘sift’ the materials coming from China to screen out the bad while encouraging the high end manufacturers that produce superior quality ingredients. · June 2009 is the effective date for the majority of the supplement industry for GMP compliance. Will FDA dramatically increase inspections, and will we see a true reform of manufacturing quality as a result? In the coming months, we will have a much clearer understanding of how this new cast of players will begin to affect the world of supplements and functional foods. One thing I can say for sure is there will be changes.
By Loren Israelsen, 20-Jan-2009
The final piece of this puzzle will be the FDA Commissioner yet to be named. There are several names being floated, but at this writing there has been no one confirmed as yet.
Elsewhere in the Senate, our long-time champions Senators Hatch and Harkin remain the primary defenders of DSHEA and the natural products industry. They remain very senior and respected members of the Senate, and yet they will be called upon once again to protect and build on DSHEA, with no new champions of equal stature on the horizon. There are a number of younger members who have signaled their interest and support for natural health issues, and must now be seasoned and tested to demonstrate they can share the work of advancing DSHEA and related matters in the new Congress.
President Obama comes to our industry tabula rasa. We know little about his personal views or use of supplements. His only legislative history is sponsoring a bill to ban the sale of ephedra in the state of Illinois while in that state’s legislature. There are many tantalizing – possibly mythical – rumors of organic gardens on the White House grounds, which if true suggest he and his well-liked wife Michelle fit the profile of LOHAS consumers. But all of this remains to be seen.
By all accounts, the election and inauguration of Barak Obama as 44th President of the United States is an event matched by few others in modern American history.