Left To Right: Richard Durbin, Henry Waxman, John Dingell, Edward Kennedy

I concluded my January/March 2007 article with a forecast, "In all, the current session of Congress, under the renewed control of the Democrats, should make for an interesting year. But as the old Chinese curse goes, 'May you live an interesting life.'"

As the NHF's lobbyist, I can report that this in fact has and is transpiring in legislative and regulatory bits and pieces. To change to a more contemporary American musical metaphor, some may remember the big hit in the 1980s by the Alman Brothers Band entitled, "No Way Out," with the chorus of "No Way Out, Just Can't Get Out That Door." In the current Congressional environment, this is exactly what is being faced by health-freedom advocates and the health-freedom agenda. A history quiz here. When the Dietary Supplement Health and Education Act of 1994 (DSHEA) was enacted, which one member of the Democratic leadership names listed in the article title above (all of whom voted against DSHEA by the way) was not in Congress? Answer - Dick Durbin. The Senator was first elected in 1996. However, effective lobbying strategies, and the lobbying efforts of the NHF can, and have, thus far, gotten past this Legislative Door for the most part. There are "Ways Out." These are not always what people normally equate with Congressional legislative processes. Continue reading to find out more.

Health-freedom advocates and NHF members also need to see the bigger picture. They need to continue to proactively and constructively confront a biased and deleterious group of key Congressional decision-makers, and FDA bureaucrats, on specific issues. A brief summing-up of what has transpired, and what the NHF has and is doing on these two fronts, is, by my way of thinking, instructional. After all, it is the bits and pieces that, when woven together, color and influence the day-to-day life of NHF members. A summation may help with staying focused on the political/legislative context and on the work needed to influence Congressional decision-makers in matters impacting our health freedoms.

FDA Recap

There first was the FDA’s publication of the CAM Guidance, which, while not a regulation or a law, presented FDA thinking on how CAM alternative-medical therapies and the use of supplements, herbs, and other alternative products fit within the context of FDA food-and-drug regulation. The FDA thinking was and still is seriously flawed on several counts. The NHF took great pains to explain in detail how the Guidance was not the end of access to nutritional foods and supplements, as we now know it, but just a written reflection of long-existing FDA views. This was bad for health-freedom policy, but not the “End of the World” scenario depicted by many. Where were the Chicken Littles when the NHF was fighting this very issue more than a decade ago? It’s old news.

The FDA then issued its Good Manufacturing Practices (GMPs) for supplement manufacturers, which is far more serious a threat to health freedom than the CAM Guidance document. While the small-manufacturer exclusion in the regulation was a pitiful band-aid, these new regulations deliberately made dietary-supplement companies subject to – in some cases – harsher and more-costly manufacturing regulations than those imposed upon the drug companies. In ten years’ time, the net result of this action will be to decimate the number of small- and medium-sized manufacturers, leaving the larger manufacturing companies to occupy the lion’s share of the field.

The NHF opposed, and still opposes, these unnecessary FDA requirements. The Dietary Supplement Health and Education Act of 1994 (DSHEA) that mandated GMPs for the dietary-supplement industry was very explicit on the subject: GMPs must be based on food. Yet, the FDA violated that law with its ridiculous obsession with turning supplements into drugs. As always, this was and is bad for consumers in the end.

The FDA has never liked DSHEA. Since under that law supplements are their own class of “foods” and should be treated as such, they can be differentiated only if DSHEA were changed. The FDA has an economic incentive to have drug-like requirements for supplements.

Health-freedom adherents firmly believe that, at best, the FDA and its bureaucracy have no common sense. There are ample examples of this lack of common sense and the NHF has been involved with them over the years. A decision earlier this year did show that the FDA does have the ability to make an intelligent decision, at least one out of 99 times. The Agency changed its position on access to experimental or investigational new drugs. The regulation gives people and their physicians the ability to access drugs and therapies undergoing FDA approval when a serious disease or condition has been diagnosed, and when no other treatment options are available. This was but a very small step for health freedom of choice. Non-FDA regulated access to drugs and therapies approved as safe and in use in other countries, but not FDA approved for use in our country, is far better, and Republican Congressman Dana Rohrabacher’s bill (H.R. 2599) addresses this issue. (Additional information on these matters is posted on the NHF website at
http://www.thenhf.com/government_affairs.html.)

Congressional Recap

As the NHF's lobbyist, I attended numerous Congressional hearings and bill mark-ups on S.1082 and H.R. 2900, the FDA User Fee/Revitalization legislation that among other things reauthorizes the FDA to collect fees from drug companies. Numerous meetings with staff and Members have and are taking place on several NHF legislative priorities. These activities may not slow down until December when Congress is expected to adjourn. As the saying goes, the country is not safe as long as Congress is in session. This is especially the case in the current political landscape. It is the Dingell-Waxman and Durbin-Kennedy era, at least until January of 2009.

On S.1082, working with the staff of Senators Harkin and Hatch, and others, the NHF was able to get the hideous Durbin Food Safety Agency bill, S. 645, withdrawn as an amendment to the bill. The Durbin bill contained language that would have divided the Food and Drug Administration into two separate agencies, a Food Agency and a Drug Agency, leaving dietary supplements under the jurisdiction of the truncated Drug Agency and not with the new federal food safety agency. Dietary supplements would have had to be reclassified and regulated as drugs.

If Durbin had been successful, this would have been a catastrophic legal and policy change impacting supplements. This is not nor will it be the last time that Durbin will use his leadership role to attempt to have supplements regulated as drugs. You may recall another successful NHF lobbying effort, two years ago, which prevented Durbin from amending a Department of Defense (DOD) bill, to regulate supplements as drugs.

Then there is the Regan-Udall Foundation issue and its potential for future abuse by the FDA against supplements and nutritional foods. Again, the NHF was able to get Senators Hatch and Harkin to have a "colloquy" on the Senate floor with S.1082 bill authors and floor leaders, Senators Enzi and Kennedy. The on-the-record discussion clarified that nothing nothing being proposed in S.1082 would change the letter of the law or the regulation of supplements under DSHEA. The importance of this otherwise unknown Congressional procedure is that it is a statement of Congressional intent on how a bill and its specific provisions are to be, or not be, interpreted by a federal agency or a federal court.

Health-freedom advocates, the NHF, and other supporting groups once again came close, but lost, on allowing U.S. citizens to freely import cheaper FDA-approved drugs from Canada and European countries. There are ongoing legislative efforts to change this outdated, pro-pharma-backed policy that forces U.S. citizens to pay significantly higher prices for prescription drugs.

The proactive NHF lobbying effort to protect health freedoms, supported by the NHF grassroots letter-writing campaign, at the time of this writing continues with the NHF using the FDA Revitalization legislation as an opportunity to prevent FDA actions that really could go against the core of our health-freedom beliefs.

In this case, the NHF wants to see controls placed upon an otherwise-unaccountable FDA and how it conducts any future regulatory actions seeking to ban supplements based upon the use of a post-market, drug-like safety standard for supplement products. The FDA, in its ban of ephedra-based supplements, did just this. Right now, there are no limitations on what public-policy, health-safety standard can be used by the FDA to ban any other supplement product on the market. The FDA has a blank check. Without restriction by Congress on FDA’s actions, it is open season on supplements or nutritional food products, in contravention of DSHEA. This is clearly a serious threat to health freedoms.

At the time of publication, Congress passed and President Bush has signed H.R. 3580 (PL 110-85), the FDA Amendments Act of 2007. This is the compromise legislation for S.1082 and H.R.2900. It contains the Reagan-Udall Foundation and the DSHEA exemption provision applying to the Durbin Food Safety Registry. In short, nothing in the new law creates any new FDA powers applying directly to supplements and nutritional foods as regulated under DSHEA. However, the bill report for the new law has yet to be finalized. NHF members and other health-freedom advocates "dodged" a few major bullets in this session of Congress, but Durbin and company will not be going anywhere soon. These key Democratic leaders, on both sides of Capitol Hill will continue next year in wanting more FDA control over U.S.-citizen decision-making, more bureaucratic command and control, and more taxpayer spending for the FDA.

The NHF has also been engaged in lobbying efforts to secure more House members as cosponsors of H.R. 2117, the Health Freedom Protection Act, an Act that NHF was among the first to trumpet. The bill is sponsored by Congressman Ron Paul. This bill would prevent the FDA from censoring truthful claims about the curative, mitigative, and/or preventative health effects of dietary supplements. It would also prevent the FTC from censoring truthful health claims made by manufacturers.

To complete the list of major issues, Democratic leaders Dingell and Kennedy also have their own bills for federally controlled national health insurance. Both have had one round of Congressional hearings on their almost identical bills. These will be discussed in future columns here; but as can well be imagined, there is no good legislation coming from these two gentlemen, to say the least. (Additional information on these matters is posted on the NHF website at
http://www.thenhf.com/government_affairs.html.)

Looking Ahead

In the past nine months the FDA has issued one major regulation and two Guidance documents. FDA interference is never good, but the FDA has yet to issue the congressionally-mandated regulations for the Dietary Supplement and Nonprescription Drug Consumer Protection Act – the AER legislation – passed in 2006. The NHF strongly opposed this legislation, which was unfortunately supported by the big players in the industry. So, this is yet another regulatory issue to be faced. And, the industry Guidance document for these regulations will be forthcoming as well.

On the Congressional front, the NHF has been and is lobbying on another five issues impacting your health freedoms and is working to control an otherwise-unaccountable FDA. The Dingell-Waxman and Durbin-Kennedy era is in place and will not be going anywhere for another fifteen months.

Getting the Durbin Food Safety Agency amendment off the table on S.1082, and the clarification on the floor of the Senate (which is Congressional intent on the purpose of a bill)that nothing in the FDA User Fee/Revitalization legislation applies to the current law or regulation of supplements under DSHEA, were successes. Getting bill-report language into this legislation, when and if it is resolved, that instructs the FDA to not use a drug-like risk-benefit, scientific-standard for dietary supplements, in contravention of DSHEA, is not yet resolved. The NHF is the only health-freedom group that is actively lobbying Congress on this last issue. The NHF will continue to lobby the Congress to pin the FDA down on this point because this is clearly a serious threat to health freedoms.

The Dingell-Waxman and Durbin--Kennedy axis is in political and legislative control of all matters impacting health freedoms, use of dietary supplements, nutritional foods, and related policy matters. These leaders are not interested in reducing FDA sovereignty, or in making the FDA accountable. Nor, for that matter, do they care about changing FDA philosophy on how supplements should be regulated.

The other Democratic leaders – Nancy Pelosi (D-CA), the House Speaker, and Harry Reid (D-NV), the Senate Majority leader – are assisting this "axis-of-evil." All of these respective Democratic leaders are liberals who want national health insurance, support more FDA authority for regulating supplements like drugs, and, of course, support more federal spending for FDA and its regulatory agenda. This is not a health-freedom, anti-FDA group of Congressional leaders friendly to the NHF point of view. This is why direct lobbying, supported by grassroots lobbying, is so important to the goal of preventing full-scale assaults on those issues facing the health-freedom community.

As the oldest and best-respected health-freedom group on Capitol Hill, the NHF continues to be the credible source of objective assessment, and proactive actions on Congressional legislation and FDA matters that have meaningful impacts upon our freedom-of-health choices.