Ephedra-containing dietary supplements have substantially dominated health-freedom news and events throughout this decade. As a sort of “poster child” for the industry, ephedra supplements are also considered by regulators and anti-supplement elements to be the weak link in the supplement industry and thus a vulnerable and important target against which to direct regulatory action that will serve as a model for restricting all supplements.

The U.S. Supreme Court’s Ruling, or Lack Thereof

On May 14th of this year, the United States Supreme Court denied the writ of certiorari sought by Plaintiff in the case of Nutraceutical Corp vs. Eschenbach. This case, known as the Ephedra case, was initiated by the Plaintiff company following the April 2004 decision by the Food and Drug Administration (FDA) to ban the sale of all supplements containing ephedra, and ephedrine alkaloids, as adulterated foods. A history of this issue can be found on the NHF Webpage (www.nationalhealthfederation.org), in the Government Affairs section, under Ephedra.

The Court’s refusal to hear the case (which is what a “writ denial” means) is not the same as the Court making a specific ruling on the FDA’s decision to ban the sale of supplements containing a daily dosage of 10 mg or less of ephedrine alkaloids. Granting review would have provided the Court with an opportunity to rule on whether or not the FDA had overstepped the authority granted to it by the Dietary Supplement Health and Education Act of 1994 (DSHEA).

It would have been better if the Court had ruled on whether the "scientific study risk-based analysis" standard applied by the FDA in banning ephedra dietary supplements was consistent with Congress’ intent when it enacted DSHEA – especially with regard to showing a real, evidenced-based, public health-safety risk. Importantly, the FDA’s authority to withdraw any adulterated supplement was never in dispute; it was more the way in which a food was found to be adulterated and the means that were applied to remove the threat that was at issue here. And, remember, in the realm of implementing federal laws by federal agencies, Congressional intent is a guiding legal doctrine that is often considered by American courts when reaching their decisions.

Ephedra, Long a Target

First targeted by the FDA in the 1990s, those ephedra supplements containing more than 8 milligrams per serving of ephedrine alkaloids were the target of a proposed FDA ban coupled with a requirement for strict label warnings and instructions on those having 8 milligrams or less. That proposal went nowhere. Not enough data existed, ephedra’s defenders correctly and successfully argued, to warrant the product’s removal from the market. This issue lingered on until 2006 and, in effect, may still not be fully resolved.

In the beginning, the FDA's focus, prompted by Senator Dick Durbin (D-IL), was only on herbal products containing pure ephedra. These products were being marketed for weight loss or for enhancing sports performance. Yet, in the end, the scope of the ban was in fact expanded to include all supplements (but, curiously enough, not OTC drugs) containing ephedrine alkaloids. In short, the focus grew from one fixed upon a simple ingredient in a type of supplement product to one directed against an entire class of supplements.

Risk-Benefit Analysis Is a Key Point

Throughout the many twists and turns of the Ephedra case, a central question has been whether the FDA’s use of a "risk-benefit," science-based review standard treated supplements as foods (as Congress intended them to be under DSHEA) or as prescription drugs. In this case, the FDA applied a drug-like, post-marketing review of a dietary-supplement product! This was, and still is, an incredible threat to supplements.

As is contained in the final rule banning the sale of ephedra supplements, the FDA has taken the position that Congress clearly gave it the authority to conduct risk-benefit analysis under DSHEA. Yet, there are several sub-issue flaws applying to this general position statement. In short, how can the FDA brand supplements as being adulterated foods when there are no drug-like, risk-benefit analysis standards that apply to foods or food ingredients? As we all know, foods are not drugs and supplements are regulated as a subset of foods. The FDA does not now have, nor does it now apply, a post-marketing, scientific-study, risk-based analysis standard to regular food products or food ingredients. So, why should one be applied to supplements?

According to its 2004 Final Rule on ephedra supplements, the FDA conducted "an exhaustive and highly resource-intensive evaluation of the relevant scientific data evidence on the safety of ephedrine alkaloids." Those familiar with the proceedings will recall that the FDA did ask, via a Public Comment Notice, for submission of pro- and anti-scientific studies on the safety of ephedrine alkaloid supplements, only to reject the preponderance of the studies submitted in support of the safety of ephedra supplements. Instead, the Agency paid the Rand Corporation to do a "meta-analysis" (i.e., a second-hand, statistical-probability analysis of published studies) on ephedra. Not surprisingly, this “hatchet job” document supported the FDA's decision.

On both of these matters, thanks to the U.S. Supreme Court’s failure to accept the Ephedra case for review, the question remains: Is there authorized legal authority for the FDA's use of this type of standard for making its decisions? Or, should the FDA be allowed to use the same risk-benefit comparison standard in the post-market review of dietary supplements that is supposed to be reserved only for the pre-market review of drugs?

One Federal District Court – the court of original standing in Utah – said “no.” It ruled that the FDA must amend its Final Rule banning ephedrine-alkaloid supplement sales for supplements containing 10 mg or less of ephedrine alkaloids per daily dose, while allowing the FDA's ban on high-dose supplements to remain in place. The FDA appealed and the 10th Circuit Court of Appeals reversed the lower-court decision. Unfortunately, as stated above, the Supreme Court chose not to take up this issue, thereby letting the appellate-court decision remain in place, leaving the FDA’s risk-benefit analysis in place.

The Hidden Agenda Behind Adverse Event Reporting

When the FDA issued its Final Rule, it said that it had received 1,600 specific voluntary Adverse Event Reports (AERs) relating to ephedra-containing supplements. In my view, this is an interesting statistic since, based on FDA's own data, only 1,300 AERs were received in the year 2002 for all dietary-supplement products on the market. Did someone fudge some numbers? Why is this important?

By looking at what has happened since the start of the Nutraceutical Corp vs. Eschenbach case in 2004, and the recent Supreme Court decision, we can see its importance in the enactment of last year's mandatory AER-reporting law for supplements and over-the-counter drugs.

When it issued the ephedra ban, the FDA had very little hard data on the real public health-safety threat posed by ephedrine alkaloid containing supplements. For example, using the "inflated" 1,600 number with the estimated six million users of supplements, the safety threat would be a very, very, very small percentage (0.000267). You may also recall that even in the two highly publicized “ephedra-death” cases – the baseball pitcher and a high-school athlete in Senator Durbin's home state of Illinois – substantially differing medical opinions existed as to the cause of death. So, without substantial "hard data" (even the AER data is suspect), there was no place else for the FDA to go other than the scientific study "risk-benefit analysis" model. The conclusion was based upon scientific studies that the FDA itself selected as “proof” of support for its decision. It would seem that the only good science in the eyes of the regulators is that “slated” science that supports their public-policy decisions. Truly good science, absent politics and political influence, is a completely different matter, in my view, and the goal always to be strived for.

The mandatory AER law enacted last year (for which the FDA still must issue implementing regulations as well as industry guidance) leaves significant ambiguity in determining whether a prescription drug or a dietary supplement has caused the "life-threatening" medical outcome that resulted in the filing of the required AER by a supplement manufacturer or supplier. Even though there are substantial criminal penalties for filing false reports, there is enough anti-supplement bias extant throughout the medical community that even the most naïve among us can see, in a health emergency involving the consumption of both a drug and a supplement, which one of the two will be blamed. The implementing regulations will have to address this matter. But, then, those regulations will be drafted by the FDA – no friend of supplements.

More importantly, the AER law allows those who are required to file to also submit follow-up scientific studies, published or unpublished, that could be supportive of a supplement product not being the cause of a life-threatening, adverse medical outcome associated with a supplement. Some have argued that the AER law, and the yet-to-be-issued regulations, may fill the "hard evidence" and "objective scientific evidence" voids that existed in 2004. The NHF hopes that this will be the case in the future, but until the regulation is issued it cannot be clearly known. What is known is that there is a history of “science” and statistics being manipulated by the food-and-drug regulators, in concert with their pharmaceutical-industry pals, to justify whatever increasing powers they seek to impose upon us. This is why the NHF seeks to minimize the likelihood of such future transgressions, at least in this area.

The existence of the AER law will not change the current situation with the ephedra case law decisions. However, a possible silver lining in an otherwise very dark cloud is that the new AER law could provide a basis for Congress to challenge the FDA's use of a "risk-benefit" scientific standard in the future if it seeks to withdraw individual supplements or a class of supplements from the market as being an adulterated food unsafe for public consumption. Such a possible challenge, however, rests upon the very slender straw of congressional fortitude in this area.

What Is Next For Congress?

The preceding information and thoughts are important to know and understand because they do impact Congressional decisions upon FDA policies and the implementation of federal law. So, how can these matters be addressed with the current Congress? There are several options. Before pursuing any legislation, it is necessary to have a policy goal in mind. In my view, the NHF strategy should be to effectively prevent the FDA from using its ephedra-style application of a “science-and risk-based" post-marketing standard against supplement products in the future.

The idea of successfully getting a Democratic-controlled Congress, with the likes of Kennedy, Waxman, Durbin, Dingell, et al. in charge, to tell the U.S. Supreme Court to change its decision, to instruct the Tenth Circuit Court of Appeals to change its decision reversing the favorable lower court decision, or have the FDA repeal the 2004 ephedrine ban would have extremely little likelihood of success.

Too, the idea of successfully getting the current Democratic-controlled Congress to amend DSHEA in a way favorable to us is equally a non-starter. Instead, the following strategy and options are being proposed to and considered for proactive implementation by the NHF to address the current situation.

First, using the current FDA legislation moving forward in the House, and the expected Conference Committee between the Senate and House passed bills, the NHF could have Bill Report language included that instructs the FDA to review the 2004 ephedra ban and its application of a "risk-based" post marking standard in light of the new AER law. In other words, the idea is, through this language, to force the Agency to justify to Congress its use of a scientific, risk-based analysis under DSHEA and to inform Congress on what, if any, impact, the new AER law has on The FDA’s understanding and implementation of DSHEA in the future. This would include a date-specific reporting timeline.

A similar approach could be used to have Bill Report language included that instructs the FDA that when it publishes its yet-to-be-issued AER regulations and industry guidance it include language specifically stating that in future supplement cases involving decisions to ban an adulterated supplement product, or class of products, the FDA can only rely on that data collected through the mandatory AER reporting system when making a decision to ban or not to ban a supplement. This should also be included in the to-be-issued, and required, guidance to industry.

There is also the option of including both of the above in the Bill Report language relating to the food-safety provisions of the FDA revitalization legislation. This would be even better and more legislatively practicable, especially in the current Congressional political climate.

To clarify, the use of Bill Report language is not the same as authorizing bill language. It is simply Congress instructing the FDA to do something and to report back to Congress – specifically, the House Energy and Commerce and Senate HELP Committees. The FDA would be required to do this. When the FDA will act on the issuance of AER regulations and guidance is anyone's guess. It could be years. But at least the Agency would be required to act in a more rational manner when issuing these regulations and guidance document.

Although it would need to be forced upon it, a revised public statement from the FDA that narrows, or eliminates, the future use of the methodology employed in the ephedra case, either to Congress, or when it issues the AER regulation, could very well rectify the existing problem with the FDA’s senseless ephedra ban and its improper use of the risk-benefit method of analysis.

Related to these Congressional change options are the more routine supporting activities to influence policy decisions – such as, getting health-freedom, dietary supplement supporters in the House and Senate to have a colloquy on the floors of the House and Senate on the subject. Although decried by some as worthless, a colloquy can and does have its uses since courts, when ruling upon a law, will look to such colloquy to resolve any ambiguities in one direction or another. So, if a dangerous bill such as S.1082 cannot be favorably amended or defeated, then the next best thing would be to make sure that pro-health freedom legislator language is entered into the record. This was exactly the case for S.1082 when, as requested by the NHF, Senators Harkin and Hatch stated that the activities of the Reagan-Udall Foundation would not apply to DSHEA. These types of orchestrated discussions do not just accidentally happen, nor are they just based on constituent emails.

Alternatively, having health-freedom, dietary-supplement legislative supporters in the House and Senate send an NHF-drafted letter to FDA Commissioner Eschenbach requesting an opinion from the FDA on its understanding of the impact the new AER law has on its understanding and implementation of the DSHEA in the future, in light of the recent Supreme Court decision. In other words, let us smoke out the FDA by placing it on record that the use of the methodology in 2004 has or has not been changed as a result of the 2006 legislation. And, if not, why not? Force the FDA to take a stand that leaves it little wiggle room.

These are the practicable, influencing activities the NHF will be pursuing as the current Congress proceeds with its business, this year and the next. And, as is always the case, the grassroots support of the health-freedom community, and especially by NHF members, will be needed to help succeed in our Congressional-influencing endeavors.

It is important to note that, to date, no other health-freedom group has addressed this very important issue for dietary-supplement consumers. There are leaders and followers. When this information becomes more generally known within the health-freedom community, NHF supporters and followers will be more informed, aware and active, even if they do not always agree upon strategy or tactics.

On the other hand, be prepared, NHF opponents and competitors will most likely claim credit, or be critical of the leadership role being taken by the NHF. These groups or persons – which still deserve respect and appreciation for those beneficial things they do –don't have a lobbyist who successfully gets the Durbin Food Safety Agency bill excluded from S.1082, or who gets a statement of Congressional intent on the activities of the Reagan-Udall Foundation not applying to the DSHEA law done by the Senate authors of the DSHEA law. But, with all due respect, this is one of the advantages of an experienced organization like NHF, which makes use of all-too-necessary and vital lobbying efforts.