By Len Monheit
Yesterday, in a significant and high profile decision, a United States District Court in Utah has ruled against the Food and Drug Administration and in favor of Nutraceutical International Corporation, as that company challenged the FDA's broad ban on ephedrine-containing supplements, initiated last year. Nutraceutical, in challenging the Rule, forced the court to determine whether FDA's use of risk:benefit analysis was appropriate, and whether a broad ban that had no regard for dosage levels or the use of warning labels was supported by sufficient evidence of "significant or unreasonable risk of illness or injury."
Specifically in the case of Nutraceutical, the product in question was a low dose supplement, containing 10mg or less per day of ephedrine alkaloids. And in that case, the court found that the evidence was lacking (in fact only one reference was available and even that was a kinetic extrapolation, of epinephrine, not ephedrine, and involving intravenous injection and not oral administration). In short, the court found that FDA had inadequately proved risk at low dose.
On the subject of the use of risk:benefit analysis, the Court determined that the approach employed meant that companies had to prove a benefit prior to bringing a product to market, and the principal of risk:benefit analysis in general was more drug-like rather than food-like. As it turns out, these are contentions noted by the major trade associations right from the time of the Rule introduction. The ramifications on a broad scale of a risk:benefit analysis as the basis for removing a product from the market was seriously worrying. Taken to extreme, this approach not only, as the court noted, placed a different onus on supplement companies clearly not envisioned by DSHEA, but with the philosophical disbelief in supplement benefits expressed certainly by the medical community and frequently by FDA, any risk:benfit analysis would almost always end up to the detriment of industry. Conceivably, we would lose product after product through this mechanism.
Michael McGuffin, American Herbal Products Association (AHPA) president notes, “This court has provided a rational opinion that the amount of an ingredient must be considered when evaluating the safety of that ingredient.” New CRN President and CEO Steven M. Mister, Esq. stated, "Both companies and individuals have a right to challenge laws and regulations and it is reasonable to expect regulations to conform to statutory standards in order to withstand legal challenges."
So if this ruling is so correct and rational, then why am I not cheering?
Well, as the CRN and AHPA statements go on to point out, the decision leaves in place a ban on all but those dietary supplements with 10 mg or less of ephedrine alkaloids per daily dose (and not those formerly sold for weight loss), it underscores that supplements are to be treated as foods and not drugs, and presumably proves that DSHEA works, at least as far as industry is concerned.
This decision will have a legal impact, obviously, but at the same time, a huge media/perception impact. If the mainstream population is still unconvinced about industry integrity and the level and appropriateness of regulations, then this ruling reinforces their beliefs. If legislators, (nursing frustration at their inability to, in their own minds, 'adequately regulate the industry'), want a forum and focus to point out the flaws in DSHEA, they now have it. If the media wants to highlight the diet part of the dietary supplements industry, and talk about an industry constructed on ephedra and ephedra-type ingredients and all the pending litigation, then that is now more likely to occur.
It was interesting, this morning, to review the literally thousands of headlines about this ruling. In fact, it's interesting to note that in the year (and a day) since the ban was implemented, we have not seen such prominent coverage of anything in our industry. And once again we've been identified as the industry that sells ephedra, in fact several articles have begun again referring to it specifically as the 'diet supplements industry."
Predictably, industry's adversaries were publicly outraged at the court ruling, ranging from key senators, to consumer groups to consumers themselves. Lost in the shuffle too were the three states, Illinois, California and New York who had passed legislation banning ephedra before the FDA rule came down.
In today's coverage, the number of ephedra-related deaths is established in various 'credible' newspaper sources at between 80 and 155, DSHEA has been re-described as 'fatally flawed', and the industry as 'powerful and unregulated'. Senator Kennedy, in one article, through a spokesperson said, "If F.D.A. can't take a supplement as dangerous as ephedra off the market, then Congress needs to change the law to allow it to do so."
Lobbying groups have been quoted as saying that the decision is unlikely to trigger manufacturers to reintroduce ephedra products, and since the ruling specifically applies to Nutraceutical only, and more specifically to low-dose products, any other product reintroduction would be a violation of the law. Having said that, would anyone be terribly surprised to see, especially considering traditionally limited enforcement practices, some sales channels begin offering higher dose products again?
Interpretation of the scope and significance of this ruling varies. In many cases it's been described as a complete overturning of the ban itself, which it is not. As noted, it applies to Nutraceutical and to low-dose products and means FDA will likely appeal and alter the principles under which it determines 'unreasonable risk' (if it can). Specifically, as AHPA notes, "FDA was not, however, specifically instructed to refrain from acting against other brands that contain less than 10 mg of ephedrine while it reviews its current regulation."
Marc Ullman, from the law firm Ullman, Shapiro Ullman notes that it might have been better if the ruling against the FDA had been determined based on inadequate or poor science or even biased or distorted measurement of 'risk', compared to how FDA interpreted 'benefit'. The fact that the entire premise of risk:benefit has been determined 'improper' leaves open a big question, "How else is FDA to determine unreasonable risk?" It is conceivable that the answer to that question might eventually be "Any risk at all is deemed to be an unreasonable risk". And that would be bad, very bad.
The more cynical among us might propose that FDA envisioned this type of ruling right from the outset. After all, what are the possible outcomes? - A rewriting of the law to give FDA the power to take products off the market with greater ease? A focus on one ingredient and the challenges it presents rather than the entire scope of high potential products the industry offers? The 'any risk is unacceptable risk' approach described above?
The ripple effect from the decision will be substantial. The media has been aroused, as have legislators, and all of industry's traditional enemies. Practices will be under the microscope and because we have inadequately differentiated the core, responsible, committed industry from the fringe that is less so, any 'bad' news will implicate the entire sector. Media also now has another, more resonating lever to associate with any potentially negative stories, whether this be alleged contaminated supplements in sports, to the promotion of supplements in high school to neutral or negative scientific studies.
When much of our focus should be on raising expectations regarding quality and science, while I understand the need to defend precedent and to anticipate future pitfalls, I fear too many resources will be spent debating and dissecting ephedra and not enough moving the industry constructively forward.