Some individuals are good at predicting the future, while others are not.  Since the future is at best uncertain and at other times completely unknown, it is very easy for anyone to mispredict it.  Peter Drucker, the well-known author and business consultant, investigated the power of prediction and came to the realization that “the best way to predict the future is to create it.”

That is why it is hard to ignore people who are actually creating the future.  In our whole-foods industry, Jonathan Emord, the Washington, D.C.-based attorney who has won many legal battles against the Food and Drug Administration (FDA) in the past, and his clients Nutraceutical Corporation and Solaray are doing just that.

Live ephedra specimen

The Underlying Case

You may recall that after several fatal incidents blamed upon ephedra supplements, the FDA curiously banned ephedra in supplement form, but not in food form or in over-the-counter-drug form.  Then, Nutraceutical and Solaray sued the FDA in Federal court in Utah, seeking to enjoin the ban as to their low-dose ephedra supplements.  Their attorney, Jonathan Emord, put forward several arguments before the Court as to why the FDA’s ban was illegal and should be enjoined.  Thanks in no small part to Emord, the Plaintiffs won their motion for summary judgment and defeated the government’s own cross-motion for summary judgment before U.S. District Court Judge Tena Campbell.

Among other things, plaintiffs argued that (1) the FDA’s use of risk-benefit analysis was inappropriate for dietary-supplement products because it illegally shifted the burden of proof from the government to product sellers in violation of the Dietary Supplement Health and Education Act (DSHEA) and (2) the FDA had insufficient evidence to conclude that products containing 10 mg. or less per day of ephedrine alkaloids “pose a significant or unreasonable risk of illness or injury.”  The government’s attorneys argued that deference should be given to the FDA’s rule and the ban upheld as appropriate under DSHEA.

In finding for the companies, Judge Campbell stated that the agency’s ban on supplements containing 10 mg or less per day of ephedrine alkaloids, based as it was upon the use of a drug-regime-like risk-benefit analysis, was improper, contrary to the clear intent of Congress, and improperly shifted the burden of proof onto the shoulders of manufacturers and distributors of such products in violation of DSHEA.  Moreover, the Court noted, the FDA’s reliance upon one review of the effects of injected epinephrine was not enough to support a ban upon low-dose oral ingestion of ephedrine alkaloids.  In short, there was neither legal nor scientific support to justify continuing the government’s ban upon low-dose ephedrine-alkaloid supplements.  The ban on high-dose ephedrine-alkaloid supplements was left in place.

The Appeal

When we last left this story, we wondered whether or not the FDA would appeal the district court’s decision.  Well, the FDA did.  And in a three-justice-panel written decision of the 10^th Appellate Court, filed on August 17, 2006, the appellate court set forth its reasoning, reversing the lower-court order and remanding the case to the district court for disposition in accordance with the panel’s findings.

Specifically, the 10^th Circuit Court panel found that the term “unreasonable risk” was unambiguous and necessarily requires a weighing of the risks.  That the lower court also found the term unambiguous, yet reached an exact opposite conclusion as to its “clear” meaning did not seem to bother the panel in the least.

After deciding that the FDA’s employment of a risk-benefit analysis was appropriate, the panel then found that the FDA had more than sufficient evidence to conclude that ephedra at any level was dangerous.  In doing so, the panel – amazingly enough –accepted as valid the FDA’s reliance upon a hypothetical drug model of injectable ephedrine alkaloids and not on the actual dietary ingredient at actual dose levels.

Yet, as another Washington, D.C.-based attorney, Todd Harrison, has observed, the panel noted that the FDA had spent a significant amount of time and research in determining whether ephedra posed an unreasonable risk of harm.  To his point of view, and Harrison is no lightweight when it comes to analyzing such matters and defending health-food companies, this was not a decision lightly entered into by the FDA and the agency should normally be provided deference in evaluating scientific evidence.

In my opinion, though, the FDA should have spent more time figuring out which section of the Food, Drug, and Cosmetic Act (FDCA) supported its position that “unreasonable risk” meant a risk-benefit comparison.  In the district-court case, the FDA’s lawyers very unwisely argued that the FDCA’s medical-device classification section (21 U.S.C. §360(a)(2)(C)) provided the legal underpinnings for its risk-benefit comparison.  That is, the FDA legal team made this argument until someone who could actually read the law saw that this §360(a) does not even use the term “unreasonable risk” and applies only to classifying medical devices!

At the appellate level, the FDA suddenly coughed up a new argument – that it was really relying upon the “unreasonable risk” definition found in the FDCA’s New Drugs section (21 U.S.C. §355(i)(3)(B)(i)).  Besides the fact that this sort of post facto rationalization is expressly prohibited upon appeal (see Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 419), the FDA’s reliance upon this section is just as feeble as upon the previous section because this use of “unreasonable risk” was never intended to apply to foods and in the one court case where it was applied, that court dealt with patent issues far removed from those argued in this dispute.

Important Legal Mumbo-Jumbo

As esoteric as all of this may sound, the ephedra case is important because at trial and on appeal, it turned upon those very words, “unreasonable risk.”  If “unreasonable risk” meant, as the FDA claimed, the risk-benefit comparison found in the New Drugs section, then the FDA has the right to find any dietary supplement adulterated if there is even a slight risk of injury but no substantial countervailing benefit.  This effectively turns DSHEA on its head, allowing the FDA to target any dietary supplement any time it wishes simply by finding a risk of injury, however slight, at any dosage level and then requiring the company selling the product to prove a substantial benefit.  That’s the way that drugs are regulated, but not the way that foods are regulated.

Elaborating upon this concept, Jonathan Emord argues that the panel’s decision imposes the same risk-benefit comparison standard in the FDA’s post-market review of dietary supplements that is reserved by statute for pre-market review of drugs.  In other words, he says, “[i]t grants FDA authority to declare any dietary ingredient adulterated on FDA’s subjective assessment of the adequacy of the ingredient’s health benefits if FDA finds even so much as an infinitesimal risk of illness or injury from ingestion of the ingredient (a ubiquitous condition because all ingredients pose some risk at some dose).”

Moreover, Emord further argues, “the [FDA] Rule forbids Nutraceutical from selling its low-dose [ephedrine alkaloids] in a dietary supplement but allows it to sell the very same substance (indeed, any amount of ephedrine alkaloids) in a tea bag.”  This, he notes, makes nonsense of the FDCA’s food-adulteration section by irrationally and inconsistently allowing what may not be sold as a dietary supplement to be sold as a food.

But under DSHEA, dietary supplements are to be regulated as foods, not drugs.  (21 U.S.C. §321(ff))  Under a food regime such as we have in the United States, foods need only be safe in order to be marketed and proof of any benefit is not required of them at all.  On the other hand, the FDCA clearly requires that drugs be both safe and efficacious.  (21 U.S.C. §321(p), §355)  That is why the panel’s decision is so dangerous and a real threat to the dietary-supplement industry:  it, in essence, gives the green light to the FDA to regulate dietary supplements as if they are drugs.

Now, start putting the pieces of the puzzle together.  We have drug-like Good Manufacturing Practices established by the FDA for use by the dietary-supplement manufacturing industry.  We have drug-like Adverse Event Reporting requirements for dietary-supplement companies on the verge of being passed in Congress.  We have a so-called Safe Food Act hovering in the background, which Act, if passed, would create a separate food agency for food regulation while leaving dietary supplements abandoned like an orphan child in the careless arms of the renamed Drug Administration (formerly Food and Drug Administration).  Then, we would have this appellate-court decision, if left unchallenged, as legal precedent supporting the FDA’s treatment of dietary supplements as drugs despite DSHEA.  Locking these puzzle pieces together begins to show even the most naïve of us the puzzle’s true picture, and that picture is most certainly not one where dietary supplements are sitting on the same cozy park bench as foods.  Rather, it’s a drab picture of a jail cell where lily-white supplements are locked up with hardened gangs of drugs.

More and more, Emord and his clients, Nutraceutical and Solaray, are looking like very real heroes in this fight to keep the FDA and its backers from eviscerating DSHEA.  When I last spoke with Jonathan Emord, he made it clear that he and his clients were pursuing an appeal of the panel’s decision to the full 19-justice bench of the 10^th Appellate Court.  And if that appeal were to fail, they, along with legal expert Richard Epstein, fully intend to petition the U.S. Supreme Court for a hearing before that Court.  “This case,” he said, “is far from over.”

Those are encouraging words from someone who is our ally in creating the future – our future.  We at NHF support this lawsuit and, given the legal arguments on our side, foresee a favorable outcome.