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Ephedra Decision Is A Mixed Blessing
By Scott Tips Editor of Health Freedom News Board Member and Legal Counsel for NHF
July 08, 2005

It’s funny but ephedra has become something of a modern-day Frankenstein monster.  As in the Mary Wollestonecraft Shelley novel of the Victorian era, our ephedra Frankenstein seems to be constantly pursued by an angry and fearful mob of ignorant peasants with burning torches who have not the faintest understanding of what they are seeking to destroy.

In this case, the relatively recent government ban on ephedra dietary-supplement sales has resulted in the loss to all of us of a natural product whose safe and effective use as a bronchodilator dates back thousands of years.  First targeted in America in the 1990s, the Food and Drug Administration (FDA) initially sought to ban all sales of those dietary supplements containing more than 8 milligrams per serving of ephedrine alkaloids and to require strict label warnings and instructions on those supplements of 8 milligrams or less.  That proposal went nowhere, despite strong support from certain, predictable circles.  Not enough data existed, ephedra’s proponents correctly and successfully argued, to warrant its suppression.

But as the whole-foods industry continued to grow, successful use of its natural products such as ephedra grew with it.  So, too, did the abuse of these products by marginal sectors of the industry which were not above spiking natural ephedra with synthetic ephedrine to increase its punch.  Often, buyers were not aware of this unethical, nondisclosed practice.  The inevitable problems occurred, media coverage ensued, and the FDA and its pharmaceutical masters then once again had their excuse to pounce on ephedra.  After a show of gathering data, the FDA announced its ban on natural ephedra in December 2003, with regulations promulgated two months later, which in turn took effect in April 2004.

But, paradoxically, even those children of tender years who are literate enough to read a label can still scoot across the pharmacy aisles this very minute and pick up a bottle of much more-potent synthetic ephedrine alkaloids that are sold like candy as OTC drugs.  Everyone knows that.  Nothing has changed except that the pharmaceutical companies, having let slip their attack-dog regulators upon the ephedra Frankenstein, successfully eliminated the competition.  Now they get to make the money off of ephedra.  Very slick.  What they could never accomplish in a free marketplace, they have now accomplished with the stroke of a regulator’s coercive pen.

The Counterattack

Yet, certain companies of principle, such as Nutraceutical Corporation and Solaray, Inc., were not about to take the ban lying down.  In a lawsuit filed on their behalf by attorney Jonathan Emord in the United States District Court, Central District of Utah, against Lester Crawford, the Acting Commissioner of the FDA, the plaintiffs challenged the validity of the FDA’s regulation banning all ephedrine-alkaloid dietary supplements.  Strategically, the lawsuit only attacked the FDA’s ban of low-dose (under 10 mg.) ephedrine-alkaloid containing supplements, ignoring that portion of the ban that covered higher-dose supplements.

At a recent hearing on Nutraceutical and Solaray’s motion for summary judgment and the government’s own cross-motion for summary judgment, U.S. District Court Judge Tena Campbell heard the evidence from both sides.  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 the Court should give deference to the FDA’s rule and uphold the ban as appropriate under DSHEA.

In a 19-page Order, Judge Campbell painstakingly analyzed the issues and made clear her decision: 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 upon 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.

Judge Campbell, thus, ruled in favor of the plaintiff’s motion and denied the government’s cross-motion.  Her written order, which may be read at http://www.nutraceutical.com/courtruling.pdf, was equally clear:  The FDA must amend its Final Rule on ephedrine-alkaloid supplement sales and is enjoined from preventing plaintiffs’ sale of any such supplements containing 10 mg. or less of ephedrine alkaloids per daily dose.  The ban on high-dose ephedrine-alkaloid supplements remains in place.

The Counter-Counterattack

As of the writing of this article, it is not yet known whether the FDA will appeal this ruling.  If it does, it risks turning a lower-court decision with relatively limited impact into a much broader-based circuit-court ruling of more durable and widespread authority.  On the other hand, perhaps the FDA is feeling lucky and will want to strangle this baby in its cradle.  Or, it may act emotionally, wanting to get back at Jonathan Emord for the many smarting defeats it suffered at his hands in the Pearson v. Shalala line of cases on qualified health claims.  Time will of course tell.

In the meantime, the anti-supplement press is using the decision to tell the World that it was, after all, correct about the poor, powerless FDA.  See, the press writes, the FDA tried to use DSHEA to take a dangerous supplement off of the market and the court just slapped it right down.  In an April 21, 2005, editorial, the New York Times made exactly this argument and further opined that DSHEA “should be amended to give health regulators clear and unambiguous power to take harmful products off the market.”

Todd Harrison, a food-and-drug law partner at the respected Washington, D.C.-based law firm of Venable (www.venable.com), is a strong supporter and able defender of DSHEA.  But he has observed that “The regulatory scheme for dietary supplements may have been jeopardized by the recent ephedra decision out of Utah.  Indeed, the court’s decision is likely to play into the hands of the enemies of DSHEA and provide the impetus in Congress to strengthen FDA’s already substantial regulatory authority over dietary supplements.”

In fact, as Harrison has predicted, Senator Dick Durbin (D-Ill) has said that the Utah court’s ruling emphasizes the need for a mandatory and uniform system of reporting adverse health events that result from the use of certain dietary supplements.  And old supplement enemy Congressman Henry Waxman (D-CA) issued a post-ruling statement saying “It will clearly be time for Congress to revisit DSHEA and give FDA the authority it needs to protect American consumers from dangerous supplements.”  Predictably, anti-supplement Senator Ted Kennedy (D-Mass), who desperately needs supplements if anyone ever did, also chimed in with his agreement that DSHEA should be revisited.  Clearly, the peasant mob is gathering force and lighting its torches.

The Ruling’s Immediate, Practical Effect

Unfortunately, the immediate, practical effect of Judge Campbell’s ruling may be quite limited.  Even if not appealed, the injunction against the FDA only applies to the two plaintiffs’ products and does not touch any State-law bans or restrictions upon the sale of ephedra-alkaloid containing supplements.  And an embargo on imports of foreign ephedra products remains in place.

But the real killer is insurance coverage.  As Todd Harrison has also asked himself, “Why was this case brought in the first place since the insurance industry had effectively removed most ephedra products from the marketplace and is unlikely to issue low-to-moderately priced product-liability insurance that covers low-dose products?”  The National Nutritional Foods Association has warned its members that “no insurance companies are currently underwriting coverage for either manufacturers or retailers who sell ephedra.  This means full exposure financially in the event of a civil lawsuit.”

But it gets worse, Harrison counsels, because the Federal Trade Commission (FTC) will step into the void.  As he puts it, “the FDA in connection with the FTC will likely take regulatory action against companies that make any type of claims, especially weight loss, for low-dose ephedra products because the scientific evidence supporting the use of less than 10 mg. of ephedra per day is utterly lacking.  In essence, the FTC will seek to fill the void created by the Court’s decision by stepping up its already aggressive policing of the supplement industry.”

Silver Linings

Another legal advocate for DSHEA freedoms, New-Jersey-based lawyer Ralph Fucetola (www.vitaminlawyernews.com), feels that the most important part of Judge Campbell’s’ decision, insofar as health freedom is concerned, was the Judge’s citation in her Order of the Senate Report on DSHEA (“the legislative history of the DSHEA indicates that Congress generally intended to harmonize the treatment of dietary supplements with that of foods when it added the dietary supplement subsection.”).  As Fucetola notes, “the Court held that FDA’s attempt to apply a drug standard ‘risk-benefit’ analysis was contrary to law.  Vitamins are foods, not drugs!  They are presumed to be safe.  This means, then, that any FDA attempt to ‘harmonize’ US law with drug-like international standards will now have even less chance of being upheld by the US courts.  If food-supplement laws are to be harmonized, DSHEA (as correctly understood by Judge Campbell) is the model.”

Regardless, the risk-benefit analysis used by the FDA in banning ephedra has been found wanting by the court.  This is important because the FDA has been persistently attempting to straight-jacket dietary supplements with drug-like rules and regulations.  It is happening with good manufacturing practices as it has happened with the ephedra ban.  Judge Campbell has wisely said no to this.  We shall see if her ruling stands upon appeal, if any is made.  But we can all predict that the attacks upon supplements such as ephedra are far from over.

Fortunately, the National Health Federation is there; and we will take whatever appropriate action is necessary to fight and defeat any Congressional attempt to change or eliminate DSHEA.  Our eagle-eyed NHF Lobbyist, Lee Bechtel, is alert to any such attempts and he will both advise us and intensely lobby our representatives so as to prevent our health freedoms from being impacted.

Ephedra has been around a long time.  It will take more than an ignorant mob’s torches, pitchforks, and bullets to destroy this natural wonder.  It existed before us, it will be there long after us.

It’s funny but ephedra has become something of a modern-day Frankenstein monster.  As in the Mary Wollestonecraft Shelley novel of the Victorian era, our ephedra Frankenstein seems to be constantly pursued by an angry and fearful mob of ignorant peasants with burning torches who have not the faintest understanding of what they are seeking to destroy.

In this case, the relatively recent government ban on ephedra dietary-supplement sales has resulted in the loss to all of us of a natural product whose safe and effective use as a bronchodilator dates back thousands of years.  First targeted in America in the 1990s, the Food and Drug Administration (FDA) initially sought to ban all sales of those dietary supplements containing more than 8 milligrams per serving of ephedrine alkaloids and to require strict label warnings and instructions on those supplements of 8 milligrams or less.  That proposal went nowhere, despite strong support from certain, predictable circles.  Not enough data existed, ephedra’s proponents correctly and successfully argued, to warrant its suppression.

But as the whole-foods industry continued to grow, successful use of its natural products such as ephedra grew with it.  So, too, did the abuse of these products by marginal sectors of the industry which were not above spiking natural ephedra with synthetic ephedrine to increase its punch.  Often, buyers were not aware of this unethical, nondisclosed practice.  The inevitable problems occurred, media coverage ensued, and the FDA and its pharmaceutical masters then once again had their excuse to pounce on ephedra.  After a show of gathering data, the FDA announced its ban on natural ephedra in December 2003, with regulations promulgated two months later, which in turn took effect in April 2004.

But, paradoxically, even those children of tender years who are literate enough to read a label can still scoot across the pharmacy aisles this very minute and pick up a bottle of much more-potent synthetic ephedrine alkaloids that are sold like candy as OTC drugs.  Everyone knows that.  Nothing has changed except that the pharmaceutical companies, having let slip their attack-dog regulators upon the ephedra Frankenstein, successfully eliminated the competition.  Now they get to make the money off of ephedra.  Very slick.  What they could never accomplish in a free marketplace, they have now accomplished with the stroke of a regulator’s coercive pen.

The Counterattack

Yet, certain companies of principle, such as Nutraceutical Corporation and Solaray, Inc., were not about to take the ban lying down.  In a lawsuit filed on their behalf by attorney Jonathan Emord in the United States District Court, Central District of Utah, against Lester Crawford, the Acting Commissioner of the FDA, the plaintiffs challenged the validity of the FDA’s regulation banning all ephedrine-alkaloid dietary supplements.  Strategically, the lawsuit only attacked the FDA’s ban of low-dose (under 10 mg.) ephedrine-alkaloid containing supplements, ignoring that portion of the ban that covered higher-dose supplements.

At a recent hearing on Nutraceutical and Solaray’s motion for summary judgment and the government’s own cross-motion for summary judgment, U.S. District Court Judge Tena Campbell heard the evidence from both sides.  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 the Court should give deference to the FDA’s rule and uphold the ban as appropriate under DSHEA.

In a 19-page Order, Judge Campbell painstakingly analyzed the issues and made clear her decision: 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 upon 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.

Judge Campbell, thus, ruled in favor of the plaintiff’s motion and denied the government’s cross-motion.  Her written order, which may be read at http://www.nutraceutical.com/courtruling.pdf, was equally clear:  The FDA must amend its Final Rule on ephedrine-alkaloid supplement sales and is enjoined from preventing plaintiffs’ sale of any such supplements containing 10 mg. or less of ephedrine alkaloids per daily dose.  The ban on high-dose ephedrine-alkaloid supplements remains in place.

The Counter-Counterattack

As of the writing of this article, it is not yet known whether the FDA will appeal this ruling.  If it does, it risks turning a lower-court decision with relatively limited impact into a much broader-based circuit-court ruling of more durable and widespread authority.  On the other hand, perhaps the FDA is feeling lucky and will want to strangle this baby in its cradle.  Or, it may act emotionally, wanting to get back at Jonathan Emord for the many smarting defeats it suffered at his hands in the Pearson v. Shalala line of cases on qualified health claims.  Time will of course tell.

In the meantime, the anti-supplement press is using the decision to tell the World that it was, after all, correct about the poor, powerless FDA.  See, the press writes, the FDA tried to use DSHEA to take a dangerous supplement off of the market and the court just slapped it right down.  In an April 21, 2005, editorial, the New York Times made exactly this argument and further opined that DSHEA “should be amended to give health regulators clear and unambiguous power to take harmful products off the market.”

Todd Harrison, a food-and-drug law partner at the respected Washington, D.C.-based law firm of Venable (www.venable.com), is a strong supporter and able defender of DSHEA.  But he has observed that “The regulatory scheme for dietary supplements may have been jeopardized by the recent ephedra decision out of Utah.  Indeed, the court’s decision is likely to play into the hands of the enemies of DSHEA and provide the impetus in Congress to strengthen FDA’s already substantial regulatory authority over dietary supplements.”

In fact, as Harrison has predicted, Senator Dick Durbin (D-Ill) has said that the Utah court’s ruling emphasizes the need for a mandatory and uniform system of reporting adverse health events that result from the use of certain dietary supplements.  And old supplement enemy Congressman Henry Waxman (D-CA) issued a post-ruling statement saying “It will clearly be time for Congress to revisit DSHEA and give FDA the authority it needs to protect American consumers from dangerous supplements.”  Predictably, anti-supplement Senator Ted Kennedy (D-Mass), who desperately needs supplements if anyone ever did, also chimed in with his agreement that DSHEA should be revisited.  Clearly, the peasant mob is gathering force and lighting its torches.

The Ruling’s Immediate, Practical Effect

Unfortunately, the immediate, practical effect of Judge Campbell’s ruling may be quite limited.  Even if not appealed, the injunction against the FDA only applies to the two plaintiffs’ products and does not touch any State-law bans or restrictions upon the sale of ephedra-alkaloid containing supplements.  And an embargo on imports of foreign ephedra products remains in place.

But the real killer is insurance coverage.  As Todd Harrison has also asked himself, “Why was this case brought in the first place since the insurance industry had effectively removed most ephedra products from the marketplace and is unlikely to issue low-to-moderately priced product-liability insurance that covers low-dose products?”  The National Nutritional Foods Association has warned its members that “no insurance companies are currently underwriting coverage for either manufacturers or retailers who sell ephedra.  This means full exposure financially in the event of a civil lawsuit.”

But it gets worse, Harrison counsels, because the Federal Trade Commission (FTC) will step into the void.  As he puts it, “the FDA in connection with the FTC will likely take regulatory action against companies that make any type of claims, especially weight loss, for low-dose ephedra products because the scientific evidence supporting the use of less than 10 mg. of ephedra per day is utterly lacking.  In essence, the FTC will seek to fill the void created by the Court’s decision by stepping up its already aggressive policing of the supplement industry.”

Silver Linings

Another legal advocate for DSHEA freedoms, New-Jersey-based lawyer Ralph Fucetola (www.vitaminlawyernews.com), feels that the most important part of Judge Campbell’s’ decision, insofar as health freedom is concerned, was the Judge’s citation in her Order of the Senate Report on DSHEA (“the legislative history of the DSHEA indicates that Congress generally intended to harmonize the treatment of dietary supplements with that of foods when it added the dietary supplement subsection.”).  As Fucetola notes, “the Court held that FDA’s attempt to apply a drug standard ‘risk-benefit’ analysis was contrary to law.  Vitamins are foods, not drugs!  They are presumed to be safe.  This means, then, that any FDA attempt to ‘harmonize’ US law with drug-like international standards will now have even less chance of being upheld by the US courts.  If food-supplement laws are to be harmonized, DSHEA (as correctly understood by Judge Campbell) is the model.”

Regardless, the risk-benefit analysis used by the FDA in banning ephedra has been found wanting by the court.  This is important because the FDA has been persistently attempting to straight-jacket dietary supplements with drug-like rules and regulations.  It is happening with good manufacturing practices as it has happened with the ephedra ban.  Judge Campbell has wisely said no to this.  We shall see if her ruling stands upon appeal, if any is made.  But we can all predict that the attacks upon supplements such as ephedra are far from over.

Fortunately, the National Health Federation is there; and we will take whatever appropriate action is necessary to fight and defeat any Congressional attempt to change or eliminate DSHEA.  Our eagle-eyed NHF Lobbyist, Lee Bechtel, is alert to any such attempts and he will both advise us and intensely lobby our representatives so as to prevent our health freedoms from being impacted.

Ephedra has been around a long time.  It will take more than an ignorant mob’s torches, pitchforks, and bullets to destroy this natural wonder.  It existed before us, it will be there long after us.