The Ephedra Decision: The Real Story ...

The Ephedra Decision: The Real Story ...

Its not about Ehpedra -- its about DSHEA ...	Darrell Miller	05/24/05
Federal Court Overturns FDA Ban on Ephedra at Low Doses	Darrell Miller	06/09/05

Date: May 24, 2005 08:58 AM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Its not about Ehpedra -- its about DSHEA ...

On april 14th 2005, a federal court in UTAH Ruled against the FDA's ban on low dose ephedra products. The plaintiffs were Nutraceutical Corporation and its subsidiary Solaray. They sued not just to protect their ephedra product, but to protect your access to other supplements. Why did they sue and what does this mean for you?

Media and Political Rhetoric Vs. Real Science

Protecting DSHEA and your access to dietary supplements

Why did Nutraceutical challenge FDA's actions?

We wanted to make sure the FDA followed DSHEA (The Dietary Supplement Health And Education Act) and uses sound science to stop the sale of ingredients at dose levels that cause harm.

We were concerned about a new concept -- a "Risk-benefit" test -- that caused all supplements to be treated like drugs and gave FDA the power to ban any dietary supplement at its discretion.

Dietary supplements should not be treated like drugs. Supplements are typically natural food products. Treating them like drugs -- with pre-market approval and clinical studies required -- would mean an end to consumer access to supplements.

We believed our low-dose ephedra product was safe. It was not designed for weight loss, but for traditional uses, like respiratory support.

Why did FDA Ban Ephedra?

Over eighty years, FDA proposed, withdrew and re-proposed limits on dietary supplements with ephedrine alkaloids. Until the final rule, all the proposed rules exempted low-dose ephedra products.

During those eighty years, FDA took few actions against manufacturers who sold high-dose ehpedra. The Result? Negative and often inaccurate publicity surrounding ephedra supplements.

In the final Rule, FDA announced to ban all dietary supplements containing any ephedrine alkaloids, but did not ban them in foods like chinese herbal teas.

What did the court Decide?

Under DSHEA, dietary supplements are to be regulated as foods.

Like other foods, Dietary supplements are "presumed to be safe."

FDA's "risk-benefit" test is contrary to what Congress intended when they passed DSHEA in 1994.

To ban a dietary supplement, FDA must establish that the specific dose recommended in the label presents a significant or unreasonable risk of illness or injury. FDA didnt do that for low-dose ephedra. FDA cant stop Nutraceutical and Solaray from selling their low-dose ephedra product.

FDA has to rewrite its Ephedra rule.

How does the Decision affect me?

The courts rulling protects your access to dietary supplements. FDA cant arbitrarily ban them.

The ruling requires FDA to pay attention to dosage in determining if a supplement is dangerous.

The rulling prohibits FDA from Treating dietary supplements like drugs -- it must treat them like foods, as DSHEA specifies.

Does the ruling mean that ephedra is safe?

Nutraceutical's case only involved Solaray® Ephedra, a low-dose whole food product.

The court said FDA did not have adiquate scientific evidence that low-dose ephedra is unsafe.

Since low-dose ephedra is a food, it is presumed to be safe.

The court did not analyze scientific evidence about the safety of ephedra producs at higher doses.

What's Next for Ephedra?

FDA Must exempt low-dose ephedra at 10mg or less of ephedrine alkaloids per day. FDA must reopen the rulemaking to establish the precise dose level above 10mg ephedrine alkaloids at which ephedra presents a significant or unreasonable risk or illness or injury.

FDA can also choose to appeal the court's ruling.

We are evaluation the reintroduction of Solaray® ephedra. We want to do it in a way that is consistent with our obligations to our customers and in compliance with the law and the recent court decision.

What can I do to protect my access to supplements?

Let your congressman and Senators know that access to supplements is important to you. A useful website for contacting them is: www.saveoursupplements.org

contact Nutraceutical by email at: Savesupplements@nutracorp.com

Note: Solaray® Whole herb ephedra was formulated to have 10mg or less ephedrine alkaloids per daily dose(two servings). © Nutraceutical corporation...

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VitaNet ®
VitaNet ® Staff

Date: June 09, 2005 08:41 AM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Federal Court Overturns FDA Ban on Ephedra at Low Doses

Federal Court Overturns FDA Ban on Ephedra at Low Doses

by Rakesh M. Amin and Mark Blumenthal

A Utah Federal District Court recently limited the scope of a year old Food and Drug Administration’s (FDA) Final Rule1 banning the sale of all ephedrine-alkaloid dietary supplements.2 The Court’s ruling has a limited affect on the ability of companies to sell ephedrine nationally, but is important regarding FDA procedure for creating rules and enforcement powers. Ephedrine alkaloids are found primarily in the controversial herb ephedra (Ephedra sincica Stapf., Ephedraceae).

The District Court determined that the FDA’s use of a risk-benefit analysis was against the intent of Congress in passing the Food, Drug and Cosmetic Act,3 which presumes all foods are safe and requires the FDA to prove the existence of a significant or unreasonable risk. The court held that to require food producers to establish a benefit before selling their product places an improper burden on them and was inconsistent with Congress’s intent when it passed the Dietary Supplement Health and Education Act of 1994 (DSHEA) to clearly place the burden of proof of safety of a dietary ingredient on the FDA.4

Secondly, the court determined the FDA had to show by a preponderance of the evidence “a significant or unreasonable risk of illness or injury.”5 Therefore, in order to ban all sales of a given product, the FDA must first prove that the dosage amount in the product presents an unreasonable risk.6 Prior to this ruling, the FDA was not required to consider dosage size before banning a substance.

This ruling has limited effects at the moment since the FDA may appeal this decision. Additionally, the ruling has no effect on the laws of several states (including California, Illinois and New York) which have banned all sales of ephedrine alkaloids in dietary supplements. The ruling also only applies to products containing 10 mg or less of ephedrine alkaloids per daily dosage. Any product exceeding that amount is still banned and will continue to be enforced under the FDA rule.7

The court, in its ruling, specifically precluded the FDA from taking any enforcement action against Nutraceutical Corporation, the company that filed the lawsuit, for its sale of products containing 10mg or less of ephedra and for the FDA to consider further rulemaking “consistent with this Order”.8 However, the court did not specifically instruct the FDA to refrain from taking enforcement action against other brands containing less than 10mg of ephedrine.9 As such, companies considering launching new products containing ephedrine alkaloids are advised to do so carefully.

Nutraceutical Corporation president Bruce Hough was cited in The New York Times as saying that the company’s reason for filing the suit was not based on ephedra and that his company had no plans to begin marketing ephedra supplements in the near future.10 Hough was quoted as saying, “We filed it [the lawsuit] because the FDA established rules that could cause problems to the rest of our business.” Hough was referring to the legal basis upon which the FDA banned the sale ephedra. He told the American Botanical Council that the FDA was applying a drug standard of risk vs. benefit to herbs and dietary supplements – technically foods under the law. [Hough B. Personal communication to M. Blumenthal, Apr. 27, 2005.] His company filed the lawsuit in an attempt to deter FDA’s new procedure for creating what he considered arbitrary rules which contradict the plain meaning of existing federal law (DSHEA).

The American Herbal Products Association (AHPA) issued a statement on April 26 clarifying its policy on the sale of ephedra in dietary supplements.11 AHPA has notified all its members that at this time it is the organization’s policy that none of its members should be selling low doses (10 mg or less) of ephedra in dietary supplements until the FDA has clarified its position on the Court decision. At this time it is not clear whether FDA plans on appealing the decision or will implement the new policy set by the Court.

The court decision does not affect the sale of the herb ephedra in traditional formulations intended for use that is consistent with traditional uses, e.g., pulmonary complaints, and are dispensed by licensed healthcare practitioners.

As might be expected, court’s decision has stimulated a new round of media and congressional criticism of the relative safety of herbs and dietary supplements as well as DSHEA. For example, a highly critical article by Chris Mooney was posted on the website of the American Prospect on April 25.12 The Prospect is relatively influential in Democratic and progressive political circles in Washington. The article uses language such as the court decision is a “scandal” and a “disturbing ruling”, refers to DSHEA as “a terrible law” and a “peculiar and misguided law” and the “wrongheaded standards encoded in the DSHEA”, and repeats the often-cited media mantra about “unregulated herbal supplements” and that the “FDA has been hamstrung and effectively rendered impotent.”

More information regarding the sale of ephedrine products or FDA regulations in general is available from the law offices of Rakesh M. Amin at (312) 327-3382 or rakesh@amin-law.com.

References

1 21 C.F.R. Pt. 119, Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk (Published February 11, 2004) (Effective April 12, 2004) available at /dockets/98fr/1995n-0304-nfr0001.pdf

2 Nutraceutical Corporation and Solaray, Inc. v. Lester Crawford, D.V.M., Acting Commissioner, U.S. Food and Drug Administration, et al., Case No. 2:04CV409TC, U.S. District Court for the Central District of Utah; available at gov/reports/204cv409-28.pdf