Ephedra (Alkaloids): Is it legal?

NO

FDA: Sale of Dietary Supplements Containing Ephedra ( Ephedrine Alkaloids) is prohibited in the U.S.

The FDA listed a range of botanicals containing ephedrine alkaloids that are part of the ban: Ma Huang (the Chinese name for ephedra), country mallow (Sida cordifolia L., Malvaceae; also known as bala ), the Chinese herbban xia (Pinellia ternata [Thunb.] Makino, Araceae), and most members of the genus Ephedra that contain the ephedra alkaloids, e.g., E. sinica , E. equisetina Bunge, E. intermedia var, tibetica Stapf, and E. distachya L.
Supporter's of ephedra claim the ban is unfair and that pharmaceutical drugs consistently bring far more deaths and side-effects than ephedra ever has or will.  Ephedra will remain a controversial supplement, and one should rely on their own judgment to make a healthy conscious decision.

The short-term use of ephedrine, ephedrine plus caffeine, or the assessed dietary supplements containing ephedra and herbs with caffeine is associated with a statistically significant increase in short-term weight loss (compared to placebo).

Is there any legal Ephedra?

YES

Some species in the Ephedra genus have no alkaloid content, and therefore remain legal. One alternative form of Ephedra which remains legal is Ephedra Viridis and can be found in the very popular thermogenic weight loss product: Proxylean E(v).

Supreme Court Refuses Ephedra Appeal...

May 15, 2007

The U.S. Supreme Court on Monday refused to consider an appeal by Nutraceutical International Corporation, which sought to overturn a federal ban on the dietary supplements containing ephedrine alkaloids. The court's decision, issued without comment, lets stand a 2006 ruling by a federal appeals court that upheld the Food and Drug Administration's (FDA) 2004 ban.

David Seckman, executive director and CEO of the Natural Products Association commented on the refusal. “Obviously we were concerned about the consequences of the circuit court’s ruling on the risk benefit standard the FDA used in removing ephedra from the market, which is why we filed our amicus brief. As we clearly stated in the brief, we believe Congress did not intend for such a standard to be used. But, since the Supreme Court decides to take up only between five to 10 percent of cases brought to it, it is not a shock that they’ve decided not to hear it. We should note, however, that the denial of the Nutraceutical petition is not an affirmation by the Supreme Court that they agree with the lower court’s decision,” Seckman said.

In April, the Natural Products Association had filed a "friend of the court" or amicus brief with the U.S. Supreme Court that challenged the lower court ruling on the standard used by the FDA to impose a 2004 ban on ephedrine alkaloids in dietary supplements.

August 2006

 U.S. Court of Appeals for the Tenth Circuit disagreed and ordered the lower court judge to enter summary judgment in favor of the FDA. Its ruling concluded that Congress intended to integrate a risk-benefit analysis into DSHEA and that the FDA had met its legal burden by doing extensive research before ordering the ban. In March 2007, after agreeing that the FDA had acted properly, the lower court judge granted the FDA's motion for summary judgment and ordered the case closed. However, an appeal to the U.S. Supreme Court is still pending.

April 13, 2005

In February 2004, two companies (Nutraceutical Corp. and Solaray, Inc., the plaintiffs) filed a lawsuit against the FDA. This lawsuit challenged the validity of the FDA's February 2004 regulation banning ephedrine-alkaloid containing dietary supplements.

What The Plaintiffs Sought From The Court:

• Declare the FDA's rule invalid.

• Remand the matter to the FDA for further rulemaking consistent with the court's decision.

• Enjoin the FDA from taking enforcement action against the plaintiffs for their sale of dietary supplements containing 10 mg or  less of ephedrine alkaloids per daily dosage.

In their lawsuit against the FDA, the plaintiffs approached the situation through reasoning, versus the unsubstantiated reactionary and biased approach taken by the FDA. The plaintiff Solaray (now owned by plaintiff Nutraceutical) has sold an ephedrine containing product since 1988.

This product contains 375 mg of Ephedra sinica powder, one capsule taken no more than twice each day. This recommended dosage contains less than 10 milligrams of ephedrine alkaloids per day.

In 1997 the FDA initially published a proposed regulation that would permit the sale of dietary supplements containing under 8 milligrams per serving (within a 6 hour period) up to a total of under 24 milligrams of ephedrine alkaloids per day. Other requirements of use were also proposed (see rule overview below).

During this process, the General Accounting Office (GAO) conducted its independent review of the situation at the request of the Congress' House Committee on Science.

In this GAO report (see highlights of this report as provided below) recommended that FDA provide stronger evidence between establishing the link between the intake of ephedrine containing dietary supplements and the occurrence of adverse reactions that support the FDA proposed dosing level and duration of use limits.

The GAO report also recommended that the FDA should consider additional information to determine whether a dietary ingredient limit or some alternative approach would be appropriate to regulate ephedrine dietary supplements.

During FDA's proposed rule making process they considered GAO's input and actually on April 3, 2000 partially withdrew the proposed rule; the restrictions on dosages and directions for frequency of use and the proposed prohibition on labeling claims for uses encouraging long-term intake.

FDA also withdrew the proposed warnings advising consumers not to exceed the recommended dosages or use the product for more than seven days.

In this revision to the proposed rule, the FDA did however retain other warnings statements and the proposed prohibition for combining ephedrine dietary supplements with other stimulant ingredients.

Federal District Court Judge Tena Campbell's Decision:

A Step In The Right Direction.

After reviewing the evidence submitted to the court by the plaintiffs, Judge Tena Campbell ruled that the FDA has to reevaluate their decision to ban ephedrine alkaloid containing supplements, and also are prohibited from taking any enforcement action against the plaintiffs to prevent the sale of their dietary supplement containing 10 mg or less of ephedrine alkaloids per daily dose.

While former hardcore ephedra product users may not get excited about taking a product that just contains 10 mg or less of ephedrine alkaloids per daily dose (most of the ephedra product of days gone by supplied daily dosages several times more than this per day), Judge Campbell's court order is a win for the dietary supplement industry and dietary supplement taking public.

The FDA is now forced by Judge Campbell's court order to review the data and establish regulations consistent with what science proves about ephedrine alkaloid containing supplements like ephedra; putting political pressure aside.

Judge Campbell's Two Main Points Of Consideration:

1. Whether FDA's use of a risk-benefit model is appropriate under the conditions of the Dietary Supplement Health and  Education Act (DSHEA); and

2. Whether the FDA has provided sufficient evidence to support the conclusion that ephedrine dietary supplements containing 10 milligrams or less of ephedrine alkaloids pose a significant or unreasonable risk of illness or injury.

Due to the fact that supplements are regulated as foods, not drugs, and under present law a dietary supplement, as with any food, is presumed to be safe. Additionally food producers are not required to establish a benefit before the sale of the product. This places the burden of proof on the FDA that a food or dietary supplement product is injurious to health.

The court therefore concluded that FDA's actions leading up to its decision to ban ephedrine containing products was contrary to the intent of Congress and improper. However, please note that there were other complex related legal issues involved in this part of the decision.

Judge Campbell also found that the FDA did not provide evidence to support the conclusion that consumption of ephedrine dietary supplements containing 10 milligrams or less per day of ephedrine alkaloids pose a significant or unreasonable risk of illness or injury.

To declare all ephedrine dietary supplements adulterated, as FDA has done, the FDA must prove that any dosage amount presents a significant or unreasonable risk of illness or injury. The FDA failed to provide scientific evidence that low-dosage ephedrine dietary supplement intake poses unreasonable or significant risk or illness or injury.

Supplements With Ephedrine Alkaloids

What Does The Future Hold?

This Federal Court decision and order means that Solaray can legally sell their low-dose ephedra product. It also means that the FDA has to determine what the upper daily intake of ephedrine alkaloids is in dietary supplements that is safe.

In practical terms, because the cost of product liability insurance is very high or coverage is not available to companies making dietary supplements containing ephedrine alkaloids, it will be interesting to see what companies re-enter the marketplace with such product.

Additionally, FDA might be able to appeal this court order and try to reverse the decision. Also note that some states still have laws in place that ban or regulate ephedrine alkaloid containing dietary supplement products.

April 12 2004

The Food and Drug Administration (FDA) announced today that the final rule on dietary supplements containing ephedrine alkaloids is effective immediately. The rule, which was published on February 11, 2004 in the Federal Register, declares dietary supplements containing ephedrine alkaloids (ephedra) adulterated because such supplements present an unreasonable risk of illness or injury.

The FDA listed a range of botanicals containing ephedrine alkaloids that would be part of the ban: ma huang (the Chinese name for ephedra), country mallow (Sida cordifolia L., Malvaceae; also known as bala ), the Chinese herbban xia (Pinellia ternata [Thunb.] Makino, Araceae), and most members of the genus Ephedra that contain the ephedra alkaloids, e.g., E. sinica , E. equisetina Bunge, E. intermedia var, tibetica Stapf, and E. distachya L.

The ephedrine alkaloids that appear to be pharmacologically active in plants and which are covered by the ban include l-ephedrine, d-pseudoephedrine, 1-norephedrine, 1-methylephedrine, d-norpseudoephedrine, and d-methylpseudoephedrine. The final rule does not apply to conventional foods (such as herbal teas) that contain ephedrine alkaloids, nor does it apply to OTC and prescription drugs. The FDA also stated that most American species of ephedra do not contain ephedrine alkaloids (e.g., Mormon tea [E. viridis Coville,]) and are therefore not part of the ban.