In February 2004 the United States Food and Drug Administration (FDA) issued a ban on dietary supplements containing the alkaloid ephedrine. As of April 12, 2004, dietary supplements containing ephedrine are no longer legal to sell in the United States.
The ban is now in effect.
Note: Seeds and plants are unaffected by the ban. It is legal to grow your own ephedra or ma huang for personal use.
Ephedrine is the main stimulant alkaloid found in the traditional Chinese herb, ma huang. Ma huang is commonly identified as Ephedra sinica, but several other Asian Ephedra species are sold and used as ma huang also.
Media reports, and the FDA’s own releases, have suggested that the intended targets of the ban are products sold for weight loss, muscle building, athletic performance, or as an alternative to illicit street drugs. No doubt there have been egregious abuses by companies selling such products. Often the products contain ephedrine derived from artificial sources having nothing to do with the traditional Chinese ephedra herb. Some companies even sell pure ephedrine which is highly dangerous.
Traditional Chinese herbal products made from the true ephedra (Ephedra sinica and others) are thought by some to be excluded from the ban. However, the FDA’s final ruling published on Feb. 6 makes no mention of any provision to exclude products made with the Chinese herb. Here is the final ruling:
Sec. 119.1 Dietary supplements containing ephedrine alkaloids.
Dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury under conditions of use recommended or suggested in the labeling, or if no conditions of use are recommended or suggested in the labeling, under ordinary conditions of use. Therefore, dietary supplements containing ephedrine alkaloids are adulterated under section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act.
The effect of this ruling is far more sweeping than many had expected. It amounts to a complete ban on anything containing ephedrine, including the Chinese herb. Even though the ephedrine in Chinese ephedra is present at relatively low levels, its presence means that the herb is now considered "adulterated" and is therefore illegal to sell under the ruling.
Ephedra is one of the most important herbs in Chinese herbal medicine. To lose access to it is a serious setback to the practice of a 5000 year old traditional form of herbal medicine in America. Ephedra is considered one of the best herbs for the treatment of chills, fevers, cough and wheezing associated with colds and flus. Chinese herbalists say that ephedra is one of the first herbs that they are taught to use.
Most herbalists would not object to the banning of products to which ephedrine is added or concentrated beyond natural levels. This would be a sensible action for the FDA to take in the face of industry abuses and the reports of serious adverse reactions including death. But herbalists believe that the ephedra herb itself should not be banned. In Canada, the ephedrine alkaloid is limited to levels well below the excesses seen in U.S. products, a policy that allows the continued sale of traditional Chinese ephedra products.
A group advocating the repeal of the ephedra ban has organized a letter writing campaign. The group believes that the FDA overreacted by banning all products containing ephedrine and instead should have imposed a rule requiring warnings on products. Click here to read more.
A diet pill company, NVE Pharmaceuticals, launched a legal challenge to the ephedra ban. In a March 9th Forbes Magazine report, the Andover, N.J., manufacturer of ephedrine-based Stacker 2 dietary supplement, asked the court to delay the start of the ban on April 12, 2004, and to hear "new evidence." That request was denied (AP report, Apr. 12), but the NVE challenge is going ahead. Metabolife International, the largest U.S. diet pill manufacturer, is said to be weighing its options which may include a legal challenge of the ban also.
The American Herbal Products Assocation (AHPA), an industry association of herbal and dietary supplement manufacturers, petitioned the FDA on March 12th to consider changes to the ephedra ban. The AHPA’s Chinese Herbal Products Committee is pushing for a modification to the final ruling "to allow the sale of dietary supplements that contain ephedrine alkaloids" provided that the products are traditional Asian formulas and "are marketed only to licensed health care practitioners for use within their scope of practice and in a manner consistent with traditional practice." Otherwise, these products will likely have to be licensed as drugs, an all but impossibly difficult and expensive option for herb companies.
On March 24th, the California State Oriental Medical Association (CSOMA), a professional association of oriental doctors, issued a call to action to its members to "fight to preserve our right for continued access to our medicine." It is urging its members to write to senators and congressmen to protest the FDA’s ban and how it will effectively take away their right to use ephedra and other important ephedrine-containing herbs. Following discussions with four FDA attorneys, CSOMA discovered that there will be no legal basis for its members to continue to use and prescribe ephedra despite the FDA’s statements to the contrary. CSOMA has concluded that the FDA comments are in fact wrong and do not reflect the true legal impact of the ban. For the full text of CSOMA’s call to action, click here.
Court Rules Against the FDA’s Ban on Ephedra
On April 13th, 2005, a Utah District Court ruled that the FDA must revise its ban on ephedra products in accordance with the Dietary Supplement Health and Education Act (DSHEA). According to a press release issued by the Nutraceutical International Corporation, the court found that the FDA unlawfully treated ephedra as a drug when Congress intended dietary supplements to be regulated as foods and "presumed to be safe." Nutraceutical and its subsidiary Solaray had been marketing whole-herb ephedra products as dietary supplements since the 1980s. The court ordered the FDA against "taking enforcement action against Nutraceutical or Solaray for the sale of dietary supplements containing 10 mg. or less of ephedrine alkaloids per daily dose."
In the days following the decision, the FDA announced that its ban on ephedra still stands for products containing more than 10 mg of ephedrine per daily dose. But products made from whole-herb ephedra are not likely to exceed this limit and effectively the Utah court’s ruling made them legal to sell in the U.S. again. In the months after the ruling, ephedra products began to appear on the market again.
Appeals Court Overturns Lower Court Ruling
On August 17th, 2006, an appeals court upheld the FDA’s ban on dietary supplements containing ephedrine. The U.S. Court of Appeals for the Tenth Circuit Court in Denver reversed the 2005 District Court of Utah decision that made low dosage ephedrine products legal to sell again for more than a year. But now the full ban on all ephedra-based products appears to be back on.
The lower court had ruled that the FDA did not have the authority from Congress under the Dietary Supplement Health and Education Act (DSHEA) to ban a dietary supplement based on the FDA’s own risk-benefit analysis. The FDA had amassed a 133,000 page administrative record, including 19,000 adverse-events reports filed with the Government Accountability Office and the National Institutes of Health. The appeals court said in its unaminous decision that in fact the FDA is "unambiguously required" by Congress to conduct a risk-benefit analysis under the law.
The appeals court said that the data in the administrative record was "sufficiently probative to demonstrate by a preponderance of the evidence that ... [ephedra-containing dietary supplements] at any dose level pose an unreasonable risk." It went on to say that the FDA was neither "arbitrary" nor "capricious" in banning ephedra products as the Utah court had found.
In a press release, the FDA said that products containing ephedrine are "illegal and subject to FDA enforcement action." It added that "[n]o dosage of dietary supplements containing ephedrine alkaloids is safe" which suggests that the ban is again a total ban on all ephedra and ephredrine-containing products, not just the ones with more than 10 mg ephredrine per daily dose.
[Updated Sept. 15, 2006]