On June 14, 2001, Health Canada, the Canadian equivalent of our Department of Health and Human Services, advised that country’s citizens not to use products containing the herb Ephedra, either alone or in combination with caffeine and other stimulants, for weight loss, body building or increased energy. The Canadian authorities are particularly concerned about products containing Ephedra or ephedrine, one of the active chemicals of natural Ephedra, in combination with caffeine and other...
On June 14, 2001, Health Canada, the Canadian equivalent of our Department of Health and Human Services, advised that country’s citizens not to use products containing the herb Ephedra, either alone or in combination with caffeine and other stimulants, for weight loss, body building or increased energy. The Canadian authorities are particularly concerned about products containing Ephedra or ephedrine, one of the active chemicals of natural Ephedra, in combination with caffeine and other stimulants.
Because of the stimulant properties of ephedrine, such as raising heart rate and blood pressure, it may cause serious, possibly fatal adverse effects, when combined with other stimulants. Ephedrine is chemically and pharmacologically similar to the amphetamines (“speed”-like drugs) and phenylpropanolamine, or PPA for short. The Food and Drug Administration (FDA) asked producers of products containing PPA to voluntarily remove them from the market after a study done at Yale University found increased risk of stroke with their use (see the September 2000 issue of Worst Pills, Best Pills News). Many PPA producers have complied but the FDA has indicated that it will seek a total ban of PPA.
Ephedrine-containing products may list the following ingredients on their labels: ma huang, Chinese Ephedra, ma huang extract, Ephedra, Ephedra Sinica, Ephedra extract, Ephedra herb powder, Sida Cordifolia or epitonin. Sources of caffeine or other stimulants may include: green tea, guarana, yerba mate, cola nut and yohimbe.
Health Canada based its advisory on adverse reaction reports obtained from the FDA. The adverse reactions associated with the use of ephedrine reported to the FDA range from episodes of dizziness, tremors, headaches and heart rate irregularities, to seizures, psychosis, heart attacks, and strokes.
The regulation of dietary supplements, known in Canada as natural health products, is similar to that in the U.S. before the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994 which significantly weakened FDA’s regulatory authority. In Canada, if a supplement producer makes a health claim, the product is regulated as a drug rather than as a food, and regulators can seize the supplement. Supplements containing Ephedra cannot legally be sold for weight loss, body building or increased energy because under Canadian rules these are health claims.
In this country, supplement producers are allowed under DSHEA to make “structure-function” claims which are nothing more than thinly camouflaged health claims. Only a lawyer can differentiate between these types of claims. DSHEA also requires supplement producers to label their products with the following cryptic disclaimer:
This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.
A less obscure and more accurate disclaimer for dietary supplements would read:
This product has not been shown to be safe or effective for any use and the conditions under which it was manufactured are unregulated and unknown.
DSHEA brought changes that twisted the regulation of dietary supplements to the detriment of American consumers. Under DSHEA, the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed.
Unlike drug products that, before marketing, must be proved safe and effective for their intended use, there are no pre-approval provisions in the law regarding dietary supplements. Also, unlike makers of drug products, manufacturers and distributors of dietary supplements are not currently required by law to record, investigate or forward to the FDA any reports they receive of injuries or illnesses that may be related to the use of their products. Under DSHEA, once the product is marketed, the FDA has the responsibility for showing that a dietary supplement is unsafe, before it can take action to restrict the product’s use or removal from the marketplace.
Trade groups representing the dietary supplement industry have steadfastly maintained that DSHEA leaves the FDA with the regulatory authority to ensure that dangerous dietary supplements do not remain on the market. We have strongly asserted the opposite, that DSHEA ties the FDA’s hands so completely that dietary supplements are for practical purposes unregulated.
The FDA has not attempted to remove a supplement from the market since the passage of DSHEA so there is no case law to serve as a precedent. Unquestionably, the FDA could begin proceedings to remove a dangerous supplement from the market. But then the agency would face DSHEA’s first road block to regulation from the part of the law that says “…the United States [the FDA] shall bear the burden of proof on each element to show that a dietary supplement is adulterated.” The meaning of “adulterated” is an ingredient of a dietary supplement that presents a “…significant or unreasonable risk of illness or injury.”
As mentioned above, the FDA now has the responsibility, or burden, to prove that a supplement ingredient is unsafe rather than the producer having to prove that it is safe. Different standards of proof have always been used to show that a product is effective for its claimed use versus being unsafe or dangerous. A controlled clinical trial is required to prove that a product “causes” a benefit. The standard for removing drugs or adding warnings to the labeling of a product has always been a presumption of cause based on a knowledge of pharmacology, reports of adverse reactions, and observational studies that technically do not show cause. However, conducting a controlled clinical trial to prove that an ingredient in a dietary supplement is unsafe would be unethical.
The second DSHEA road block is the statement “The court shall decide any issue under this paragraph on a de novo basis.” The reference to the court is somewhat unusual in the language of the law. The Latin phase de novo means that the court will not show the FDA deference as experts in litigation involving the safety of dietary supplement ingredients. As a general rule, the courts do defer to the expertise of federal regulatory agencies.
A court could decide either that the FDA must meet the controlled clinical trial standard to show that a dietary supplement ingredient is unsafe or could rely on the less stringent standard that has always been used in issues of product safety, the pharmacology of the ingredient, reports of adverse reactions, and observational studies that technically do not show causality. The FDA would have to take a chance in court.
Another potential road block to the effective regulation of dietary supplements is that under DSHEA, if the FDA believes that a specific ingredient presents a significant or unreasonable risk to the public and there are 20 products on the market containing that ingredient, for example, it is possible that the FDA would be required to take action against each product individually.
DSHEA prevents the FDA from acting independently to protect the public from dangerous dietary supplements. Dietary supplement proponents who continue to maintain that the FDA has sufficient regulatory authority over dietary supplements are grossly misleading the American public for their own economic gains. DSHEA clearly violates a fundamental right of American citizens, the right to a marketplace free from untested products that are promoted for unsubstantiated uses.
Congress has tied the FDA’s hands in regulating dietary supplements. Meanwhile in Canada, a rational regulatory framework to prevent the possibility of needless harm from dietary supplements has been proposed in addition to the warning already issued about ephedra. The major elements of the Health Canada proposal are as follows:
- Premarket approval would be required for dietary supplements. A product license would be needed from the Natural Health Products Directorate before sale.
- A license would be required for all locations where dietary supplements are manufactured or packaged.
- In applying for a product license, an applicant would provide the following information:
- The name, address, telephone number, FAX number, e-mail address of the applicant. (As unbelievable as it may seem, there is no requirement on the FDA to keep a list of names and addresses of dietary supplement producers and what they make. Perhaps we should not be surprised given the fact that this industry is essentially unregulated.)
- A description of the products to be produced.
- Information that supports the safety of the dietary supplement.
- Information that supports the recommended use of the dietary supplement.
- Good Manufacturing Practice (GMP) regulations similar to pharmaceuticals rather than those used for foods would be required.
- Adverse reaction reporting. Any serious adverse reaction, including one that is unexpected occurring in Canada, would have to be reported within 15 days. Any serious, unexpected adverse reaction occurring outside of Canada would also be reported within 15 days.
- A product license for a dietary supplement could be immediately suspended when the supplement presents a serious risk to the public.
The Canadian government has come up with a sensible framework for the regulation of dietary supplements. While U.S. regulation of these products is mired in the 19th century in that it allows untested products to be promoted for unsubstantiated uses, our northern neighbors have moved consumer protections into the 21st century. We would expect nothing less from a government that has made a conscious decision to ensure that all of its citizens have access to health care.
A spokesperson for Health Canada expected the new regulations to be in place at the end of 2001 or early 2002. We hope that the Canadians are able to institute their dietary supplement regulations intact.
We can see no reason why the FDA does not warn the American public about the risks of Ephedra and Ephedra products sold in combination with other stimulants as was done in Canada. In fact, the agency’s failure to do so is simply irresponsible. Ephedra no longer has a legitimate medical use and there is no evidence that it promotes health. On the contrary, the weight of evidence is that its risks outweigh any known benefit for any use. Is the FDA afraid of the heat it might take from the supplement industry applied through a Congress that is always looking for campaign contributions?
What You Can Do
You should not use supplements containing Ephedra. There is no known benefit for them, and there are substantial serious risks.
Ask your Senator or Congress-person to support the repeal of or significant amendments to DSHEA.