Robert S. McCaleb, HRF President
April 28, 1995, Austin, Texas.
The Texas Department of Health (TDH), has proposed banning certain ephedra and ephedrine-containing products made by dietary supplement companies, while preserving products of the pharmaceutical industry. This interesting--if a bit convoluted--proposal seeks to make the following changes in regulating products in the state of Texas:
There are numerous inconsistencies in this proposal, which apparently seeks to prevent the sale of even low-dose natural products containing these stimulant ingredients, while protecting the products of the pharmaceutical industry. The rhetoric and emotions have run high on this issue. It our hope to provide a rational perspective on the issue of plants which contain ephedrine and related active chemicals (alkaloids) and caffeine with its related alkaloids.
Tea is a stimulant beverage with an ancient history of use. Coffee is another. Another is ephedra, which the Chinese call ma huang. Like coffee and tea, it has been brewed into a beverage for thousands of years and consumed for its stimulant effects. Cola nuts, which contain caffeine, are used to make the stimulant beverage, Coke. Legally we classify these stimulant beverages as foods.
When a spoonful of any of these "concentrates" is added to a cup of hot water, it makes a stimulant beverage, no more concentrated or toxic than before it was concentrated.
All of these concentrated foods can be safely used, and are...every day.
Dietary supplements, including vitamins, minerals and other substances are almost always concentrated. That is the nature of dietary supplements: they are concentrated ways to supplement the diet with something in a convenient form. Many herbal dietary supplements are also concentrated. Dietary supplements are regulated in the U.S. as foods, under laws established by the US Congress.
The over-the counter (OTC) drugs Vivarin® and NoDoze® contain pure caffeine. They are no longer food. But the amount of caffeine in each pill is about the same as that in a strong cup of coffee, so they still aren't considered dangerous.
Primatene® is an OTC drug which contains ephedrine, the major active chemical from ma huang. Millions of Americans use this drug every day to treat asthma. Sudafed® contains another stimulant alkaloid from ma huang, pseudoephedrine. It too is used by millions of Americans. Pseudoephedrine has a less potent action on the heart than ephedrine, but is still contraindicated in those with high blood pressure, heart disease, diabetes, thyroid disease or prostate enlargement.
Dietary supplements containing ephedra alkaloids, including ephedrine, are also used every day in this country. Some ephedra products also contain cola nuts or guarana, natural caffeine sources.
It is common for ephedrine and caffeine to be consumed together. For example, like most other Americans, most asthmatics who use OTC medications like Primatene® also drink coffee, tea, or cola. People taking cold remedies containing ephedra alkaloids also routinely consume caffeinated beverages.
Texas Department of Health (TDH) has proposed legislation which implies that ephedrine and caffeine are dangerous together, and that ma huang combinations with cola or other caffeine sources be forbidden. If this is truly a risky combination, then all combinations of caffeine and ephedra alkaloids are also dangerous in similar quantities:
There are no warnings on these bronchodilator, decongestant and stimulant OTC drug products to warn people against using them together, and no caution on caffeine-containing foods to warn that asthmatics or cold-sufferers using these medicines should avoid caffeine.
These OTC drugs are freely available to all Americans, of any age, at pharmacies and groceries, because they are considered by FDA to be safe enough for most people to use in recommended amounts. Those who shouldn't use them are warned on the packages to avoid them.
The key issue in safety is quantity consumed. This is where we need to focus our efforts. The best we can say about the safety of ANY food or drug is that is safe "when used in reasonable amounts by normal consumers." "Reasonable amounts" because nearly anything can be abused; coffee, Primatene, butter, ma huang. "Normal consumers" because there are people who may be especially sensitive to certain things. For example, many people can't drink milk, eat peanuts or use caffeinated beverages. Some cannot safely use Primatene®, as the label warning states.
The Herb Research Foundation recommends a sensible policy toward all of these substances:
It is not our intention here to assert that ephedrine and/or caffeine containing products are "safe." We neither condemn nor condone their use. FDA considers them safe enough to be purchased by people of all ages in pharmacy, grocery or convenience stores. If they are labeled with appropriate usage levels, and contraindications, they are equally safe whether sold by a drug company or a natural products company. They must be consistently regulated.
Natural source ephedrine extracts are probably safer than purified alkaloids, but to our knowledge there is no direct toxicity comparison between the two.
The Herb Research Foundation has developed a "Herbal Stimulant Factsheet" which compares caffeine and ephedrine content of various consumer products, including both foods and drugs. It also discusses the relative safety of such products, and provides contra-indication information about persons who should avoid either substance.