Ephedrine Remains a Public Health Threat While Regulatory Squabbles Linger
By S. Van McCrary, Health Law & Policy Institute
A recent controversy in Texas mirrors a national debate over the proper regulation of ephedrine, a stimulant which is associated with numerous deaths across the U.S. The Texas Department of Health (TDH) and the manufacturers of ephedrine products are battling over newly proposed rules setting an allowed maximum dose size of 25 milligrams (mg) of ephedrine, which is more than three times the maximum dosage allowed under a rule proposed by the federal Food and Drug Administration (FDA). A public hearing on the proposed Texas rules will be held on February 25 in Austin.
Ephedrine is a powerful amphetamine-like, stimulant drug that affects the cardiovascular system and central nervous system. It is an ingredient in dietary supplements sold for the purposes of energy-boosting and weight loss. The only over-the-counter uses of ephedrine currently approved as drugs by the FDA are for treatment of mild asthma, nasal decongestion, hay fever, and hemorrhoids. In bulk quantities, ephedrine can be separated from other compounds and used as an ingredient in the manufacture of methamphetamine, an illegal drug also known as "crank." Adverse events associated with ephedrine use include heart attacks, strokes, elevated blood pressure, irregular heartbeats, seizures, hallucinations, and deaths. Long term side effects of ephedrine use are unknown. The FDA received reports of at least 28 ephedrine-associated deaths nationally between 1991 and 1997.
In 1997, the FDA proposed a rule stating that a dietary supplement is adulterated if it contains eight milligrams (mg) or more of ephedrine per dose (or "serving"), or if its labeling suggests usage of 24 mg or more of ephedrine per day. The Council for Responsible Nutrition (CRN), a trade organization which represents 85 companies that manufacture or distribute dietary supplements, has recommended that ephedrine products be limited to 10 mg per dose, with a daily intake of no more than 40 mg. In contrast, a typical current dosage of ephedrine in over-the-counter products used for energy-boosting and weight loss is 25 mg per dose, which may be repeated several times per day. Thus, current dietary supplements contain substantially higher amounts of ephedrine than the proposed FDA rules would allow or the CRN guidelines suggest.
Under the 1994 federal Dietary Supplement Health and Education Act, the FDA’s authority to regulate dietary supplements was significantly reduced so that the FDA now bears the burden of proving the supplement is unsafe before removing it from the market. It appears there is a consensus at the FDA that ephedrine is dangerous but that insufficient studies exist at this time to prove that conclusion. The proposed FDA rules on ephedrine are being challenged by dietary supplement manufacturers and have no legal effect at this time. Thus, states currently have the burden of regulating ephedrine in any meaningful manner.
The Texas Medical Association and TDH recently convened separate expert medical/scientific panels to address ephedrine products. Both of these panels recommended that ephedrine products be available only by prescription.
At least 27 other states have attempted to regulate in some manner the use of products containing ephedrine. The state law is inconsistent but contains common themes. First, ephedrine is regulated in some states as a "precursor drug," which means that sales of ephedrine in bulk are prohibited because of the potential use of the drug as an ingredient in methamphetamine. Second, ephedrine in some states is mandated to be a prescription drug only, but in virtually every case this designation of prescription status is followed by language creating generous exceptions for ephedrine when used as a dietary supplement. Numerous states also have established ephedrine as a controlled substance, thus recognizing its methamphetamine-precursor status, but these laws also create exceptions for use of ephedrine products as a dietary supplement. Some states regulate ephedrine according to brand name of products in addition to the chemical name. In addition, some states use a combination of the approaches discussed above, i.e., precursor status, prescription-only, and/or controlled substance. The effect of this complex statutory and regulatory situation appears to be that ephedrine products are routinely available over the counter in many states when purchased in doses sized for personal use.
The most appropriate regulatory response to the ephedrine issue is to make products containing ephedrine available only when prescribed by a licensed physician, except for products formally approved as drugs by the FDA for purchase over the counter. This would eliminate the legal use of ephedrine in dietary supplements for weight loss and increased energy.
This controversy should serve as a wake-up call to consumers who might assume that products they purchase as dietary supplements are regulated for safety. The next time you consider purchasing a dietary supplement marketed for quick energy or fast weight loss, check the label--ephedrine is likely to be an ingredient. The ready availability of a potentially dangerous product like ephedrine illustrates the toothlessness of current federal and state laws. Until there are changes in this lax regulatory environment, the rule for consumers of dietary supplements should be caveat emptor.