Ephedra: Legal consequences
Last modified: Sunday, 31. May 2009 - 2:42 pm
Legal consequences of Ephedra
Like most herbal supplements, the federal regulation that applies to ephedra is the Dietary Supplement Health and Education Act (DSHEA). This law was first passed in 1994 and allows supplement manufacturers to market and sell products without federal regulation. The FDA can only step in to regulate ephedra or other herbal supplements when they are proven to be unsafe or pose a risk to users.
Although DSHEA essentially tied the FDA’s hands with regard to ephedra, individual state governments do have the power to enact laws about it. In the 1990s, there were reports of potential problems and serious ephedra-related health consequences such as heart attacks and strokes. Some states decided to pass their own legislation. In 1994, Ohio became one of the first states to pass a law restricting ephedra, which in fact banned the sale of products containing ephedrine. Texas also passed a similar ban in 1994, although the law was overturned a few weeks after it was passed.
More and more states are passing laws to regulate ephedra sales and labeling. By 2001, nearly half of the states in the United States had passed laws to regulate sales or labeling of ephedra products. Essentially, legal restrictions on ephedra fall into a few categories. A state may regulate how a product is formulated. This type of law might mandate that ephedra must occur naturally, that is, it is not produced synthetically in a laboratory. Another type of restriction is a dosage restriction.
States may also restrict labeling and marketing of ephedra products. In a few states, the law requires that labels of ephedra products comply with DSHEA or federal laws. Other states prohibit the term ephedrine on the label. Some states require exact dosing information on the product label, while other states require that the label inform users of potential risk and adverse health consequences, particularly with improper use. In New York, the Department of Health forbids manufacturers to market ephedra as a legal stimulant or legal alternative to illegal drugs. The FDA’s Medwatch phone number must be printed on the label of any product containing ephedra that is sold in Texas. A few states prohibit the sales of ephedra to consumers under the age of 18. Finally, in some states if a product indicates the term ephedrine (vs. ephedra) on the label, it must be sold as prescription instead of an over-the-counter supplement.
Ephedra has been the subject of a number of lawsuits in the United States. As users report adverse events, lawyers have started to champion their causes and sue product manufacturers. Some lawyers advertise on the Internet and seek clients who believe that they have been harmed by ephedra. An ephedra lawsuit can garner a lot of money for a lawyer and a client.
Ephedra has a long history of legal use in the United States and around the world. Today, the laws that apply to ephedra cover sales, formulation, and labeling by manufacturers; they do not outlaw its use by consumers as with street drugs such as marijuana and cocaine. Because ephedrine can be used to manufacture methamphetamine, companies that sell bulk ephedrine and ephedrine tablets are subject to laws designed to halt the conversion of ephedrine into methamphetamine.
Federal guidelines, regulations, and penalties
Since clandestine lab operators use ephedra to make methamphetamine, the DEA monitors supplements containing ephedrine. One kilogram of ephedrine, the equivalent of 48,000 25-mg ephedrine tablets, can be used to produce anywhere from 1.1 to 1.6 lbs (.5 to 0.75 kg) of methamphetamine in a drug lab. Pseudoephedrine can be used for the same purpose.
In the late 1980s, drug traffickers and clandestine laboratory operators began to purchase bulk ephedrine powder to make methamphetamine. The government responded in 1988 and passed the Chemical Diversion and Trafficking Act (CDTA) to control the import, export, and distribution of bulk ephedrine powder. The drug traffickers then turned to ephedrine tablets to make methamphetamine, which were exempt from the CDTA. Drug traffickers and lab operators found that they could buy large quantities of ephedrine tablets and convert them to methamphetamine. A number of mail-order companies even advertised 1,000-count bottles of ephedrine tablets in national magazines. Although the CDTA allowed for criminal prosecution of companies selling tablets if they knew the tablets were being used to make an illegal substance, the companies were able to claim they had no knowledge of their products’ ultimate use.
In 1993, Congress passed a new law, the Domestic Chemical Diversion Control Act (DCDCA), to include ephedrine tablets in the first law. According to the law, all distributors, importers, and exporters who sell List 1 chemicals, such as ephedrine, must register with the DEA. The DEA can deny registration or revoke registration to companies whose actions threaten public health and safety. Thus, if the company sells ephedrine tablets that are then converted into illegal substances, its registration may be denied. By 1994, lab operators responded by using pseudoephedrine to make methamphetamine.