The law that governs how FDA can regulate dietary supplements, the Dietary Supplement Health and Education Act (DSHEA), requires FDA to bear the burden in determining that a lawfully marketed dietary supplement presents a significant or unreasonable risk and should be removed from the market. In contrast to real drugs, which must be proven pure, safe and effective to be marketed, DSHEA requires FDA to develop evidence after the supplements are already on the market that a dietary supplement presents an “unreasonable risk of illness or injury.” FDA has no authority to require any studies of safety or effectiveness for dietary supplements. This is reminiscent of the “patent medicines” of yesteryear that only required being “patented” to get on the market without any drug testing for purity, safety and efficacy. FDA first proposed regulating ephedra in 1997, but public outcry demanding ephedra stay along with other commenters including the U.S. General Accounting Office generally believed that FDA had not developed sufficient evidence for certain actions proposed. So, this dangerous drug was continued to be produced in a manner substandard to real drugs and provided without a prescription over the counter with the help of misleading advertising campaigns to a public that largely doesn’t have a clue how to use the drug safely and we wonder why people died. I still wonder why the alternative medicine industry isn’t shut down for the snake oil salesman tactics they use to sell their untested products manufactured to sub-standard specifications with voluntary quality controls using deceptive advertising tricks to an unwitting nation. Since we are having trouble stopping the spread of these dangerous untested drugs masquerading as harmless safe dietary supplements, it is time to shut down this industry in their pocketbooks with lawsuits. And even though Ephedra is not Generally Recognized as Safe (GRAS) for foods and not approved for use as a food additive, some ephedra containing products will remain on the market, including: traditional Chinese herbal remedies; and, dietary supplements that are marketed as substitutes for dietary supplements containing ephedrine alkaloids. Hopefully, as many lawsuits for innocent people victimized from ephedra are settled for large amounts of money, this will keep the number of people who will be exposed to ephedra in the post ban era to a minimum.