No FDA-approved medication is smoked. In addition to the concerns about potential carcinogenicity (especially in heavy marijuana users , but apparently not in occasional users ), there is great difficulty in delivering the exact dose, if a “dose” even exists. Unlike FDA-approved medications, medical marijuana is not a specific product with controlled dosages. Medical marijuana bypasses the century-old, scientifically based drug approval procedure and the carefully regulated distribution of medications through licensed pharmacies. The FDA does not evaluate chemicals or plants like marijuana; it evaluates specific standardized products for their safety, efficacy, and purity. However, the potential therapeutic value of the cannabinoids in the marijuana plant should be harnessed to produce medications that can be approved by the FDA. The FDA approved dronabinol (Marinol), the schedule III synthetic delta-9-tetrahydrocannabinol (THC), in 1985. Sativex, a standardized marijuana-based product delivered by means of oromucosal spray and manufactured under the name Nabiximols in the United States, contains THC and cannabidiol in a 1:1 ratio and has been approved for use in the United Kingdom, Canada, and a number of other countries (4). It is currently being evaluated in a phase 3 trial for cancer pain in the United States. Approving medications by ballot initiatives and state legislative actions sets a dangerous precedent for public health. FDA approval has usually helped keep dangerous and ineffective—but often popular—drugs off the market. Substituting a political drug approval for that protection is hazardous to the nation's health and safety.