A. Relevant Federal Statutes and "The Grandfather Clause"

The Federal Food, Drug, and Cosmetic Act of 1938 ("the FDCA"), 21 U.S.C. §301 et seq., is designed to protect public health by regulating "new drugs" that are intended for use in interstate commerce. Barnes v. United States, 142 F.2d 648 (9th Cir.1944); United States v. Kordel, 164 F.2d 913 (7th Cir.1947); United States v. Two Bags, Poppy Seeds, 147 F.2d 123 (6th Cir. 1945). There exists, however, a "grandfather" clause which exempts certain old drugs from this "new drug" status. 21 U.S.C. §321(p)(1); United States v. Rutherford, 442 U.S.544, 546-48 (1979); Rutherford v. United States, 541 F.2d. 1137, 1140-42 (10th Cir.1976) (reversed on other grounds, 442 U.S. 544).

As explained by federal regulators, when Congress revamped the FDCA in 1939, it "accepted those drugs marketed prior to 1938 which had been subject to the 1906 provisions of the FDCA [requiring drugs to be identified in recognized medical authorities such as the National Formulary, United States Dispensatory, Pharmacopeia of the United States, or other similar sources] provided these very old drugs retain their exact formulations and are never promoted for new uses." 57 Fed.Reg. 10499, 10503 (1992) (citing 21 U.S.C. §321(p) and (w)). As further explained, these pre-1938 drugs "are politically 'grandfathered' drugs" and "need not meet modern standards for safety and effectiveness." Ibid; United States v. Rutherford, 442 U.S. at 546-48; Rutherford v. United States, 541 F.2d. at 1140-42.

As will now be shown, marijuana is one of those "very old drugs" that was grandfathered in as a medicine back in 1938. Marijuana (more commonly known as cannabis) was widely recognized for its medicinal use in the medical journals of that time, and brand-name companies, such as Parke-Davis and Eli Lilly, were cultivating "home-grown cannabis" and selling the "flowering tops" of the plant for use in the treatment of illnesses such as anorexia, chronic pain, spasticity, and nausea.
litespeed Reviewed by litespeed on . Would this qualify for Medical Marijuana consideration? I had a Brain Injury in 1994, and had found Cannabis to affect me to a much greater extent than Cocaine, Acid, or even Crack. It, mostly, cures my double-vision and tinitis. I just found this from a 2002 study. Abstract Mounting in vitro and in vivo data suggest that the endocannabinoids anandamide and 2-arachidonoyl glycerol, as well as some plant and synthetic cannabinoids, have neuroprotective effects following brain injury. Cannabinoid receptor agonists inhibit glutamatergic Rating: 5