The FDA’s refusal to allow companies to market CBD as a dietary supplement is based on the fact that federal classification as a dietary supplement requires that a substance has not been authorized for investigation as a new drug or medicine. Since Epidiolex has been studied in clinical trials by GW Pharmaceuticals going back several years now and was granted orphan drug status by the FDA in 2013, CBD cannot therefore be classified as a dietary supplement. Or so the FDA says. But cannabis companies are arguing that they started marketing CBD as a dietary supplement before there were any drug trials involving CBD, such that they should still be allowed to claim dietary supplement status for their products. Thus far however, the FDA isn’t budging on this issue.
Juliana Birnbaum is trained as a cultural anthropologist and skilled in four languages and has lived and worked in the U.S., Europe, Japan, Nepal, Costa Rica and Brazil. In 2005 she founded Voices in Solidarity, an initiative that partnered with Ashaninka indigenous tribal leaders from the Brazilian Amazon to support the development of the Yorenka Ãtame community-led environmental educational center featured in Sustainable [R]evolution. She was the first graduate of the Cornerstone Doula School, one of the most rigorous natural birth programs in the U.S., focusing on a holistic model of care. She is engaged variously as writer, editor, teacher, midwife assistant and mother when not attempting new yoga poses or learning how to garden.