May 24, 2020

May 22, 2020

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Data Call-in for Reproductive Toxicity Data on Cannabis Under California’s Proposition 65

  • The California Office of Environmental Health Hazard Assessment (OEHHA) has tasked the Developmental and Reproductive Toxicant Identification Committee (DARTIC) of OEHHA’s Science Advisory Board with evaluating whether cannabis (marijuana), marijuana (cannabis) smoke, cannabis extracts, and Δ-9-Tetrahydrocannabinol (THC) have been shown to cause reproductive toxicity (developmental toxicity endpoint).  Chemicals identified as reproductive toxicants by the DARTIC are added to the Proposition 65 list.

  • OEHHA is initiating the development of hazard identification materials on cannabis chemicals and is requesting scientific information relevant to whether they cause reproductive toxicity (developmental toxicity endpoint).  The data call-in period will end at 5:00 p.m. on April 29, 2019.  The committee meeting is tentatively planned for Fall 2019, but the exact date is yet to be determined.

  • This Proposition 65 development occurs after the U.S. Food and Drug Administration (FDA) showed signs of potentially loosening its opposition to the inclusion of cannabidiol extracts in food or dietary supplements.  As reported in this blog, FDA Commissioner Scott Gottlieb had announced the formation of a working group to develop rules that would permit the use of certain extracts from hemp in food or dietary supplements and indicated that a public hearing was being planned for April to discuss how some uses of cannabidiol in food and dietary supplements might be legalized.  FDA’s website has no details about an April hearing and it is not clear if Commissioner Gottlieb’s plans to leave FDA at the end of the month will slow work on this matter.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...