“My name is Zoe Sigman, and I’m the Program Director at Project CBD, an educational nonprofit focused on cannabis science & medicine. Ten years ago, we introduced CBD to the medical cannabis community in California. It spread like wildfire and has become the hugely popular phenomenon that it is today.
There are occasions when public health priorities and pharmaceutical prerogatives are not equivalent. We believe this is the case with CBD and cannabis. We urge the FDA to maintain public health at the core of your decision-making process.
CBD is a non-toxic, non-intoxicating, non-habit-forming, neuroprotective antioxidant. What’s not to like? Given CBD’s intrinsic safety & many potential benefits, it should be legally available without a prescription.
Sensible regulations can assure product safety without going through expensive, time-consuming clinical trials. The goal should be easy public access to diverse cannabis product options that are subject to rigorous manufacturing and compliance oversight.
Toward this end, we propose the formation of a Committee for Traditional Herbal Medicinal Products to assist in implementing regulations for CBD, cannabis, and other medicinal plants. Project CBD will provide a detailed account of the Committee’s responsibilities in a written submission to the FDA.
A few closing comments:
- Regarding pregnancy – When confounding variables (alcohol, cigarettes) are accounted for, there is no science that demonstrates harm to the fetus from cannabis, as Project CBD documented in a report to California health officials.
- Contraindications and drug interactions are easily manageable. Project CBD has published an extensive report on cannabinoid-drug interactions, noting few problems except with high doses of CBD isolates.
- Project CBD advocates banning artificial thinning agents and flavor additives from cannabis oil vape cartridges unless these additives are proven safe when heated and inhaled.
Let’s regulate CBD to promote public health. Let’s make the most of this historic opportunity.”
Zoe Sigman is Project CBD’s Program Director.
Copyright, Project CBD. May not be reprinted without permission.
This report represents a comprehensive response to the FDA’s inquiry and includes a regulatory framework for cannabis and other traditional herbal medicinal products.
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