Three Areas Of Questions On Docket

FDA's health and safety risks questions are:

"Based on what is known about the safety of products containing cannabis and cannabis-derived compounds, are there particular safety concerns that FDA should consider regarding its regulatory oversight and monitoring of these products?"

"What are the characteristics of a successful system to collect representative safety information at the national or State level about products containing cannabis and cannabis-derived compounds?"

"What endpoints or outcomes would define a maximal acceptable daily intake from all products?"

Under manufacturing and product quality, FDA's questions are:

"Are there any data known that would support the safe use of cannabis and cannabis-related compounds in general food use (including dietary supplements), including data regarding exposure levels to cannabis and cannabis-related compounds in foods (including dietary supplements) that would be acceptable from a food safety perspective?"

"Are there particular standards needed to address any safety issues related to the manufacturing, processing, and holding of products containing cannabis and cannabis-derived compounds (e.g., genotoxic impurities, degradation of active compounds)?"

"Are there particular standards or processes needed to ensure manufacturing quality and consistency of products containing cannabis or cannabis-derived compounds, including standards applied to evaluate product quality?"

And its marketing/labeling/sales questions are:

"How should consumers be informed about the risks associated with such products (e.g., directions for use, warnings)? What specific risks should consumers be informed about?"

"Are there any subpopulations for which additional warnings or restrictions are appropriate?"

"What statutory or regulatory restrictions are in place under State or local law to warn about the use of these products by certain vulnerable human populations (e.g., children, adolescents, pregnant and lactating women) or animal populations (e.g. species, breed, or class)?"

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