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FDA Requests Information for Products Containing Cannabis or Cannabis-Derived Compounds

7/08/2019
ANSI News

The U.S. Food and Drug Administration (FDA) has extended its public comment period on products containing cannabis or cannabis-derived compounds until July 16, following their May 31 public hearing, "Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds."

FDA's Federal Register notice from April 3 seeks input on standards to address manufacturing and product quality issues, including:

- 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?

- What validated analytical testing is needed to support the manufacturing of safe and consistent products?

- Are there any currently used standardized definitions for the ingredients in cannabis products (e.g., "hemp oil")? If standardized definitions would be helpful, what terms should be defined and what should the definition(s) be?

The American National Standards Institute (ANSI) encourages all parties with in an interest in this topic to provide input.

FDA has made available presentations from the May 31 public hearing on their website. In his opening remarks, Norman E. Sharpless, FDA's acting commissioner of food and drugs, encouraged all stakeholders to submit comments to the public docket.

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