Univec Inc (UNVC)

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Zeller, Jessica<[e-mail]> Thu, Nov 2, 2017 at 10:42 AM
To: ORA Ombudsman <[e-mail]>

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Thank you for your e-mail. To date, the FDA has not approved a marketing application for marijuana for any indication. The FDA is aware that marijuana or marijuana-derived products are being used for a number of medical conditions. In late February 2015 and again in 2016 and 2017, FDA issued several warning letters to firms that market unapproved drugs for the diagnosis, cure, mitigation, treatment, or prevention of diseases. Some of these firms claim that their products contain cannabidiol (CBD), a derivative of marijuana. FDA tested those products and many were found to not contain the levels of CBD they claimed to contain and, in fact, no CBD was detected in some of them. The links to the test results for these products and copies of the Warning Letters issued to these firms can be found at the sites at the following links:

When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.

Please let me know if I can be of further assistance.

Jessica L. Zeller, JD, MA
ORA Ombudsman
U.S. Food and Drug Administration
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