FDA – Tobacco Control Directorate of the Controlled Substances and Cannabis Branch of the Department of Health of Canada
STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION
NOT TO PUBLICLY DISCLOSE INFORMATION SHARED BY THE TOBACCO CONTROL DIRECTORATE OF THE CONTROLLED SUBSTANCES
AND CANNABIS BRANCH OF THE DEPARTMENT OF HEALTH OF CANADA
The Tobacco Control Directorate (TCD) of the Controlled Substances and Cannabis Branch (CSCB) of the Department of Health of Canada, as part of its mandate to regulate the manufacture, sale, labeling and promotion of tobacco and vaping products, is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding tobacco and vaping products as part of cooperative law enforcement or cooperative regulatory activities, including regulatory compliance activities.
FDA understands that, unless otherwise specified, the information provided by TCD is to be used only for cooperative law enforcement or cooperative regulatory activities related to the purposes for which it was originally collected, namely, tobacco and vaping product regulation activities.
FDA understands that some of the information it receives from TCD may include non-public information exempt from public disclosure under the laws and regulations of Canada, which is confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal pre-decisional information.
FDA understands that this non-public information is shared in confidence and that TCD considers it critical that FDA maintain the confidentiality of the information. Public disclosure of this information by FDA may seriously jeopardize any further scientific and regulatory interactions between TCD and FDA. TCD intends to advise FDA of the non-public status of the information at the time that the information is shared.
Therefore, FDA certifies that it:
- has the authority to protect from public disclosure such non-public information provided to FDA in confidence by TCD;
- will not publicly disclose such TCD-provided non-public information without: (a) the written authorization of TCD or, if TCD cannot provide that authorization, from the individual or entity that can provide such authorization, as determined by TCD and FDA on a case-by-case basis; or (b) written statement from TCD that the non-public information has become publicly available;
- will inform TCD promptly of any effort made by a judicial or legislative authorities to obtain TCD-provided non-public information from FDA. If such judicial or legislative authorities order disclosure of TCD-provided non-public information, FDA will take all appropriate legal measures in an effort to ensure that the information will be disclosed in a manner that protects the information from public disclosure; and
- will promptly inform TCD of any changes to the United States of America’s laws, or to any relevant policies or procedures, that would affect FDA’s ability to honor the commitments in this document.
This text does not create rights and obligations under international or national law.
This Statement of Authority and Confidentiality Commitment supersedes the Statement of Authority and Confidentiality Commitment from the United States Food and Drug Administration Not to Publicly Disclose Information Shared by the Controlled Substances and Tobacco Directorate of the Healthy Environment and Consumer Safety Branch of Health Canada, signed by FDA on January 26, 2012. FDA will continue to provide the same protections for any non-public information provided by the Controlled Substances and Tobacco Directorate under the 2012 Statement of Authority and Confidentiality Commitment.
Signed on behalf of FDA:
Mark Abdoo Associate Commissioner for Global Policy and Strategy
U.S. Food & Drug Administration
10903 New Hampshire Avenue,
Silver Spring, Maryland 20993