STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE TOBACCO CONTROL DIRECTORATE OF THE CONTROLLED
SUBSTANCES AND CANNABIS BRANCH OF THE DEPARTMENT OF HEALTH OF CANADA NOT TO PUBLICLY DISCLOSE INFORMATION
SHARED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION
The United States Food and Drug Administration (FDA), is authorized under 21 C.F.R. § 20.89 to disclose non-public information to the Tobacco Control Directorate (TCD) of the Controlled Substances and Cannabis Branch (CSCB) of the Department of Health of Canada regarding tobacco products (including nicotine vaping products) as part of cooperative law enforcement or cooperative regulatory activities, including regulatory compliance activities.
TCD understands that, the information provided by FDA 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 products (including nicotine vaping products) regulation activities.
TCD understands that some of the information it receives from FDA may include non-public information exempt from public disclosure under the laws and regulations of the United States of America, which is confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information.
TCD understands that this non-public information is shared in confidence and that FDA considers it critical that TCD maintain the confidentiality of the information. Public disclosure of this information by TCD may seriously jeopardize any further scientific and regulatory interactions between TCD and FDA. FDA intends to advise TCD of the non-public status of the information at the time that the information is shared.
Therefore, TCD certifies that it:
- has the authority to protect from public disclosure such non-public information provided to it in confidence by FDA;
- will not publicly disclose such FDA-provided non-public information without: (a) the written authorization of FDA or, if FDA cannot provide that authorization, from the individual or entity that can provide such authorization, as determined by FDA and TCD on a case-by-case basis; or (b) written statement from FDA that the non-public information has become publicly available;
- will inform FDA promptly of any effort made by a judicial or legislative mandate to obtain FDA-provided non-public information from TCD. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, TCD 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 FDA of any changes to Canada’s laws, or to any relevant policies or procedures, that would affect TCD’s ability to honor the commitments in this document.
This Statement of Authority and Confidentiality Commitment does not compromise the regulatory authority of TCD to carry out its responsibilities.
This Statement of Authority and Confidentiality Commitment is not legally binding.
This Statement of Authority and Confidentiality Commitment supersedes the Statement of Authority and Confidentiality Commitment from the Controlled Substances and Tobacco Directorate of the Healthy Environments and Consumer Safety Branch of Health Canada Not to Publicly Disclose Information Shared by the United States Food and Drug Administration, signed by the Healthy Environments and Consumer Safety Branch on January 13, 2012. TCD will continue to provide the same protections for any non-public information provided by FDA under the 2012 Statement of Authority and Confidentiality Commitment.
Signed on behalf of The Tobacco Control Directorate of the Controlled Substances and Cannabis Branch of the Department of Health of Canada:
Assistant Deputy Minister
Controlled Substances and Cannabis Branch
150 Tunney’s Pasture Driveway
Ottawa, Ontario K1A0K9