Requesting clarity on "Proven" claims
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Hello, I was hoping you could provide some clarity on why the claim "Proven efficacy" can appear without the direct association of supporting data, and why this is not considered an unsubstantiated claim when it appears with the indication, and if this would also apply to claims of "Proven safety".
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Hello, I was hoping you could provide some clarity on why the claim "Proven efficacy" can appear without the direct association of supporting data, and why this is not considered an unsubstantiated claim when it appears with the indication, and if this would also apply to claims of "Proven safety".
Hello @username
The copy “Proven efficacy” CANNOT stand on it’s own. It must be immediately supported by the indication which sets the limitations of the copy ”proven efficacy” as assessed and authorized by Health Canada. The indication acts as the ‘supporting copy’. The copy “proven efficacy” should not appear above single study findings as it overstates the level of evidence of single past tense study findings.
“Proven safety” is not acceptable since it is absolute. One could use the copy “Proven safety profile” if it is immediately supported with the most common adverse events and percent incidences from the PM. This reflects the safety profile that Health Canada has assessed in order to grant market authorization.
Note that either example "Proven efficacy" or "Proven safety profile" would also prompt the inclusion of the highest level fair balance.
