Health Canada Eyes Regulatory Reform, Reclassification Of Sunscreens

Consultations planned for the fall will explore a proposal that would create a new oversight framework for lower-risk consumer health products currently regulated as drugs, including selected skin-care, acne and oral-care items. At the same time Health Canada will consider reclassification of sunscreens and anti-dandruff products, potentially as cosmetics, according to the Canadian Cosmetic, Toiletry and Fragrance Association.

Health Canada is reevaluating its oversight of sunscreens and other lower-risk health products currently regulated as drugs, with a view toward reducing “unnecessary red tape” where appropriate.

The agency announced in June that it will launch a consultation this fall to explore the proposal that “lower-risk products be separated from the framework for prescription drugs and be moved under a new framework for consumer health products.”

In a July 17 email, Health Canada confirmed that acne-therapy, diaper-rash, medicated skin-care, antiseptic skin-cleansing, skin-whitening, tooth-whitening and fluoride-containing anti-caries products are among items under consideration for the shift to a new oversight unit.

Meanwhile, the agency is in discussions with stakeholders regarding Canada’s regulatory classifications for sunscreens and anti-dandruff products and will hold separate consultations on the subject later this year, it says. Currently, the products are drugs subject to monograph requirements in Canada, similar to the U.S.’s over-the-counter drug monograph system.

According to the Canadian Cosmetic, Toiletry and Fragrance Association, sunscreens and cosmetics with SPF could be considered for regulation under Canada’s existing cosmetics framework in a model similar to that in place in the European Union.

The trade group’s President and CEO Darren Praznik offered perspective in a July 16 interview with “The Rose Sheet.”

“The EU regulates sunscreens and secondary sunscreens under their cosmetic regs, [and] they use their authority under those regulations to ensure that the safety and efficacy of the active sunscreen ingredients are proven or demonstrated,” he explained, adding: “We would suggest that Health Canada probably has that same authority under Canada’s cosmetic regs.”

Speaking to the “bizarre” scenarios that arise out of Canada’s current regulatory framework, Praznik questioned, “Do you really want to have manufacturers of lipstick with SPF register with a drug-shortages website to advise people that they’re discontinuing a color line?”

Praznik noted that the move would be in the spirit of international harmonization at a time when initiatives like the Transatlantic Trade and Investment Partnership between the U.S. and EU, and efforts between Canada and the U.S. under the Regulatory Cooperation Council, are seeking to promote regulatory convergence (Also see "EC Proposes Harmonizing Cosmetics Safety, Labeling With U.S. Through TTIP" - HBW Insight, 2 Jun, 2014.).

“What’s exciting about this is that this undertaking in Canada is not being done out of context; it is being done in the context of regulatory alignment between trading partners,” he said.

Reclassification of sunscreen products in Canada would represent a step away from alignment with U.S. regulations. Current reform efforts in the states seek changes within the existing OTC drug regulatory system, including legislation aimed at promoting greater efficiency in sunscreen oversight, specifically with regard to FDA’s backlog of Time and Extent Applications (Also see "Revised House Sunscreen Bill Promotes Review Transparency, Feasibility" - HBW Insight, 16 Jul, 2014.).

Regulating “Right”

In its release, Health Canada says the updated framework under consideration for lower-risk consumer health products “will take into account the potential risk of the product in order to ensure that the right level of oversight throughout regulations is applied,” noting that “the health and safety of Canadians will remain the first priority.”

Praznik similarly stressed that the aim of the initiative is to implement “appropriate” regulation.

“This is about appropriate regulation. And currently under the Canadian model, you have the inappropriate regulation of certain products because they’re classified as drugs, [which] puts them in the realm of prescription pharmaceuticals with sometimes very bizarre regulatory results that were never intended.”

For example, he said, drug products imported into Canada are quarantined and retested under Canadian law. With respect to cosmetics containing SPF, antidandruff products and other lower-risk consumer products, he questioned, “Is there a need to do that? Is there a public safety issue with that? Not really. It’s just that by defining that product as a drug, you’re caught under those rules.”

Praznik supplied another example, pointing to Health Canada’s May notice to industry directing firms to provide advance notification of any drug discontinuances to help address the problem of drug shortages.

“When they sent that out, that also went to cosmetic manufacturers who had lipsticks and cosmetic products that contained SPF. We asked, ‘Do you really want to have manufacturers of lipstick register with a drug-shortages website to advise people that they’re discontinuing a color line?’ Of course not, that was never intended.”

CCTFA views the potential new framework for lower-risk products and reclassification of selected categories “a very welcome reform,” Praznik concluded, noting that the trade group is committed to working with Health Canada as the initiative moves forward.