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Regulatory Review—US and Canada Updates: Canadian Cosmetic Harmonization and the FDA's Claim Crackdown

By: David C. Steinberg, Steinberg & Associates

Posted: January 4, 2013, from the January 2013 issue of Cosmetics & Toiletries.

Several major regulatory changes are coming in cosmetics from Canada, while in the United States, the U.S. Food and Drug Administration (FDA) has been active in sending out warning letters to cosmetic companies making unapproved drug claims. This column provides an overview of them.

Canadian Updates

As noted, many changes and proposed changes in Canada will impact the cosmetics industry, including regulations, environmental issues and advertising claims.

Cosmetic regulations: The biggest change with the greatest impact for the cosmetics industry is Health Canada’s efforts to modernize cosmetic regulations. This is long overdue, and the goal is to better ensure safety and harmonization with trading partners such as the United States and Europe. Health Canada’s changes often reflect European Union (EU) regulations while maintaining a conversation with the United States to reduce trade barriers—efforts that are often at odds. The important point is that Canada is trying to regulate cosmetics whereas the United States is not.

Guidelines surrounding “cosmetic” OTC drugs are the major reason Canada is harmonizing cosmetic regulations. These products, i.e., sunscreens, dandruff shampoos and lip protectants with SPF, are regulated as drugs but considered by consumers to be cosmetics. These can be regulated as Natural Health Products (NHPs) or by the Therapeutic Products Directive (TPD) in Canada, depending on the active ingredient(s). For example, a sunscreen with titanium dioxide is an NHP but a sunscreen based on the active octinoxate is a TPD. Both require pre-approval and the issuance of a Drug Identification Number (DIN) or NHP number, which must appear on the label.

To break the logjam of registration backlogs, Health Canada has issued harmonized monographs between NHPs and the TPD, and is transitioning some cosmetic-type drugs to cosmetics. The first was antiperspirants, which are now considered cosmetics. This aligns such products with EU regulations but makes it impossible to have dual-labeled products with the United States, where antiperspirants remain OTC drugs and require Drug Facts labels. The second group of products considered was sunscreens but they are on hold while Health Canada modernizes its sun care regulations, to avoid a piecemeal effort. Note that complying with a monograph in Canada is not the same as in the United States. After registration in the United States, a cosmetic manufacturer can enter the market but in Canada, a manufacturer must obtain Health Canada’s approval and the NHP or DIN number before entering the market. Health Canada has made information access easier for both industry professionals and consumers by creating a new website for consumers, healthycanadians.gc.ca; the industry’s website will remain as healthcanada.gc.ca/cosmetics.