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.

page 4 of 5

There are some important issues in this regulation to consider, the first of which is the identification of chemicals of concern. The list from the California Department of Toxic Substances Control (DTSC) is a list of 1,200 chemicals from many sources. The DTSC will need to prioritize these chemicals and the products that contain them. Another issue is whether there will be a minimum level. Once the list is decided upon and products are prioritized, finished products will be subject to an extensive outside assessment by certified auditors, which can conclude if they are safe or that they must be reformulated and removed from the market.

In October 2012, California senators and assembly members wrote to the governor to delay until the DTSC provides answers to the following questions: total cost that businesses and individuals may incur; total number of businesses impacted; number of businesses that will be created or eliminated; and jobs created or eliminated. Sixteen California legislators sent a letter to current Governor Jerry Brown asking him to delay green chemistry initiatives. In relation to this letter, Sen. Michael J. Rubio commented, “These regulations could affect nearly every product sold in the state of California—from cars and computers to shampoo and cleaning products—potentially impacting every manufacturer, business and consumer in California.”²

Comments

Canada’s plans to align closer to the EU will isolate the United States even further in terms of harmonized regulations. It’s likely that within the next four years, the United States may be the only country to regulate sunscreens as drugs and not cosmetics. Currently, OTC drugs in the United States must include a “Drug Facts” label, which make it challenging to export U.S. products.

Canada’s maximum levels for heavy metals is a great idea. If all countries would adopt these levels, perhaps the phone calls from the media about lead in lipsticks would cease. Also, Canada no longer allows “free-from” claims, and the world should follow. This will stop consumers from questioning what other harmful chemicals are in their products. “Free-from” claims led NGOs and politicians to lobby for the pre-approval of all cosmetics and ingredients.

There have been bills on cosmetic s regulation introduced to the U.S. House of Representatives (H.R. 4262 and H.R. 4395); however, these bills have not progressed. California will not wait for the House to initiate more cosmetic regulation, so it enacts its own laws.