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

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.

The cosmetics industry also will be impacted by Health Canada’s finalization of the Guidance for Heavy Metal Impurities.¹ The maximum levels of heavy metal impurities are as follows: lead, 10 ppm; arsenic, 3 ppm; cadmium, 3 ppm; mercury, 3 ppm and antimony, 5 ppm. These levels have been deemed safe from extensive scientific reviews including exposure levels, comparisons to allowable levels in drinking water, and levels adopted by the German government. These guidelines will be helpful in combating constant proclamations of “toxic” chemicals in cosmetics by nongovernmental organizations (NGOs); if the FDA would adopt these, perhaps the “lead in lipstick" scare would disappear.

Sometime in early 2013, Canada will begin online electronic notifications for cosmetics. Currently, cosmetics manufacturers are required to notify Health Canada by completing a PDF and mailing it within 10 days of placing the product on the market. The levels of each ingredient are submitted using Canada’s ranges, unlike the exact amounts required in the EU and elsewhere. The forthcoming electronic system will eliminate these mailings. Still under debate is whether notification would be required before entering the market and how far in advance. Also under debate is whether exact amounts should be required or only exact amounts of ingredients found on Health Canada’s Hot List. Finally, Health Canada is debating the listing of EU fragrance allergens.

Important to note is that Health Canada’s Hot List will be revised soon. The plan is to change the format to separate prohibited items and restricted items, similar to the EU, which will make it more user-friendly. A further breakdown of prohibited ingredients that have never been or may have been used in cosmetics would really be helpful to formulators.

Environmental issues: The long review of D-4 (INCI: Cyclotetrasiloxane) and D-5 (INCI: Cyclopentasiloxane) will finally conclude for non-Canadian producers of cosmetics. D-4 will be restricted under Environment Canada’s regulations to control its bulk shipping and use, which leaves imported product makers free to use it as an ingredient. This would not allow Canadian producers to use it, however, as they must buy it in bulk. D-5 will have no such restrictions. It is best to wait until the final rules are released, as Environment Canada may make additional changes.

In relation, since REACH in the EU may place more restrictions on all uses of D-4 and D-5, it is still recommended not to use the generic term “cyclomethicone” on an ingredient listing. Environment Canada’s agenda for the future includes dealing with triclosan and VOC limits, where it is leaning toward following California.

Advertising claims: Advertising Standards Canada (ASC) established the Cosmetic Advertising Advisory Group (CAAG) in 2006, and CAAG recently updated its acceptable and unacceptable cosmetic claims. These changes are shown in Table 1. The CAAG meets annually to develop and propose revisions to Health Canada’s Guidelines to meet current and emerging industry needs and remain consistent with the regulatory framework. CAAG includes representation from key stakeholder associations, the public, ASC, the Cosmetics Division and Health Canada’s Therapeutic Products Directorate and Natural Health Products Directorate.

US Updates

FDA warning letters: In September and October 2012, the FDA issued warning letters to: Lancôme, Greek Island Labs, Janson Beckett, Andes Natural Skin Care, Bioque Technologies and Avon Products, perhaps due to pressure from NGOs. These letters referred to product claims made on the company websites positioning the products as unapproved new drugs. All letters required the companies to reply within 15 working days to the FDA and notify the agency of how they plan to correct and prevent these violations from occurring again.

Cited claims include:
• boosts the activity of genes and stimulates the production of youth proteins;
• shown to improve the condition around stem cells and stimulate cell regeneration to reconstruct skin to a denser quality;
• significant deep wrinkle reduction in UV damaged skin, clinically proven;
• organic cedarwood
• helps to strengthen hair growth … and combat … hair loss;
• blemish free skin in just three days;
• clinically proven to reduce breakouts and blemishes by 84%;
• safe and effective alternative to Botox;
• the first anti-wrinkle product to combine the three latest cutting-edge peptides … each peptide interrupts wrinkle production; acetyl hexapeptide (argireline) … was the first peptide to offer effects similar to Botox;
• alpha lipoic acid, the most potent antioxidant on the market today, helps repair aged skin while preventing future damage;
• dual source vitamin C promotes collagen synthesis;
• repairs sun damage at the cellular level;
• inhibits microbiological activity of dangerous, pathogenic skin bacteria, including acne; • serum vitamin E to heal scarring;
• with regular use and in as little as four weeks, achieve a 42% increase in skin’s firmness and a 37% reduction in fine lines and wrinkles;
• this gel contains ingredients that, when absorbed into fatty deposit areas beneath the skin, is designed to stimulate blood flow and cell metabolism to help your body to naturally dissolve fat deposits; • the at-home answer to wrinkle-filling injections; and
• formulated with pomegranate and fennel extracts to help boost production of collagen and elastin.

The FDA considers these claims to be drug-related under its definition of: “intended to affect the structure or any function of the body of man or other animals.” Some of those listed here are clearly drug claims but some have been considered “cosmetic” claims, and inaction has allowed marketers to stretch the boundaries of claims until the warning letters arrived. This in turn has triggered lawsuits of false advertising claims which, in California, can lead to class action suits.

California: In 2008, Gov. Arnold Schwarzenegger signed into law the California Green Chemistry Regulation (AB 1879). The purpose of this regulation was to identify and prioritize chemicals of concern, evaluate alternatives and specify regulatory responses where chemicals are found in finished products, including cosmetics. In relation, Schwarzenegger also passed SB 509, which requires an online, public, toxic information clearinghouse including science-based information on the toxicity and hazard traits of chemicals used in daily life. All consumer products are covered by these bills except food, some prescription drugs and insecticides. To go into more detail would take another column. Nothing is set in stone yet, and this author hopes changes occur before this is published.

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.

Publishing what terms or claims makes a product a drug in Canada is far better than the arbitrary guessing game in the United States, where methods encourage marketers to “push the envelope” on claims until the FDA sends out a warning letter. In the past, a product manufacturer changed claims after being caught and went on with its business. Now, lawyers in California can sue manufacturers over false claims, so “the price of poker just went up!” Instead of a “buyer beware” mentailty, there is a “marketing department” beware. Notice how many different claims were cited in the warning letters. Using the defense, “Everyone else is doing this, so I must do it to compete,” does not look so bright, now.

The California Green Chemistry issue sounds good, as everyone is after a safe and clean environment. However, this law will not make products more expensive rather than safer, making many products disappear from store shelves. When their favorite products are not on retail shelves in California, the state’s consumers will obtain their product online, ultimately hurting California’s revenue.

References
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1. Guidance for Heavy Metal Impurities in Cosmetics, Health Canada, www. hc-sc.gc.ca/cps-spc/pubs/indust/heavy_metals-metaux_lourds/index-eng. php (Accessed Nov 16, 2012)
2. 16 Legislators Ask Governor Brown to Delay “Green Chemistry” Regulations, http://michaelrubio.org/16-legislators-ask-governor-brown-to-delay-greenchemistry- regulations/ (Oct. 21, 2012) (Accessed Nov 16, 2012)