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.

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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.