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From California to Colorado: Three Battles Against Cosmetics
By: David C. Steinberg, Steinberg & Associates
Posted: May 27, 2010, from the June 2010 issue of Cosmetics & Toiletries.
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1. Companies should market products only after the safety of each ingredient and the finished product have been substantiated. Ingredient safety can be based on Cosmetic Ingredient Review (CIR) publications.
2. If a company markets a product with an ingredient that exceeds the limits set by the CIR, it should possess sufficient data to substantiate the safety of the ingredient at this level and make this data available to the FDA during an inspection.
3. If a company markets a product with an ingredient the CIR has found to have insufficient data to determine its safety, the company should possess sufficient data to substantiate the ingredient’s safety and make this data available to the FDA during an inspection. 4. Companies should participate in the FDA Voluntary Cosmetic Reporting Program to register a product’s manufacturing location and ingredient usage.
5. The company should notify the FDA of any serious or unexpected adverse events, as defined by the FDA, and make this information available to the FDA during inspections.
6. Companies should maintain safety information about their products and make this information available to the FDA during inspections.
Emboldened by the victory of SB 484, the EWG went for the jugular in a third battle against cosmetics in Colorado. On Feb. 22, 2010, Representative Dianne Primavera (D–Broomfield, CO) introduced HB 1248, the Colorado Safe Personal Care Products Act. This author suspects it was no coincidence that during the same time, the PCPC was holding its annual meeting in Florida, and ICMAD was holding its California workshops. With both groups in meetings, their offices were unavailable to react. This bill is surely the new model from the EWG to destroy the cosmetics industry. It plays on the success of California and changes only a few words, which likely were expected to go unnoticed, to add enforcement provisions that would allegedly cost the state nothing. By doing so, this bill would be more palatable to other elected officials in this day of major government deficits.
The provisions prohibit manufacturers from selling, offering for sale, or distributing for sale in Colorado any personal care product that contains a chemical identified as causing cancer or reproductive toxicity. The identification of these chemicals will be determined by authoritative bodies, similar to California SB 484. The definition of personal care products in HB 1248 is the same as the definition under the Food, Drug and Cosmetic Act. Private citizens may file suit to enforce the act and may recover attorney fees and costs if a violation is found. HB 1248 would impose a fine for violation of up to US $5,000 per violation per product for the first offense and US $10,000 for the second and all subsequent offenses. The HB 1248 text states:4
Independent testing in the United States and the European Union has determined that many cosmetic products contain substances known or suspected to cause cancer and reproductive toxicity that can harm adults and children. Neither the federal Food and Drug Administration, nor the Colorado Department of Public Health and Environment require safety testing, review or approval of personal care products such as shampoos, lotions and moisturizers before those products are offered for sale to the public. While most consumers use some personal care products, cosmetic products intended to beautify are most commonly used by women of childbearing age, increasing the likelihood of exposing mothers, fetuses, and nursing children to substances that can cause cancer and reproductive toxicity. Alternatives to chemicals that cause cancer or reproductive toxicity or that contribute to other harmful effects are readily available for use in personal care products.
It continues: Numerous manufacturers, including small domestic producers and large multinational corporations, have eliminated substances that cause cancer or reproductive toxicity from their personal care products. Based on these findings, the General Assembly declares it to be in the best interest of the people of this state to take steps to ensure that personal care products sold and used in this state are safe and do not contain substances that cause cancer or reproductive toxicity.