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Cosmetics Registration in California and the FDA's Electronic-only Drug Registration
By: David C. Steinberg, Steinberg & Associates
Posted: September 29, 2009, from the October 2009 issue of Cosmetics & Toiletries.
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After manufacturers were required in 2007 to report their products to the California Division of Environmental and Occupational Disease Control (DEODC), also referred to as the Division, the DEODC could conduct an investigation to review: health effect data and studies; work site health hazard evaluations; epidemiological studies to determine health effects of exposure to chemicals in various subpopulations; and exposure assessments to determine total exposures. The DEODC may require manufacturers to submit relevant health effects and studies, and other information such as concentration in the product, or the amount, volume or weight of the product that comprises the average daily exposure. Within 180 days of receiving the results of this investigation, the DEODC must then develop and present one or more proposed occupational health standards.
The second part of The Safe Cosmetics Act requires the DEODC to investigate cosmetic products that contain unsafe ingredients according to the Cosmetic Ingredient Review (CIR). If these products do not have a warning on their label stating that their safety has not been determined (21CFR700.10), the DEODC must determine if the product’s safety has been adequately substantiated and whether the product contains an unsafe ingredient. The results of this investigation are then reported to the US Attorney General and the FDA for enforcement action.
How to Register
It took nearly two and a half years but California finally issued instructions for manufacturers to report their products and thus comply with this act. Filing for the California Safe Cosmetics Program must be conducted electronically, and complete information, including the forms, may be obtained online.1 The information presented here is the main steps and is intended to serve as an overview.
Who must file: The party responsible for filing is the company whose name and address appears on the label. This task can be delegated to the manufacturer or even a third party (e.g., a consultant). If a third party is utilized, a written agreement should be drawn up outlining all possible costs involved. Companies that do not own the product formulations may want to consider this approach, especially if the owner of the formulation does not wish to disclose detailed information to the customer; third parties can discretely disclose the necessary information to the state.
Requirements: Companies must report whether they sell products in California and if they have realized more than $1 million in global sales for the previous tax year. Products reported should contain one or more ingredients in their list; this excludes trace contaminates and only applies to ingredients included in the product. All the components of purchased mixtures are considered ingredients, including flavors and fragrances (see below). Products submitted must meet the FDA definition of a cosmetic or cosmetic/drug. Products exempted include FDA-exempted soap and drugs that make no cosmetic claims. Private label companies selling the same product to multiple companies may file once on behalf of all parties.