Q: What do I need to do to prepare for a U.S. FDA inspection?

A: First, you must be clear on the applicable categories for your products. Most importantly you must have procedures, documents and validation in place. Personnel should also have appropriate training, and this should be documented.

Q: What is a Dossier?

A: A Dossier (French for “file”) is also known as a Product Information Package. The Dossier is a compilation of safety-related information about the product, and is required to have a formal file Assessment by a Qualified Safety Assessor.

This file is a European Union requirement, and it must be available upon the request of a Health Authority’s request. Each country in the E.U. has the privilege of asking for this information. A Dossier is required for every Cosmetic product sold in any country that is a member of the E.U.

Q: What do I have to do for California VOCs (Volatile Organic Compounds)?

A: There is a filing due on March 15, 2005, for the California Air Resources Board. It is more complex than earlier Surveys, so be sure to start early.

Q: Do I have to file my VOC forms, even if I didn’t get anything in the mail?

A: You are responsible to file, even though you did not receive forms in the mail, if you have the following categories:

Antiperspirant Deodorant Anti-microbial dry hand wash Anti-microbial hand or body cleaner or soap Aromatherapy bath or shower product Astringent and toner (OTC) Astringent and toner (non OTC) Body wash/mousse/gel/soap/foam/scrub Body wipes/towelettes Chemical peels Eye makeup remover Exfoliant/peel/polish Face wipes/towelettes General use hand or body cleaner or soap Hand wipes towelettes Other face soaps/cleaners/scrubs Other hand soaps/cleaners/scrubs Aroma therapy/body mist products Depilatory Self tanning preparation Skin colorant (including body paint) Skin lightener Skin protectant/lubricant/humectant

Spray on stocking Other facial and body treatments Deodorant body spray Personal fragrance product (sold in CA from 1/1/1994 to 2003) Hair mousse Hair spray Temporary hair color or glitter, aerosol Rubbing alcohol Topical anti-fungal product Witch hazel Mascara Base coat/undercoat nail polish Nail polish/lacquer/paint Nail treatment product Nail top coat Aftershave products Electric shaver cleaning or lubricating product Shaving cream (aerosol) Shaving cream (non aerosol) Shaving soap Other shaving products

Q: Do I need to register with FDA to import product into the U.S.?

A: FDA registration may be required, depending on the products involved, you may also need to register your company as well. Failure to do so will delay your product getting through Customs.

Q: How come I see some products with Drug Facts labeling, and other products don’t have it?

A: Some types of products require Drug Facts labeling, such as Acne products, Fluoride toothpaste, and Antiperspirants. Some of these products may have been produced before the effective date which requires Drug Facts labeling.

 

 

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