FDA COMPLIANCE - COSMETICS -

Thanks to our partners in the United States, we can assist concerned

companies with the following:

• Compliance with FDA standards,

• Registration services,

• U.S. agent services,

• Regulatory support for the cosmetic companies.

• USAFrance, LLC has forged a strategic alliance with a FDA consultant (who has more than 30 years of expertise).

• Our consultant, as a “FDA team member” worked as a chemist and a compliance officer concerning CDER, CFSAN, CDRH, ORA CVM.

• Thanks to his technical knowledge of applicable standards (GLP, GMP, QSR, HACCP, QSIT, ISO and PIC/S (the Pharmaceutical International Convention)), he contributed in developing regulations and policies regarding:

• The risk of drugs,

• Non-clinical testing in laboratory,

• Bioterrorism,

• Importation procedures,

• The performance standards of medical devices.

• Our partner is also the source of compliance decisions concerning non-

clinical drugs studies, medical equipment, and veterinary products.

• He is also an expert for pre-importation approaches, customs clearance and

post-importation approaches (after the customs clearance and the entry on

the U.S. soil).

• Thanks to the wealth of his experience at the FDA, we are able to assist

concerned companies, answer their questions about products’ compliance

and support them to ensure constant importations into the United States.

• With our partner, we can offer our services to the following industries:

o Food and food supplements.

o Cosmetic

o Pharmaceutical

o Medical equipment and diagnostic devices.

This service is a program to assist companies concerned by:

• Reports asked by the California Safe Cosmetics Program (CSCP),

• The delivery of the ingredient list to the FDA (CPIS),

• The registration of cosmetic companies to the Voluntary Cosmetic

Registration Program (VCRP)

Labeling and ingredients listing are different from the ones we have in France. The United States has its own particularities and usually, companies make small mistakes that can cost a lot. This is why we help companies to comply the FDA regulations regarding the cosmetics

labeling.

This service includes the delivery of corrected graphic files ready for impression, and a detailed report of applicable regulations.

1. Product identity

2. Net contents

3. Product ingredients

4. Direction of use

5. Country of origin

6. Name/Location of manufacturer or distributor

7. Recommended period of use after opening

8. Denotes that the company contributes to

European programs for the proper disposal

and recycling of all packages components.

9. Warnings/Cautions

10. Denotes that you should refer to the notebook

• The regulatory labeling for drugs is established to ease the lecture

and the comprehension of label’s information.

• It is noteworthy that products considered as cosmetics AND drugs

(for example a lipstick that also act as a solar protection), must

comply to the drugs labeling AND the cosmetics labeling.

• Products that must comply with COSMETIC regulation:

Any product with active cosmetic ingredients.

The list of inactive ingredients and the list of cosmetic ingredients must

comply with the requirements of cosmetic labeling (cosmetics

ingredients appear by decreasing order of importance and inactive

drug ingredients in alphabetical order)

• Products that must comply with the DRUGS regulations:

o The products with API (Active Pharmaceutical Ingredients that has intended therapeutic effects). The FDA regulates APIs as drugs because they are drug components.

o OTC products, (OTC = Over The Counter)

o OTC/Cosmetics,

o Prescription drugs,

o Veterinary products.

You will then need to register your business and your products with the FDA (manufacturer but also the packaging company).

• Only electronic registrations (online) are allowed for drug listings and for company’s annual updates.

• These products must comply with both drugs and cosmetics

regulation requirements.

Products Europe USA

• Sometimes, companies send their products to the U.S. and have

their shipment subject to “Detention without physical examination”

by the FDA.

• If this is happening to you, that means your products have been

seized at the port of entry and the FDA will do more tests and

analysis.

• These temporary seizures can be challenging for the concerned

company and could prevent it to deliver the merchandise on time.

• This is why, with our partner, we do everything to prevent and avoid

such issues.

• The FDA defines the Warning Letter as “a correspondence that

notifies regulated industry about violations that FDA has

documented during its inspections or investigations.”

• Usually, the Warning Letter informs a company or a person about

the non-compliance (according to the FDA) with one or several

products, practices, process or any other activity with the U.S.

regulation (according to the Federal Food, Drug and Cosmetic Act).

• This warning is only sent in the event of material breach that may

lead to corrective actions if nothing is done by the company to

comply with the law.

• The warning letter is one of the main ways the FDA has to ask for

compliance.

• It is a notice and the company has 15 days to answer it.

• If you don’t communicate any answer, the FDA will start taking

corrective measures.

• The clock is ticking, you have 15 days to organize yourself, figure

what the problem is, fix it and communicate your answer to the FDA.

• This is why an expert might be helpful.

• Before answering a Warning Letter, a 4 steps approach might help

you redacting correctly the answer, and help to visualize the

measures necessary to comply with the regulation.

Indicate the corrective actions (taken or planned)

Rephrase the observation or the comments.

Specify the cause of the problem.

Set a due date

Step1

Step2

Step3

Step4

1. Understand what is causing problems. Keep abreast of FDA’s observations to other companies and study these companies to compare similar operations.

2. Ask for an external help. Do not stay alone to evaluate your compliance. You must ask to experts with experience and knowledge. Having a second opinion is highly recommended.

3. Rethink everything systematically. Settling for one answer is a mistake. Find what is causing the problem and systematically search for other possible problems.

4. Keep it simple. Complexity will only add more difficulty for the people in charge. Simple illustrated instructions and procedures will ease your capacity to comply with the FDA requirements.

5. Do not settle for less. Execute every action with determination.

6. Keep an open mind. It exists several ways to comply with the FDA. Although in certain circumstances only one will be possible. Once again, an external help is essential to really understand your options.

• Telephone (US): +1-828-327-2290

• Telephone (Fr): 09 70 46 46 35

• E-mail: [email protected]

• Website: www.startingupinusa.com

• Website: Nouveau site internet… ?