How to File Discontinuance Form FDA 2514

Discontinuance of Commercial Distribution of Cosmetic Product

NOTE: Submission of Form FDA 2514 will discontinue an entire Cosmetic Product Ingredient Statement (CPIS). All Brand Names reported under this CPIS Number will be discontinued. If more than one cosmetic product has been filed under the CPIS and you wish to delete one or more of the Brand Names, but not all of them, file an amended Form FDA 2512 deleting those cosmetic products that are no longer manufactured.

• FDA CPIS NO.

Enter the 7-digit CPIS number as found on the Official Receipt that you received as acknowledgment of filing your original submission.

• FILING DATE

Enter the Filing Date as found on the Official Receipt that you received as acknowledgment of filing your original submission.

• DISCONTINUANCE DATE

Enter the date when the formulation was removed from commercial distribution.

• NAME OF MANUFACTURER/PACKER/DISTRIBUTOR (On Label)

Enter the firm name exactly as it appeared on the label of the cosmetic formulation being discontinued.

• BRAND NAME OF COSMETIC PRODUCT

List any Brand Name of a Cosmetic Product sharing the cosmetic product formulation, as it appeared when filed, to verify that the proper filing is being discontinued.

• COMMENTS (If any)

Any comments concerning the discontinuance may be stated in Block 6.

• TYPED NAME AND TITLE OF AUTHORIZED INDIVIDUAL

State the name and title of the person authorized by the filer to disclose the information to FDA. Provide the telephone number, including the area code and any extension, of the authorized individual.

• SIGNATURE AND DATE

The authorized individual must sign and date Form FDA 2514. FDA can not accept an unsigned submission.

If you are using preprinted forms mailed to you by FDA, remove the back page, REGISTRANT'S COPY, and keep it for your files. DO NOT separate the MASTER FILE COPY from the DATA PROCESSING COPY. If you have printed your form FDA 2514 from FDA's Web site, make two copies of each completed form. Keep one copy for your records. Mail the original and one copy to FDA. FDA will not send an Official Receipt or acknowledgment for submission of a discontinuance.

Once more make sure that the submission is signed and dated. FDA cannot accept an unsigned submission.

Alternatives to Filing Form FDA 2514

There are three other ways to discontinue a listing in the VCRP:

• A participant may request, in writing, a complete computer listing of all products currently on file with FDA under the VCRP. The participant may then cross out all product formulations no longer in commercial distribution, sign and date the listing, and return the listing to FDA for updating of the participant's records.
• A participant may submit, in writing, a listing of product formulations no longer in commercial distribution, along with their CPIS numbers, to FDA for updating to discontinued status.
• Use Form FDA 2512 as follows:

TYPE OF SUBMISSION: Check the box marked "DISC" in the upper right corner of Form FDA 2512 to discontinue a submission of a cosmetic product formulation.

FDA CPIS NO.

Enter the 7-digit CPIS number as found on the Official Receipt that you received as acknowledgment of filing your original submission.

FILING DATE

Enter the Filing Date as found on the Official Receipt received as acknowledgment of filing your original submission.

1. NAME OF MANUFACTURER/PACKER/DISTRIBUTOR (On Label)

Enter the firm name exactly as it appeared on the label of the cosmetic formulation being discontinued.

16. BRAND NAME OF COSMETIC PRODUCT

List in the space for BRAND NO. 01 any Brand Name of a Cosmetic Product sharing the cosmetic product formulation, as it appeared when filed, to verify that the proper filing is being discontinued.

Enter in the space for BRAND NO. 02, "AND ALL OTHER PRODUCTS LISTED UNDER THIS CPIS NUMBER".

17. TYPE OF ACTION

Enter "DISC".

18. DATE OF ACTION

Enter date formulation was removed from commercial distribution.

19. TYPE NAME AND TITLE OF AUTHORIZED INDIVIDUAL

State the name and title of the person authorized by the filer to disclose the information to FDA.

20. TELEPHONE NO.

Provide the authorized individual's telephone number, including the area code and any extension.

21. SIGNATURE AND DATE

The authorized individual must sign and date Form FDA 2514. FDA cannot accept an unsigned submission.