N.J. Admin. Code § 8:21-1.10

Current through Register Vol. 56, No. 23, December 2, 2024

Section 8:21-1.10 - Certificate of Free Sale application process, fees, appeal process

(a) An entity desiring to obtain a Certificate of Free Sale shall make application to the Commissioner of the Department of Health for a Certificate of Free Sale or any other certificate or affidavit, on forms approved by the Department, in accordance with the requirements of this section. Certificate of Free Sale application forms may be obtained by writing to the following address:

Public Health and Food Protection Program

Consumer, Environmental, and Occupational Health Service

Department of Health

PO Box 369

Trenton, NJ 08625-0369

(b) Each application shall be for a single Certificate of Free Sale that will address up to, but no more than, 25 specific food, drug, cosmetic or medical device products regulated under Title 24 of the New Jersey Statutes and manufactured, distributed and offered for sale in this State and labeled in conformance with the applicable food, drug, cosmetic or medical device laws.

(c) Applicants for a Certificate of Free Sale shall:

1. Submit a self-addressed and stamped envelope, air bill or equivalent;

2. Provide the applicant's business name and mailing address and the name and telephone number of a contact person;

3. Type and complete the application form;

4. Certify that the product or products for which a Certificate of Free Sale is sought is for sale or available for sale and not under embargo, seizure or other restraint;

5. Submit the nonrefundable fee specified at (f) below by means of certified check or money order, made payable to the Department of Health;

6. Submit complete product labels for each product for which a Certificate of Free Sale is sought;

i. Labels shall meet the requirements of applicable State and Federal labeling requirements; and

7. Provide other documentation as requested by the DHSS to substantiate that the product is not under embargo, seizure or other restraint and to attest to the validity of the product and its contents.

(d) Applicants for Certificates of Free Sale whose applications have been denied shall have 60 days from the date of denial to meet the requirements of this section.

1. After 60 days, applicants seeking a Certificate of Free Sale for articles for which a Certificate was denied must submit a new application in compliance with the terms of this section.

(e) Applicants whose applications for a Certificate of Free Sale have been denied have 30 days from the date the application is denied within which to appeal by submitting a written appeal to the address specified in (a) above.

1. The written appeal shall provide the explanation and justification contesting the denial and any supporting materials and documentation.

(f) The fee schedule for applications for a Certificate of Free Sale (CFS) is as follows:

1. $ 50.00 per CFS containing three or fewer items;

2. $ 75.00 per CFS containing four through nine items;

3. $ 100.00 per CFS containing 10 through 25 items; and

4. Certificates of Free Sale that attest to the sanitation or processing of food, cosmetics or drug products without reference to an individual product shall be assessed a fee of $ 50.00.

N.J. Admin. Code § 8:21-1.10

New Rule, R.2005 d.5, effective 1/3/2005.
See: 36 New Jersey Register 1155(a), 37 New Jersey Register 52(b).
Notice of readoption with technical change, effective 12/20/2021.
See: 53 N.J.R. 2191(a).