Sanitarian Services

Registration may have many different meanings, depending on its context. In the Commercial Body Art Program, we say that CBA Operators (that is, tattoo artists, piercing specialists and similar occupations) are "registered" with FDU, signifying that they have received authorization from DHH to practice their chosen profession by paying the requisite fees and meeting the state's training requirements. In the UV Tanning Program, the terms "registration" and "permit" are frequently used interchangeably to refer to a state document provided by DHH to facilities that meet the minimum requirements of Louisiana's Tanning Facility Regulation Act. However, within other areas governed by FDU regulations, a Certificate of Registration is distinct and separate from a Permit to Operate. All facilities that fall under the auspices of Part VI, Part X, Part XXVIII, or other Food and Drug regulations must be permitted. Only those facilities which produce a packaged food, drug, or cosmetic commodity are required to register such commodities with FDU.

My business is located out of state. Do I still have to register?

If you sell a packaged food, drug, or cosmetic product in the state of Louisiana, your product(s) must be registered with FDU.

My product is shipped in bulk form (by tanker truck or rail car). Do I still have to register?

If your product is received in Louisiana in bulk form and packaged here, it must be registered. However, if you are shipping your product outside of Louisiana in bulk form to be packaged elsewhere, it does not need to be registered.

Okay, I manufacture or distribute packaged food, drugs, or cosmetics inside the state of Louisiana. How do I register my product(s)?

First, you need an Application for Product Registration Form. The form you will need to complete depends upon the product that you are registering. If you are an out-of-state soft drink manufacturer selling products in Louisiana, your products must be registered using an FD-35 form (see below). For each flavor with a distinct label that you are registering, there is a fee of $25; there is no limit to the number of flavors you may register, but a fee is required for each one. In addition, you must attach specimen labels for each flavor to be registered to your FD-35. If you are selling any other packaged food, drug, or cosmetic in Louisiana, your products must be registered using an FD-9 form (see below). For each product with a distinct label that you are registering, there is a fee of $20; the maximum annual fee for a non-out-of-state soft drink registration is $200. However, you must attach specimen labels of all products you wish to register.

If I am registering 30 products, but only paying for 10, why do I have to send labels for all 30? Can't I just send a list of products?

A list of products does not meet the requirements stated in LSA R.S. 40: §627(B), which says, in part, "submission of a catalog and specimens of labels shall be required at the time of application for registration" (emphasis mine). Therefore, Louisiana law mandates that FDU be provided with specimen labels for review prior to the issuance of a Certificate of Registration. Labels shall meet the minimum requirements described in 21 CFR 101 (Food Labeling). Specimen labels may be submitted by email (to Brian R. Warren [bwarren2@dhh.la.gov]), fax (to 225-342-7672), and regular mail. We will accept CD-ROM copies of label specimens as an alternative to paper.

If I am paying an excise tax to the state of Louisiana to import my goods into the state, why must I also pay to register my products with FDU?

Enforcement of Louisiana tax law is the purview of the Louisiana Department of Revenue (http://www.revenue.louisiana.gov/). If you have some question regarding taxes the state is requiring you to pay for importing your goods, it would be wise to contact LDOR. Irrespective of any import taxes, Louisiana statutory requirements (LSA R.S. 40: §627) and regulatory requirements (§105, Title 51, L.A.C.; 49:2.2130-49:2.2170, State Food, Drug, and Cosmetic Law) specifically authorize and mandate the collection of fees by DHH for the registration of food, drug, and cosmetic products.

I have a grocery store or warehouse that sells packaged food, drugs, and cosmetics. Do I have to register these products?

No. Federal law mandates that packaging for such commodities have a manufacturer's name and address listed on the label. The individual or company whose name is present on the label is the entity responsible for registering that product with FDU. Products on grocery store shelves, unless they are manufactured and packaged for sale in that store, are not registered by that store. Food, drug, or cosmetic storage warehouses are required to be permitted, but said facilities should not be registering products unless they have multiple operations operating under one roof (including a manufacturing facility).

How can I get a list of products that I have/my company has registered?

Unfortunately, there is no simple answer to this question. If you have a specific label/product that you wish to verify the registration status of, you can call our office at (225) 342-7517 with the label/product information and your registration number, and we will check your file. At this point in time, however, we have no means of easily generating a list or database of registered products.

Why am I paying a registration fee on labels with a dba (doing business as) listed when it is the same company? Why do I need to pay fees to cover products manufactured in different cities for the same company?

Actually, there is a simple answer to this question; §105(B) of Part VI specifically requires that products be registered in the firm name appearing on the label. Therefore, if you have a company name as manufacturer on a product label, that company is considered, for the purposes of Louisiana law, the registrant of that product, irrespective of whether it is a subsidiary of your parent company. This is also the reason that a manufacturer in a different city must have its own registration; again, the registration goes by the manufacturer's name and address (or the "manufactured for" or "distributed by" name and address) present on a particular label.

My company formerly manufactured Product Z. However, we ceased production on this product/no longer distribute this product anywhere in the state of Louisiana in/since 2002. I recently received an invoice for a registration fee for Product Z including late fees. Why?

Presently, FDU inspectors lack both the time and resources to investigate, verify, and document the registration status of every single packaged food, drug, and cosmetic product sold in Louisiana. As a result, we are usually not privy to the knowledge of when a product goes off the shelves unless we are contacted in advance by the manufacturer or distributor. As the product registrant, it is your responsibility to contact FDU in a timely fashion to advise us of any status changes to your registration (product labels changed, products deleted, products added); failure to do so may result in the type of occurrence described above.

The following documents may be of use to you (all documents below are in Adobe Acrobat format; go to the Acrobat website to obtain Reader software if needed):

FD-9(N) Application for a New Product Registration Form - This form is used for all products other than soft drinks imported from outside Louisiana.

FD-35(N) Application for a New Out-of-State Soft Drink Registration - This form is used for soft drinks imported into the state of Louisiana.