In general, you will need to provide this office with proofs or specimen copies of labelling for the product(s) that you wish to register. In addition, you will need to submit an FD-9(N) Application for a New Product Registration form (available here), the appropriate fees via check or money order payable to DHH, and a catalog listing of the products that you with to register (including the brand name, standard of identity, and container size).
For in-state products by new manufacturers, it is highly recommended that the operator first submit label proofs for review before having labels printed or submitting the remainder of the packet. Labels may be submitted by email, regular mail, or facsimile to the district sanitarian who covers the parish in which you intend to operate. Contact information for these personnel may be found at the Find Your Inspector page.
You may also be required to provide testing results for certain products, including bottled water or items that may be classified as acidified low-acid foods or thermally-processed low-acid canned food products. For more information on testing required for bottled water products, please see here. Putative low-acid canned and acidified low-acid products will need to be evaluated by a process authority to determine whether they fall under federal regulations pertaining to such products (21 CFR 108, 113, 114). See our list of process authorities here.
Any food, drug, cosmetic or prophylactic produced at wholesale and sold at retail in package form is required to be registered with this office. The necessary forms and documents vary depending upon the nature of the product(s) to be registered.
Exemptions from product registration requirements include the following:
Bulk products (this is not statutorily defined and is determined on a case-by-case basis); however, if your products are distributed exclusively in Louisiana in rail cars, tanker trucks, or super-sacks (2000-lb. containers), you may safely assume that your products are exempt
Products that do not appear for sale at retail in package form
Products that are distributed exclusively at exempt fairs and festivals; this does not include farmer's markets
Products that fall under a specific statutory exemption: LSA R.S. 40:4.9 provides that producers of honey, honeycomb products, jams, and jellies whose gross revenues do not meet or exceed $5,000/year are exempt from any state regulatory requirements
Products that are not regulated by the Food and Drug Unit, such as soaps and unprocessed agricultural products
Products that are sold at retail only through a storefront (or multiple storefronts) owned by the same entity as the manufacturer; please note that it must be precisely the same entity: for example, two stores owned by different LLCs that may share one or more common members are not owned by the same entity
No. Medical devices are not registered by the Food and Drug Unit under product registration regulations. If you are marketing a medical device either intrastate or interstate, it is in your best interest to check with FDA regarding whether the device may require premarket approval (see here).
Also, unless you market your products exclusively and directly to patients, you will likely be required to obtain a license with the Louisiana State Board of Wholesale Drug Distributors.
Yes. Labelling for alcoholic beverages is the joint responsibility of FDA (under provisions of the Federal Food, Drug, and Cosmetic Act) and ATF (specfically, the Tax and Trade Bureau, under provisions of the Federal Alcohol Administration Act). As a rule of thumb, alcoholic beverages containing greater than 7 percent alcohol by volume are governed primarily by TTB regulations and beverages that are less than 7 percent are governed primarily by FDA regulations. However, in all cases, any beverage that is greater than 0.5 percent by volume ethanol must bear an Alcohol Health Warning Statement (see here).
Any beverage governed primarily by TTB must have its label approved by that agency. TTB issues a Certificate of Label Approval (COLA) or Certificate of Exemption from Label Approval (CELA) [for beverages sold intrastate only] based on the formulation of the product and presence of mandatory label statements. Any firm applying for a product registration for for such products must supply copies of such certificates in addition with the usual requirements (completed FD-9, fees, and listing of products). Because COLAs typically incorporate product labels, it is not necessary to provide separate copies of labels for the products to be registered.
Note that alcoholic beverages are classified as "foods" for purposes of categorization on the FD-9 registration form.
Product registration certificates are renewed on an annual basis according to the state's fiscal operating year (July 1 - June 30). This office mails FD-9(R) Application for Registration Renewal documents to the mailing address provided by the firm, usually during the first week of May. Firms may then return this notice with the appropriate remittance along with supporting documentation, as needed.
Supporting documentation may include lists of new or deleted products and specimen copies of labels for new products. Note that if your firm is adding new products, labelling or COLAs (for alcoholic beverages) must be included.
At this time, we can only accept money orders and personal, cashier's or business checks for the payment of registration fees. It is our hope that in the near future we will be able to accept various forms of electronic payments but at this time we do not have the infrastructure to support this option.
Mailing Address: Department of Health & Hospitals | P. O. Box 629 | Baton Rouge, LA 70821-0629 Physical Address: 628 N. 4th Street | Baton Rouge, LA 70802 | PHONE: 225.342.9500 | FAX: 225.342.5568 | DisclaimerCustodian of Records Medicaid Customer Service 1-888-342-6207Bayou Health1-855-BAYOU4U (1-855-229-6848 )