Boldfaced words are in the glossary at the bottom of this page.
§105 of Part VI of Title 51 of the Louisiana Administrative Code requires that all food, drug, and cosmetic products sold in packaged form within the state of Louisiana be registered with the Food and Drug Unit.
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 retail-packaged food, drug, or cosmetic commodity are required to register such commodities with FDU. See the FAQ section below for detailed information on this topic.
Standard Product Registrations
The term "standard" applies to the registration of any products that are not classified as "out-of-state soft drinks." By "out-of-state," we mean that the responsible party declaration includes an address that is not within the state of Louisiana. These products require a different form and are assessed a fee according to a different schedule from other food, drug, cosmetic, and prophylactic products. More information on these registrations can be found below.
All other products subject to registration will be handled via the following process:
Most responsible parties for in-state (Louisiana-manufactured/distributed) items will require a Permit to Operate from the department for their warehouse or manufacturing facility. The only exceptions are those copacked (private-label) products that are distributed by the copacker or that are taken directly from the copacker's premises to the retailers that will be marketing them. For products whose distributor or manufacturer requires a permit, the first point-of-contact should be the sanitarian who covers the area where the permitted facility will be located. This information can be found here. The responsible party should provide copies of labelling or label proofs to the relevant sanitarian for a preliminary review. At his or her option the sanitarian may then forward the labels/proofs to the registration progam manager for a final review. When the labels have been assessed and accepted for registration, the sanitarian will notify the responsible party, who may prepare a registration packet to be provided at the time of permitting of the facility.
For products that do not require a Permit to Operate and out-of-state non-soft-drink items, the labels or proofs may be sent directly to the program manager for product registration for review. The program manager will notify the responsible party of any necessary revisions and when the labels are accepted for registration, the responsible party may forward a registration packet to the Central Office for processing.
Registration packets include the following items: a completed copy of the FD-9(N) Application for a New Product Registration Form, a list of the products being registered, copies of labelling or label proofs, samples for foods (see below), and a check or money order payable to DHH for the amount of the registration fee.
Registration fees are calculated on the following basis:
note that under no circumstances will the food and drug unit process registration packets with no labelling attached. if you submit such a packet it will be returned to you without processing.
Alcoholic beverage registrations should include Certificates of Label Approval (COLAs) as issued by the Tax and Trade Bureau (TTB) of the U.S. Department of the Treasury in lieu of labelling, for those products exceeding 7% ABV (alcohol by volume). This serves the dual purpose of providing specimen labels and verifying that the product has been reviewed by the TTB.
Out-of-State Soft Drink Registrations
Out-of-state soft drink registrations require the same information as other product registrations but use a different form and fee schedule.
Registration packets for out-of-state soft drinks include the following items: a completed copy of the FD-35 Application for a New Out-of-State Soft Drink Registration form, a list of products to be registered, specimen copies of labelling, samples (see below), and a check or money order payable to DHH for the registration fee.
Registration fees for out-of-state soft drinks are calculated on the following basis:
all registrations are renewed on an annual basis. renewal notices are sent to the mailing address on file during the first week in may and fees are due no later than june 30. after september 15, a delinquent penalty of $10 per product is applied to each outstanding account for non-out-of-state soft drink products.
Mardi Gras Registrations
There are special procedures for obtaining a temporary product registration certificate as a Mardi Gras parade vendor. These vary depending on the the registrant and the products in question. The vendors fall into one of several categories: 1) seasonal vendors who manufacture products only during Mardi Gras for retail and wholesale distribution; 2) currently-permitted wholesale food manufacturing facilities; and 3) currently-permitted retail food service establishments selling packaged products at Mardi Gras.
Seasonal vendors typically make products for sale in fixed locations or from mobile units permitted by the parish sanitarian. These products are then distributed through the mobile unit and/or through carts that are located along parade routes. In order to be added to the list of approved vendors, the applicant must complete the following paperwork with the District I Food and Drug Unit staff: 1) an FDU Mardi Gras Food Vendor Application Form; 2) an LHS-31 Application for a Temporary Permit to Operate Form; 3) an FD-9(N) Application for a New Product Registration Form; and 4) a Mardi Gras Vendor Referral Form. While the FD-9(N) form is available from our website, the application process requires that an application be processed in person by meeting with a sanitarian in our New Orleans district office (see Locations). A copy of the applicant's driver's license is required at the time of form submission. Additionally, if a mobile unit is to be used for manufacturing products, a copy of a contract for wastewater disposal will be required.
The seasonal permit fee is $45 for the wholesale manufacturing operation and an additional $20 registration fee per product distributed (to a maximum of $200). The applicant will complete the FD-9(N), Mardi Gras Food Vendor Application, and LHS-31 with the assistance of Food and Drug Unit staff. The Mardi Gras Vendor Referral Form is completed by a Food and Drug Unit clerk or sanitarian and provided to the parish health unit by the applicant in order to obtain a retail Permit to Operate.
Vendors with Food Manufacturing Permits:
Vendors currently permitted and registered by the Food and Drug Unit for food manufacturing require a recent inspection to verify current compliant status in order to be added to the list of approved vendors. No additional fees are required.
Vendors with Food Service Establishment Permits:
Vendors currently permitted by the Retail Food Program as food-service establishments will need to provide the following documentation: 1) FD-9(N) Application for a New Product Registration; 2) specimen copies of labels for review; 3) a check or money order payable to DHH for $20 per distinct product up to a maximum of $200; 4) a copy of the current-year Permit to Operate document; and 5) a copy of the most recent facility inspection by the parish sanitarian responsible for the area that includes the food-service establishment.
Labels are subject to compliance review as part of the registration process for products with an in-state responsible party declaration, in accordance with LSA R.S. 40: 627. This review verifies that the labels meet certain basic requirements. However, this office does not "approve" labels and final responsibility for compliance with federal and state regulations lies with the responsible party. Below is a brief discussion of label requirements under state and federal mandates.
The principal display panel or PDP is the part of a label that is immediately visible to the consumer when it is placed on a retail shelf. For wraparound bottle or can labels, this is the "front"; for boxes or cartons, this is the "top."
Statement of Identity/Name
Each product must bear a statement of identity on the principal display panel. This is simply a declaration of the nature of the product; e.g., "raisin bread", "salsa", "fish fry."
Net Quantity of Contents
Each product must bear a statement of the net quantity of contents of the container, in both metric and English units. This must also be present on the PDP. For liquids, these statements should be in units of fluid measure (such as fluid ounces, liters, gallons, quarts, et cetera); for viscous or solid products, these statements should be in units of weight measure (ounces, pounds, grams, kilograms, et cetera). The statements should use the smallest appropriate unit for that quantity (250g in lieu of 0.25Kg).
Each product must include a statement of the ingredients that comprise it. Each ingredient must be listed by common or usual name, with a few notable exceptions ("MSG" should be listed as "monosodium glutamate"). All ingredients must be listed in descending order of predominance in the finished food product (in other words, the ingredient that is the largest constituent of the food must be listed first). All compound ingredients (items that are composed of one or more subingredients) must be followed by a parenthetical list of subingredients (e.g., butter (cream, salt)).
Those items that are classified by the Food and Drug Administration as spices may be listed collectively as spices, but not as "herbs" or "natural flavors." Only those items that are actual flavor ingredients, as defined by FDA, may be listed as natural or artificial flavors. Flavors are not required to have subingredients listed on the labels of foods in which they are used as ingredients.
Review the information in the labelling document below or at this link for more information on spices, colors, and flavors.
Responsible Party Declaration
Each product must bear the name and address of an actual or juridical person, association or partnership that is legally responsible for said product. In the case of a sole proprietorship, the name will be the actual person's full name and in the case of a juridical person (corporation, LLC), it will be the full name of the entity, as listed with the Louisiana Secretary of State. The address must always include a city, state, and ZIP code (unless the product is an alcoholic beverage that has been approved by the federal Tax and Trade Bureau without bearing a ZIP code). Unless the firm is listed in a local telephone or internet directory, the address declaration must also include the street name and number.
Major Food Allergens
In accordance with the Food Allergen Labelling and Consumer Protection Act of 2004, ingredients belonging to any of the eight major food allergen groups must be listed by name on a food product label. These groups are the following: tree nuts, peanuts, crustacean shellfish, fish, milk, eggs, soy, and wheat. Each specific allergen must be listed by name in either the main ingredient statement declaration or in a separate "contains" statement (e.g., "Contains pecans, milk, and eggs."). Contains statements are not mandatory but if provided must be complete.
FDA requires that food products list the quantities of certain nutrients and nutrient groups in a specific format, as provided for in 21 CFR 101.9. Several exemptions from this requirement have been established; the most commonly-referenced of these is the small business exemption. If your firm has fewer than 10 full-time employees and sells less than 10,000 units of product per year, you are automatically exempt. If your firm has fewer than 100 full-time employees and sells less than 100,000 units of product per year, you may apply to FDA for an exemption. More information on this subject may be found here. Please be aware that any health or nutrition claims present on the product label or associated marketing materials (flyers, website, etc.) automatically trigger the requirement for a nutrition facts label, irrespective of any exemptions.
Special Topics of Note
Gluten-free declarations require proof of the absence of gluten in the finished food in the form of an ingredient statement that lacks any typically gluten-containing items as well as one of the following: 1) documentary proof that all ingredients used are gluten-free; or 2) laboratory testing that confirms less than 20 ppm gluten present in the finished food.
Acidified or Low-acid canned foods require evaluation by a process authority and process and facility registration through FDA. If your products do not fall under an obvious exemption, you may be asked to for this additional paperwork. See here for more information.
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):
GLOSSARY OF TERMS
amenable - foods which USDA exercises primary regulatory authority over; these include meat and/or eggs from cattle, sheep, swine, goats, equines, chickens, turkeys, ducks, or geese
responsible party declaration - a mandatory statement (as provided for by federal regulations) that is to include the name and address of the manufacturer or distributor and must include the city, state, and ZIP code
copacker - a manufacturer who packs products on behalf of a third-party firm which does not wish to or lacks the facilities/capacity to pack its own products
primary container - the container that actually contacts the food product (for beverages, this is typically a bottle, can, box or flexible pouch; for foods, it may be highly variable)