Who is responsible for what
When a 3PL stores and ships your packaged food, responsibility is shared. The warehouse is responsible for holding food under conditions that prevent contamination and deterioration, and for meeting the regulatory requirements that apply to facilities that hold food. Your brand, and your manufacturer or co-packer, remain responsible for the product itself: its formulation, safety, labeling, allergen declarations and claims.
This guide summarizes the main U.S. rules that touch the storage and distribution stage. It is general information, not legal advice. Requirements depend on your specific products, and you should confirm details with qualified regulatory counsel or a food safety professional.
FDA food facility registration
Under the Federal Food, Drug, and Cosmetic Act, as amended by the Bioterrorism Act and FSMA, facilities that manufacture, process, pack or hold food for consumption in the United States generally must register with FDA. A warehouse that stores your packaged food is a facility that holds food.
Registrations must be renewed every two years, during a renewal window at the end of each even-numbered year. Registration is not an approval or certification by FDA; it tells FDA where food is located so it can inspect facilities and respond to emergencies. When you evaluate a 3PL, ask for confirmation that the specific building holding your products is registered.
FSMA and current good manufacturing practice
The FDA Food Safety Modernization Act shifted food safety toward prevention. Its Preventive Controls for Human Food rule requires many registered facilities to maintain a written food safety plan. However, facilities that only store packaged food that is not exposed to the environment are generally subject to modified requirements, focused on temperature controls for packaged food that requires refrigeration for safety.
Current good manufacturing practice requirements still shape how a food warehouse should operate, including sanitation, pest control, storage conditions that protect against contamination, and protection of food from allergen cross-contact. FSMA's Sanitary Transportation rule also addresses practices for transporting food by motor and rail vehicles, such as vehicle cleanliness and temperature control where safety requires it.
The FSMA Food Traceability Rule
FDA's Food Traceability Rule, from section 204 of FSMA, requires additional traceability records for foods on FDA's Food Traceability List. The list includes items such as certain soft cheeses, shell eggs, nut butters, many fresh fruits and vegetables, fresh-cut produce, and certain finfish and shellfish.
Covered entities must keep Key Data Elements tied to Critical Tracking Events such as receiving, shipping and transformation, and be able to provide an electronic sortable spreadsheet to FDA on request within 24 hours. FDA has extended the compliance date to July 20, 2028. Many shelf-stable snacks and pantry goods are not on the list, but nut butters and products containing listed ingredients deserve a careful review with your regulatory advisor.
Allergen labeling and handling
U.S. law recognizes nine major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame was added by the FASTER Act, effective January 1, 2023. Packaged foods must declare major allergens on the label as required by the Food Allergen Labeling and Consumer Protection Act and subsequent amendments.
Label declarations are the brand's responsibility. The warehouse's role is to avoid introducing cross-contact, which in a packaged-goods environment mostly means handling damaged and leaking packages promptly, keeping kitting to sealed units, and slotting allergen-containing products thoughtfully. If you build mixed kits that combine allergen-containing and allergen-free items, make sure the outer packaging reflects the full contents.
USDA-regulated products
Most packaged foods are regulated by FDA, but meat, poultry and certain egg products fall under USDA's Food Safety and Inspection Service. Jerky, meat sticks and other products that contain meat or poultry above certain thresholds are typically FSIS-regulated at the producer level, with their own labeling and inspection requirements.
Certain businesses that store or distribute FSIS-regulated products, such as some warehouses and distributors, may have registration obligations with FSIS. If your portfolio includes meat snacks or other USDA-regulated items, confirm with your 3PL how those products are handled and whether the location meets the applicable requirements.
California Proposition 65
California's Proposition 65 requires businesses to provide a clear and reasonable warning before knowingly and intentionally exposing people in California to chemicals on the state's list, unless an exemption applies or exposure falls below established safe harbor levels. Some foods contain listed chemicals, such as acrylamide, which can form in some cooked or roasted foods, or lead in certain ingredients.
Whether your product needs a warning depends on its composition, exposure levels and applicable safe harbors, and determining that is the brand's responsibility. Warnings can appear on the product label or, for internet sales, be provided to purchasers before purchase as the regulations specify. A 3PL's role is to ship the correctly labeled product and include any required warning materials you provide.
Practical steps for brands
A few practical steps keep you on the right side of these rules:
- Confirm FDA registration for the specific warehouse location holding your products.
- Ask for an overview of the warehouse's pest control, sanitation and damaged-goods procedures.
- Check whether any of your products appear on the Food Traceability List.
- Make sure every case carries lot and date information the warehouse can capture.
- Review allergen handling for kits and mixed orders.
- Identify any USDA-regulated products and confirm handling with your 3PL.
- Run a mock recall with your 3PL at least once a year.
These steps do not replace regulatory advice, but they build the records and habits that make compliance and recall response far easier.
Frequently asked questions
Does a warehouse storing packaged food need to register with FDA?
Generally yes. Facilities that hold food for consumption in the United States must register with FDA and renew every two years, with limited exemptions.
Does the FSMA Food Traceability Rule apply to snacks?
It applies only to foods on FDA's Food Traceability List. Many shelf-stable snacks are not on the list, but items such as nut butters are, so review your portfolio with a regulatory advisor. The compliance date is July 20, 2028.
How many major food allergens are there in the U.S.?
Nine: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame, which was added effective January 1, 2023.