If you live in the United States, you’ve encountered FDA labels. They’re everywhere from the milk you buy in the grocery store to the cosmetics you purchase at the mall. While you may not think much about these three little letters signifying the US Food and Drug Administration, they exist for the protection of all consumers. 

Exaggeration? Definitely not. The FDA ensures that goods have been handled with all necessary safety precautions to keep customers from getting sick or hurt. For example, if milk wasn’t FDA-certified you wouldn’t have verification that the cows producing it are healthy. Or if cosmetics with color additives didn’t need to be approved by the FDA before going to market then they could seriously cause harm to people rather than beautify them—like before the mid-1900s when certain eyelash-mascara treatments blinded people. True story.  

ShipMonk is an omnichannel ecommerce fulfillment enterprise that services ecommerce brands of all sizes across all verticals, including ecommerce brands that need FDA registration. Accordingly, our US ecommerce fulfillment centers have the FDA registration needed to safely store and handle these products.  

What is the FDA?

The Food and Drug Administration (FDA) is responsible for ensuring the security and safety of United States public health in relation to food, beverage, biological products, cosmetics, drugs, veterinary products, medical devices, and products that emit radiation.

As you can imagine, the list of products that fall under FDA regulation is extensive. What these diverse groupings all have in common is how they’re protected within the US by the FDA’s high standards for them, and the facilities that handle them (like ecommerce fulfillment centers). 

All facilities in the US handling goods that fall under the above categories must be registered with the FDA. FDA registration must be renewed every two years, and all participating facilities grant the FDA permission and access to inspect their grounds, which typically occurs once every three years. In general, these standards safeguard citizens against products that could be harmful to health, food-related emergencies, and bioterrorism. 

FDA-registered Ecommerce Fulfillment Centers 

With a wide array of ecommerce fulfillment centers storing and shipping thousands of products for ecommerce brands, it is vital that ShipMonk abide by, and be up to date on, FDA registration requirements. With that in mind, all eight ShipMonk US facilities are currently registered with the FDA and are consistently renewed in perpetuity. That includes:

• Florida
• Pennsylvania
• New York
• New Jersey
• Kentucky
• Texas
• Nevada
• California

When registering a site with the FDA, different categories are selected for the types of items being stored. For example, Coffee, Food for Animal Consumption, and Cosmetics are all different category types. Medical devices have additional regulations attached, especially if an ecommerce brand requests the fulfillment center or fulfillment centers storing them to perform any re-packing or re-labeling.

Since registration regulations can change by state, ShipMonk stays vigilant of requirements so our ecommerce brand clients are always meeting FDA compliance standards. 

FDA registration must be updated if a new category of product is brought onsite to any facility, ecommerce fulfillment center or otherwise. Basically, you always need to tell the FDA if a new relevant product is joining the party. 

ShipMonk Satisfying State Requirements

In addition to FDA registration national standards, sites must comply with state and county regulations. Each state and county has a different set of regulations requiring ecommerce fulfillment center registration for storing the following items:

• Human Food
• Processed Food
• Animal Food
• Dietary Supplements
• Cosmetics
• Organic Food
• Hemp Infused Products 
• Radioactive Products (Ex: Watches)

State and county registration of warehouse/fulfillment center sites depends on the products being held there. For example, in California, if a product is infused with hemp the warehouse/fulfillment center is not required to be registered with the state or county, but the ecommerce brand in question does need to register the product with the state. 

Overall, it is a dual responsibility. Clear communication with our ecommerce brand clients regarding products being stored in our ecommerce fulfillment centers is required to ensure compliance with state and county regulations. And due to the differing FDA compliance standards, and often-changing requirements by state and by county, registration is always an ongoing process.

Organic Products 

Products that fall under this category might have additional requirements depending on United States Department of Agriculture (USDA) regulations for the state or county of the ShipMonk ecommerce fulfillment center(s) storing them. Although registration by state and counties may not be required every time, ShipMonk must still follow USDA regulations. When an ecommerce brand intends to sell an organic product, ShipMonk must be notified so that our local Quality and Compliance Representatives can ensure storage standards are met. 

Note – Some organic products may require additional certifications for warehousing and distribution, but this needs to be looked at per case.

Lot Numbers

Lot traceability is a requirement in the Code of Federal Regulations (CFR) that was established to perform effective recalls on products. According to the FDA Food Safety Modernization Act (FSMA), certain fresh foods require lot numbers to be tracked throughout the distribution process. 

If ecommerce brands keep products that are on this list in our fulfillment centers, they are responsible for assigning lot numbers to their products. In this case, ShipMonk (and all such fulfillment facilities) are also required by law to track said products, and the products’ lot enabled features must be on.

At client request, ShipMonk can track inventory by Lot number and/or expiration date with advanced features on our advanced and proprietary 3PL fulfillment platform. If an ecommerce brand stores any food that is not on the FSMA list, lot traceability in the ShipMonk app is not required, but it is highly recommended as it will speed up any recalls that might happen. However, the ecommerce brand is responsible for their own lot traceability of products in the event of a recall. 

Food Allergen Safety

Products containing food allergens need to be stored appropriately to prevent cross-contamination. If an ecommerce brand has an allergen, it is vital to evaluate in advance if the selected fulfillment center can safely store said product(s). The FDA defines the following as major food allergens:

• Milk
• Eggs
• Fish
• Crustacean Shellfish
• Tree Nuts
• Peanuts
• Wheat
• Soybeans
• Sesame

Temperature Requirements

According to CFRs, certain finished FDA products must be stored under conditions that will preserve the products’ identity, purity, strength, and composition. Those products may include food, dietary supplements, cosmetics, and medical devices. 

ShipMonk ecommerce fulfillment centers are committed to adhering to our clients’ temperature needs. It is the responsibility of every ecommerce brand to clearly establish temperature and light requirements prior to inventory arriving at a fulfillment center so ShipMonk can ensure that goods are warehoused in the proper facilities. For example, ShipMonk has three fulfillment centers with temperature-controlled storage: New Jersey, Nevada, and Texas. Therefore, if an ecommerce brand sells products that require temperature-controlled storage in the US, orders would need to be fulfilled from one of these specialized facilities.

Note – fulfillment centers and temperature-controlled storage areas do not have temperature mapping. However, temperatures are being monitored and logged in those areas.

Keeping Your Products, and the People Who Buy Them, Safe and Secure

According to the Code of Federal Regulations (CFR), all domestic and foreign facilities that manufacture, process, pack, and/or hold food for human or animal consumption in the United States must register with the FDA. ShipMonk is dedicated to upholding all FDA Registration standards so our ecommerce brand clients and their customers can rest easy. 

To speak with a ShipMonk Client Experience rep about how our FDA-registered US ecommerce fulfillment centers can take care of your ecommerce brand’s goods, contact us today.