Cue the scene: You have confirmed FDA/Customs compliance for an imported FDA-regulated product, riding high with not a compliance care in the world – all is set. Goods are imported and then comes the news…the goods have been placed on an “Agriculture Hold.” You think – “What in the world is that? They must have issued this Hold to the wrong company. The goods are FDA-regulated and compliant.” Enter the Emergency Action Notice (EAN) advising that the product fails to comply with USDA requirements and/or lacks an authentic veterinary certificate or phytosanitary certificate, and will need to be re-directed, destroyed, or possibly exported within a short window of time if not brought into compliance. Storage fees start accruing, and you feel blindsided.
Have you ever wondered what seeds imported for planting, chicken broth in frozen imported soup, or vitamins and minerals derived from animal origin materials in dietary supplements have in common? Well, they may all be caught in the regulatory crossfire described above, jointly overseen by the USDA and the FDA.
For businesses in the food, agriculture, and dietary supplement sectors, navigating USDA (U.S. Department of Agriculture) and FDA (Food and Drug Administration) regulations can feel like stepping into a regulatory ring where the rules are complex and the stakes are high. Understanding when both agencies have a say in your products—particularly when USDA permits are required for FDA-regulated items—is key to avoiding costly mistakes. Failing to secure the necessary permits before importing products can lead to delays, storage fees, or worse—destruction or re-export costs. So, whether you’re dealing with animal products, plant-derived foods, or supplements, it’s essential to know when and why a USDA permit is necessary.
Let’s break down the tag-team match between the FDA and USDA and help you avoid a misstep in this complex regulatory landscape!
The Roles of the USDA and FDA: Who’s Got What Covered?
Before we dive into the details of permits, it’s important to understand what each agency regulates. USDA is primarily responsible for overseeing agricultural products like meat, poultry, certain egg products, and the health of plants and animals. USDA’s principal focus is on preventing diseases and pests from entering the U.S. through regulatory programs. By comparison, FDA regulates the safety of most food products not overseen by the USDA, including dairy, seafood, fruits, vegetables, processed foods, and even animal feed and drugs. The FDA ensures these products are safe for human consumption and that they meet the necessary labeling and quality control requirements.
Understanding which agency regulates what is your first step toward compliance, as overlapping jurisdictions often require both USDA permits and FDA approvals.
Clearing the Fences: USDA Permits for Animal Products and Byproducts
When it comes to animal-derived products, certain USDA permits are required, and they go beyond just meat products:
- Importation of Meat, Poultry, and Egg Products: While the FDA may handle the safety of some animal-based foods, the USDA’s Food Safety and Inspection Service (FSIS) regulates meat, poultry, and egg products. If you’re importing these goods, you’ll likely need a USDA import permit to ensure that the products meet FSIS safety standards. It’s a critical process to avoid contaminated or misbranded items from entering the market.
- Importation of Animal Byproducts: Think hides, bones, or fats. These byproducts can pose a risk of spreading animal diseases like BSE (mad cow disease) or foot-and-mouth disease. To protect against these risks, a USDA permit is likely required.
- Veterinary Biologics: Vaccines, diagnostic kits, and other veterinary biologics fall under USDA’s jurisdiction as well. These require a VS permit to ensure that they meet safety standards before being imported, produced, or distributed in the U.S.
- Transport of Animal Products Across State Lines: Moving animal products between states can require a USDA permit, particularly if the products are subject to quarantine restrictions or state-specific disease controls. The goal is to prevent the spread of diseases from state to state.
Green Light for Greens: Navigating USDA Permits for Plants and Plant Products
Yes, plants need their own permits too! Here’s when USDA typically regulates plant products:
- Importation of Plants, Seeds, and Plant Products: The USDA’s APHIS Plant Protection and Quarantine (PPQ) program ensures that live plants, seeds, fruits, and vegetables imported into the U.S. are free from harmful pests and diseases. A PPQ permit is required for these imports to safeguard U.S. agriculture from invasive species.
- Movement of Regulated Plant Products Within the U.S.: Some plant products are subject to movement restrictions to protect against pests like the gypsy moth or diseases like citrus canker. If you’re transporting these products across state lines, a USDA permit is often required to comply with federal and state quarantine regulations.
- Genetically Engineered Organisms (GEOs): The USDA regulates the importation and testing of genetically engineered organisms, including genetically modified plants. If you’re dealing with GEOs, you’ll likely need a USDA permit to ensure they’re safe for agriculture and the environment, complementing FDA regulations on genetically modified food products.
- Importation of Plant-Derived Food Products: The FDA typically handles the safety of food products, but if you’re importing raw plant materials, such as fresh produce or grains, USDA may require a PPQ permit. This is particularly important to ensure that pests and diseases don’t hitch a ride on your imports.
When USDA and FDA Regulations Cross Paths
Now, here’s where things get interesting: when do USDA and FDA regulations overlap, and when do you need a permit from both? Here are a few examples:
- Animal-Derived Food Products: If you’re importing dairy or other animal-derived foods, the FDA oversees safety and labeling, but the USDA might require permits for the animals themselves or their byproducts (e.g., bones or fat).
- Plant-Based Foods: The FDA ensures that plant-based foods are safe for consumption, but the USDA may require permits for the importation of raw plant materials like seeds or fruits to make sure they’re free from pests and diseases.
As you can see, USDA and FDA regulations intersect more often than you might think. When these overlaps happen, it’s crucial to understand which agency is responsible for what and which permits you need to keep your operations smooth and compliant.
Why Does This Matter? The Cost of Non-Compliance
The consequences of not securing the proper USDA permits can be expensive and time-consuming. From costly storage fees and shipping delays to the risk of having your product rejected, re-exported, or even destroyed, failing to understand the joint regulatory requirements can add up quickly. Additionally, non-compliance could lead to Emergency Action Notices or other legal, regulatory or enforcement action depending on the severity of the violation.
So, whether you’re importing animal products, plant products, or FDA-regulated products containing animal-derived ingredients, or plant products, understanding when and why a USDA permit is necessary is key to avoiding these pitfalls and ensuring that your products make it to market without unnecessary hiccups.
The Permit Shuffle—A Dance You Don’t Want to Skip
Navigating the regulatory requirements for USDA and FDA permits can feel like performing a complicated dance. One wrong step, and you might find yourself caught in a costly mess. But by understanding the roles of each agency and when each permit is needed, you can keep your business in step with the law—and avoid costly mistakes.
In the end, mastering the permit shuffle isn’t just a legal necessity—it is a critical part of your compliance strategy. So, next time you’re gearing up to import a product, don’t forget to check whether you need a USDA permission slip to get your goods across the border—and into the hands of your customers.
For more information on USDA and FDA regulation of FDA-regulated goods, including whether a USDA permit is required, obtaining a USDA permit, or questions on veterinary certificates, EANs, or other regulatory compliance and enforcement, please email info@garg-law.com.
