As FDA detentions and refusals continue to climb, whether it’s for missing nutrition facts information, or lack of required FDA registration, it reminds us that getting an FDA import rejection notice is about as fun as being stood up on a blind date!
While the FDA isn’t exactly sending you a love letter when they detain or refuse your shipment, and the process can feel like the plot twist in your supply chain saga, it doesn’t represent the end of the road.
We’ll dive into how to handle FDA import rejection like a seasoned pro to help keep you and your business a 10/10!
Understanding the FDA Import Detention Process: What Exactly is an FDA Import Detention?
The FDA import detention process begins when the agency determines that one or more products in a shipment may not comply with U.S. regulations. This could be due to reasons such as safety and quality concerns, improper labeling, lack of regulatory clearance or approval, contamination, or missing documentation. When the FDA flags a shipment, they issue a Notice of Detention, which is a formal notice informing you that your product cannot be released until the compliance issues are resolved.
Why Does the FDA Detain Products?
There are several potential reasons why the FDA may detain your shipment. Common causes include:
- Misbranding: The labeling doesn’t meet FDA standards or is misleading.
- Adulteration: The product may be contaminated, unsafe, or made with non-compliant ingredients.
- Inadequate Documentation: The shipment is missing essential documents, such as certificates of analysis, labels, affirmation of compliance information, or key entry information (e.g. 510(k), device listing, FDA registration)
- Failure to Meet U.S. Standards: The product is not approved for sale or does not comply with other health and safety regulations.
Types of FDA Import Detentions
The FDA can take different actions, depending on the severity of the violation:
- Notice of Hold: The product is temporarily detained and under review while the FDA evaluates compliance.
- Notice of Sampling: The FDA may collect product samples to test for safety and quality.
- Refusal of Admission: If the product is deemed in violation of U.S. laws and regulations, the FDA may refuse its entry into the U.S. until corrective actions are taken.
If the issues are not resolved and the products are not compliant, Refusal of Admission will likely follow. Once a refusal is issued, the product must either be exported, destroyed, or reconditioned to meet U.S. standards.
What to Do When You Receive an FDA Import Detention Notice
When you receive an FDA notice of sampling, hold or FDA detention notice, give us a call. We will assess the bases for the detention, obtain any additional information from FDA, and quickly identify whether the detention is based on an oversight or an actual violation. We’ll also communicate with the FDA, develop a corrective action plan, gather supporting documentation and evidence, and provide a substantive response to the FDA.
What Happens if the FDA Refuses Admission?
If the FDA issues a Notice of Refusal of Admission, this means the Agency has determined that your product cannot enter the U.S. until compliance issues are resolved. It is important to comply with the refusal notice (export or destruction of the product within 90 days), to avoid liquidated damages, which can significantly increase your costs.
Preventing Future FDA Import Detentions
While import detentions are a part of doing business in regulated industries, it is important to stay updated on regulations, audit your processes regularly, develop a compliance program, and work with experts to prevent them from recurring. This will help prevent import and product delays and keep consumer confidence high.
Conclusion: A Bump in the Road, Not a Dead End
While receiving an FDA import detention notice may feel like a major setback, by addressing the issue head-on, staying compliant, and working closely with the FDA, you can get your products back on track and avoid the detention drama. With the right systems in place, businesses can navigate import detentions with confidence, ensuring compliance with FDA regulations, safeguarding their import operations and reputation…just pure compatibility!
For assistance with an FDA import detention, FDA import refusal, Import Alert, or other U.S. FDA and/or Customs compliance questions including FDA import best practices, please contact us at info@garg-law.com.
