When importing FDA-regulated food products into the USA, an FDA Notice of Action can be a challenging hurdle to overcome. It indicates potential non-compliance and may result in FDA detention, delaying or denying entry of your goods.
The U.S. FDA oversees the safety of more than $2.6 trillion worth of food, tobacco, and medical products, much of which is imported annually and manufactured in approximately 140,000 registered foreign facilities.
Tasked with ensuring public health and safety, the FDA has the authority to conduct product examinations and/or sample collections to ensure compliance with regulations and laws. Importers must be prepared for the FDA to execute this authority. Some inspections are routine, some are risk-based, and some are in response to increased vigilance because of past violations.
What is a Notice of Action Letter? How should responses be handled?
Let’s get started.
What is an FDA Notice of Action Letter?
An FDA Notice of Action letter is an official communication indicating the FDA has reviewed a shipment and found it non-compliant with U.S. regulations.
It serves as a formal notification that a shipment does not meet regulatory requirements, outlining specific violations such as mislabeling, contamination, or missing documentation. It provides importers an opportunity to respond by addressing the issues, submitting additional evidence, or correcting errors to avoid further enforcement actions like FDA detention or refusal of entry.
What to do When You Receive an FDA Notice of Action
Having accurate and complete documentation on file with the FDA (including assignment of a U.S. Import Agent), a registered foreign facility (as applicable), and compliant product labeling are three up-front ways to demonstrate your commitment to compliance.
Even so, an FDA Notice of Action may be issued at any time. It is your responsibility as the importer, consigner, or filer to respond to FDA requests in an expeditious and thorough manner.
You must indicate acknowledgement of the FDA Notice of Action and confirm that your products are available for examination and sampling. Should you need more time to respond to a notice of FDA action, you may request an extension; however, the FDA may not grant it, depending on your justification for the delay.
How Do I Respond to an FDA Notice of Action Letter?
Should the FDA decide to examine or sample your shipment, an FDA Notice of Action will be provided to the filer, importer, owner and/or consignee on record.
The FDA Notice of Action will specify the entry number, items (lines) in question, and alert you as to why the product is being held. It is important to be in close communication with your U.S. Agent, who can act as a conduit of information between your company and the FDA.
Upon receipt of an FDA Notice of Action, a response with the information requested must be submitted through FDA’s Import Trade Auxiliary Communication System (FDA ITACS) or through the local FDA Import office. You will be asked to include for each line item requested:
- Entry number
- Submitter’s name and contact information
- Complete address for location of product
- Contact name and phone number at the location
- Warehouse/storage lot number, if applicable
- Warehouse hours of operation (if known)
- Additional documents if requested by the FDA
There is no specific timeline by which the FDA will complete the examination and sampling, though the Agency moves as quickly as possible. Your compliance with providing requested information in a timely manner and ensuring products are manufactured, packaged, labeled, transported, and held in accordance with cGMPs will go a long way toward expediting the process.
Notice of FDA Action: What is the Agency Looking For?
An FDA Notice of Action will consist of one or more of the following:
- Field or physical examination of product
- Product label examination
- Collection of product samples
Field Examinations
- Does the container’s product quantity match what is listed on the label?
- Is there evidence of rodent activity, unusual odors, or spoilage?
- Is the storage temperature during transit appropriate for the product?
The FDA’s field examination looks for anything unusual. It even may test for lead in ceramicware. Ensure that your product was manufactured, packaged, stored, and transported in sanitary conditions and in appropriate temperatures.
How is all of this accomplished?
Through diligent adherence to current Good Manufacturing Practices (cGMPs) set forth by the FDA and documented in Standard Operating Procedures (SOPs). Regular and appropriate laboratory testing should also be conducted throughout production to identify problems.
Product Label Examinations
The FDA’s label examination will evaluate appropriate ingredient nomenclature and listings and confirm that all required information is in English.
For drug products, the FDA will also cross-reference the product label against its drug listing database. Food products are required to include allergen labeling for the “big nine”.
If your product makes health claims, you must be prepared to demonstrate the validity of such claims with scientific data. In addition, colors used in the manufacture of products sold in the U.S. must be certified in the U.S., regardless of status in other countries.
- Does your product make health claims?
- Does it fail to declare food allergens?
- Are you using a non-approved color or additive?
- Does your label include shelf-life or expiration dating as determined by laboratory studies?
It is your responsibility to develop labels specific to FDA requirements. You must also inform the FDA of all Rx and OTC products sold in the U.S. through the creation of product listings in the FDA’s searchable database. These listings include not only front-of-pack labeling but details found in the package inserts. You must register the locations of facilities with the FDA in which all imported food and drug products are manufactured.
These are just a few omissions that would trigger an FDA Notice of Action.
Product Sampling
The FDA may take samples of your product to their laboratory to confirm its identity and safety before releasing the product for sale. Much like field examinations, preparing for FDA product sampling is accomplished long in advance of an FDA Notice of Action through adherence to cGMPs.
- Does the composition of your product match the label?
- Have the contents been verified through independent laboratory testing?
- Is the product safe from contaminants and does it meet specifications?
Remember – enlisting a professional independent laboratory and consultant can help. The FDA’s sampling program is strictly to confirm regulatory compliance. In the event violations are found, the FDA will not inform you of how to correct them.
What is an FDA Notice of Detention?
Should the physical examination or analytical results of sampling indicate the product appears to be in violation, a second FDA Notice of Action called Notice of Detention and Hearing will be issued and the product will remain on hold pending additional follow-up and/or testing. The FDA will include a “specific respond by” date in a Notice of Detention and Hearing. Ensure that your evidence is provided to FDA accordingly.
Should no violation be observed, the FDA will release the products with confirmation provided to the entry filer.
Vigilant adherence to cGMPs, ensuring appropriate labeling, and a diligent, trusted laboratory testing partner will help resolve an FDA Notice of Action.
Our experts can help you respond to your FDA Notice of Action Letter and navigate the import process. Certified Laboratories provides laboratory testing to help get your products released from FDA detention.
Our regulatory partners at EAS Consulting Group can help ensure your products meet FDA requirements for admissibility, including acting as a U.S. Import Agent.