The Food and Drug Administration (FDA) label & claims review and regulations consist of hundreds of pages containing thousands of rules, options, and critical details that you must follow. Beyond the regulations, you must also contend with many written and unwritten FDA policies.
All of these apply to your product labels, as well as other advertising and marketing efforts. Failure to comply with FDA labeling requirements can result in Warning Letters, import detentions, placement on Import Alerts (automatic detentions), and, in the case of allergen labeling, nationwide product recalls.
Having an advocate that has extensive experience in navigating these regulations and possible enforcement actions is critical to keeping your product on the market.
These are called “Red List” alerts – meaning that you will be detained if you are on the Red List. The FDA also has country-wide import alerts for countries that the FDA believes has problems complying with certain regulatory requirements.
Country-wide alerts allow the FDA to detain every product from every manufacturer from that country. This kind of Import Alert has a “Green List” which lists companies that are exempt and will not be detained under the alert because they have petitioned FDA.
Import Alerts are an enforcement short-cut for the FDA. The FDA has the authority to detain and refuse any goods that appear to violate the Federal Food, Drug, and Cosmetic Act (FDCA).
That’s right, after their inspection, the FDA can detain and refuse your imported goods for merely appearing to violate the law. Placement on an Import Alert shifts the burden of proof to the importer.
When your product or country is on an Import Alert, the FDA no longer needs to inspect your goods to find a violation. They can automatically detain the goods without any inspection and force you to prove that your goods are in compliance.
Whether you are an importer or manufacturer, getting your product off an Import Alert quickly is critical to your business. Detentions cause shipping delays that can last weeks or even months.
Producing the necessary evidence to get your products released often includes obtaining expensive private laboratory testing. Additionally, placement on an Import Alert can damage the manufacturer’s reputation and even derail their key importers’ FDA required Foreign Supply Verification Programs (FSVP) – forcing importers to find other suppliers.
We can help you with a new or ongoing enforcement action. If you already face an FDA detention or Warning Letter, an FTC (Civil Investigative Demand), or an NAD case, we can quickly evaluate your situation, respond to the government, help you control the damage, and create a plan to avoid future such issues.
Detain – When the FDA stops your shipment from distribution in the U.S. because the goods appear to violate the FDCA.
Refuse – When the FDA determines that your goods violate the FDCA and then requires you to destroy or export the goods. If you distribute refused goods in the U.S, Customs will charge you under your import bond with liquidated damages, amounting to three times the value of the goods.
Hearing –Typically a series of emails or phone calls where you submit your testimony to demonstrate that your product follows FDA law and regulations.
Charges – The alleged violations or reasons your product has been detained.
DWPE – This stands for Detention Without Physical Examination and is how the FDA titles all import alerts. It describes their claimed authority to detain your goods without any evidence.
Red List – A list of companies and products who are on an Import Alert and may be detained without inspection. You must file a petition to be removed from a Red List. See an example of a regular import alert here: Import Alert 66-41 Detention without Physical Examination of Unapproved New Drugs Promoted in the US.
Green List – A list of manufacturers who are exempt from a country-wide Import Alert. You must file a petition to be placed on a Green List. See an example of the country-wide Import Alert here: Import Alert 21-07 Detention without Physical Examination of Tamarind Products.
The petition process can take many months. The actual length of time will depend on how long it takes to identify the underlying cause of the violations, correct those issues, and compile the documentation.
Getting off the Import Alert also requires shipping a certain number of shipments to the U.S. and having them released to prove that you have corrected the violation. The petition process is dependent upon successfully getting those shipments through the FDA and the port without new charges.
We can help you avoid pitfalls and get everything resolved as quickly as possible.
- Corrective Action Plan: We’ll help you find the source of the violations, show you how to correct the violations, and we’ll document the changes so that you can prove to the FDA that you have addressed their concerns.
- Manage Entries: As part of the petition process, we will help you manage the required shipments to the U.S. and interact with the Agency during the detention period.
- Draft, Submit, and Shepherd the Petition: We will create a petition that documents and incorporates your corrective actions and successful shipments. Once submitted, we will handle interaction with the FDA including responding to any objections or requests for clarification.
Our team has years of experience successfully getting companies removed from import alerts. We can make the process easier, faster, and less stressful. We will be your trusted advisor, helping you and your team understand each step in the process so that your organization can easily come together to face this challenge.
Take the first step to freedom and schedule a call with us today.