Abady Law Firm, P.C. – Customs and Import/Export Attorney Blog

Learn the Basics of Customs and International Trade Policy and Procedure

Archive for the "FDA Attorney" Category

Kratom Imports and FDA Import Alert 54-15

Lately it has come to our attention that kratom (MITRAGYNA SPECIOSA) is being targeted more frequently in the past couple of months.  Specifically, U.S. Customs and Border Protection (“Customs” or “CBP”) and the U.S. Food and Drug Administration (“FDA”) have been examining and detaining kratom shipments from overseas.  Additionally, express consignment operators such as FedEx, UPS, and DHL, are cautious to ship the product because of the potential problems associated with this botanical.

These delays can be attributed to FDA’s import alert 54-15.  The alert provides for:

DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENTS AND BULK DIETARY INGREDIENTS THAT ARE OR CONTAIN MITRAGYNA SPECIOSA OR KRATOM

The language of the import alert focuses on “DIETARY SUPPLEMENTS AND BULK DIETARY INGREDIENTS.”   These types of goods implies an end use for human consumption purposes.  By classifying the product plainly and vaguely as kratom (MITRAGYNA SPECIOSA) on Customs and shipping documents, you are leaving the examining officers at ports of entry across the U.S. with the ultimate decision as to admissibility.   We have also seen declarations such as: incense, soap scrubs, and clothing dye.  Accordingly, the intended use of kratom when imported provides an important factor in determining the kratom’s admissibility. Thus, one must articulate to the federal agencies the use of the kratom properly so as to argue that it falls outside the scope of the import alert.

Please be aware that the FDA has brought action against company’s they find are selling for human consumption:

See here:

U.S. Marshals seize botanical substance kratom from southern California facility

and here:

United States of America v. 577 Cartons et al

We currently represent numerous kratom importers to establish a plan and dialogue with the federal agencies who regulate kratom so as to avoid unnecessary delays and improve clearance of their shipments.  As a result, we have been successful in getting kratom released from detention/seizure by Customs/FDA.  Contact us immediately if your shipment is being detained by the federal agencies.

For more information about an importing kratom or for assistance with any of the issues noted above, contact Abady Law Firm, P.C., at 800.549.5099, to speak with a international trade attorney today!

Everything You Need to Know About an FDA Notice of Action

The U.S. Customs and Border Protection (CBP or Customs) works in conjunction with the Food and Drug Administration (FDA) to ensure that products are in full compliance before they are imported or exported to and from the United States. At times, the FDA or Customs may deny the entry of a product if they determine that a good or product fails to meet strict import/export requirements. When this happens, the product is detained for further examination. Depending on the findings of the examination, the FDA may issue a Notice of Action.

FDA Notice of Action

Regulated products must comply with the FDA’s Food, Drug and Cosmetic Act. Any products entering U.S. customs that are found to be or are suspected of being non-compliant are detained for further physical examination. The FDA district office then issues a “Notice of FDA Action.” This notice specifies the nature of the violation and gives the consignee or owner of the product an opportunity to respond and provide evidence as to the admissibility of the product.

Responding to The FDA Notice of Action

While you may feel like venting your frustrations or anger with the FDA or Customs officer who detained your product, it is wise to keep your cool and consult with a Customs law attorney who can advise you on your legal options and your next course of actions. You must act promptly when you receive a Notice of Action because it is time-sensitive.

  • Gather all pertinent facts about the detention. Do not respond to the Notice of Action until you have all of the facts.
  • Thoroughly review the Notice of Action. It would be a good idea to do this with a Customs attorney so he can explain the violation(s) for which your product was detained and address any questions and concerns you have.
  • Note the “Response By” date by which you must submit your response. If you do not respond by the specified date, the FDA will issues another Notice of FDA Action that will refuse admission of the product. You will be ordered to export the product elsewhere or destroy the product within 90 days.  Further, it is highly difficult to have the FDA rescind a refusal once one has been issued.
  • You response should include a detailed explanation and and any evidence showing that you have taken the necessary measures to bring your product into compliance and have resolved the circumstances that lead to the violation (s). A Customs lawyer can assist you with this.

If you have a good or product that is detained in Customs, plan to import a product and need information on importing requirements and procedures, or you simply need assistance obtaining import documentation, contact a Customs law firm right away.

Don’t wait until your product is tied up in bureaucracy or sitting in an FDA detention center. An import and export attorney will work diligently to make sure your product is in full compliance with all FDA and international requirements to the mutual satisfaction of all parties involved.

For more information about an FDA notice of action or for assistance with any of the issues noted above, contact Abady Law Firm, P.C., at 800.549.5099, to speak with a customs law attorney.

How to Successfully Be Removed from the FDA’s Import Alert List

It’s not always a good thing to be “on the list,” particularly if you’re on the black list. One such black list is the FDA’s Import Alert list. Being placed on this can mean big problems for a company, and it requires the assistance of a professional customs attorney to petition for removal.

What is the FDA’s Import Alert List?

Basically, if a company is placed on this list, it means the FDA is providing a warning to importers around the world that the company’s products present safety concerns. If an Import Alert is placed on products or a company, it can mean not only big headaches, but also significant costs.

The FDA is able to automatically detain said products at the border, also known as Detention Without Physical Examination (DWPE). Although many products flagged with an Import Alert can still be imported into the U.S., it becomes a very expensive process for importers, lowering the amount of money they’re willing to pay for the flagged products.

If the FDA opts to refuse a shipment as a result of the importer doing nothing about an automatic detention, the shipment is either exported or destroyed. It’s also possible for the FDA to request Customs seize the detained products.

A few examples of reasons are placed on these lists are because of pesticide and contaminant residues and the presence of salmonella.

The FDA has set-up a comprehensive Import Alert page allowing users to search by company name, country and other criteria.

If a company is placed on the FDA’s black list, it can’t be removed until sufficient evidence is produced, showing the merchandise meets FDA compliance requirements.

Removal from the Import Alert List

The exact methods used for removal from the Import Alert list are directly related to the reason a company was placed there to begin with. If a food finds its way to the list as a result of misbranding, the FDA requires that at least five consecutive shipments enter the U.S., with at least one of those being audited for compliance by the FDA. It’s also worth noting these shipments can’t be made over one day or any other unreasonably short period of time.

In addition to the auditing process, it’s necessary that a Petition be filed directly with the FDA, requesting removal from the list. Important information included in a Petition include the specifics of the products in question, their entry numbers, and a variety of other relevant documentation.

A Petition isn’t just a cut and dry process. It has to be persuasive, and convincingly show the problem has been completely remedied.

While there are instructions provided by the FDA demonstrating how the removal process works, most people find success through the assistance of a qualified and experienced customs attorney. A customs attorney such as www.customsesq.com (Abady Law Firm, P.C) helps their client make a convincing case for removal, and they can also guide them through the lengthy and extensive paperwork and documentation required during the process.

Not only is the company charged with showing the problem has been fixed for current shipments, but it’s also responsible for outlining how a future problem will be avoided.

If your company is losing money as the result of placement on the FDA’s Import Alert list, contact us. Our import/export attorneys can provide you with the counsel you need to regain your profits and be removed from this highly detrimental list.

Please see article by Virtual-Strategy Magazine entitled Less than 3% of Companies on FDA Import Alert Red Lists Petition for Exemption Read more: http://www.virtual-strategy.com/2014/11/05/less-3-companies-fda-import-alert-red-lists-petition-exemption#ixzz3IEOALsE6

Resource Information

For more information about this blog post, please contact Abady Law Firm, P.C. and speak with our customs attorney at (800) 549-5099. Also visit www.customsesq.com to chat with a customs lawyer — who has insight into the FDA import alert list — about your company’s import situation and to schedule a consultation.  To chat with us, click the bottom right corner tab of our homepage.

Don’t forget to LIKE US on Facebook for firm news, import/export news and legal updates.