Get clarity on how to properly import products into the U.S.
Imported products are subject to detailed scrutiny by the FDA. If your products are unapproved, misbranded with improper labeling, or are potentially adulterated, you may face enforcement by the Agency.
Are your imported products held up by customs at the border? We can help you get back to business — but you have to act fast.
With over a decade of experience helping clients navigate time-sensitive FDA regulations, we know how to bring cases to quick resolutions. We can assist with:
Notice of Action: This notice advises that the product will be held by the FDA for examination or sampling. It means that they have flagged a potential issue that could lead to the destruction or refusal of the shipment. We can help you quickly identify the reason for the detention, and find the right FDA contacts to resolve the issue. You only have 7 days to respond to a Notice of Action, so you have to act now. A quick response will help you avoid other penalties like a warning letter.
Form 766: This is the process to resolve a Notice of Action, and it’s very time-sensitive. If your issue can be “reconditioned”, we prepare the FDA Form 766 Reconditioning Request and ensure it includes the correct details. This can help you avoid destroying your entire shipment.
Import Alert: If the FDA believes that your imported product “may appear” to violate regulations, they can use an Import Alert to identify product types, country of origin, and companies with prior violations, and detain the shipment for examination. The Import Alert is a public and highly visible alert, leads to lengthy delays, and is best avoided when you’re trying to enter the market. We can help your business avoid an Import Alert by ensuring your paperwork is in order. If you are on the Import Alert already, we can petition to have your product removed.
Enter the market seamlessly by meeting FDA import regulations. Get in touch with us today so we can help you get back to business.
How We Help
Are you in trouble with the FDA?
Don’t panic — you’ve got backup. Download 5 Tips to Help You Navigate FDA Enforcement and learn how to resolve the situation now.
Expert knowledge of FDA regulations that helps you strategically grow your business
Marc Sanchez has provided our company with expert advice and letters that have saved us time and money in dealing with the FDA. We have worked with many FDA attorneys and consultants in the past and they can't hold a candle to the knowledge and expertise that we have found with Marc.
Jeff Maier (VP Sales & Marketing)
Marc is incredibly intelligent, poised and able to make reasonable, timely recommendations about risk. Additionally, he is extremely organized, has a calm demeanor and has provided insightful counsel to me on many regulatory issues. I strongly recommend him.
Physician- Entrepreneur- Consultant
I am truly impressed… Marc understands the workings of the regulatory agencies and this allows him to very effectively achieve the results that his customers want without creating an environment of confrontation. Beyond that, he has insight into the laws governing foods, supplements, and medicine that goes beyond that of the federal officials involved in these regulatory areas. This allows him to open avenues of compromise and agreement that would not have existed before he was brought to bear on the difficulty. Even as he produces compromise and agreement, it is clear that he holds his customer's interest at heart.
I have never found a more powerful and effective counsel.
Steven Frank CEO
Nature's Rite Remedies
We retained Marc to answer some extremely time-sensitive and complex questions regarding COVID-19 and FDA regulations. Despite being overloaded with clients, Marc was very responsive and was able to provide us with the comprehensive answers we needed within 24 hours. This enabled us to respond quickly and effectively to the changing regulatory landscape. I strongly recommend using Marc and look forward to working together again in the future.