The FDA’s Incredible Power to Regulate Imports
If you are associated in any way with any industry that imports into the United States of America, you are probably aware of the FDA and the regulations the agency enforces. What you might not be aware of is the incredible low burden the agency must meet to stop your product from coming into the United States, if the agency decides your product “appears” to be in violation of a regulation. The appearance of a violation is many times is a lower level decision within the agency which detains the product. The detention might be a precursor to a product refusal. A stand- alone detention can cause a lost ranging from customers to product even if the product is not ultimately refused entry.
The following two paragraphs are extracted from the FDA’s Regulatory Procedures Manual, which is the manual that guides the agency’s staff on taking regulatory actions in the field.
Evidence Required for Detention
Every detention must be based upon evidence of a violation of the law(s) enforced by FDA. This does not mean that comprehensive examinations are required as a condition for detention, or that detention cannot be based upon very brief examinations if these are sufficient to furnish evidence creating the appearance of a violation, or a violation.
Furthermore, it is not essential that a detention invariably be based upon examination of a sample, as Section 801(a) of the FD&C Act provides for refusal of admission if "it appears from the examination of such samples or otherwise" that the article is violate. However, in those cases in which detention is made without examination, there should be substantial evidence of a documentary type, (i.e., a violation in a previous shipment of the entered product from the same firm-see RPM chapter 9-8 "Detention without Physical Examination" for additional procedures) to warrant a charge of violation.
It is rare to see references such as “appearance of a violation” and “otherwise” in other Federal Agency’s Code of federal regulations. Note that the evidence needed does not have to be base on an actual violative sample or other hard evidence. In reality the entire detention can and is based on other evidence such as “Something the Investigator saw” during a visit to your foreign based plant or at times something that was provided to the agency by another agency. This is why it is incredibly important to monitor that visit from the FDA to your plant whether domestic or foreign based. Don’t take any chances, and prepare as much as possible, to avoid ending up on the bad side of FDA. The cost of preparing will be minimal, compared to the potential of being on the bad side of the agency.
If there are regulatory complications in any of the importation process that will land your company in an Import Alert, this might present a challenge that is time consuming, costly and many times lengthy process to remove yourself from the Import Alert. Yes, it is clear that “burden of proof” to execute detention is meant to err on the side of caution in consumer protection, which is understandable. When there is an error on the agency side, the one that pays the price is the importer with little to no recourse, at times not even an apology from the ones that made the error. Why should they apologize when they are protecting the consumer.
In summary, when the burden of proof is low on the enforcement side, the challenge to stay out of trouble is high. Never leave anything related to importing FDA regulated products to chance. Always strive to assure that you have done all you can do to import according to the regulations. Remember that the importing process is a privilege and not a right that begins when you buy your raw materials to make that product you are going to import into the US. Always be ready to receive that letter from the FDA that states they are planning to visit you plant because you are importing into the USA.