10 Steps in Dealing With the FDA

10 Steps in Dealing With the FDA

Against the backdrop of repeated general press stories about contaminated food and other invalid products being exported from China to the U.S. and elsewhere, the focus at the Food and Drug Administration changed dramatically in the summer of 2007. The agency was already overburdened with sorting through the mass of imported shipments that were arriving. When the bad news hit, the FDA quickly changed gears and started holding up almost any food or other regulated product arriving from China that did not belong to a well-recognized company. While currently focused on items originating in China, the delays caused by not being in compliance with FDA rules and regulations can impact any product subject to the agency’s jurisdiction. Whether you import food, drugs, medical devices, dietary supplements or nutraceuticals (health promoting ingredients), you must know what is expected of you, or your just-in-time shipment will sit at the border, dock or warehouse where it arrived. Whether you lose your order or have to explain the situation to your customer, it is a very unhappy and unpleasant place in which to find yourself.

The suggestions below cannot guarantee that your dealings with the FDA will be problem-free, but if you follow them, you will at least be ready for those problems should they arise.

1. Know your product.

It is no longer enough to concentrate on only the financial aspects of your transaction. To make sure you do not run into delays, you also must know the regulatory requirements that apply to those products. In fact, even that is no longer enough. It is one thing to know that your dietary supplement meets the required sanitary standards and is safely packed, and good manufacturing practices were followed, but what about its packaging? How should it read? How is the product advertised on the Internet? Have the requirements under the Nutrition Labeling and Education Act been met for your food importation? Was prior notice filed properly and timely under the Bioterrorism Act? Is your importation even subject to prior notice?

2. Know your business partners.

Given how easy it is to find yourself in a situation where the product you ordered is not what is delivered, what steps have you taken to screen your business partners? Promises of good quality, timely delivery and a reasonable price are important, but what have you done to confirm that your proposed supplier can really deliver as promised? Is the supplier the subject of an FDA Import Alert? If so, do you really want to do business with him?

3. Screen your business partners.

In the FDA context, one of the most important questions you can ask your suppliers is about their good manufacturing practices or other standard operating procedures. Is the food additive generally recognized as safe? If so, how has the supplier documented that conclusion and how recently was that documentation updated? If a seafood product or orange juice, you should ask to see a copy of the Hazard Analysis and Critical Control Points (HACCP) plan. Is it current? Is it complete? When was that plan last updated? Is it maintained in English or just in the home country language? How does the farmer who grows your fresh fruit or produce keep track of which pesticides are used and which ones are to be avoided?

4. Know the regulatory requirements.

Once you have determined that your imported shipment meets Customs’ requirements of being properly valued and classified, you still need to meet the admissibility, or FDA, requirements. Do you know the differences in the regulatory scheme between the FDA regulations that apply to food, drugs, medical devices, dietary supplements or nutraceuticals? If not, how do you expect to get your product to market in time and on budget?

5. How are your goods labeled?

FDA and Customs, of course, require that every imported product be marked with its country of origin. There are also special rules that apply if you state your U.S. address on the label, but beyond that, what claims have you made for your product? Have you made statements that make the dietary supplement or nutraceutical you plan to sell sound like it will cure a disease or ailment? If so, you just turned it into a drug. Do you have the necessary testing ready behind it to have FDA accept those claims? How have you described the wonderful things your medical device can do? Do you transform it from a Class 1 device to one that is in Class 2 or 3 by making those claims? If so, have the proper tests been performed and the necessary registrations filed? Is your food free of prohibited pesticides? If canned, is the facility properly registered as a low-acid canned-food establishment? Is that registration current? Does it include the specific food you are importing?

6. How are your products being advertised?

One of the evolving areas is Internet advertising. In many instances, you may purchase a product for sale and be told by the seller exactly what you are allowed to say about it on your Web site, or in the product inserts or other forms of marketing materials. Keep in mind that FDA is viewing Web sites when it looks at a given product and how it is packaged and marketed. If your Web site makes unacceptable claims, your product will get held up. The same is true if the marketing materials or product inserts say the wrong thing. When was the last time you checked to make sure you were not making unacceptable claims?

7. Are there other agencies that can stop your importation?

While food is typically subject to the jurisdiction of the FDA, it is important to keep in mind that the U.S. Department of Agriculture has regulatory jurisdiction over meat, poultry and egg and other products. Milk, wine and similar products also may be subject to state regulation. Have you done your homework to make sure you don’t get held up by any of those agencies? Have you figured out which products may be subject to joint FDA and USDA jurisdiction simply because they are a prepared food subject to FDA’s rules which also contains something subject to USDA’s rules, such as a meat ingredient?

8. Are there terms and conditions that apply?

In the air and ocean environment, there are internationally agreed upon limits of liability. Do you know them and the other usual terms and conditions that transport companies apply? Have you insured your shipment? Have you read your commercial and transportation documents and your insurance policy? Have you checked the terms and conditions that your customs broker, forwarder, NVOCC and trucker impose? Have you properly documented your loss and reported it timely?

9. Do you regularly communicate with your business partners?

If your suppliers have encountered problems shipping your goods on time, do you know why? Are they having trouble with their subcontractors or suppliers? Have the materials or ingredients used to make your products changed? Are supplier standard operating procedures inadequate or out-of-date? Have you figured out the impact of the peak season on getting your goods to market timely? Do you know the changes your business partners are planning? Have you told them what you are planning to do in the future?

10. Keep up-to-date.

With the advent of the widespread use of the Internet and presentations in the form of webinars, it is just a matter of making the time to find out the latest information about those factors important to your business. If a new strain of contaminant has been discovered, wouldn’t you want to know about it to make sure your shipment is released promptly and your cost does not go up? Wouldn’t you want to know about impending regulatory changes with which you will need to comply? As things change so rapidly, now, more than ever, it is critical for international traders to stay up-to-date about the changes that affect their bottom lines and not just where and when you may order goods.

Every transaction has different factors or considerations to it. These tips are intended to mention some of the most important ones that are typical to the different types of goods subject to FDA’s rules and regulations. These also are the ones most likely to take money out of your pocket if you have not planned ahead properly. There is no way to fully explain the ins and outs of importing FDA-regulated merchandise in this short an article. So, the best tip of all is to make sure you have good advisers around you. Following a competent and energetic staff, they are the best way to keep out of trouble.