Overcoming Regulatory Hurdles When Importing Dietary Supplements

Overcoming Regulatory Hurdles When Importing Dietary Supplements
by Andrea G. Ferrenz and Claudia A. Lewis-Eng

Despite its advantages, importation of dietary supplements can be a risky business complicated by government hurdles. Sometimes unpredictable and frequently costly delays due to government oversight actions can interrupt supply and hamper production schedules. Beyond unexpected delays, when a product is held for reconditioning or is refused entry at a U.S. port, importing instead of finding a domestic supplier can seem a poor choice. Understanding importation regulations can help prospective importers alleviate risks.

Acting in conjunction with the Office of U.S. Customs, the U.S. Food and Drug Administration (FDA) monitors the importation of dietary supplements and their ingredients at U.S. ports of entry to ensure their compliance with the Federal Food Drug and Cosmetic Act (FDCA). While a “May Proceed Notice” is the best outcome an importer can hope for (meaning the agency will not be inspecting a product), a “Notice of Sampling” gives the importer advance notice that the agency will examine the product and take a physical sample. After sampling, if FDA suspects a violation of the FDCA the importer will receive a “Notice of Detention and Hearing.” The importer has 10 days to argue for admissibility of the shipment before a hearing on the matter. The response to a Notice of Detention and Hearing should be a reasoned analysis of the admissibility of the product. In lieu of arguing for admissibility, an importer can submit an “Application for Authorization to Recondition or Perform Other Action.” Reconditioning brings the product into compliance with the FDCA. Depending upon the basis for the Notice of Detention and Hearing, reconditioning may be the best option for an importer. Refusal of admission, exportation or destruction of the merchandise are the worst case scenarios when reconditioning cannot render the substance legal for sale in the United States.

Advance preparation can help importers overcome importation barriers. Every supplement company should have a response policy that can be activated upon receipt of a Notice of Detention and Hearing. An importing supplement company should designate at least one person to be the point of contact for FDA importation issues. That person should be familiar with Customs’ and FDA’s importation processes, the importation methods of the company, and the company’s importation schedule. When Customs, FDA or Customs’ broker contacts the company regarding an importation issue, the calls should be directed to the designated importation policy person to ensure consistent, informed responses. While circumstances can vary, there are common problems and solutions.

First, understand that smooth, quick importation begins before the product leaves its home port. It is important to research FDA’s import detention records on the agency’s Web site for any prior enforcement acts against the product or ingredient your company plans to import. Use the import detention records to determine whether FDA objects to the product and address FDA’s concerns with appropriate labeling and packaging, if possible. Likewise, research the import detention records for the foreign company. Foreign exporters known as bad actors by Customs can destroy your own reputation, so it is always best to know the foreign exporters’ import history.

Next, realize importation problems often occur when labeling fails to comply with the FDCA. Another common problem encountered is non- English labeling on product containers. All shipments into the United States, even raw ingredients scheduled for further processing or bottling prior to sale, must bear English labeling (a dual language label is permitted).

Some ingredients sold as dietary supplements in the United States may be sold as drugs in other countries.The non-U.S. supplier’s package must comply with U.S. laws and regulations. Drug claims cannot appear on the imported product.

Incomplete labeling presents another problem. FDA requires non-drug ingestibles to bear the words “dietary supplement” or “food” on their principal display panels and shipping containers. In addition, the labeling should state if the shipment will be subject to further processing and manufacture.

Another common concern is disparities among ports. Despite national policies and procedures, enforcement measures vary among U.S. ports. FDA does not have the resources to inspect every package that enters a U.S. port. While a busier port may have a larger staff, it is also likely to have a higher shipment per agent ratio. Generally, a company should bring its products through one port consistently. Not only will the company become familiar with the port agents, making addressing a shipment hold easier, but port agents will become familiar (and comfortable) with the company and its products. Unique and rare dietary supplement ingredients can throw off agents that are on the lookout for unapproved new drugs and adulterated products. Using the same port consistently can reduce the risk of repeated FDA sampling when importing ingredients at risk of federal scrutiny. Establishing a shipment history with a particular port can help ease the importation process.

Finally, the Public Health Security and Bioterrorism Preparedness and Response Act (“Bioterrorism Act”), passed in 2002, created additional hurdles for importation of dietary supplement ingredients.The Act imposes a one time initial registration requirement for a food facility. The Act requires advance notice of imported food (including dietary supplements), and that can present a logistical challenge in certain circumstances. Notice of a food shipment must occur prior to the food’s arrival in the United States. FDA uses information in the notice to decide whether to inspect the product being imported. Failure to provide the required advance notice can result in customs prohibiting product imports.

Thus, while consumer demand for unique products and premium ingredients makes importation a valuable resource for dietary supplement companies, importation has inherent risks. To reduce those risks an importer should: 1) use FDA’s importation detention records to research its proposed import; 2) ensure its package labeling complies with FDA regulations; 3) bring its products consistently through one port; and 4) comply with the Bioterrorism Act. Familiarity with the process, common issues and solutions can arm any company with what it needs to increase the ease of importation.

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