July 18, 2005
Overcoming Regulatory Hurdles When Importing Dietary Supplements
byAndrea G. Ferrenz and Claudia A. Lewis-Eng
Despiteits advantages, importation of dietary supplements can be a risky businesscomplicated by government hurdles. Sometimes unpredictable and frequently costlydelays due to government oversight actions can interrupt supply and hamperproduction schedules. Beyond unexpected delays, when a product is held forreconditioning or is refused entry at a U.S. port, importing instead of findinga domestic supplier can seem a poor choice. Understanding importationregulations can help prospective importers alleviate risks.
Acting in conjunction with the Office of U.S. Customs, theU.S. Food and Drug Administration (FDA) monitors the importation of dietarysupplements and their ingredients at U.S. ports of entry to ensure theircompliance with the Federal Food Drug and Cosmetic Act (FDCA). While a May Proceed Notice is the best outcome animporter can hope for (meaning the agency will not be inspecting a product), aNotice of Sampling gives the importer advance notice that the agency willexamine the product and take a physical sample. After sampling, if FDA suspectsa violation of the FDCA the importer will receive a Notice of Detention andHearing. The importer has 10 days to argue for admissibility of theshipment before a hearing on the matter. The response to a Notice of Detentionand Hearing should be a reasoned analysis of the admissibility of the product.In lieu of arguing for admissibility, an importer can submit an Applicationfor Authorization to Recondition or Perform Other Action. Reconditioning brings the product into compliance with theFDCA. 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 whenreconditioning cannot render the substance legal for sale in the United States.
Advance preparation can help importers overcome importationbarriers. Every supplement company should have a response policy that can beactivated upon receipt of a Notice of Detention and Hearing. An importingsupplement company should designate at least one person to be the point ofcontact for FDA importation issues. That person should be familiar with Customsand FDAs importation processes, the importation methods of the company, andthe companys importation schedule. When Customs, FDA or Customs brokercontacts the company regarding an importation issue, the calls should bedirected to the designated importation policy person to ensure consistent,informed responses. While circumstances can vary, there are common problems andsolutions.
First, understand that smooth, quick importation begins beforethe product leaves its home port. It is important to research FDAs importdetention records on the agencys Web site for any prior enforcement actsagainst the product or ingredient your company plans to import. Use the importdetention records to determine whether FDA objects to the product and addressFDAs concerns with appropriate labeling and packaging, if possible. Likewise,research the import detention records for the foreign company. Foreign exportersknown as badactors by Customs can destroy your own reputation, so it is always best to knowthe foreign exporters import history.
Next, realize importation problems often occur when labelingfails 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 UnitedStates may be sold as drugs in other countries.The non-U.S. suppliers packagemust comply with U.S. laws and regulations. Drug claims cannot appear on theimported product.
Incomplete labeling presents another problem. FDA requiresnon-drug ingestibles to bear the words dietary supplement or food on their principal display panels and shipping containers. Inaddition, the labeling should state if the shipment will be subject to furtherprocessing and manufacture.
Another common concern is disparities among ports. Despitenational 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 ahigher shipment per agent ratio. Generally, a company should bring its productsthrough one port consistently. Not only will the company become familiar withthe port agents, making addressing a shipment hold easier, but port agents willbecome familiar (and comfortable) with the company and its products. Unique andrare dietary supplement ingredients can throw off agents that are on the lookoutfor unapproved new drugs and adulterated products. Using the same portconsistently can reduce the risk of repeated FDA sampling when importingingredients at risk of federal scrutiny. Establishing a shipment history with a particular port canhelp ease the importation process.
Finally, the Public Health Security and BioterrorismPreparedness and Response Act (Bioterrorism Act), passed in 2002, createdadditional hurdles for importation of dietary supplement ingredients.The Actimposes a one time initial registration requirement for a food facility. The Actrequires advance notice of imported food (including dietary supplements), andthat can present a logistical challenge in certain circumstances. Notice of afood shipment must occur prior to the foods arrival in the United States. FDAuses information in the notice to decide whether to inspect the product beingimported. Failure to provide the required advance notice can result in customsprohibiting product imports.
Thus, while consumer demand for unique products and premiumingredients makes importation a valuable resource for dietary supplementcompanies, importation has inherent risks. To reduce those risks an importershould: 1) use FDAs importation detention records to research its proposedimport; 2) ensure its package labeling complies with FDA regulations; 3) bringits products consistently through one port; and 4) comply with the BioterrorismAct. Familiarity with the process, common issues and solutions canarm any company with what it needs to increase the ease of importation.
Andrea G. Ferrenz is a senior associate and Claudia A.Lewis-Eng a principal with Emord & Associates, a law firm based in Reston,Va. Emord & Associates (www.emord.com) represents clients inthe dietary supplement, food, health care, consumer activist and scientificarenas in constitutional and administrative law cases.
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