IPCPR Issues Statement on FDA Import Delays

On August 8, 2016, FDA’s deeming regulations went into effect, extending FDA’s authority over tobacco products to cover cigars, e-cigarettes, and all other tobacco products. Although additional requirements relating to cigar manufacture, packaging, labeling, and promotion will be implemented in the future, one of the more immediate impacts of FDA jurisdiction over the cigar industry will be at the import level.

Cigar imports are now subject to FDA review. As a result, brokers will need to provide additional information about the cigar product and wait for FDA to review this information and ultimately release these entries. Essentially, product release goes from a one-step process (release by Customs only) to a two-step process (release by Customs and by FDA).

To briefly summarize the process, a customs broker will need to identify the country of origin of the import, provide a written description of the product (usually obtained from the invoice), the name and address of the manufacturer, the name and address of the shipper (obtained from entry documents), and generate a “product code.” Entry information is typically submitted electronically and your import broker should be familiar with the procedure, however FDA review is an additional step that will add time to the import process, and importers should be prepared for this. If your customs broker needs additional information on the importation procedure for an FDA-regulated product, it can be found here: https://www.fda.gov/forindustry/importprogram/entryprocess/entrysubmissionprocess/default.htm

Like other FDA-regulated products, FDA reviews and subsequent entry releases can be as quick as a few hours after receipt of information, or can take days/weeks if information transmitted is incorrect, incomplete or FDA has questions about product compliance. Cigar importers should be aware of the potential for an import delay.

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