Cuban Cigars and the FDA

With the announcement today by US President Barack Obama that the United States will begin to normalize relations with Cuba a number of questions come-up. In terms of FDA regulations, perhaps, the most interesting question will be how the FDA regulates Cuban cigars.

The FDA Center for Tobacco Products (CTP) requires registration for manufacturers of certain tobacco regulations. Under current regulations cigars may be required to register under certain circumstances. The FDA is considering a rule expanding the CTP’s authority to require registration of cigars in all circumstances. At this stage it would be prudent to initiate a review of the regulations before importing to determine if registration is required. If registration is required, then the dreaded SPL X form registration process is required. This is a more complex registration process than for food or dietary supplement products.

Please contact us with any questions as you consider importing Cuban food, dietary supplements, cigars and other tobacco products.

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Marc Sanchez

Marc Sanchez

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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