Since the 2009 passage of the Tobacco Control Act, the Troutman Sanders Tobacco Practice has been helping our clients comply with the many new Food & Drug Administration requirements for tobacco companies. These requirements include FDA registration and other filing requirements.
More recently, the Troutman Sanders Tobacco Practice has been working around the clock to help our clients file their “substantial equivalence” reports due on March 22nd. This requires reports to the FDA regarding products that were first sold after February 2007, or products that have changed since then.
Compliance with these Tobacco Control Act requirements is important, as failure to comply can render a tobacco product “adulterated” or “misbranded,” which means the product could be banned from the market. Although the Tobacco Control Act’s requirements are generally imposed on tobacco product manufacturers and importers, these requirements are also important for distributors, because if a product is deemed “adulterated” or “misbranded,” the product in your warehouse may be banned from sale.
It is not clear whether all manufacturers are complying with the FDA’s requirements, including the “substantial equivalence” reports due this week. Foreign manufacturers in particular may be unaware of these requirements, or perhaps even unable or unwilling to comply. It is also unclear whether importers are aware of these requirements. Because failure to comply with these requirements could render products unsaleable, distributors should check with their suppliers to confirm whether they have satisfied their registration and filing requirements with the FDA.