US FDA Tobacco Submissions

The Family Smoking Prevention and Tobacco Control Act gives the US FDA broad authority to regulate tobacco products. In addition to requiring that a number of warning label statements appear on tobacco packaging, certain products must now be submitted for pre-market approval and go through a regulatory process similar to pharmaceuticals.

What Regulatory Pathway Applies to Your Tobacco Product?

Drawing on our electronic regulatory submission experience with the FDA, GlobalSubmit is able to offer a variety of services to tobacco companies seeking regulatory approval for “reduced risk” claims and premarket review.

Synchrogenix’s Regulatory Services team follows established FDA processes for electronic submissions, and adapts those processes where necessary to construct complete, high-quality tobacco submissions to facilitate the FDA’s timely review.

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