Who submits tobacco health documents?
The requirements under 904(a)(4) of the act apply to each “tobacco product manufacturer or importer.” We interpret this to mean that domestic manufacturers are to submit the required tobacco health documents relating to their current or future tobacco products and, for tobacco products that are or will be imported, the required tobacco health documents are to be submitted by either the foreign manufacturer or the importer of the product. At this time, FDA intends to enforce the tobacco health document submission requirements with respect to: • manufacturers and importers of cigarettes, smokeless tobacco, and roll-your-own tobacco for consumer use; and • manufacturers and importers of tobacco, filters, papers, and pouches, whether such products are for further manufacturing of, or for consumer use as, regulated tobacco products. Products for consumer use include tobacco, filters, and papers sold separately, in kits (such as for roll-your-own tobacco), or as part of accessories. FDA inte
