The burden is on the manufacturer to provide evidence that permitting the product to be marketed is appropriate for protection of the public health, including that the modification does not augment the tobacco product's appeal to or use by minors and it does not increase toxic effects, addictiveness, or abuse liability. If the new product does not meet criteria for an exemption determination or a substantial equivalence finding, a new product application must be submitted. The FDA has issued draft guidance outlining its current thinking on what information should be included in a new product application.38 These criteria include data to show that allowing product marketing would be for the protection of public health (panel 1).
Panel 1
Questions for industry for premarket tobacco applications for new tobacco products
Health risks

    How do the health risks associated with the product compare to the health risks of other products on the market?
    How do the health risks of switching from another tobacco product to the new product compare to the health risks associated with stopping use of tobacco products?
    How do the health risks associated with the product compare to never using tobacco products?
    Scientific studies of the health risks of the new tobacco product should compare the health risks of the new tobacco product with the risks associated with quitting, using other tobacco products, and never using tobacco products.

Effect on cessation

    How will the new tobacco product affect the likelihood that current tobacco users will cease using tobacco products?
    Research should address the attractiveness of the product and product labelling to current tobacco users (particularly those users interested in quitting smoking), the addictiveness and abuse liability of the product, and cessation rates associated with users who switch to the new tobacco product.
    Evidence should show the likelihood that the new product will be used concurrently with other tobacco products currently on the market.
    Assessment of the effect of introduction of the new tobacco product on cessation rates should provide data for the attractiveness, addictiveness, and cessation rates of the new tobacco product compared with other tobacco products currently on the market.

Effect on initiation

    How will the new tobacco product affect the likelihood that never-users and former-users of tobacco products will use the new tobacco product?
    Research should address the attractiveness of the product and product labelling to never-users and former-users of tobacco products (particularly people who are especially likely to initiate or reinitiate tobacco use) and the addictiveness and abuse liability of the product.
    Scientific assessments should provide data on how the attractiveness and addictiveness of the new product compares with that of products currently on the market.
    Which product features might enhance the attractiveness or appeal of the new product to children and adolescents, and which product features could minimise the attractiveness or appeal of the product to children and adolescents?

Unless a tobacco product over which the FDA has jurisdiction is a so-called grandfathered tobacco product, failure to obtain a marketing order or exemption determination will result in the new tobacco product being deemed adulterated and, therefore, either the company, the tobacco product, or both, could be subject to enforcement action by the FDA. However, some new tobacco products are subject to a specific provision in the law for products first marketed between Feb 15, 2007, and March 22, 2011. The provision permits these so-called provisional products to remain on the market as long as a substantial equivalence report for the product was submitted before March 23, 2011. If the FDA decides, after reviewing the report, that the product is substantially equivalent, it can continue to be marketed. If the product is established as not substantially equivalent, the manufacturer will need to submit a new tobacco product application and receive a marketing order before the product can be sold in the USA (sections 910[a][2] and [c][1][A][i] of the Tobacco Control Act).34 The FDA has received many substantial equivalence reports and is in the process of evaluating them. Most reports received have important deficiencies, and the FDA has been working with industry to help them understand their new responsibilities under the Tobacco Control Act and what information is needed for the FDA's review of these submissions.39Panel 2 presents common deficiencies in substantial equivalence reports reviewed to date.
Panel 2
Common deficiencies in substantial equivalence reports submitted for new tobacco products
Substantial equivalence category

    Unclear which category of substantial equivalence the product fits in, contradictory statements about the category, or information in the report does not support the stated category

Predicate products

    Unacceptable, inappropriate, or multiple predicate products

Product design

    Incomplete information (eg, schematics, inadequate product attributes)
        Product characteristics (missing details for product or its predicate)

Product composition

    Inadequate information
        Specifications (missing information about tobacco grading system and ingredient grades)
        Tobacco blend (missing information)

Ingredients and additives

    Not identified for every product component or material
    Missing information on ranges, sources, how used, why used

Harmful and potentially harmful constituents

    Missing information (levels, test method, test date, manufacture date, product storage conditions)
    No explanation for differences in quantities compared with predicate
    Number of replicates too small

Harmful and potentially harmful constituents in smoke

    Data from multiple smoking regimens not provided