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FDA Guidance on Marketing and Distributing a "New" Tobacco Product

The Food and Drug Association (FDA) defines a new tobacco product as any new product or product modification marketed in the U.S. after February 15, 2007. Products marketed before the February 15, 2007 date are considered Grandfathered Tobacco Products, do not require premarket authorization and may also serve as a basis for comparison with new tobacco products when reporting for new tobacco products.

A tobacco product marketing order must be obtained from the FDA before new tobacco products can be legally marketed in the U.S.. There are three options for gaining approval for legally marketing new tobacco products.

Premarket Tobacco Product Applications

Premarket Tobacco Product Applications (PMTAs) are submitted to the FDA to

acquire approval for marketing new tobacco products. A PMTA must include

adequate scientific data that demonstrates the safety and general effects on

public health by individuals that may use the product. In reviewing a PMTA, the

FDA considers: the risks and benefits to the populaition as a whole; the likeliness

of the product to encourage or discourage increased tobacco use; and the

methods, facilities and econtrols used to manufacture, process and pack the


Substantial Equivalence

Substantial Equivalence (SE) reports are reviewed by the FDA to determine

whether a new tobacco product is essentially the same as a predicate product.

A predicate product can be either a grandfathered tobaaco product as

described above or a tobacco product that has previosuly passed the substantial

equivalance requirements for marketing approval. In determining the equivalence

of the products, the FDA compares either the direct characteristics or the effects

on public health of the the new and already approved products.

Request Exemption from Demonstrating Substantial Equivalence

A tobacco product may be exempted from the requirement of a SE report if it can

be demonstrated to have been modified by: (1) adding or deleting a tobacco

additive, or (2) increasing or decreasing the quantity of an existing tobacco

additive. The request for exemption must demonstrate that the modification is

minor and will not have improportionate adverse effects on consumers.

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