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 (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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