There has been a strong push to encourage development as well as sale and
use of modified risk tobacco products (MRTP) opposed to higher risk existing
products on the market.
A modified risk tobacco product is a legal designation in the United States
for a tobacco product that poses lower health risks to individual users
and the population as a whole when compared to existing products on the
market such as cigarettes.
Of course, MRTP's are still harmful to humans but they are far less
harmful than the streamline tobacco products on the market.
Section 911 of the Federal Food, Drug and Cosmetic Act, gives the FDA responsibility
to establish standards that must be met before the agency can issue an
order authorizing the marketing of an MRTP.
The main requirements under Section 911 that must be satisfied for the
FDA to issue an order approving a product for the market are:
• Appropriate to promote public health
• The label and advertising is limited to a claim that the product
does not contain or is free of a substance or contains a reduced level
or presents a reduced exposure
• Scientific evidence is not available without conducting long term
epidemiological studies; and
• Scientific evidence that is available demonstrates that a reduction
in morbidity or mortality is reasonably likely.
An order permitting the sale of an MRTP applies to only a single specific
product, not an entire class of tobacco products. Additionally, an FDA
order permitting marketing of an MRTP is not permanent. The marketing
of the product is for a fixed period of time and the only way to continue
marketing the product after the set term is if the company seeks renewal
and the FDA finds that standards above are still met.
If the FDA determines that the standards under Section 911 are no longer
met then the FDA reserves the right to withdraw the order. However, before
the FDA withdraws an MRTP order, it will provide an opportunity for an
informal hearing as required under the law.
These standards were set in place earlier this year which makes this a
growing market for tobacco manufacturers and distributors to expand their
business into. It will be interesting to see what new products will be
released into the market in the coming months.
In his law practice Mr. Donnini's primary practice is multi-state sales
and use tax as well as state corporate income tax controversy. Mr. Donnini
also practices in the areas of federal tax controversy, federal estate
planning, Florida probate, and all other state taxes including communication
service tax, cigarette & tobacco tax, motor fuel tax, and Native American
taxation. Mr. Donnini obtained his LL.M. in Taxation at NYU. Mr. Donnini
is licensed to practice law in Florida. If you have any questions please
do not hesitate to contact him via email [email protected]
or phone at 954-639-4496.