FDA has established in its regulations
a pathway for manufacturers to request exemptions from the
substantial equivalence requirements of the FD&C Act. An
exemption request must be submitted with supporting documentation,
the manufacturer's contact information, and a detailed explanation
of the modification and its purpose. This information is submitted
to FDA so FDA can determine whether an exemption from substantial
equivalence to the predicate product is appropriate for the
protection of the public health. FDA determines whether to grant or
deny the request for an exemption based on whether the criteria in
the statute have been satisfied. If FDA determines that the
information is insufficient, FDA may request additional information
from the manufacturer. If the manufacturer fails to respond within
the timeframe requested, FDA will consider the exemption request
withdrawn. FDA may rescind an exemption where necessary to protect
the public health. FDA may exempt tobacco products that are
modified by adding or deleting a tobacco additive, or increasing or
decreasing the quantity of an existing tobacco additive, from the
requirement of demonstrating substantial equivalence if the Agency
determines that (1) the modification would be a minor modification
of a tobacco product, (2) a report demonstrating substantial
equivalence is not necessary for the protection of public health,
and (3) an exemption is otherwise appropriate.
PL:
Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and
Tobacco Control Act
PL: Pub.L. 111 - 111 31 Name of Law: Family
Smoking Prevention and Tobacco Control Act
The Food and Drug
Administration (FDA) issued a final rule to deem products meeting
the statutory definition of “tobacco product” to be subject to the
Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C
Act provides FDA authority to regulate cigarettes, cigarette
tobacco, roll-your-own tobacco, smokeless tobacco, and any other
tobacco products that the Agency by regulation deems to be subject
to the law. This final rule extends the Agency’s “tobacco product”
authorities to all other categories of products that meet the
statutory definition of “tobacco product” in the FD&C Act,
except accessories of such newly deemed tobacco products.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
0910-0684_SS Tobacco Products Exemption from SE Requirements Final.docx
Report Demonstrating Tobacco Product Mod under 905(j)(3), Commercially Mkted and Compliant, and Modifications covered under 905(j)(3)