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OPEN DOCKETS FOR PUBLIC COMMENT:
NAME: Enforcement Policy for Certain (Provisional) Tobacco Products That the Food and Drug Administration Finds Not Substantially Equivalent
ACTION: Draft Guidance.
Docket No. FDA-2013-D-1600
DATES: Submit either electronic or written comments on the draft guidance by April 28, 2014.
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled “Enforcement Policy for Certain (Provisional) Tobacco Products That FDA Finds Not Substantially Equivalent.” This draft guidance provides information to tobacco retailers on FDA's enforcement policy regarding certain so-called provisional tobacco products that become subject to not substantially equivalent (NSE) orders issued under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).