And as I said before, because FDA is at least opening up door for science to have a place, they are possible national platform that could be where tide turns. Not because of them, but because of what they proposed and how they chose to word that proposal.
I don't understand what you mean by the bold part. The only place I see where the FDA is "asking" for scientific studies is in the
required applications that manufacturers and importers/vendors would have to either conduct and present (quite costly) or refer to studies already made from other sources.
Also in the deeming doc: pg 177
"The draft guidance "Applications for Premarket Review of New Tobacco Products"
explains the requirements and provides recommendations for the contents of an application for
premarket review of a new tobacco product. Contents include a cover letter; an executive
summary;
full reports of all investigations of health risks; a full statement of all components,
ingredients, additives, and properties, and of the principle or principles of operation of such
tobacco product; a full description of methods of manufacturing and processing; a listing of all
manufacturing, packaging, and control sites for the product; an explanation of how the product
complies with applicable tobacco product standards; samples and components; and proposed
labeling. If an applicant does not submit information on any of the previously mentioned items,
the application should include a statement indicating which information is not being submitted
and an explanation of why the information is not being submitted."
And this is stated, not as a mere plea for comments and questions, or what the FDA intends to do,
"FDA
intends to enforce the premarket
authorization requirements with respect to
the product"
... but what the FDA is required to do by law:
pgs 177-178
FDA is
required to deny a PMTA and issue an
order that the product may not be introduced or delivered for introduction into interstate
commerce under section 910(c)(1)(A)(ii) of the FD&C Act if FDA finds that:
• The manufacturer has not shown that the product is appropriate for the protection of the
public health,
• the manufacturing methods, facilities, or controls do not conform to manufacturing
regulations issued under section 906(e) of the FD&C Act,
• the proposed labeling is false or misleading, or
• the manufacturer has not shown that the product complies with any tobacco product
standard in effect under section 907 of the FD&C Act.
This means that the manufacturer will have to show the product is appropriate for the protection of the
public health. How would one think that they do that? Just some 'reassurances' or some scientific studies - at
their cost.
This isn't 'opening the door to science', it's shutting it for those who can't afford the key to the door.