Tuesday, January 15, 2013

Timeframe on FDA Proposed Tobacco Product Regulations

 FYI to those who may be interested:

In the Jan. 8, 2013, Tobacco E-News bulletin, NATO reported that the Food and Drug Administration had released its annual Regulatory Agenda, which states that the agency intends to issue a proposed rule to regulate other tobacco products sometime by April of 2013. While the FDA stated its intention to release proposed regulations on other tobacco products by April of this year, there are various steps that a federal agency needs to follow in drafting, proposing, obtaining public feedback and finalizing a new regulation.

This means that when the FDA releases its proposed regulations on other tobacco products, the public will have 60 days to submit comments and make recommendations on the proposed rules. Then, the FDA will review all public comments and determine whether any changes should be made to the proposed regulations prior to issuing the regulations in a final form.

Here's our chance to voice our concerns.

. ...Think that they'll listen to us smokers?


Timeframe on FDA Proposed Tobacco Product Regulations


....and let's not forget that the FDA is preparing to submit its report to Congress on its research into innovative products and treatment for tobacco dependence. Tomorrow is the deadline for the public comment period.

Comments can be submitted here Comments are limited to 2,000 characters..


Summary: The Food and Drug Administration (FDA) is extending the comment period for the notice of public hearing that appeared in the Federal Register of November 28th, 2012 (77 FR 70955). In the public hearing notice, FDA requested comments on FDA consideration of applicable approval mechanisms and additional indications for nicotine replacement therapies (NRTs), and input on a report to Congress examining the regulation and development of innovative products and treatments for tobacco dependence. The Agency is taking this action to allow interested persons additional time to submit comments.

Dates: Submit either electronic or written comments by January 16, 2013


 ...and with regards to the Tobacco Control Act:


Section 918 (b) requires that the Secretary of HHS, after consultation with recognized scientific, medical, and public health experts, submit a report to Congress examining how best to regulate, promote, and encourage the development of "innovative products and treatments (including nicotine-based and non-nicotine-based products and treatments)" to better achieve the following three goals: (1) Total abstinence from tobacco use, (2) reductions in consumption of tobacco, and (3) reductions in the harm associated with continued tobacco use.


 I sure do hope that they take a step away from the quit or die approach.

1 comment:

  1. Accompanying this article is a chart that shows the various steps that a federal agency needs to follow when considering, drafting, publishing, allowing public input, and adopting a new rule involving government regulations. Once a notice of proposed rulemaking is published by a federal agency under Step 5 on the chart, then under Step 6 the public has 60 days to file comments about the proposed regulations. In Step 7, the federal agency reviews comments and may make changes to the proposed rule based on the comments. When Step 9 is reached, a federal agency will publish the final rule in the Federal Register to finalize the rulemaking process.automateandvalidate

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