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Monthly Archives: January 2011

Substantial Equivalence for Public Health and Tobacco Control Professionals Webinar Today 10:30am EST

Gustavo Torrez, Program Manager

By Gustavo Torrez

Looking to make some sense of FDA regulation of Tobacco?

As many of you know, there are a lot of complex pieces that are associated with the FDA regulation of Tobacco. In an effort to ease some of this complex information the FDA holds webinars to help communities make sense of the regulations.  Recently, the FDA announced that certain tobacco products introduced or changed after February 15, 2007 must be reviewed to prove to be “Substantially Equivalent” to products on the market today.

OK, I know what you are thinking, what does “Substantially Equivalent” mean?

FDA Definition of “Substantially Equivalent”:

“Substantially equivalent” means the products must be the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single predicate product or have different characteristics, but not raise different questions of public health.

I assume you are all now experts in “Substantially Equivalence”

But just in case you want a little more info let me help boil some things down, and give you some insight of what will be discussed in today’s webinar.

First, the Tobacco Control Act requires manufacturers of new or modified tobacco products to submit a “premarket application” before any product can be put on the market. If a product was not altered on or before February 15, 2007 manufacturers do not have to submit a premarket application.

Under section 910(c) of the Tobacco Control Act, it states to introduce a new or modified tobacco product manufactures have to submit an application to FDA providing information on the product. So for the first time we actually will have detailed information from the industry on a products composition.

The FDA defines a new tobacco product and the definition of a tobacco product as follows:

A new tobacco product is defined (Section 910(a)(1)) of the Tobacco Control Act as:

  1. “any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or”
  2. “any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.”
    (NOTE: It is important to point out that the law defines a ‘new tobacco product’ to include a modification of a tobacco product where the modified product is commercially marketed after February 15, 2007.)

What is a tobacco product?
Tobacco product means “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).” (section 201(rr)(1))

SO, just to note e-Cigarettes do not fall under this section.

A major benefit with application process is that it will allow the FDA to evaluate the product and determine if a product is “appropriate for the protections of the public health”. SIDE NOTE: we know based on the new Surgeon General Report there is no safe cigarette so we will see how this pans out.

Well that’s is just a brief overview of a couple pieces that will be discussed in today’s call.

Below is the announcement for today’s call from the FDA:

We wanted to remind you of today’s webinar on Substantial Equivalence for Public Health and Tobacco Control Professionals. Below you will find relevant details on how to access the webinar and how to submit a question to our presenters.  We look forward to your attendance.

Public Health and Tobacco Control

When: January 14, 2011, 10:30 a.m. – 12:00 p.m. ET

Who Should Attend: Public Health and Tobacco Control Professionals

Presenters:

•       Les Weinstein, JD, MBA, CTP Ombudsman, CTP Office of the Director

•       Cristi Stark, MS, Senior Regulatory Health Project Manager, CTP Office of Science

Webinar Link: https://collaboration.fda.gov/ctp011411/

Call In Information: You may listen to this webinar through your computer. If you do not have speakers or do not have internet access, you may call our listen-only line at 1-866-901-3913; Meeting ID: 65289

Submitting Questions During Webinar

During the webinar, if you wish to submit a question, please use the chat function on the left side of your screen to type it to us. Questions will be answered after all presentations have been completed. We will do our best to answer all questions. If you are not logged into the webinar, you can call us at our main number 1-877-CTP-1373 to leave a question.

An archived version of the webinar as well as copies of the presentation will be available shortly.

For more information on our substantial equivalence webinars, please visit: http://www.fda.gov/TobaccoProducts/ResourcesforYou/ForIndustry/ucm239639.htm

 
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Posted by on January 14, 2011 in Uncategorized