As of March 22, 2011 tobacco companies must report any changes to existing products or any new products to the FDA or submit a report showing that the changes or the new product are "substantially equivalent" to products that were on the market before February 15, 2007. This means these products cannot be more harmful than products that existed on the market as of that date. Tobacco companies that made any changes to products or created new products between these dates are being asked to submit reports on these products by March 22, 2011.
This "unprecedented disclosure requirement" is similar to what food and pharmaceutical companies have had in place for a long time. It is meant to ensure that all tobacco products made or changed are evaluated by the FDA. Until this time, changes could be made to tobacco products secretly, without the millions of consumers in America even knowing what is in the product they are using.
If these new or changed products raise question of public health by being worse than existing products, they can be pulled from the market if already on the market today or the FDA can keep these products from being marketed in America. To meet this requirement, tobacco companies cannot simply prove the products are less harmful. That requirement will be balanced with the risk and benefit to the population as a whole, including those trying to quit who may get hooked on this new product, or those who are not currently using tobacco products that may become addicted as a result of this new product being marketed.
What this could potentially mean:
In the immediate future, the impact of this will mostly be seen by the tobacco companies themselves, but the long-term potential these regulations have is that fewer products that attract our youth and turn them into lifetime, addicted, tobacco customers will be seen on the market. Because every new or changed product must go through a review process, tobacco companies will likely have to be more selective in what products they attempt to push through.
For more information on the new FDA regulations from the FDA's web site click here
For The Campaign for Tobacco-Free Kids' Press Statement on the FDA regulations click here.
If these new or changed products raise question of public health by being worse than existing products, they can be pulled from the market if already on the market today or the FDA can keep these products from being marketed in America. To meet this requirement, tobacco companies cannot simply prove the products are less harmful. That requirement will be balanced with the risk and benefit to the population as a whole, including those trying to quit who may get hooked on this new product, or those who are not currently using tobacco products that may become addicted as a result of this new product being marketed.
What this could potentially mean:
In the immediate future, the impact of this will mostly be seen by the tobacco companies themselves, but the long-term potential these regulations have is that fewer products that attract our youth and turn them into lifetime, addicted, tobacco customers will be seen on the market. Because every new or changed product must go through a review process, tobacco companies will likely have to be more selective in what products they attempt to push through.
For more information on the new FDA regulations from the FDA's web site click here
For The Campaign for Tobacco-Free Kids' Press Statement on the FDA regulations click here.
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