FDA Regulation Of Tobacco: What Does It Mean?
On Friday 12th June, the US Senate voted in favor of a bill that gives the Food and Drug Administration the power to regulate tobacco products. President Obama (who as a Senator was a sponsor of the bill, as was John McCain) has indicated he will sign the bill into law.
Public health advocates have been fighting for FDA regulation of tobacco for over 15 years. However, not every public health advocate has supported this particular piece of legislation, and the fact that Philip Morris Tobacco Company supported it caused many to have doubts. But now that the bill is finally going to be law, what will it mean? As a guide to this, I’d recommend that you read the slides from a paper by Mitch Zeller at the recent Virginia Youth Tobacco Conference. Much of this post is adapted from his slides. These outline the key parts of the bill and what they mean in some detail and are worth a careful read, (Mitch Zeller is the former Associate Commissioner and Director of the Office of Tobacco Programs at the Food and Drug Administration). Download his slides here.
The bill does not require FDA to regulate tobacco exactly the same way it does pharmaceuticals (drugs and devices), partly because it would be impossible for any tobacco product to demonstrate that it is safe and effective for its purpose. So instead the legislation creates a new, parallel set of rules and procedures just for tobacco, but using much of the same regulatory framework that was created for drugs. The new standard around which the tobacco bill is based is THE PROTECTION OF PUBLIC HEALTH.
-Section 904 mandates that FDA will receive brand-specific information on ingredients, nicotine delivery, and any smoke constituent FDA identifies as harmful or potentially harmful
– Companies must also provide FDA with all documents developed after the bill is enacted related to health, toxicological, behavioral, or physiologic effects of current or future products.
– FDA also has the right to request any such industry document produced prior to the enactment of this law.
– FDA can issue performance standards to prohibit or limit the allowable levels of substances in a finished tobacco product. FDA is granted this power in section 907. Products that don’t comply with the levels established in product standards can’t be sold.
– Nicotine cannot be banned but it can be reduced to very low levels.
– FDA needs to have supporting science to back up any standards it requires, or any ingredients it wants banned.
Clearly the tobacco product standards are going to be a key part of regulation of tobacco. Here’s what the bill says on these: Read more »
This post, FDA Regulation Of Tobacco: What Does It Mean?, was originally published on Healthine.com by Jonathan Foulds, Ph.D..
