FDA Voice: Proposed Rule Would Expand FDA’s Tobacco Control Authority


April 24, 2014
Health

By: Margaret A. Hamburg, M.D.

Today we usher in a new chapter in FDA’s role in tobacco control, which began nearly five years ago when the Family Smoking Prevention and Tobacco Control Act enabled us to regulate certain tobacco products, including cigarettes and smokeless tobacco. Now, FDA has proposed a rule that would extend our authority to additional products meeting the legal definition of a tobacco product. This would include electronic cigarettes, some or all cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco and dissolvables not already under the FDA’s authority, as well as future tobacco products.

The tobacco product marketplace is evolving at a dizzying pace with many unanswered questions about the health effects of novel products. Especially in the shadow of alarming increases in the number of youths using unregulated products like electronic cigarettes and cigars, it’s more crucial than ever to help prevent early tobacco use that could lead to a lifetime of nicotine addiction. The proposed rule—which would “deem” other tobacco products to be subject to FDA authority—is poised to help make that happen.

FDA is committed to protecting public health. Expanding our authority over tobacco products gives FDA additional tools to help reduce the number of illnesses and premature deaths associated with the use of tobacco products. Under FDA’s proposal, these powerful regulatory tools would include age restrictions, rigorous review of new tobacco products and claims, and health warnings.

“Deeming” – and the new health warning requirements included in the proposed rule – would also help to correct a misperception by consumers that tobacco products not regulated by FDA are safe alternatives to currently regulated tobacco products. Equally important, “deeming” would allow FDA to issue future regulations regarding these products, including regulations to reduce their harmfulness, if we determine that would be appropriate to protect public health.

As we work to finalize the proposed rule, we welcome comments and will consider all that are submitted, as well as any data, research and other information submitted to the docket for this proposed rule. Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

 




FDA Voice: Proposed Rule Would Expand FDA’s Tobacco Control Authority

No comments yet.

Leave a Reply

* Copy This Password *

* Type Or Paste Password Here *