On April 24, FDA released its proposal to extend restriction on currently unregulated marketed products such as electronic cigarettes (e-cigarretes), cigars, piper tobacco, nicotine gels, hookah (water pipe tobacco) and dissolvables. FDA regulates product that meet the statutory definition of a tobacco product.
FDA currently regulates the following:
- Cigarette tobacco
- Smokeless Tobacco
The newly deemed tobacco products, under this proposal would have the following requirements:
- Register with FDA and report product and ingredient listings;
- Only market new tobacco products after review;
- Only make direct and implied claims of reduced risk if FDA confirms that scientific evidence supports the claim and that marketing product will benefit public health as a whole;
- Not distribute free samples.
FDA would also impose additional provisions such as minimum age and identification restrictions to prevent youth from obtaining this deemed tobacco products. It will require health warnings and prohibition of vending machine sales unless the facility never admits youth.
According to HHS Secretary Kathleen Sebelius: “ This proposed rule is the latest step in our efforts to make the next generation tobacco-free.” Since Tobacco is still one of the leading cause of death and many disease in this country, this proposed rule will would give FDA additional tools to protect the public health.
Schedule of Implementation of the proposed rule:
FDA has different compliance dates for various provisions so that small businesses and other entities will have ample time to comply with the requirements of this rule. Once the final rule has been issued, the deeming provision and age restriction would be in effect 30 days after the publication according to Food and Drug Administration. The health warning requirements will take effect two years later. There will be various compliance dates with other provisions under this proposed rule.
FDA seeks public comment
The proposed rule will be available for public comment for 75 days. FDA is still requesting comments in certain areas specifically on whether ALL cigars should be subject to deeming and which provision is appropriate or not on different kinds of cigars. An example would be e-cigarettes that does not involve the burning of tobacco and inhalation of smoke.
To see these announcement:
For more information: