US: FDA Proposes To Extend Its Tobacco Authority

Source from:  Science Recorder 06/13/2014

According to a statement from the U.S. Food and Drug Administration (FDA), to meet the requirements of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the agency proposed a new rule to expand the agency's tobacco authority, thereby overseeing additional tobacco products.

Tobacco products to be subject to FDA regulation include those that meet the legal definition of a tobacco product, including currently unregulated marketed products, such as e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe tobacco, and dissolvables. Currently, the FDA regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.

According to the Mayo Clinic, e-cigarette manufacturers claim electronic cigarettes are a safe alternative to conventional cigarettes. However, the Food and Drug Administration (FDA) has questioned the safety of these products.

When the FDA analyzed samples of two popular brands, they found variable amounts of nicotine and traces of toxic chemicals, including known cancer-causing substances.  This prompted the FDA to issue a warning about potential health risks associated with electronic cigarettes.

Under the proposed rule, manufacturers of newly deemed tobacco products would, among other requirements, be required to register with the FDA and report product and ingredient listings; only market new tobacco products after FDA review; and only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole. Additionally, manufacturers would be prohibited from distributing free product samples, must enforce minimum age and identification restrictions to prevent sales to underage youth, and must include health warnings on packaging. Enditem