March of Dimes Applauds FDA Deeming Rule on Tobacco Products
Decision Will Enable FDA to Regulate E-Cigarettes Like Other Tobacco Products
Washington, District of Columbia | Thursday, May 5, 2016
The March of Dimes, the nation’s leading nonprofit organization advocating for maternal and child health, today commended the U.S. Food and Drug Administration (FDA) for deeming e-cigarettes to be tobacco products subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act. This decision will empower the agency to regulate e-cigarettes like other tobacco products, such as traditional cigarettes and cigars.
“E-cigarettes are clearly tobacco products, and they should be strictly regulated as such,” stated March of Dimes President Dr. Jennifer L. Howse. “Lack of regulation has allowed these products to be marketed and sold without limits, including to pregnant women and youth. The March of Dimes praises the FDA for moving to protect public health, including the health of women and infants, by regulating these products appropriately.”
The FDA’s decision is a critical step toward imposing appropriate regulations on the marketing and sale of e-cigarettes. With this announcement, manufacturers will be required to comply with a range of current regulations for tobacco products. Manufacturers may only make claims of lower risk if FDA confirms that adequate, appropriate scientific evidence supports that claim. In addition, manufacturers and vendors will be prohibited from selling these products to underage youth or distributing free samples.
“The March of Dimes is especially concerned that e-cigarettes are being pitched by some as a “safe” alternative for pregnant women,” Dr. Howse added. “Absolutely no evidence exists to indicate that e-cigarettes are safe for pregnant women. The March of Dimes urges pregnant and breastfeeding women to avoid e-cigarettes and all other tobacco products to reduce the likelihood of preterm birth, low birthweight, and other health consequences.”
The FDA’s deeming rule would cover not only e-cigarettes but also cigars, pipe tobacco, waterpipe (hookah) tobacco, and novel products like nicotine gels and dissolvables. The March of Dimes has urged FDA to prioritize research into the effects of e-cigarettes and other nicotine products on pregnancy and birth outcomes. One study indicated that 40 percent of pregnant women surveyed believed electronic cigarettes are less harmful than traditional cigarettes; only 57 percent believed that e-cigarettes contain nicotine; and fewer than two-thirds of the women thought that e-cigarettes could be addictive. No data exists to indicate that e-cigarettes are safer or less addictive than traditional tobacco products, and many versions of e-cigarettes contain considerable levels of nicotine.
About March of Dimes
March of Dimes leads the fight for the health of all moms and babies. We support research, lead programs and provide education and advocacy so that every baby can have the best possible start. Building on a successful 80-year legacy of impact and innovation, we empower every mom and every family.