August 2, 2019
“As our oversight and scientific knowledge of tobacco products has evolved, so too should our requirements for manufacturers and importers to provide information about the chemicals or chemical compounds in their products that cause or could cause harm to users and nonusers. We welcome comment on the proposed additions to the list of harmful and potentially harmful constituents of 19 toxicants that may be found in tobacco products, including electronic nicotine delivery systems such as e-liquids and e-cigarette aerosol,” said Acting FDA Commissioner Ned Sharpless, M.D. “We remain committed to meeting the important goal of ensuring the public can clearly understand the real and potential risks of tobacco product use as we work to protect kids and significantly reduce tobacco-related disease and death.”
The U.S. Food and Drug Administration announced today that it is seeking public comment on the proposed addition of 19 chemicals or chemical compounds to the established list of harmful and potentially harmful constituents (HPHCs) that can cause, or could cause, harm to users and nonusers. The chemicals on this list may be found in tobacco products—including electronic nicotine delivery system (ENDS) products, hookah tobacco and cigars—and their smoke and are, or potentially are, inhaled, ingested or absorbed into the body. The agency is proposing that 19 toxicants, such as ethylene glycol, diacetyl and glycidol, should be added to the HPHC list, which was first established in 2012 to identify constituents in tobacco products that are linked to the five most serious health effects of tobacco use: cancer, cardiovascular disease, respiratory effects, developmental or reproductive effects, and addiction. This is the first time the agency is seeking public comment on the proposed addition of certain HPHCs in ENDS products.
Under the law, tobacco manufacturers and importers are required to report to the FDA the levels of HPHCs found in their tobacco products and tobacco smoke. This requirement has applied to cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco since 2009. Following the May 2016 final rule that extended the FDA’s tobacco product authority to all products that meet the statutory definition of a tobacco product, except accessories of newly deemed products, this requirement now applies to newly-regulated tobacco products including ENDS products such as e-cigarettes, as well as cigars, pipe tobacco and hookah tobacco, among others. The FDA intends to provide additional guidance in the future to assist manufacturers or importers of newly-regulated products with compliance with this requirement.
The FDA is seeking comments, including scientific and other information, on topics including whether these additional constituents, or any other chemical or chemical compounds, should be added to the established HPHC list.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.