US - Federal: The US Food and Drug Administration (FDA) and independent researchers have stated that nicotine alternatives in vaping products, such as 6-methyl nicotine, may have more potential for addiction than nicotine itself, Reuters
reports. While chemically similar to nicotine, synthetic substances are not subject to the US federal tobacco regulations, allowing manufacturers to sell e-cigarettes and alternative nicotine products with nicotine analogues without seeking FDA authorisation. In response to questions from Reuters, the FDA said it was reviewing the available data on nicotine alternatives to inform potential actions. The agency said it was considering the use of such synthetic compounds from an “agency-wide perspective” and would use all of its resources to protect youth from these products. In a letter to the FDA, Altria
stressed the emerging use of 6-methyl nicotine in vapes, and asked the agency if “products containing 6-methyl nicotine, differing from nicotine by a methyl group, subject to the PMTA [premarket tobacco product application] requirement and the other provisions of the US Tobacco Control Act (TCA), or are they indeed ‘PMTA exempt’?”