Synthetic nicotine: a challenge to FDA’s authority
Puffbar’s new product line represents a direct challenge to FDA’s regulatory authority, potentially shortcutting the premarket tobacco product application (PMTA) requirement for E-cigarette products. While products containing Synthetic Nicotine were sold before, Puffbar’s brand recognition and popularity among youth E-cigarette users should be a cause for concern. The entry of a market-leading nicotine supplier such as CNT into the Synthetic Nicotine market is further testing FDA. CNT supplies nicotine to the pharmaceutical industry for cessation products while at the same time supplying both tobacco-derived and Synthetic Nicotine to vape and smokeless product manufacturers.
By selling prod- ucts containing the more expensive Synthetic Nicotine, manu- facturers demonstrate their willingness to forgo a part of their profits in exchange for staying in the market unimpeded, while manufacturers of products containing tobacco-derived nicotine have to manoeuvre the costly and complex PMTA process. By establishing opaque manufacturing and import networks and multisourced sales channels to web sellers, convenience stores and gas stations, brands such as Puffbar demonstrate their intent to maintain sales even while facing FDA enforcement action. At this time, it is not even clear whether Puffbar products contain synthetic nicotine. The analytical approaches described above should be employed for verification. The Food, Drug and Cosmetics Act, amended by the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA), defines a tobacco product as ‘any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)’.
The FDA seems confident that this definition authorises the agency to regulate at least some recre- ational synthetic tobacco products, stating that ‘it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or Synthetic Nicotine) would not be regulated by the FDA as a tobacco product, if it is not intended or reasonably be expected to be used in such a fashion. FDA intends to make these determinations on a case-by-case basis, …’42 Manufacturers clearly dispute these claims. For example, the Chief Executive Officer (CEO) of NGL is quoted with ‘All indications from the FDA confirm our long-held position: TFN Nicotine products cannot be regulated under the Deeming Rule as they are not tobacco products, and we continue to believe that an open or closed system device for use with a choice of synthetic nicotine products will qualify as a non- tobacco product.’43 With multiple Synthetic Nicotine-containing product lines rapidly emerging, a case-by-case review strategy will likely be ineffective.
If not regulated as a tobacco product, FDA could regulate Synthetic Nicotine as a drug, as proposed in a legal analysis by Zettler et al.4 FDA attempted to regulate combustible and smokeless tobacco products as drugs in the 1990s, but lost this ability following the Supreme Court Ruling in FDA vs Brown & Williams in which the court raised concerns that tobacco products marketed in the USA at the time could never meet the safety standards required for drugs and had no therapeutic benefits as required for drugs.44 However, FDA has always regulated nicotine replacement therapy products as drugs, including nicotine gum, lozenges and patches, a status that did not change with the enactment of the FSPTCA in 2009. Especially for products with added synthetic racemic nico- tine, containing 50% R-nicotine with unknown safety if consumed regularly, a case can be made for the stringent safety and efficacy review afforded to new drugs.
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