The intensive development of cellular technologies stipulates the introduction at the global level of medicinal products based on viable human cells, which in most countries are referred to as biomedical cell products. The authors conducted a comparative analysis of the regulatory framework in different countries and determined special aspects of regulation of cell therapy products (analogues of biomedical cell products). Some countries have mechanisms for priority review of cell therapy products for marketing authorization, such as accelerated assessment, accelerated approval, or conditional marketing authorisation. These mechanisms are currently absent in Russia, because of the novelty of the regulatory framework, and the biological properties of innovative cell products. Biomedical cell products are regarded as a separate class of medicinal products in Russia, they are not treated as biologicals and are regulated by the Federal Law No. 180-FZ «On Biomedical Cell Products» of June 23, 2016. The main difference in regulation of cell-based products in the Russian Federation is the principle of unified requirements for marketing authorisation of autologous, allogeneic, and combined biomedical cellular products, and the absence of the «hospital exemptions» mechanism that exists in many countries. This mechanism allows prescription and use of personalised autologous medicines produced in the laboratory of a medical institution for a particular patient.

Introduction Recent studies have separately examined the content and demographic reach of the advertising of electronic nicotine delivery systems (ENDS). No study to our knowledge has linked the two in investigating whether racial/ethnic groups are differentially exposed to the comparative messages conveyed in online ENDS advertisements. Methods 932 unique ENDS advertisements (6311 total), which were posted on 3435 websites between December, 2009 and October, 2015, were categorized as either comparative or non-comparative with respect to the traditional cigarette. The race/ethnicity of website visitors was obtained from a proprietary source and used in constructing variables for racial/ethnic viewership. The variables for advertising content and website racial/ethnic viewership were then linked yielding a final sample of 551 unique ENDS advertisements (2498 total) on 1206 websites. A two-level hierarchical generalized linear model, used in estimating website racial/ethnic viewership as a predictor of comparative advertising, accounted for the nesting of advertisements (level 1) within 152 ENDS brands (level 2). Results In contrast to racial/ethnic minorities, a greater proportion of non-Hispanic whites visited websites with ENDS advertisements than the overall proportion of nonHispanic white U.S. Internet users. Yet, it was the advertisements on websites that appealed to Hispanics that had greater odds of comparing ENDS to traditional cigarettes. Conclusions The lower exposure to ENDS advertising among racial/ethnic minorities versus non-Hispanic whites is consistent with survey data. Yet, the greater odds of comparative advertising of ENDS on websites that appeal to racial/ethnic minorities (ie, Hispanics) could impact the longterm health of minority smokers. Implications This study’s findings have important implications for the uptake of ENDS among minority smokers. If the comparative advertising yields greater interest and eventual use of ENDS, then minority smokers could either benefit from smoking cessation because they switch to ENDS, or adopt dual tobacco use. The fate of comparative advertising of ENDS versus the traditional cigarette will depend on the Food and Drug Administration enforcement of its deeming rules and the ensuing changes in the ENDS marketplace.