Retail violations of sales to minors on e-cigarettes and cigars.

OBJECTIVES: The finalized 'Deeming Rule' extended the Food and Drug Administration (FDA) authority to regulate e-cigarettes, cigars, and other newly deemed tobacco products. We seek to assess the neighborhood characteristics associated with retail violations of sales to minors (RVSM) by tobacco product. STUDY DESIGN: We collected national inspection data on tobacco retailers during August 8, 2016, and May 31, 2018, from the FDA compliance check database. METHODS: A web scraping tool was applied to text mine the FDA decision letters and extract information on the tobacco product involved in RVSM. Separate logistic regression models with random effects were performed to examine the association between zip code-level neighborhood characteristics and RVSM by tobacco product. RESULTS: Of 268,317 minor-involved compliance inspections, 35,403 (13.2%) were identified as RVSM. Among 23,352 warning letters included in the final analysis, e-cigarettes, cigars, cigarettes, and smokeless tobacco accounted for 20.0% (n = 4673), 40.4% (9439), 35.6% (8303), and 4.0% (937) of RVSM, respectively. Flavored tobacco products were abundant among underage sales. For e-cigarettes, RVSM were more likely to occur in zip codes with a larger proportion of youth population aged 10-17 years (adjusted odds ratio [AOR] = 1.17 [1.02-1.34]). A larger proportion of African Americans was associated with a higher risk of RVSM for cigars (AOR = 1.09 [1.07-1.11]) but a lower risk of RVSM for e-cigarettes (AOR = 0.90 [0.87-0.93]). CONCLUSIONS: Retail violations of underage sales for cigars and e-cigarettes are prevalent and neighborhood characteristics associated with violations differ by tobacco product. Continued inspections with tailored strategies to reduce RVSM of all tobacco products are needed.

Comparison Study of Drug GMP Compliance Inspection Information and Its Database between China and America / 中国药房

OBJECTIVE： To provide reference for further improving China’s Good Manufacturing Practice （GMP） compliance inspection information and the construction of related database. METHODS： The relevant information on drug GMP compliance inspections from the websites of drug administration departments in China and America were collected， compared and analyzed from the aspects of the format and content of inspection report， annual report and database construction. The suggestions were put forward for the improvement of China’s drug inspection information and related databases. RESULTS & CONCLUSIONS： There was a large gap in the compliance inspection information and database functions between China NMPA and US FDA. For the drug GMP compliance inspection information， US FDA had established a special database to facilitate the public to use the search information， and had advanced search capabilities. At present， the database in China was not perfect and not a true meaningful database. It can only be browsed in order， and had almost no search function. In the content of drug GMP compliance inspection information， US FDA had made scientific and humanized measures for the description of defects， the advice or assistance provided to enterprises， and the confidentiality of key data， and the publication was timely. The details of the flight/tracking inspection notifications related to drug GMP compliance inspection issued by China CFDI were slightly poorer， and the classification of defects was not clear. The period from the end of the inspection to the release of the notification was longer. It is suggested that China’s drug GMP compliance inspection information and database functions should be improved from expanding the types and scope of GMP inspection information， improving the search function， and providing database instruction manual and refining the report content.