No-tobacco-sale orders (NTSOs), n=76, and eligibility for NTSOs among retailers that failed three or more inspections, n=144, 1 October 2015–29 March 2019
| Estimated proportion (95% CI) | Count in sample | Estimated count in population | |
| Research question 1: Is FDA implementing NTSOs according to its own interpretation of the statute? | |||
| NTSO not issued at 5th violation under FDA’s interpretation | 2.6% (1.0% to 6.9%) | 2 | 4 |
| NTSO issued at 5th violation under FDA’s interpretation | 93.4% (88.1% to 96.4%) | 71 | 138 |
| NTSO was a second or later NTSO for a location | 3.9% (1.8% to 8.6%) | 3 | 6 |
| Research question 2: Is FDA implementing NTSOs according to our interpretation of the statute? | |||
| NTSO not issued at 5th violation under our interpretation of the statute | 94.7% (89.8% to 97.4%) | 72 | 140 |
| NTSO issued at 5th violation under our interpretation of the statute | 1.3% (0.3% to 5.2%) | 1 | 2 |
| NTSO was a second or later NTSO for a location | 3.9% (1.8% to 8.6%) | 3 | 6 |
| Research question 3: What proportion of retailers who failed three or more inspections are eligible for an NTSO according to our interpretation of the statute? | |||
| Retail location eligible for NTSO under our interpretation of the statute | 73.6% (66.0% to 80.0%) | 106 | 1461 |
| Retail location ineligible for NTSO under our interpretation of the statute | 26.4% (20.0% to 34.0%) | 38 | 524 |
The population of NTSOs in our study period was N=148. The sample contained n=76 NTSOs. The population of inspections from retailers who frequently failed inspections (ie, failed three or more) in our study period was N=2095. The sample contained n=152 inspections of which n=8 had details unavailable at the time of our study for an analytical sample of n=144. The one NTSO in which the FDA issued the NTSO at the fifth violation by our count had an earlier violation outside of the 36-month date range that FDA counted as the ‘original violation’. The CI for the estimated count of retailers who frequently fail inspection and would be subject to an NTSO is 1312 to 1610. CI is calculated with a finite population correction. Estimated count is rounded to the nearest whole retailer. Percentages and weighted counts do not sum due to rounding.
FDA, Food and Drug Administration.