Market Research on Disposable E-Cigarette Nicotine Content and E-Liquid Volume | BMC Public Health
We conducted market research to compare commercial disposable e-cigarette product label claims for nicotine strength and e-liquid volume with analytically verified levels of the same parameters. The results indicate large discrepancies between labeled nicotine content and e-liquid volume compared to actual measured amounts for many product samples evaluated in this study.
The American E-liquid Manufacturing Standards Association (AEMSA) was created to develop standards that ensure the quality and safety of e-liquid products for electronic cigarettes. . AEMSA guidelines state that nicotine concentrations should be within ±10% of the concentration stated on the product label. The measured nicotine levels and e-liquid volumes of many of the products studied deviated by more than ±10% from their label claims. In many cases, the calculated total nicotine strength was less than half of the expected total nicotine strength, indicating that the consumer is receiving much less than expected. These products could potentially be considered mislabeled by the FDA .
Differences in the amount of nicotine labeled and the concentrations of nicotine measured tend to cluster depending on the manufacturer. For example, the nicotine strengths of the MNGO Stick and Posh samples were among the lowest compared to their respective label claims, while the Kangvape and Breeze Smoke products were among the highest. Eleven of the 39 samples (28%) measured total nicotine levels less than half of their expected total nicotine level (based on label claims). MNGO Stick, Puff XXL, and RARE FLOW were among the samples with the lowest measured total nicotine content compared to their respective expected total nicotine content.
Comparison of our results with those in the published literature is complicated by the fact that our study involved e-liquids contained in closed-system disposable e-cigarette devices, whereas most published studies involved e-liquid refills. -liquid. Nevertheless, market studies comparing the nicotine content indicated on the label with the nicotine content measured in e-liquid refill products frequently observe marked discrepancies between the nicotine content indicated on the label and the nicotine content measured, consistent with our findings.
Davis and colleagues reported that 35 of 54 samples of commercial nicotine-containing e-liquids deviated by more than ±10% from their product’s label claims. Differences between labeled and measured nicotine concentration ranged from -12.9% to +89.7% . Farsalinos and colleagues reported that 12 of 21 refill e-liquid samples had nicotine levels within ±10% of their label claims. Overall, discrepancies between actual nicotine content and label claims ranged from −21% to 22.1% . Kim and colleagues compared the labeled and measured nicotine content of e-liquids purchased in the United States (not= 32), South Korea (not= 29) and Poland (not= 30). Most products with inaccurate labels were those purchased in the United States. Of these, 14 had discrepancies between the nicotine content indicated on the label and the actual nicotine content of more than ± 10%. Overall, the differences between labeled and measured nicotine concentrations ranged from -92.4% to +103.7% . Peace and collaborators measured nicotine concentrations in 27 e-liquid formulations. They reported discrepancies between labeled and actual nicotine concentration that ranged from -55% to +31%. In addition, 18 of the 27 products deviated by more than 10% from the nicotine concentration indicated on the label. . Lisko and colleagues compared the labeled and measured nicotine concentration in a sample of 36 commercial e-cigarette cartridges. Investigators reported that three quarters of the products contained lower levels of nicotine than what was stated on the product labels. . Bębenek and colleagues compared labeled nicotine to measured nicotine and other aspects of e-liquids purchased in seven European countries. Commercially available e-cigarettes sold in Europe are only available in nicotine strengths of 20 mg/mL or less. Only one liquid had a quantified concentration of nicotine more than 10% higher than the amount indicated on the label. Twenty-one liquids had a quantified concentration of nicotine less than 10% of the amount indicated on the label. An e-liquid with a labeled nicotine concentration of 6 mg/mL contained no trace of nicotine .
In general, Good Manufacturing Practices (GMP) ensure proper design, monitoring and control of manufacturing processes and facilities to protect public health.Footnote 3 In the United States, the FDA has the authority to establish Good Manufacturing Practices or Tobacco Product Manufacturing Practices (TPMP) for tobacco products, but it has not yet done so. Rather than inspecting compliance with the TPMP, the FDA inspects tobacco establishments every two years from the date of registration to ensure they are in compliance with the provisions of the Food, Drug and Drug Act. cosmetics and that the products are not adulterated or mislabeled.Footnote 4 Additional provisions the FDA uses, but is not limited to, to include product registration and listing; list of ingredients ; packaging, labeling and advertising requirements; and marketing authorization for certain tobacco products.Footnote 5 Once the FDA establishes TPMPs for tobacco products, its investigators will also inspect compliance with those requirements. Perhaps the problems identified in this post would be solved by the implementation of PGEF.
A few limitations should be considered when interpreting the results of this study. Due to the large number of e-cigarette brands currently available, the samples selected for this survey may not be representative of the overall market. Some products did not list e-liquid volumes. Therefore, comparisons of label information to actual e-liquid volumes could not be made for these samples. The labels of some products did not indicate whether the percentage of nicotine indicated on the label was expressed in mg/g or in mg/mL of e-liquid. In such cases, we assumed that the percentage was expressed in mg/g. We corrected the density to compare the percentages expressed in mg/mL. This had the effect of conservatively increasing the apparent concentration of nicotine for products that expressed the percentage of nicotine in mg/g. E-liquid volumes were not measured for all samples, resulting in a smaller sample size (NOT= 39 vs 51) for e-liquid volume and total nicotine content ratings. Although the actual amount of losses due to the extraction method of e-liquids is unknown, we have conservatively assumed losses of 10%. However, the relative ranking of the samples remains unchanged regardless of the actual amount of e-liquid loss. The technology and regulatory oversight of these products are evolving rapidly. Therefore, this survey could be out of date in a relatively short time as manufacturers modify their products to maximize consumer acceptance and comply with regulations.
One of the strengths of this investigation is that we measured e-liquid volumes in closed-system disposable e-cigarette products. Relatively few published studies have compared e-liquid volumes to label claims in closed-system disposables.
The researchers noted that variations in product characteristics such as nicotine content could impact the health, safety and addictive potential of e-cigarettes. [10, 12]. As noted above, some products contained significantly less total nicotine than the expected amount according to the product label. Not only does the consumer receive less than they expect, but these products may be less effective as alternatives to slow-burning cigarettes. The results of a recently published randomized placebo-controlled trial concluded that “ENDS with nicotine release approaching that of a cigarette are more effective in enabling ambivalent cigarette smokers to quit” . Additionally, misleading labeling could erode public confidence in the benefits of ENDS as a less harmful alternative to conventional cigarettes. Label discrepancies can be caused by poor manufacturing quality control, loss during storage, or questionable business practices.
In order to maximize the harm reduction potential of ENDS, it is imperative that these products are manufactured using quality control practices, the highest quality materials, and that their labeling is clear, accurate, and compliant. applicable quality and regulatory standards.