Findings In this randomized clinical trial, 119 adult nicotine or tobacco product users rated puffs from e-cigarettes in nicotine salt (benzoic acid added) and nicotine free-base (no benzoic acid) formulations. Salt vs free-base nicotine formulations resulted in statistically significant higher ratings of appeal, sweetness, and smoothness, and lower ratings of bitterness and harshness.
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Meaning In this study, acid additives in e-cigarettes that change nicotine from free base to salt appeared to enhance the appeal and sensory experience of vaping and merit consideration in e-cigarette regulation.
Importance Alkaline free-base nicotine is bitter and a respiratory irritant. High-nicotine electronic cigarette (e-cigarette) products contain acid additives that change nicotine from a free-base to a protonated salt chemical form, which could improve the sensory experience of vaping, particularly among never smokers unaccustomed to inhaling free-base nicotine.
Objective To determine whether exposure to e-cigarettes with salt vs free-base nicotine formulations improves the appeal and sensory experience of vaping e-cigarettes and whether nicotine formulation effects differ by e-cigarette flavor and ever combustible cigarette smoking status.
Interventions Participants self-administered standardized puffs of each 10 differently flavored e-cigarette solutions using a pod-style device. Each flavor was administered in salt (benzoic acid added) and free-base (no benzoic acid) nicotine formulations with commensurate nicotine concentrations (mean, 23.6 mg/mL). The 20 solutions were administered in randomly assigned sequences. Immediately after puffing each solution, participants rated appeal and sensory attributes.
Conclusions and Relevance In this randomized clinical trial of adult current nicotine or tobacco product users, controlled exposure to e-cigarette puffs with salt vs free-base nicotine formulations appeared to increase product appeal and improve the sensory experience of vaping, particularly among never smokers. Regulatory policies limiting acid additives in e-cigarettes might reduce the appeal of high-nicotine e-cigarettes among populations deterred from vaping e-cigarettes that emit harsh aerosol.
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Abstract:As pulmonary drug deposition is a function of aerosol particle size distribution, it is critical that the dynamics of particle formation and maturation in pMDI sprays in the interim between generation and inhalation are fully understood. This paper presents an approach to measure the evaporative and condensational fluxes of volatile components and water from and to solution pMDI droplets following generation using a novel technique referred to as the Single Particle Electrodynamic Lung (SPEL). In doing so, evaporating aerosol droplets are shown capable of acting as condensation nuclei for water. Indeed, we show that the rapid vaporisation of volatile components from a volatile droplet is directly correlated to the volume of water taken up by condensation. Furthermore, a significant volume of water is shown to condense on droplets of a model pMDI formulation (hydrofluoroalkane (HFA), ethanol and glycerol) during evaporative droplet ageing, displaying a dramatic shift from a core composition of a volatile species to that of predominantly water (non-volatile glycerol remained in this case). This yields a droplet with a water activity of 0.98 at the instance of inhalation. The implications of these results on regional and total pulmonary drug deposition are explored using the International Commission of Radiological Protection (ICRP) deposition model, with an integrated semi-analytical treatment of hygroscopic growth. Through this, droplets with water activity of 0.98 upon inhalation are shown to produce markedly different dose deposition profiles to those with lower water activities at the point of inspiration.Keywords: metered dose inhaler; spray plume aging; water condensation; aerosol hygroscopic growth; deposition modelling
Although nicotine has neuropharmacologically mediated reinforcing effects once absorbed into the bloodstream, alkaline free-base nicotine is bitter and irritates the airways.4,5 Before the entry of the JUUL e-cigarette brand into the market, e-cigarettes contained nicotine in its alkaline free-base chemical form, and free-base nicotine products with higher nicotine concentrations produced aerosol that was perceived by users as harsh, bitter, and less appealing4 and were infrequently sold.1 JUUL and other manufacturers of high-nicotine e-cigarettes have begun adding organic acids to their products, which changes nicotine from a free base to a protonated salt.6 It has been hypothesized that e-cigarettes with high nicotine concentrations in salt vs free-base nicotine formulations produce less aversive sensory effects, which might make e-cigarettes easier to inhale, more appealing, and more addictive.7 To date, this hypothesis has gone untested. Evidence that nicotine salt formulations enhance the appeal and sensory qualities of vaping might suggest that new regulations limiting sales of e-cigarettes with acid additives might benefit public health for populations who do not use e-cigarettes to quit smoking.
The present study addresses this gap using a tightly controlled double-blind trial designed to experimentally control for variation in marketing, device design, flavors, cultural trends, preexisting user preferences, and other factors in product choice. The use of e-cigarette solutions that were custom-designed to match nicotine concentration level, flavors, and other constituents across nicotine salt and free-base conditions permitted isolation of nicotine formulation effects. There was specificity in the results: nicotine salt enhanced desirable sensory attributes and suppressed undesirable sensory attributes of e-cigarette aerosol and did so independently of nicotine concentration.
Tobacco companies have historically used acid additives in combustible cigarettes based on industry research demonstrating that lowering pH increases the smoothness and palatability of tobacco smoke.29 Increasing the alkalinity of cigarette smoke increases perceived bitterness,30 and lowering pH can suppress the bitter-enhancing effects of some alkaline compounds.31 The proportion of free-base to salt nicotine in tobacco aerosol increases volatility, oral and upper airway deposition, stimulation of pharynx nicotinic receptors, and sensations of harshness.5 Long-term smokers may be familiar with such effects due to experience inhaling cigarette smoke, which might explain why the relative differences in perceived harshness and smoothness between salt and free-base formulations were less pronounced in ever vs never smokers in this study.
The health implications of vaping vary by age and smoking status. For older adult smokers who are unable to quit smoking, having nicotine salt e-cigarettes on the market might be advantageous if the sensory properties of these products facilitate transition from cigarettes to e-cigarettes.32 Both ever and never smokers in this study found the nicotine salt products significantly more appealing than free-base nicotine products, although young adult never smokers were more sensitive to the harshness-reducing effects of nicotine salt formulations than ever smokers. For never smokers and young people, having palatable and smooth nicotine salt e-cigarettes on the market that encourage chronic vaping patterns might be disadvantageous. Risks from long-term e-cigarette use include exposure to respiratory and cardiovascular toxins, potential for disrupted growth of brain pathways underlying mood and attention regulation, and nicotine dependence.32,33 Regulations reducing the availability of nicotine salt e-cigarettes may benefit the health of youths and never smoker populations who are unaccustomed to inhaling free-base nicotine. Because never smokers and youths might be deterred by the bitterness and harshness of e-cigarettes with free-base nicotine formulations that lack acid additives, they might be less likely to become long-term users of e-cigarettes if free-base nicotine products were the only e-cigarettes on the market. Regulatory agencies could decline to authorize (or unilaterally prohibit) sales of new or existing e-cigarette products that contain benzoic acid or other acid additives demonstrated to change nicotine from free base to protonated nicotine salt.6
Since the FP&L Act applies only to consumer commodities and their packages as defined in the Act, cosmetic ingredient declarations are required only on the label of the outer container of cosmetics customarily sold at retail or used in the performance of services conducted within the households. It does not apply, for example, to products used at professional establishments or samples distributed free of charge, unless such products are customarily also sold at retail, even if they were labeled "For professional use only."
The compounds of the proprietary antioxidant mixture dissolved in propylene glycol must be integrated into the product formulation and declared individually in order of decreasing predominance without the term "(and)."
The value of knowing the identity and intended use of the ingredient in question may be determined in terms of the importance of the ingredient to the product formulation. It must be assumed that, to be of value, the ingredient significantly contributes to the claimed performance or other pertinent characteristics of the cosmetic and that a cosmetic not containing the claimed trade secret ingredient, or containing conventional substitutes in place of the respective ingredient, could not be expected to perform equally well or otherwise meet certain requirements. Appropriate comparative testing of a cosmetic containing the trade secret ingredient, or one containing conventional substitutes, as well as testing of petitioner's cosmetic against competitor's cosmetic of the same use category may provide factual documentation to this effect and thus demonstrate the value of the information to petitioner. The value of the ingredient information may also be determined in terms of future market performance of a cosmetic or its profitability. However, this kind of value assessment is usually a difficult and inexact task and often provides little factual data to support a value assessment. 2ff7e9595c