To all of those who have patiently waited for us to resume our retail shipping with the ever-changing tobacco regulatory and taxation landscape - THANK YOU! At long last, our most popular Nicotine Bases and Nicotine Salts in 100mg/mL are available on the website for purchase and shipment to all 50 states (and internationally). In-compliance with the PACT act and state tax law, tobacco tax rates have been built into the products we ship, so no need to worry about hidden fees upon checkout. Our team has prepared and are ready to file taxes federally and in all states, so no blackouts are anticipated!
All SKUs that are listed on the website are available to ship immediately and held in freezer-cold-storage ready to ship. If for some reason you do not see the product you would prefer to purchase, i.e. a custom nicotine strength or PG/VG ratio, please don't hesitate to send us an email at askachemist@nudenicotine.com for a prompt response on the lead time for a custom blend.
In addition, we have made some light changes to our website to make your NN experience more streamlined and easier to navigate. We hope that you find these changes helpful to use and peruse. Please let us know if you feel we can improve upon the layout/design of our online store in any fashion - we welcome and appreciate your feedback!
Cheers and thank you to all of our supporters, DIY fans, and committed customers - we appreciate you and apologize for the long wait in resuming our retail sales.
We are now making a limited supply of our products available for our international customers to purchase.
FEATURED PRODUCTS:
100mg/mL Nicotine Salts
100mg/mL Nicotine Base
100mg/mL Nicotine Base |
We’d like to give special thanks to all of our customers who reached out via phone and e-mail voicing their support for our company and products. It means a lot to us to hear such positive feedback from so many.
With the impending PACT Act and deadline announcement we made on March 10th, we’ve received an overwhelming amount of orders and are doing our absolute best to catch up so that you can stock up while we access solutions to continue servicing you.
That being said – we’ve had to make the difficult decision to close the retail store earlier than originally announced.
We will be closing (temporarily) the store for retail purchasing as of 11:59p on March 25th 2021.
Any orders that aren’t processed by the shipping deadline of April 5th, 2021 will be refunded in full.
(Please email us at putustowork@nudenicotine.com for local pick up options going forward.)
We know many of you are as disappointed as we are to be announcing this; but please trust we are working a diligently as possible to fulfill all of your orders.
And to answer a frequent question we received after the last letter regarding business to business shipping; this can only be a registered business within the industry. (Please note this is not legal advice, please seek the advice of a PACT Act specialist).
As mentioned last time we are in discussion with a number of vape shipping upstarts to mold the future of direct to consumer purchasing. We’d again like to thank you again for your support and loyalty through this difficult and ever-changing times within the industry.
Best,
Nude Nicotine & Nude Labs
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Custom Blends - Classic Nicotine Base, USP Pharma:
Custom Blends - Classic Nicotine Base, USP Chroma:
Custom Blends - Nicotine Salts, USP Pharma:
]]>International Shipping can be delayed over a month if you select USPS as your shipping method. For a more reliable shipping arrival time, please select UPS as your shipping method.
Please allow up to two weeks for your order to be delivered. With the cases of Covid-19 ramping up in California, we are traditionally back to our skeleton crew. We are processing orders as quickly as we can, all while maintaining the safety requirements issued from the State of California.
As a disclaimer, when choosing shipping options, please understand that refers to the time it takes for the carrier to ship your order once they receive the product from our warehouse. This expedited shipping charge does not refer to the time it would take the lab to process and produce the orders. It refers to the time it takes for the package to be delivered once the carrier receives it.
If you would like your order expedited over the line of orders ahead of you in the backlog, we charge an expedited fee of 5% of the order, in order to expedite it through production in the lab. We apologize for any inconvenience and thank you for your patience.
We are pleased to inform you that UPS is still shipping internationally and our international customers are still able to place an order with UPS as it's carrier. We apologize for any inconvenience this may cause.
Dear Friends and Family,
We at Nude Nicotine have taken swift action to protect you, our staff, and our community against the spread of the coronavirus (COVID-19). This means Nude Nicotine is still manufacturing and shipping, but at a reduced capacity. Please allow additional time for your order to process and ship. If you have any questions about your order timeline or delivery date, please don’t hesitate to get in touch with our support staff. Our job is to ensure your needs are met while keeping our employees safe. All non-essential staff will return to work as-normal once CDC and CA state guidelines have advised that social distancing regulations can be lifted. The health and safety of our community are top priorities.
To be clear and concise, our corporation has taken the following steps:
Demand for nicotine products has also increased and we are working around the clock to address this! This means:
Our prayers are with all of you during these trying times. Wishing you health, safety, and comfort,
Jake Rubenstein
President & Chairman of the Board
Nude Nicotine & N.N. Analytics, Inc.
Jake.R@NudeNicotine.com
]]>Nude Nicotine & NN Analytics's Corporate Statement serves as an overview to our Scientific Review of the "Vaping Illness," AKA EVALI - Electronic Vapor-Associated Lung Injury. We cover the modes of exposure, specific products that have lead to exposure, and public health concerns regarding the illicit CBD and THC vapor products involved.
Our corporate statement speaks to the analytical protocol we feel must be instituted at a manufacturer-level for products to remain safe and on-the-market, our political views as to vapor regulation and "flavor bans," as well as the directions we as a company unit will be moving forward in support of free-access to all vapor products across the USA, under compliance with the FDA's 21CFR1100 regulation with PMTAs.
We truly hope you enjoy this read, and feel free to post comments to this page! We are happy to engage in conversation, whether in public, or via private message. Vape strong!
Short Video Overview:
Corporate Statement PDF Download Link:
DOWNLOAD FULL PDF STATEMENT HERE
More Information on Oil Testing for Contaminants at Nude Nicotine:
CDC "Vaping Illness" Oil Testing
Corporate Statement Text:
Nude Nicotine & N.N. Analytics Corporate Statement – Addressing the “Vaping Illness" – Acute Lung Failure & Lipoid Pneumonia
Authored by Jake Rubenstein – President, Nude Nicotine & N.N. Analytics – San Diego, CA – October 15th, 2019:
My name is Jake Rubenstein. I am blessed and privileged to be able to submit a written statement on behalf of my manufacturing facility Nude Nicotine, analytical laboratory N.N. Analytics, and regulatory consulting agency eLiquid GMP. I am here to speak proudly, boldly, and without reserve, on behalf of my colleagues in the scientific community and our collective research teams involving Electronic Nicotine Delivery Systems (ENDS – FDA terminology) here at Nude Nicotine & N.N. Analytics in San Diego. We, and our partner stakeholders, take tobacco control very seriously – when a product, service, or message is a detriment to public health, we feel it our mission to research, inform, discuss, and react in a collective manner. This is not only the scientific method, but a healthy approach to public policy. When the comments associating the “Vaping Illness” arose with correlations to flavored tobacco products, especially in those cases involving minors, we felt immediate action was necessary.
Inhalation Toxicology is one of Nude Nicotine’s (and other valuable stakeholders in the tobacco science sector) core competencies. Many outside the tobacco industry do not realize this fact – the data is in its conclusions are clear – flavors used in validated and FDA-reviewed eLiquids do not contain compounds, or levels of compounds, deemed harmful to the appropriate Protection of Public Health (APPH – FDA terminology) by inhalation at normal usage rates. Not only do our customers products contain extensive toxicological data for inhalation of their products by computer modelling, but many, if not most of them, have begun to endure the rigorous journey of independently-reviewed (IRB-approved) clinical trials on their products in humans to prove these facts. These demands are mandated by the FDA for market authority in the US by May 2020 under the Pre-Market Tobacco Application (PMTA) program.
Parents, teachers, and community leaders were rightfully outraged – the flood of broadly-classified news reports in combination with the CDC’s initial reports of the “Vaping Illness” linked to all vapor products sent the public into damage-control mode. Some considered this a “public health crisis” and rightfully so. There are friends and loved ones who will no longer be with us due to their inhalation of substances from THC and CBD vapor products. I, our partners, and the entire community, mourns these losses, and are equally frustrated at the public for not having proper control measures in place to test for, control, and enforce against THC and CBD companies selling these products. From one viewpoint, we must applaud the public health officials’ and governments willingness to address the issue – for us stakeholders, we are appreciative of the ability to address core issues of tobacco control – our missions are aligned wholly in this manner. However, our frustration has peaked over an even more toxic issue – the “bundling” of two equally important, but separate issues – tobacco control and the “Vaping Illness.” From this other viewpoint, we must protest the hasty way decisions were made. When honest, scientifically-transparent companies like many in the ENDS industry, are bundled with illicit cannabis and hemp companies as the cause of the “Vaping Illness,” they (and we) will not stand idly by. These companies, mostly small to medium sized businesses, not tobacco corporations, will not stand for this categorization of their products, or intent of their business.
Public policy is, and always has been, driven by subject-matter-expert review, and with proper impact studies prepared to demonstrate the effectiveness of the public policy. This “Vaping Illness” is not, has never been documented to, or will never be the result of, minors’ access to tobacco products. The media’s failure to address the scientific literature of the real issue at-hand – and even more damaging, replacing it with tobacco control issues like minors’ access to tobacco products, has truthfully, disabled the public’s ability to allow for proper public policy related to tobacco control. All vested stakeholders will agree with the following statement – “flavored tobacco products should never be sold in a location with exposure to, or directly to, children under the legal smoking age.” However, now that the public’s most trusted officials, their public health departments, have been fed broad statements by the CDC and poorly educated health “professionals” and public policy “experts.” A community-driven approach was not taken. The data was not reviewed to address the source of the “Vaping Illness,” resulting in poor public policy that will not stop the hemp and cannabis companies producing products with these harmful or potentially harmful chemicals (HPHCs – FDA terminology).
eLiquid products containing nicotine, historically, have never used non-polar components to the water-soluble chemistry of the solution. These compounds’ inhalation toxicology is well known to the medical literature as GRAS for inhalation, with most critical data being publicly available over a decade ago. No acute illness, known to the medical literature, had been ascribed to (an) ingredients used by vaporization, especially not one affecting over 1000 patients. Prior to 2019 there were very few adverse effects, even as the electronic industry grew to its first peak in 2015. The few isolated cases were traced to exposure to an e-liquid that was not manufactured to proper standards. However, in the summer of 2019, a large amount of lipoid pneumonia cases began to appear in patients who were known “vapers.” Upon closer clinical, radiological, and sometimes pathological scrutiny, these patients had been exposed to lipids not found in traditional e-cigarettes with nicotine, but from cannabis and hemp oils with adulterants.
It had become clear that the HPHCs connected to the cases of acute lung failure associated with vaping is linked to a new class of lipoid pneumonia, eVapor-Associated Lung Injury (EVALI) (5). These HPHCs - triglycerides, vitamins, and oils – are atomized in an electronic cigarette or vaporizer, most often from THC and CBD products. The sources of exposure of aerosol containing these contaminants can be attributed to the improper use of topical products labeled as “oils” in a vaporizer, or the presence of these HPHCs in the product formulation itself. Hemp and Cannabis industry stakeholders do not test for, consider, or provide ingredients list disclosure of their products sold to consumers. These HPHCs are commonly added by the manufacture to “cut,” dilute, and/or lower the cost of their final product while maintaining an oil-like consistency; they do so without regard to the potential adverse effects of the inhaled aerosol of these compounds.
“Vaping” or “Vapor” can constitute many products, including ENDS, THC vaping products, CBD vaping products, untested holistic therapies, and black-market products of many variants. This information was revealed in patient case studies from hospital networks as-early-as August of 2019, but corroborated by the CDC on October 11th with the following statements:
Nude Nicotine & N.N. Analytics recommend a community-driven approach to approach the federal government for resources and assistance – the CDC will directly-mediate to assist in the validation of scientific reasoning, public health impact statements, and will assist with minor and major cost factors. The “EPI-AID (2)” resource center is the Federal Government’s “hotline” for issues like these – public health emergencies. States like Illinois and Wisconsin have both called upon this center for assistance. Both governments are now working diligently with the CDC and DEA to identify products, locate manufacturing operations, and arrest proprietors of illicit black/grey market CBD and THC vaping product operations. Another State, Colorado, not less than 48 hours ago, arranged a State Board of Directors hearing to meet with its Marijuana Enforcement Division (4). The state is in the process of finalizing the addition of vitamin-e, medium-chain triglycerides (MCT oil), and polyethylene glycol (PEG), three of these unhealthy diluents/adulterants, to the required list of analytes to-be-tested for in all vaping products. We can only applaud these three State’s approaches to data-driven, and community-driven public policy, allowed to be commented on by all relevant parties, like the source of the EVALI itself – cannabis and hemp companies.
THC Vaping Products are regulated by State-run agencies, like the California Bureau of Cannabis Control (BCC) & Hemp products are not regulated in the same fashion but fall under the jurisdiction of California’s Department of Food and Agriculture. We formally recommend communities to speak directly to the Cannabis Advisory Committee in their state on their responsibility in addressing the needs of additional analytical testing, enforcement, and future regulatory concerns. Surprisingly, the state-mandated analytical protocols do not mandate testing for these oil-soluble ingredients – it is their liability to educate their stakeholders and the public. Unfortunately, as of the last 60 days, it has fallen upon the ENDS-industry-stakeholders to bring light to this fact. In many states, a discovery of such information is mandated to be disclosed to the proper authorities for further action. In California, this is a mandated requirement of the Department of Food and Agriculture and the Department of Public Health under Business and Professions Code Section 26014.
As an industry stakeholder, Nude Nicotine & N.N. Analytics have a professional agenda to address the “Vaping Illness” with 1 immediate action item to address EVALI and 2 ongoing action items to address proper tobacco control policy:
Immediate: Proper Analytical Testing: All vaping products, whether containing nicotine, CBD, or THC, must be submitted for analytical testing by a 3rd-party laboratory to be sold to the public. This protocol is recommended to be added to the FDAs HPHC list, as defined in the 21 CFR Part 1100, as well as applied to any, and all inhalation products, as in cannabis products under state-regulated statutes.
Ongoing: Mediated Scientific Review: Local governments are recommended to hold both open and closed meeting sessions with all relevant stakeholders and the public able to submit comments. In addition, CDC-EPI and other federal government resources should be consulted on developing an effective policy, as well as make public the results of the impact study of the proposed policy.
Ongoing: Smart Tobacco Control and Public Health Policy: We recommend each government entity to evaluate the resources, locally, state-wide, and federal, to commit ENDS, cannabis, & hemp vapor businesses to register and maintain licensure to do business in the region. In addition, we recommend that the public comment on manners in which they would like to regulate the businesses, commit to taxation, and act in support of enforcement of unregistered products as well as their sale to adults of age. In order to facilitate an approach that is most effective in reducing rates of smoking and restricting access to minors, each proposed policy must be produced with a 3rd-party-reviewed impact study. Without an impact study, the political intentions of legislation and/or policy cannot be considered as impartial.
With kind regards,
Jake Rubenstein
(858) 256-7620 Office
Jake.R@NudeNicotine.com
]]>
Nude Nicotine's & NN Analytics's Scientific Review is an in-depth analysis of the sources of exposure to the "Vaping Illness," AKA EVALI - Electronic Vapor-Associated Lung Injury. We cover the modes of exposure, specific products that have lead to exposure, and public health concerns regarding the illicit CBD and THC vapor products involved.
Furthermore, we include a thorough review of the clinical and radiological criteria that classify a patient with acute lung injury from exposure to harmful vapor. Colleagues and peers within our San Diego Medical community have stepped up to offer their opinions and review to this document, understanding its purpose - to further educate medical professionals on modes to assess patients and keep them safe.
We truly hope you enjoy this read, and feel free to post comments to this page! We are happy to engage in conversation, whether in public, or via private message. Vape strong!
Short Video Overview:
Scientific Review PDF Download Link:
DOWNLOAD FULL PDF STATEMENT HERE
More Information on Oil Testing for Contaminants at Nude Nicotine:
CDC "Vaping Illness" Oil Testing
Scientific Review Full Text:
Title:
Acute Lung Failure & Lipoid Pneumonia – Addressing the “Vaping Illness”: Diagnostic Criteria & Harmful Constituents in Hemp & Cannabis Products
Subtitle:
A Scientific Review of the Status of Literature, Medical Reports, & Industry-Practices of the Addition of/Exposure to, Harmful Constituents by Inhalation in Hemp & Cannabis Products.
Written by Jake Rubenstein
September 24th, 2019
President & Chairman of the Board – Nude Nicotine, Inc. & N.N. Analytics, Inc.
Laboratory, Analytical, & Regulatory Offices in Sorrento Valley, San Diego, CA
Brief Executive Summary:
This review shall serve as a guide and directive for local, state, and federal authorities, more specifically the CDC & CDC Emergency Center, to institute a set of diagnostic criteria for Vapor-Induced Exogenous Lipid Pneumonia (V-ELP), caused by the inhalation of non-polar lipids. This directive speaks to clinicians and radiologists. It allows target product identification and mandates analytical testing for a set of potentially-harmful constituents (HPHCs) involved in the production of cannabis or hemp products.
Moreover, this is a call-to-action to local government officials to separate “flavor bans” from the important public health risk – black market cannabis and hemp vapor products. As evident from the analytical testing reports, clinical, and radiological criteria, the cases of Illness presented are not rooted in the formulation or usage of nicotine-containing eLiquids. “Flavor bans,” in our professional opinion, do not address this lung illness, and should be separated in conversations about what is Appropriate for the Protection of Public Health (APPH). In a separate argument, flavored tobacco products should never be sold in a location with exposure to, or directly to, children under the legal smoking age. However, this scientific dissertation is focused on clinical, radiological, and analytical criteria of a “vaping illness” and is not intended to enforce a political agenda.
Nicotine-containing products used an Electronic Nicotine Delivery System (ENDS), historically, have never used non-polar components in their vaporized liquids due to the water-soluble chemistry of the three ingredients constituting over 95% of solution volume of all nicotine-containing e-liquids: propylene glycol (PG), vegetable glycerin (VG), nicotine. These compounds’ inhalation toxicology is well known to the medical literature as GRAS for inhalation within the parameters of the testing environments. Prior to 2019 there were very few adverse effects, even as the electronic industry grew to its first peak in 2015. The few isolated cases were traced to exposure to an e-liquid that was not manufactured to proper standards. However, in the start of 2019, and especially in the summer of 2019, a large amount of lipoid pneumonia cases began to evolve from those “vaping” (Vaping is the act of inhaling vapor produced by a vaporizer or electronic cigarette)
However, in 2019, particularly the summer of 2019, a large amount of lipoid pneumonia cases began to appear in patients who were known “vapers.” Upon closer clinical, radiological, and sometimes pathological scrutiny, these patients had been exposed to lipids not found in traditional e-cigarettes. According to the reports, in 82% of these cases THC or CBD products turned out to be the culprit of oil-exposure leading to V-ELP rather than those bought from a reputable vendor or manufacture.
Hypothesis:
It has become clear that the HPHCs connected to the cases of acute lung failure associated with vaping is linked to a new class of lipoid pneumonia. These HPHCs - triglycerides, vitamins, and oils – are atomized in an electronic cigarette or vaporizer, most often from THC and CBD products. The sources of exposure of aerosol containing these contaminants can be attributed to the improper use of topical products labeled as “oils” in a vaporizer, or the presence of these HPHCs in the product formulation itself. In a New England Journal of Medicine review of patient case studies, over 80%* were found to have consumed Hemp or Cannabis Vape Products procured from the black or grey market. Hemp and Cannabis industry stakeholders do not test for, consider, or provide ingredients list disclosure of their products sold to consumers. These HPHCs are commonly added by the manufacture to “cut,” dilute, and/or lower the cost of their final product while maintaining an oil-like consistency; they do so without regard to the potential adverse effects of the inhaled aerosol of these compounds.
*Pulmonary Illness NEJM, September 2019 – DOI: 10.1056/NEJMoa1911614
Proposal:
Nude Nicotine recommends the establishment of triage and diagnostic tools, both in the hospital and in the laboratory (clinical/radiological with tandem chemical analysis) to identify patients exposed to this new class of lipoid pneumonia, V-ELP.
SECTION 1: Background:
In the late months of August 2019, the nation began to see its first cases of a mysterious “Vaping Illness” with patients presenting to the emergency room in acute lung failure. Each of these patients presented similar symptoms and could all attest to have vaporized eLiquids of many kinds. To stop the spread of an unknown contaminant in the vaporization space, the CDC needed to act quickly. They issued a nationwide Health Alert Network (HAN) statement on August 30th, 2019, titled: “Severe Pulmonary Disease Associated with Using E-Cigarette Products”
https://emergency.cdc.gov/han/han00421.asp
As a result of this ongoing investigation, the CDC released the following statement:
“While this investigation is ongoing, if you are concerned about these specific health risks, consider refraining from using e-cigarette products.”
This broad statement sent the nation into panic in September. Vapers across the nation were not encouraged to continue vaping out of fear of an unknown contaminant in the supply stream. The source, product line(s), and origins were unknown. However, there seemed to be a statistically significant link within the growing case reports of illnesses. A very large cohort of patients within these case studies (over 80%*) admitted to using CBD or THC vaping products in addition to traditional ecigarettes with nicotine.
*Pulmonary Illness NEJM, September 2019 – DOI: 10.1056/NEJMoa1911614
“The mean monthly rate of visits to the ER for severe respiratory illness as identified by syndromic surveillance between June 1 and August 15, 2019,… was twice the mean monthly rate that occurred between June 1 and August 15, 2018 ( 7.4cases per 10,000 visits vs. 3.8 cases per 10,000 visits), in Illinois counties.”
Moreover, these case studies were appearing more rapidly in states without legal access to cannabis or hemp products on the legal market.
(Pulmonary Illness NEJM September 2019 – DOI: 10.1056/NEJMoa1911614 ) – “On July , the WDHS issued an alert to clinicians describing the clinical syndrome and requested that similar cases of pulmonary disease associated with e-cigarette use be reported to public health authorities. The WDHS was subsequently contacted by a physician in Illinois seeking clinical treatment guidance for a patient with similar clinical presentation and e-cigarette product exposure, and the WDHS promptly notified the IDPH in July. A joint WDHS–IDPH public health investigation was initiated sometime in August to identify additional case patients and to characterize the pulmonary clinical syndrome related to the use of e-cigarettes and related products. The CDC was consulted for technical assistance early in the investigation, and a CDC epidemiologic assistance weld team (Epi-Aid) was deployed to the WDHS and IDPH on August 20, 2019.”
The most important finding, however, is within the dates of the supposed V-ELP cases. The references section in the CDC’s warning, as well as the Status of the Literature, does not list case material more current than the Summer of 2019.
One of the only notable cases before the summer of 2019, was a non-conclusive study, relating to a similar illness using vaping products (undisclosed if nicotine or THC vaping)*
*Respiratory Bronchitis, Respirol, April 2017 – doi: 10.1002/rcr2.230
This has not been an issue pre-spring/summer 2019. Previous cases were of other types of pneumonia associated with exposure to a specific chemical, or class of chemicals (popcorn lung – diacetyl, diketones)*. As the example, diketones, like diacetyl, and acetyl propionyl, are chemicals present on the FDAs list of harmful chemicals (HPHCs – harmful or potentially harmful chemicals) within the 21 CFR Part 1100. Nude Nicotine and N.N. Analytics support this analysis on a qualifying basis for introduction to the market as per FDA ruling.
“Occupational exposure to 2,3-butanedione (BD) vapors has been associated with severe respiratory disease leading to the use of potentially toxic substitutes… (Toxicol Pathol. 2016 Jul; 44(5): 763–783. Published online 2016 Mar 29. doi: 10.1177/0192623316638962)
However, this exposure has not lead to a specific death in any clinical case using an ENDS with nicotine eLiquid in the Status of the Literature….
SECTION 2: An overview of lipoid pneumonia, its risk factors, and the newly-identified subset of lipoid pneumonia related to the “Vaping Illness:”
Lipoid pneumonia Medical Overview:
(Citation – Lipoid pneumonia: an overview – DOI: 10.1586/ers.10.74) –
“Exogenous lipoid pneumonia is related to inhalation or aspiration of fatty substances, whereas in endogenous lipoid pneumonia, intra-alveolar lipid accumulation occurs as a result of obstruction, chronic lung infection/disease or a lipid storage disorder.”
The definition of the subset of lipoid pneumonia we will use for the oil-soluble aerosol exposure from vaping cannabis or hemp products is Exogenous Lipoid Pneumonia (ELP).
“In the case of exogenous lipoid pneumonia due to inhalation/ aspiration, mineral oils/fat enter the tracheobronchial tree without stimulating the cough reflex and impair the mucociliary transport system… Once inside the alveoli, it is difficult to expectorate the lipid…. [and] oil is taken up by macrophages after emulsification. Because alveolar macrophages cannot metabolize the fatty substance, the oil is repeatedly released into the alveoli after death of the macrophages… The oil released elicits a giant-cell granulomatous reaction (hence also called lipid granulomatosis), chronic inflammation, and alveolar and interstitial fibrosis.”
(Pulmonary Lipid-Laden Macrophages and Vaping – DOI: 10.1056/NEJMc1912038) “A notable and consistent feature of the cases we report is the presence of lipid-laden macrophages seen with oil red O staining in BAL samples that are not attributable to aspiration of exogenous lipoid material. In addition, the diffuse parenchymal opacities seen on CT scans did not have low attenuation (in Hounsfield units) consistent with classic lipoid pneumonia. Although the pathophysiological significance of these lipid-laden macrophages and their relation to the cause of this syndrome are not yet known, we posit that they may be a useful marker of this disease.”
Clinical Criteria:
(Citation – Lipoid pneumonia: an overview – DOI: 10.1586/ers.10.74) –
“Blood investigation results are usually normal. However, leukocytosis and an increased erythrocyte sedimentation rate may occur”
Radiological Criteria:
(Citation – Lipoid pneumonia: an overview – DOI: 10.1586/ers.10.74) –
“The typical findings include homogenous dense consolidation, often with air bronchograms and sometimes a fine, ‘spun glass’ appearance may be observed [34]. The most common findings described on CT scan include airspace consolidations, areas of ground-glass attenuation, airspace nodules and ‘crazy-paving’ pattern [38]. Consolidations are usually heterogeneous and their negative density values, as low as -30 to -150 HU, are a diagnostic criterion for lipoid pneumonia…. Other radiological abnormalities that can be seen in these patients include pneumatoceles, pneumomediastinum, pneumothorax and pleural effusions.”
Disease Progression & Resolution:
(Citation – Lipoid pneumonia: an overview – DOI: 10.1586/ers.10.74) –
“The radiologic manifestations of acute exogenous lipoid pneumonia usually show a partial to complete resolution over time after stopping exposure to lipids. Resolution of opacities is usually observed within 2 weeks to 8 months, however, they may be progressive or static in some cases, even after stopping the exposure and symptomatic improvement… There can be scarring of lung parenchyma, which can cause persistence of radiological shadow… Fibrosis and coalescence of oil can result in nodules and masses with irregular margins, closely mimicking lung cancer”
ELP described this case subset perfectly - cases from aspirating oils and non-polar compounds that are not able to be hydrolyzed by semi-basic environment of alveolar mucosa.
(Exogenous lipoid pneumonia - doi: 10.1002/rcr2.356) – “Repeated oral administration of plant-based oil for cultural reasons was reported by 10 of 11 caregivers. Cough (12/12), tachypnoea (11/12), hypoxia (9/12), and diffuse alveolar infiltrates on chest radiography (12/12) were common at presentation. Chest computed tomography revealed ground-glass opacification with lower zone predominance (9/9) and interlobular septal thickening (8/9). Bronchoalveolar lavage specimens appeared cloudy/milky, with abundant lipid-laden macrophages and extracellular lipid on Oil-Red-O staining (12/12)”
An example from industry – inhalation of aerosol containing lipids can result in a similar form of ELP:
(Pulmonary Lipid-Laden Macrophages and Vaping -DOI: 10.1056/NEJMc1912038) “Further work is needed to characterize the sensitivity and specificity of lipid-laden macrophages for vaping-related lung injury, and at this stage they cannot be used to confirm or exclude this syndrome. However, when vaping-related lung injury is suspected and infectious causes have been excluded, the presence of lipid-laden macrophages in BAL fluid may suggest vaping-related lung injury as a pro visional diagnosis.”
THC use and prevalence of patients affected is high compared to nicotine use:
(Pulmonary Illness NEJM September 2019 – DOI: 10.1056/NEJMoa1911614 ) –
“80% reported use of THC products, and 7% reported use of CBD products (Table 2). A total of 37% of the patients reported using THC products only, whereas 17% reported using nicotine-containing products only.”
Report of brand – “Dank Vape” – 59% prevalence of use – high likely target for analytical testing of HPHC profile reported by Nude Nicotine/NN Analytics
https://www.dankvapes.org/product/mimosa-dankvapes-dank-carts-vape-pen/
Diagnosis is not related to viral or bacterial factors – negative testing
(Tree-In-Bloom – March 2017 – AnnalsATS Volume 14 Number 3) “An upper respiratory viral panel was negative and HIV serology and rheumatologic tests were all negative. Microbiologic culture was negative for all samples.”
(Pulmonary Illness NEJMSeptember 2019 – DOI: 10.1056/NEJMoa1911614 ) – “All the patients who received antibiotics on an outpatient basis had reported progression of respiratory symptoms, which had prompted subsequent hospital admission.”
Approximately 50% of patients exhibited lipid pneumonia:
(Pulmonary Illness NEJM September 2019 – DOI: 10.1056/NEJMoa1911614 ) – “A total of the cytology reports on bronchoalveolar-lavage specimens noted lipid-laden macrophages with oil red O stain; the other reports did not comment on the use of oil red O stain. Of the samples with noted lipid-laden macrophages, reports listed moderate lipid-laden macrophages”
Technique = bronchoalveolar-lavage AKA BAL (J Cytol. 2014 Jul-Sep; 31(3): 136–138.)
“Bronchoalveolar lavage (BAL) is a diagnostic procedure by which cells and other components from bronchial and alveolar spaces are obtained for various studies. One of the main advantages of BAL is that it can be done as a day care procedure. Material obtained by BAL can give a definite diagnosis in conditions such as infections and malignancies.”
Technique = measurement of ground-glass opacity (GGO) - doi: 10.3978/j.issn.2218-6751.2013.09.03)
(Pulmonary Illness NEJM September 2019 – DOI: 10.1056/NEJMoa1911614 ) – “Ground-glass opacities in both lungs were characteristically observed on CT, sometimes with subpleural sparing. Of the 48 patients who underwent CT imaging, 4 cases of pneumomediastinum, 5 pleural effusions, and 1 case of pneumothorax were present (in 8 patients). One patient had both a pneumomediastinum and a pneumothorax, and one patient had both a pneumomediastinum and pleural effusion.
Other conditions to consider for CT scan to determine the need for a definitive PET scan.
Pneumomediastinum
Pleural effusion
Pneumothorax
SECTION 3: Background to Patient Disclosure of illicit (or socially unacceptable) substance use - Reporting for THC and CBD cannot be considered completely accurate:
As noted by Bachhuber et al, a gentle approach to patient counselling is required to reveal specific products that the patient might have been exposed to. Illicit substances, like THC, or if not illicit, socially-unacceptable use of THC and CBD products lead to a large cohort of users who do not disclose the use of, or extent-of-use-of hemp and cannabis products.
Citation: (Pulmonary Illness NEJM September 2019 – DOI: 10.1056/NEJMoa1911614 ) – “Information on product use is based on reports by the patients, and patients may be reluctant to report illicit drug use.”
Citation: (Protecting Privacy or Protecting the Public March 2010 – Health Policy & Ethics): “According to a recent report published by the National Institute of Medicine, ‘‘[T]he HIPAA Privacy Rule does not protect privacy as well as it should, and ... as currently implemented, it impedes the conduct of important health research.’’ There is no question that these privacy protections are important and serve the public interest. In today’s tense climate of fears of identity theft, privacy violations, and other unwanted personal intrusions, however, it is easy for the public, and regulators, to lose sight of how easily the increasingly broad body of restrictions limiting access to medical and public health data can undermine efforts to better understand and improve public health.”
Another example of the same phenomenon outside of industry: (Harvard Men's Health Watch) – MSM HIV Reporting Statistics
“Yet, so far, most of the available data are from animal experiments or observational studies that rely on people's willingness to report their marijuana use. "And since most users are recreational, it's tough to accurately measure dosage and frequency," says Dr. Mukamal. It's no surprise, then, that the science is so cloudy. For instance, an analysis published in 2015 in The Journal of the American Medical Association examining almost 80 trials involving nearly 6,500 people found that most of these studies suggested that marijuana use was associated with relief of some symptoms, but the findings were inconsistent.”
Example within-industry:
Bachhuber et al – https://dx.doi.org/10.1089%2Fcan.2017.0051 - Willingness to Participate in Longitudinal Research Among People with Chronic Pain Who Take Medical Cannabis: A Cross-Sectional Survey:
“For respondents' indicating a willingness to participate in the proposed study (for any length of time), we presented a list of potential reasons why and asked participants to check all that apply. Similarly, for respondents not willing to participate, we displayed a list of potential reasons why not and asked respondents to check all that apply.”
“Of 405 respondents (estimated response rate: 30%), 54% were women and 81% were white non-Hispanic. Neuropathy was the most common pain condition (67%) followed by inflammatory bowel disease (19%). Of respondents, 94% (95% CI 92–97%) thought that the study should be done, 85% (95% CI 81–88%) would definitely or probably enroll if asked, 76% (95% CI 72–81%) would participate for ≥1 year, and 59% (95% CI 54–64%) would respond to questions at least daily. Older age was the only factor associated with lower willingness to participate, lower willingness to participate for ≥1 year, and lower willingness to respond to questions at least daily.”
Outside example –
HIV patients on the “down-low” – (Focusing :down low” – J Natl Med Assoc. 2005 Jul; 97(7 Suppl): 52S–59S.)
Case Study of Chronic Marijuana Smoker with almost identical symptoms to ELP, but without oil-red stain.
Example that BLA is required to investigate:
“38-year-old male with no past medical history who came for an evaluation due to a cough with hemoptysis and shortness of breath that started immediately after smoking marijuana. The patient was afebrile, and his blood pressure was 122/81 mmHg. His heart rate was 79 beats/min and his oxygen saturation was 90% in room air. Examination of his lungs indicated bibasilar rales… A bronchoscopy with bronchoalveolar lavage (BAL) was initially bloody, but subsequently became clear (Figure 4). BAL cell counts showed leukocytes at 120 cells/mm3, with 98% neutrophils, and red blood cells at 28,250106 cells/mm3. A transbronchial biopsy revealed chronic inflammation.”
(Citation: Hashimi et al – A Case Report of Cannabis Induced Hemoptysis – doi: 10.1097/MD.0000000000003232)
(Citation: Can J Respir Ther. 2015 Winter; 51(1): 7–9. - …Vapourized cannabis and respiratory risk)
Marketplace practices for Cannabis and Hemp Manufacturers of Vaporized Oils:
Commonplace diluents are used in vaporized THC and CBD eLiquid for manufacturers to obtain a certain terpene profile, viscosity, or diluted concentration to maximize on cost. These practices are, unfortunately, commonplace. Multiple manufacturers use high concentrations of monoterpenes, not sourced from cannabis, but from other plants, vegetables, and oils, to “flavor” their product. In addition, some manufacturers will dilute their product to maximize on cost, or “thicken” the product to hide the fact that they have diluted its concentration of the API, CBD or THC.
THC and CBD products are, unfortunately, also mislabeled in relation to their API. The early-adopters of CBD and THC vaporization technology used total percentage of the distilled oils (THC distillate and/or CBD distillate) to hide the fact that this was not the true concentration of the API in the product. Most, if not all manufacturers of these THC and CBD vaping products, label their packaging with this concentration, most often between 80-95%. In fact, the CBD/THC distillate used in these products is mostly of fair to excellent quality, free of the HPHCs noted above. The distillation process of CBD and THC, if conducted properly, eliminates the presence of these HPHCs, if even present in the starting extract (very low possibility), by way of boiling point separation. However, manufacturers dilute this distillate to a VERY low percentage, sometimes as low as 10-30%. The diluting agents are labeled below and represent the majority of the HPHCs that are causing acute lung failure by way of the lipoid pneumonia mechanism.
Between 2015-2019 as the industry matured, more grey-market and black-market THC and CBD vaporization products entered the market as well as among dealers on the street. These products were manufactured to the same disappointing labelling standard. Consumers purchasing products claiming to be “pure” THC or CBD were in fact pure before they manufactured the product. The oil itself was pure. But the manufacturing process introduced a plethora of HPHCs as the product formulators diluted and flavored their products. This trend has led to a reporting of “highly pure” cannabis or hemp products, which in fact, have been contaminated by diluents and have gone undisclosed. This is a direct supporting statement to the case study cited previously – Tree-In-Bloom – March 2017 – Annals ATS Volume 14 Number 3.
Section 5: How can we define compounds that, upon exposure, can lead to lipoid pneumonia:
Octanol: Water Partition Coefficient:
Definition of a compounds partitioning into oil (lipophilicity) or water (hydrophilicity), or a range in between.
It is worth noting that small molecule drugs in the LogP <2 range exhibit high solubility in lung mucosa, but their solubility is through a different mechanism:
Transcellular pathway – integration into the lipid bilayer of cell membranes.
Water soluble compounds diffuse by way of the:
Pore-diffusion @ cellular tight-junctions
(Citation – Patton et al – The Lungs as a Portal of Entry for Systemic Drug Delivery – doi: 10.1513/pats.200409-049TA)
Section 4: What compounds in Vaping products can be classified as lipoid-pneumonia
Please see list below labeled “Diluents Used:”
Diluents used:
High concentrations of monoterpenes
Lab Effects Terpene Diluent:
https://labeffects.com/the-cut-terpene-diluent/
TERPS USA Terpene Diluent:
Solutions marketed as diluting agents, “cutters,” and/or “thickeners”
Floraplex – mostly Phytol
https://www.buyterpenesonline.com/product-category/terpenes/diluent/
https://www.buyterpenesonline.com/terpenes-for-sale/terpene-diluent/
Mineral Oil (CAS 8012-95-1):
National Library of Medicine HSDB Database Case Report: Inhalation of Mineral Oil:
“We report a case of acute exogenous lipoid pneumonia in a 34-year-old-fire-eater. Six hours after inhalation of liquid paraffin, dyspnea, cough, fever, hemoptysis, and chest pain developed in this patient. Chest-computed tomography showed nodular infiltrations with ground glass opacities (GGO) in the right middle lobes, GGO alone in the right lower lobes, and consolidations with GGO in the left lower lobes. Lipid-laden alveolar macrophages in bronchoalveolar lavage fluid were detected by lipid staining (Sudan III stain, oil-red-O stain) and transmission electron microscopy. The symptoms and lung infiltrations were improved by treatment with prednisolone, together with antibiotics and urinastatin.”
(Citation: https://toxnet.nlm.nih.gov/cgibin/sis/search/a?dbs+hsdb:@term+@DOCNO+1922)
Vitamin E (tocopherols)
Vitamin E-acetate
MCT Oil
Coconut Oil
Other Cooking Oils
Section 6: Alternative hypothesis to product contamination:
Improper packaging as “FOR TOPICAL USE ONLY” – Topical Products are being inhaled in vaporizer devices:
Similar to eLiquid bottles – “boston round” 30-60mL with a dropper cap – markedly similar to eLiquid packaging. If a user mistakes this for their eLiquid, or by way of the packaging, assume it is intended for vaporization is a critical error. Aerosolization of oils and oil-soluble compounds is a direct source of the lipoid pneumonia – extremely similar lung case studies to aspirated mineral oil in infants as cited:
(Exogenous lipoid pneumonia - doi: 10.1002/rcr2.356) – “Repeated oral administration of plant-based oil for cultural reasons was reported by 10 of 11 caregivers. Cough (12/12), tachypnoea (11/12), hypoxia (9/12), and diffuse alveolar infiltrates on chest radiography (12/12) were common at presentation. Chest computed tomography revealed ground-glass opacification with lower zone predominance (9/9) and interlobular septal thickening (8/9). Bronchoalveolar lavage specimens appeared cloudy/milky, with abundant lipid-laden macrophages and extracellular lipid on Oil-Red-O staining (12/12)”
Conclusions & Recommendations:
It has become clear that the HPHCs connected to the cases of acute lung failure associated with vaping is linked to a new class of lipoid pneumonia. These HPHCs - triglycerides, vitamins, and oils – are atomized in an electronic cigarette or vaporizer, most often from THC and CBD products. The sources of exposure of aerosol containing these contaminants can be attributed to the improper use of topical products labeled as “oils” in a vaporizer, or the presence of these HPHCs in the product formulation itself. Hemp and Cannabis industry stakeholders do not test for, consider, or provide ingredients list disclosure of their products sold to consumers. These HPHCs are commonly added by the manufacture to “cut,” dilute, and/or lower the cost of their final product while maintaining an oil-like consistency; they do so without regard to the potential adverse effects of the inhaled aerosol of these compounds.
Moreover, this is a call-to-action to local government officials to separate “flavor bans” from the important public health risk – black market cannabis and hemp vapor products. As evident from the analytical testing reports, clinical, and radiological criteria, the cases of Illness presented are not rooted in the formulation or usage of nicotine-containing eLiquids. “Flavor bans,” in our professional opinion, do not address this lung illness, and should be separated in conversations about what is Appropriate for the Protection of Public Health (APPH). In a separate argument, flavored tobacco products should never be sold in a location with exposure to, or directly to, children under the legal smoking age. However, this scientific dissertation is focused on clinical, radiological, and analytical criteria of a “vaping illness” and is not intended to enforce a political agenda.
Now:
Products samples are tested for HPHCs in the same manner as the Product Testing recommendations listed below. This protocol is recommended to be added to the FDAs HPHC list, as defined in the 21 CFR Part 1100, as well as applied to any, and all inhalation products, whether by smoke, or by vapor, adherent to ISO 20768:2018, 20778:2018, 3308:2012, & 7210:2018 mandated requirements.
There should be a focus on the procurement and analysis of hemp & cannabis vapor cartridges, vape “oils,” and other products intended for (or appearing to be intended for) vaporization. The state-regulated testing requirements for cannabis and hemp testing must quickly enact this protocol (as being-developed) as mandated testing before sale on the market. Regulated cannabis and hemp markets do not currently employ any testing for these constituents, while ENDS nicotine-containing products do. Nude Nicotine, Inc. & N.N. Analytics, Inc. applaud the FDAs foresight of these chemicals as HPHCs in other industries; we recommend applying these to 21 CFR Part 1100 HPHC testing mandates.
Ongoing:
Collection of samples from street vendors to put out (DO NOT BUY LIST)
Prosecution & Legal Action against “grey market” and “black market” cannabis & hemp vapor product producers, as well as those ENDS products not currently registered with the FDA.
Triage #1: Diagnostic Criteria for Patient Exposure –
recommend the following analytical procedures to triage patients exposed to hemp & cannabis products exhibiting shortness-of-breath, wheezing or coughing, nausea, vomiting, and/or elevated heart-rate:
If SPO2 readings are below 96% and CT scan reveals abnormal lung function as indicated in point #2, admit patient, and submit for more-extensive diagnostics as-indicated in Triage #2
Triage #2: Clinical Techniques for evaluating the chemistries of HPHCs in cannabis & hemp products from Triage #1 –
recommend the following analytical procedures to examine BAL fluid for HPHCs that can expose a patient to ELP:
Triage #3: Methodologies for Patient Counselling & Treatment to Reveal Products containing HPHCs –
As noted by Bachhuber et al, a gentle approach to patient counselling is required to reveal specific products that the patient might have been exposed to. Illicit substances, like THC, or if not illicit, socially-unacceptable use of THC and CBD products lead to a large cohort of users who do not disclose the use of, or extent-of-use-of hemp and cannabis products.
Teens and underage users should never be coerced into disclosing their use, rather approached without family, and in a calm setting, to ensure to the patient that full-disclosure is in the best interest of their health, without punishment from parents. Underage patients do require admission and by a parent or guardian, whom are required to be disclosed this information. This is a sensitive topic. In whatever way possible, doctors, nurses, hospital staff, parents, and family alike must approach the underage patient with love, care, and kindness – never judgement based on what substances they have been exposed to.
In the same manner, adults with family present and whom would rather not immediately disclosure their substance use should be treated carefully and kindly.
These approaches are necessary if the goal is two-fold:
Triage #4: Chemical Analysis Criteria for Product Testing with Results from Triage #1-3 –
Nude Nicotine and Nude Nicotine Analytics recommend the following analytical procedures to examine all vaping products, specifically those containing cannabis or hemp, to evaluate for HPHCs form that can expose a patient to ELP:
Product (solid/liquid) testing:
Nude Nicotine Analytics Method ID – “VOL-DB-MS” –
Refinement of AOCS Official Method 5a-40: Free Fatty Acids in Crude and Refined Fats and Oils – applied to vaporized liquds in e-cigarette devices:
esterification of the lipid components into their corresponding FAMEs are not capable of discerning the FAMEs produced from FFAs in the sample from FAMEs produced from TAGs in the sample. Standard methods such as AOCS Official Method Ce 2-66.
(Citation: Hydrolysis Optimization - doi: 10.1186/1752-153X-5-67 – Salimon et al.: Hydrolysis optimization and characterization study of preparing fatty acids from Jatropha curcas seed oil. Chemistry Central Journal 2011 5:67.)
(Citation: Christie, W.W.; Gas chromatography and lipids. The Oily Press, Bridgewater, UK, (1989), pp. 184. - Lipids, chemical analysis I. Title 547.7'7046)
(Citation: https://doi.org/10.1093/chromsci/bms093 - Kail et al. Determination of Free Fatty Acids and Triglycerides by Gas Chromatography Using Selective Esterification Reactions)
Target analytes:
Alpha-Tocopherol (E307 – Vitamin E)
Hexadecanoic acid (75-10-3)
Dodecanoic Acid (143-07-7)
Decanoic Acid (334-48-5)
Octanoic Acid (124-07-2)
Emissions (Aerosol Testing):
Protocols are developed with protocols adherent to N.N. Analytics’ procedures utilizing ISO 20768:2018, 20778:2018 mandated requirements. Additional document controls and product chain-of-custody-requirements are also embodied for 21 CFR Part 1100 (2019):
Patent Pending by Nude Nicotine, Inc. & N.N. Analytics, Inc.
Products samples are tested for HPHCs in the same manner as the above Product Testing recommendations. This protocol is recommended to be added to the FDAs HPHC list, as defined in the 21 CFR Part 1100, as well as applied to any, and all inhalation products, whether by smoke, or by vapor, adherent to ISO 20768:2018, 20778:2018 3308:2012, & 7210:2018 mandated requirements
]]>We are pleased to announce the release of one of our most requested Products, our Patented Nicotine Salts™ formulae combined with our ARMOR v1 and ARMOR v2 packaging! Nude Nicotine is committed to offering not only the best nicotine solutions available but providing meaningful solutions when it comes to the long term storage of our products.
You can easily find these variations under the Products>Nicotine menu selection!
Nicotine is the heart and soul of everything we do here at Nude Nicotine and we identified a solution very early on to help with the delicate nature of nicotine, when we first released our ARMOR v1 series of products it revolutionized the way people think about the storage of their nicotine base, left on its own nicotine has a tendency to oxidize very quickly and by replacing with oxygen with heavier argon we significantly increased the shelf life of our solutions.
With our ARMOR v2 series we looked at packaging and we sought to tackle the problem of both oxidation as well as a convenient way to dispense the solution, the inclusion an inlet it allowed us to offer a packaging option that both kept oxygen out while being used as well as made the bottle spill resistant.
You may notice a new tab on the Products Page on the Nude Nicotine website – have a look at the Nicotine Salts Nicotine Base page!!! Rarely do we have new nicotine formula releases
“Signature,” “Hit,” and “Smooth” Nicotine Salt formulations are designed around harnessing the differing properties of nicotine inhalation character. Each of these three formulae are a differing blend of multiple cationic acids known to bind electro-negative nicotine on the tobacco leaf, and others that we have unique IP in-development at the laboratory!
Numerous cationic acids exist on the tobacco leaf; we know this since the pH of tobacco smoke is closer to 5 on the pH scale (1-14) than that of the basic nicotine, which is closer to 8. These acids possess positive charges, AKA free hydrogens, with exhibit attraction to nicotine’s basic nitrogen centers. This is nature’s beautiful way of stabilizing the nicotine molecule for prolonged activity and defense against oxidative degradation. The binding of a cationic salt at nicotine’s electronegative nitrogen center(s), inhibits the oxidative damage it would suffer in comparison to a non-salt formulation!
X-Ray Crystallography and other data from literature was aggregated in-lieu of traditional GC/MS or LC/MS reports due to the weaker binding forces that hold these cationic-anionic pairs together. Basically, they have to be frozen down to cryogenic temperatures to lock bonds in-place and then analyzed in-situ. This reveals the pairs of nicotine and acid bound together that would normally be separated when solvated into solution! We are able to bind these pairs in-situ at the Nude Nicotine laboratory pre-dilution to achieve this effect.
Nicotine Salts are formulated at 100mg/mL concentration and diluted in PG or VG and ready for use immediately. The use of the cationic salts may accelerate the color change of the nicotine salt solution, but is by no means indicative of oxidation therein. The binding of the two molecules results in a sharing of electrons from the cationic salt with the anionic nicotine, resulting in color!!!
]]>If you haven’t vaped a yogurt flavor from your local eLiquid manufacture, you may just want to take a second look at the formulation of these products.
Butyric acid is the common ingredient in these yogurt flavor, the major constituent imparting the rancid and creamy flavor of cultured yogurt. Cool chemistry to think about! And to-date, no journalistic evidence exists proving the butyric acid chemical to be harmful by inhalation by itself.
“BY ITSELF” being the operative words here. Recent rummaging around the interwebs and speaking with an old UCSD professor of mine has yielded an astounding piece of literature –
https://www.ncbi.nlm.nih.gov/pubmed/18940962
TL;dr (science stuffs) = Butyric Acid is a modulator of diacetyl reductase, the emzyme that breaks down diketones of many forms (think diacetyl, acetion, acetyl propionyl, etc…). If butyric acid is present in solution, it will downregulate the activity of diacetyl reductase, effectively allowing the diketones to remain in your body for longer periods of time, leaving them to their naughty business for longer periods of time (not good).
Conclusion – Butyric acid in eLiquids should be safe for inhalation based upon the current literature, however its presence should be accompanied by NO DIKETONE CONTENT WHATSOEVER. This presents an increased health-risk if they are indeed present in solution.
As a result, we are adding butyric acid as our newest analyte-of-interest to the Nude Nicotine library of compounds to detect for. Our qualifications will be a requirement of non-detectable results for all 3 major diketones if the presence of butyric acid is positive.
Vape safe friends! Best regards,
Jake
CEO, lead chemist – Nude Nicotine
We’ll admit, nicotine ‘aint cheap. Next to your flavoring compounds, nicotine solution is likely the most expensive component of your DIY mixing. Why let it go to waste? While the shelf-life of your solution may vary depending on a multitude of factors (to be explained in a few), there are 3 variables you can help to mitigate oxidation, thus preserving your precious nicotine from unwanted oxidation and hydration.
Without getting heavy into oxidation chemistry, let’s simplify by saying that these three buggers accelerate the oxidation of nicotine in your solution to its nicotine oxides. Not necessarily dangerous for inhalation (as all solution possesses this to some degree), however it will add to the commonly seen brownish/yellowish (/sometimes pinkish) hue, rank-wet-dog (pyridine) smell, and peppery taste. Sounds delicious? Ew (Shout-out Jimmy Fallon). These factors are evident of an oxidized nicotine solution, whether kept out of proper storage conditions, or preformulated and not fresh for use.
THESE ARE YOUR ENEMIES – FIND WHERE THEY SLEEP. SEEK. DESTROY. KILL.
1) Oxygen 2) UV Light 3) Heat
1) Oxygen is pesky. It easily solvates into solution by shaking, and will flood any container when uncapped and exposed to the atmosphere. It is everywhere in out atmosphere, thus is pretty difficult to isolate from your nicotine. However a wee bit isn’t going to degrade the solution. Naturally you will need to shake your solution, uncap for use, and recap. Although you can MINIMIZE this process! Consider dividing a 500mL bottle into x4 125mL bottles in order to limit oxygen exposure. With only 125mL exposed at one time, 375mL remain properly capped and stored from excessive oxygen. This is our thought process behind the Nude ARMOR argon-purged nicotine base.
2) UV light is a much easier variable to stamp out. Cobalt or amber tinted storage solutions block the UV-range of light from entering a storage bottle. An even easier solution is to place out of all rays of light… say… a freezer? Which leads us to #3:
3) What is this exotic piece of lab equipment you call a freezer? PLEASE PLEASE PLEASE make sure that your freezer is not accessed by children if storing your nicotine solution. Lock if necessary. Temperature is always a catalyst to reactions, and in this case (bad joke time):
Pink Floyd voice screams in – “WE DON’T NEED NO… OXIDATION…”
Cue awesome guitar: brow brow brow …..
Pink Floyd voice screams in – “WE DON’T NEED NO LIGHT FSHO……….”
Cue awesome guitar: brow brow brow …..
Everyone’s voice screams in – “Just put your nic behind that, LOCKED freezer wall.”
Few last points to cover – shelf-life varies largely by nicotine strength, as well as PG/VG ratio. Higher nicotine strengths will possess more nicotine molecules, less likely to be completely solvated by their carrier (PG/VG). Put simply – 100mg/mL formulations will keep for less time than a 24mg/mL formulation. PG is also a much better solvent for this purpose – it has an extremely low viscosity, will dissipate dispersed oxygen bubbles quickly (say that 4 times fast!), and has a longer shelf-life chemically (2 years from DOM, vs. VG – 1 year). Thus some may only see a short shelf-life for a 100mg/mL solution kept on a shelf compared to a 24mg/mL solution kept in multiple frozen aliquots. Remember, nicotine solution solvated in wither PG or VG WILL NOT FREEZE!
A few other points to cover – if storing your nicotine solution for longer than 6 weeks, please do transfer your solution into a glass bottle for prolonged storage (Remember – amber/cobalt!). Some plastics will not provide a complete vapor barrier against outside atmosphere and thus can leak over time. In addition, some LDPE plastics are known to have such a low density as to allow for other medium-sized molecules to migrate through the plastic wall. Not such a good thing to happen when a glass bottle would have solved all problems!
We at Nude Nicotine have cryogenically frozen pure, 100mg/mL, 24mg/mL, and 6mg/mL concentrations a while back (~8mo ago as of 9/14) which show minimal degradation. It is possible to store your solution for some time without a worry! Just keep the oxygen, UV light, and heat at bay
Here at Nude Nicotine, we utilize a variety of glassware, polypropylene containers, graduated cylinders, syringes, serological pipettes, and many other tools for our measurements. Here we will review some tools at our disposal that are not outrageously expensive and can be realistically obtained for the home DIY user.
Transfer pipettes, or pasteur pipettes, are commonly seen in plastic or glass with detachable rubber bulbs. Transfer pipettes are a VERY inexpensive and easy solution for the transfer of small amounts of eliquids when graduated measurements are not necessary. Commonly plastic transfer pipettes are molded with plastic graduations but most are uncalibrated and very difficult to read a meniscus in.
Syringes are a great way to utilize a high powered suction action for the transfer and measurement of viscous eliquids, commonly high in VG content. Most, if not all syringes with graduations are required to be calibrated, so you can be assured that the volume you are measuring is indeed true. Syringes are fairly inexpensive and a must-have tool for any DIY formulator in 1mL, 2.5mL, 5mL, 10mL, 20mL, and 60mL sizes. Most syringes are disposable if not constructed of glass. We also recommend the use of serological pipette tips (or syringes) to be used for the measurement of nicotine, as these tools minimize the probability of spills in comparison to pouring from a graduated cylinder.
Serological pipettes are a vacuum and gravity/pressure-operated measurement tool for non-viscous fluids. A disposable pipette tip is inserted into the unit, which provides suction of the liquid up the pipette tip, as well as the proper flow, or pressure, to expel the liquid. Flavorings, PG, and nicotine are very easily and quickly measured using serological pipettes, however closed-tip designs are too restrictive for the flow of viscous VG. We also recommend the use of serological pipette tips (or syringes) to be used for the measurement of nicotine, as these tools minimize the probability of spills in comparison to pouring from a graduated cylinder. Common sizes for serological pipette tips are 1mL, 5mL, 10mL, 25mL, 50mL, and 100mL. While the electrical units range from $150-400, manual models can be had for $50-100 and pipette tips are a great alternative expense-wise to syringes.
Everyone knows these! They are a very easy tool to read graduated measurements. They are inexpensive, reusable if washed clean with distilled water, and a great tool for the DIY home formulator. However, it is critical to be sure all liquid is evacuated from the cylinder to ensure a proper dispense. Viscous liquids like VG will take some time to extract from a graduated cylinder, and it is advised for smaller measurements, stick to a more controlled measurement solution such as a serological pipette or syringe. One additional piece of advice – VG’s viscosity also lends itself to its adhesiveness, which can prove a problem in the lengthy dispense times from borosilicate glass graduated cylinders. (While for PG, this is less of a problem). Therefore we recommend polpypropylene (PP) graduated cylinders for the measurement of VG, while borosilicate glass should be used for the majority of other measurements.
Most mixing for the DIY home formulator can be performed by hand. Nicotine is very non-viscous and disperses well in solution, along with a wide selection of flavorings. The only real problem arises in mixing volumes of eliquids with VG. Due to its viscosity, VG makes obtaining a well-mixed solution difficult. However, persistent hand-shaking will eventually obtain a well-mixed solution. IF you require some assistance, hobby-based paint bottle shakers work excellent for mixing bottles of eliquids. Here at the laboratory, we use a pneumatic-powered apparatus similar to a paint can shaker, but this is obviously overkill for most IDY home formulation scenarios. A quick confirmation can be done by visualizing an even dispersion of bubbles throughout the solution after thorough mixing, as well as the absence of any visible nicotine ‘pockets,’ evident as very transparent ‘whips’ in solution.
As for steeping, three variables are critical to shortening your steep time, while not endangering the chemical integrity of the eliquid. Avoiding heat, excess UV light, and to provide ample agitation. Our goal is to oxidize flavoring molecules and ensure they are adequately solvated by the PG/VG solvents without oxidizing the nicotine:
AVOID excessive heat at all costs! Heat will only accelerate the oxidation of nicotine. While it will also accelerate the oxidation of the flavorings, the activation energy to do so is much lower than required. Within our laboratory, we have concluded that a room-temperature after bath between 20-30C is ideal for maintaining a stable steep temperature.
Agitation is key in achieving adequate dispersal of your flavoring in solution. Constant agitation would be ideal, but unless you have access to a shaker, this might not be attainable. However, this is not needed in most cases. Another way to assist in agitation is through the use of sonication. By pulsing sound waves through the eliquid, all molecules in solution are further agitated and dispersed, all while in the absence of added heat. This is why sonication is a great method for agitation and won’t accelerate oxidation of your nicotine. A frequency of ~600Hz should provide adequate agitation but remain under the activation energy required to accelerate the oxidation of nicotine further. These sonicators are obviously intended for the laboratory, but a common home jewelry cleaner can work wonders as well. Make sure the bath is filled with distilled water to prevent buildup of mineral deposits on the interior of your sonicator, and have at it! Common sonication times range from 3-10 minutes per session. Give your liquid some time to settle in between sonications.
Oxygen is helpful in the steeping process, especially to accelerate the oxidation of flavoring molecules. If kept at room temperature and away from UV light, eliquid will be at the optimum ‘steeping’ conditions, avoiding the unwanted oxidation of nicotine in solution. Feel free to steep with your caps open! It can help to evaporate excess ethanol in solution from flavorings, and in combination with ample shaking/sonication, is an excellent approach to accelerating the steeping of eliquids.
For 100mg/mL nicotine base, we recommend storage in a freezer capable of temperatures between -10-20C. For short-term storage under months, PET bottles are more than adequate. However for longer storage times, we recommend the use of glass bottles and storage under argon gas. By minimizing the damage done from our three enemies heat, light (hidden in the freezer), and oxygen (argon displaces atmospheric oxygen sealed inside the storage bottle), we can lengthen the expiration of our nicotine base to its maximum potential.
As for diluted eliquids <36mg/mL (3.6%), storage in a cool (<40C), dry place away from light is an ideal short-term storage environment. However, for longer-term storage, we advise using a refridgerator in the ange of 2-8C. These storage guidelines can also be applied to flavor concentrates as well
]]>Our packages containing 100mg/mL nicotine base, and our other nicotine products shipped through USPS ‘Priority Mail’ have a unique packing method that ensures a leak-free, robust, and safe packing solution for all of your Nude Nicotine products. The following pictures demonstrate the packaging of a 250mL bottle of 100mg/mL nicotine base:
Layer 1: LDPE Polycone Caps provide a tight seal against our PET amber plastic and glass bottles:
Layer 2: LDPE heat-sealed bags ensure if a leak is to occur, the solution will stay contained within the LDPE bag. (Of course if you see any evidence of liquid leak into the LDPE bag, please contact us immediately. We will aid you in the disposal if this liquid and issue a replacement IMMEDIATELY) :
Step 3: Preparations of the rigid cardboard container in which the sealed bag will rest:
Steps 4 and 5: Additional sealing of the bottle in a second protective layer – bubble wrap followed by a third layer – bubble mailer:
Step 6: Top layer of protection the thrice-sealed bags:
Step 7: Appropriate ‘fragile’ and ‘glass’ labels placed visibly on packaging:
And there you have it! A properly packaged Nude Nicotine order on its way safe-and-sound to its destination anywhere across the US
Let’s have a look: The Nude Nicotine Package Drop:
]]>Of course this is the active ingredient in our eliquid. Nicotine for eliquid is obtained from the distillation of scrap tobacco leaves and further purified by chromatography or further distillation toobtain the 99.9% pure 1.0g/mL nicotine base we use here at Nude Nicotine. Concentration of nicotine in solution is commonly denoted in two manners – mg/mL or by % (As a quick reference, 12mg/mL would be equivalent to 1.2%). Nicotine in its purest form is a colorless, pyridine-odored, non-viscous liquid. Concentrations of >100mg/mL must be dealt with using full Personal Protective Equipment (PPE), adequate ventilation, in a biohazard-zoned facility with proper biohazard disposal. Concentrations of 50-100mg/mL should be handled using low-level PPE (long sleeves, gloves, safety eyewear) along with adequate ventilation. Common nicotine concentrations seen in finished eliquids are seen ranging from 2mg/mL – 36mg/mL. Nicotine imparts a throat hit to eliquids, and is characterized by many as a ‘peppery’ throat hit that lingers in the throat after vapor has been exhaled.
Propylene glycol is one of the two common solvents that composes eliquid (along with VG). PG is a clear, odorless, fairly non-viscous liquid that is a very common solvent used in a range of medical aerosol devices, most commonly seen in albuterol inhalers. A common misconception with PG is Left in its purity. Many in the public sphere have seen electronic cigarette use as harmful as a result of this solvent, claiming the use of an antifreeze as an ingredient., While they are correct, PG in a very unpure nd unrefined grade, is used in antifreeze as a glycol to lower freezing boints and raise boiling points. However, in electronic cigarettes, the grade of PG used is much higher, free of the heavy metals and other unwanted contaminants present in low-grade PG. Food-grade or greater PG is used in eliquid.In comparison to VG, PG is very non-viscous, and solvates nicotine extremely well, able to be mixed by hand in short amounts of time. PG also posesses a lengthier expiration date – 2 years – when stored in a cool (<40C), dry place. Nicotine in PG-carrier solvent is also a much easier solution to aliquot with graduated measuring equipment (i.e. graduated cylinders, conicals, syringes, etc…) due to its low viscosity. We recommend using PG as a nicotine solvent whenever possible, due to its lengthier expiration date and low viscosity, lowever using VG-solvated nicotine base may be necessary for some higher nicotine solutions or 100% VG eliquids. PG imparts a dessicating throat hit to eliquids, as well as providing very high flavor solubility due to its low viscosity and lower molecular weight.
VG is a colorless (or VERY light tan-opaque), odorless, very viscous liquid, the other common solvent used in eliquid (along with PG). When stored properly, in a cool (<40C), dry environment, VG will remain free from oxidation or degredation for one year. Most highly regard VG for its smoothness and large vapor production, and it is excellent in these two areas. However, VG lacks the robust flavor solubility that PG posesses, and has a quicker expiration date. In addition, with liquids containing VG, the vaper must be conscious to vape within range of VG’s flash point (176C). Vaporizing eliquid is a function of atomizing eliquid at the flash point, and our goal is to hover around this temperature as the flash point of VG is the higher than both PG and nicotine. However, with VG, at the boiling point(290C), carcinogenic acrolein is produced. This fact should be considered with vapers using rebuildable atomizers reaching high temperatures vaporizing high-VG eliquids. Please be wary of your operating temperatures
Flavorings vary widely between eliquids, but are commonly extracted from natural sources by distillation, or synthetically prepared in the laboratory mimicing naturally-occuring substances. Carrier solvents commonly include PG, VG, water, and ethyl alcohol. Many flavorings are extracted under differing distillation processes, resulting in a wide concentration of end-products. While our flavorings produced here at Nude Nicotine are recommended for use at between 0.5% – 7.5%, many other products are intended for use at between 10%-25%. This usually defines the difference between a concentrated, and non-concentrated flavoring extract. While there are a wide range of food-based flavorings that would be seemingly appropriate for use in eliquids, the DIY vaper must be conscious of the hydrophobicity of the flavoring in question for health reasons. Water-soluble flavorings carried in PG, VG, ethanol or water are most commonly appropriate for eliquid use, due to their hydrophilicity. However, oil-based flavorings of a lipid source can lead to a condition deemed ‘lipid pneumonia,’ a result of continued buildup of lipids effectively suffocating the alveoli of the lungs. We at Nude Nicotine encourage everyone to explore the world of vape-safe flavorings on the market! And we know it can be a daunting task As always, you can turn to our concentrated flavorings for a guaranteed-safe and delicious solution, however if you are concerned about another vendor’s flavor you would like to use in your DIY recepie, please don’t hesitate to contact us and we would be happy to impart some advice wherever we can.
And here are a few additional ingredients that are common to many eliquids, but are not part of the main ingredients list:
Here at Nude Nicotine we do not utilize water in our eliquids, however, many use them to assist in the lowering of viscosity in high-VG eliquids. When a smooth vapor is desired, free of PG, water would be the additive of choice (rather than PG) to lower the viscosity of the solution. Distilled water must be used, as to avoid hard mineral deposits on atomizer coils and wicks.
And the recipes can be made much more complex with additional sweeteners, sours, salts, and much more. While quality chemistry in an eliquid an never be feigned, a well-trained culinary figure always makes a solid addition to your DIY team!
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