Important message re.: the diacetyl and acetyl propionyl Issue

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A Very Important Message from NicVape

NicVape’s E-liquids received a taste lift…and a new look. We are always striving to provide the highest quality e-liquids in the industry by researching, analyzing and adapting our business processes and even changing our products in the best interest of our customers. We have made dramatic changes to address what has been referred to as the DA/AP issue. We have reformulated our most popular liquids and flavors; some new and exciting liquids will be introduced using our “E-flavors” flavoring concentrations. E-Flavors is the first flavoring specifically engineered for vaping. We kept in mind your taste buds, as well as your well-being. We listen to our customers, and these changes are for you!

Below is important information on the current state of the industry and what NicVape is doing to help insure your products are not only the best on the market but also provide you the peace of mind that everything is being made with transparency and responsibility.

What is Diacetyl and Acetyl Propionyl and why should I care?

Independent Toxicologist, R. Patrick Rainey, Ph.D., DABT, recently performed an evaluation of the use of Diacetyl and Acetyl Propionyl in e-liquid. His conclusion was:

“Upon critical evaluation of the available toxicology and epidemiology data described within this monograph and more thoroughly within the associated references, along with the smoking behavior data collected on both human subjects and CF-PD simulations describing compensatory smoking behaviors and more deep lung exposures from e-cigs/vaporizers, it is concluded that diacetyl and 2,3-pentanedione should not be considered as candidates for flavoring in the e-cig/vaporizer solution. Furthermore, any consideration of reactive volatile organic carbonyl compounds for inclusion into the e-cig/vaporizer solution should be thoroughly evaluated based upon the most recent toxicological and epidemiological data.”

To read the full paper you can find it here: https://drive.google.com/file/d/0B0JrO25MOsG5VjBBd0d4SlVNOXM/edit?usp=sharing

Dr. Konstantinos Farsalinos published in the journal Nicotine and Tobacco Research, evaluating the presence of two inhalation toxins (diacetyl and acetyl propionyl) in e-cigarette liquids. Researchers, led by Dr, Konstantinos Farsalinos from the Onassis Cardiac Surgery Center in Athens-Greece, obtained 159 e-liquid samples (all sweet-flavored) from 36 manufactures and 7 countries (6 European and the US). They tested them for the presence of diacetyl and acetyl propionyl. These two chemicals are ingredients of flavorings and, although safe for use in food, have been associated with the development of respiratory dysfunction when inhaled.

The study found that 74.2% of the samples contained either diacetyl or acetyl propionyl, with more samples containing diacetyl. The levels were on average slightly lower than currently-established safety limits (set by NIOSH), but more than 40% of the samples had higher than safety levels. Of note, the highest amount of diacetyl found was 495 times higher than safety limits, while for acetyl propionyl it was 22 times higher. Tobacco cigarette smoke contains both compounds, at levels 100 times higher for diacetyl and 10 times higher for acetyl propionyl compared to e-cigarette average daily exposure.

You can find more information here:

http://www.ecigarette-research.com/web/index.php/research/2014/178-da-ap

What NicVape has done and is doing about Diacetyl and Acetyl Propionyl

NicVape position on Diacetyl and Acetyl Propionyl:

DIACETYL IN E-LIQUIDS

The absence of sufficient information on potential risks from and the incomplete database on the toxicology of diacetyl exposures by inhalation indicate that to protect consumers from potential adverse effects the use of this ingredient in e-liquid flavors should be avoided.

Since its founding in 2010, NicVape has been dedicated to the principles of quality, health and safety. NicVape is a founding member of the American E-Liquid Manufacturing Standards Association (AEMSA), the first and only manufacturer’s trade association completely dedicated to creating responsible and sustainable standards for the safe manufacturing of e-liquids used in e-cigarettes and advanced personal vaporizers.

As part of our commitment to consumer safety, we are constantly evaluating our products, the ingredients used in them, as well as our manufacturing practices. In this regard, two substances that are present in some e-liquid flavors have recently been singled out as being of particular concern if inhaled from e-cigarette vapor: diacetyl and acetyl propionyl (2,3-pentanedione), a common diacetyl replacement.

Although no specific health risks have been established for the use of these substances at the levels typically present in some e-liquid flavors, after considering the available scientific evidence and consulting with third-party experts, we have determined that the absence of sufficient information on potential risks from and the incomplete database on the toxicology of diacetyl exposures by inhalation indicate that to protect consumers from potential adverse effects the use of this ingredient in e-liquid flavors should be avoided. Therefore, NicVape will not use diacetyl or acetyl propionyl as ingredients in any of its e-liquid flavors.

Experts have evaluated and determined that diacetyl by ingestion is safe in low concentrations when present in food. [i] Indeed, diacetyl occurs naturally in foods such as apples, beans, butter and is present in alcoholic beverages (as a byproduct of fermentation). Diacetyl is commonly employed as a flavoring agent to impart a buttery taste, as well as for other purposes. However, exposure to diacetyl by inhalation has been documented to be associated with bronchiolitis obliterans, a severe, irreversible, sometimes fatal respiratory illness. [ii] The disease has been most commonly reported in the microwave popcorn production industry, but has occurred in the flavor manufacturing industries and elsewhere where work-place inhalation exposures occur. In addition to bronchiolitis obliterans, other abnormalities involving obstruction with breathing and other respiratory symptoms have been associated with exposure to diacetyl. [iii] Current data suggest that diacetyl and chemicals with similar structures (such as acetyl propionyl) are the primary agents responsible for the well- documented debilitating disease associated with inhalation exposures. [iv] The nature and magnitude of possible effects include; comprising debilitating fatigue and potentially irreversible incapacitation. [v] Results from high levels of inhalation exposure to diacetyl suggests that strong precautionary measures should be taken to ensure that no consumer is at unnecessary risk of these effects from any consumer product.

Laboratory studies have confirmed the role of diacetyl and similar chemicals in the development of bronchiolitis obliterans and related disorders. [vi] Following the outbreak of bronchiolitis obliterans among microwave popcorn flavor workers, scientists affiliated with the National Institute of Occupational Safety and Health (NIOSH) carried out several epidemiological and toxicological studies on diacetyl and other butter flavoring substances. [vii] In short term exposures using mice and rats using airborne concentrations of heated butter flavoring, of which diacetyl was the primary constituent, resulted in significant lung damage. Further studies using longer exposure periods have confirmed that no inhalation exposure level to diacetyl has yet been observed that can serve as the basis to assure consumers that inhalation of diacetyl and similar chemicals will not result in irreversible or disabling lung effects.[viii] In other words, while a there may be a “safe” inhalation exposure level to diacetyl, such level has not yet been determined.

NicVape has committed to taking the most cautionary approach that will guarantee no risk of harm from potential exposure to diacetyl and similar substances: we will not use diacetyl or acetyl propionyl as ingredients in any of our e-liquid flavors . Specifically, all NicVape e-liquids will be made with our own flavor concentrates that have been engineered specifically for the vaping industry and independently tested.

We believe that the e-liquid industry should work together to ensure that ingredients that may pose a health or safety concern when inhaled are not present in flavors. We encourage all e-liquid manufacturers and flavor suppliers to have their products independently tested by accredited laboratories using appropriate methodologies and detection limits.

How did we get where we are today?

Since our founding in 2010, NicVape has utilized flavorings designed for foods; something that was common to the e-cigarette industry at that time. All the flavors that NicVape utilized between 2010 and 2014 were understood by NicVape to be diacetyl-free due to Material Safety Data Sheets (MSDSs) that were supplied by the food flavoring producers and product specifications provided by the supplier. None of the MSDSs provided to NicVape indicated that diacetyl was an intended or unintended ingredient. Additionally, labels did not indicate diacetyl as an ingredient and in some cases certifications of tests were provided that indicated there was no diacetyl in the product. Further, product specifications were also sent to NicVape by flavorings manufacturers that indicated that their products were diacetyl and acetyl propionyl-free.

NicVape was alerted in January 2014 that some of the flavorings NicVape used could potentially contain diacetyl despite the supplier indications. In response, NicVape began to test every flavoring used in production. We performed this testing in January of 2014. We began testing our root flavorings in the order of most likely to contain diacetyl or acetyl propionyl to least likely. Diacetyl and acetyl propionyl was detected in 38 of 69 flavors at levels ranging from non-detected (ND) to 6423 µg/ml. Those items where immediately discontinued.

We approached our flavoring providers and asked them to remove diacetyl and acetyl propionyl from their products. If the flavoring manufacturers were not amenable to the change, NicVape found new manufacturers that would adhere to NicVape and AMESA diacetyl standards.

Subsequent to approaching our providers and in some cases, finding new ones, NicVape again tested all of our flavorings for diacetyl and acetyl propionyl in March 2014. Diacetyl and acetyl propionyl was detected in 4 flavorings. To complicate the issue we found that diacetyl or acetyl propionyl in a flavoring could vary from batch to batch, indicating that the supply chain as we knew it was unreliable. Due to the few trace level concentrations of diacetyl or acetyl propionyl detected in some bathes of the flavoring supply, NicVape decided to reformulate all of their products, and go “diacetyl acetyl propionyl-free ” using GMP certified sources with flavorings that are independently certified.

Beginning after the March 2014 round of testing, NicVape found a flavoring manufacturer that is in the top 10 worldwide providers for flavorings, that provided flavors with no detectable diacetyl or acetyl propionyl that was willing to work with us to produce a line of flavors specifically engineered for e-cigarettes. In the past, the industry standard was to use food flavorings and adjust them for use in e-cigarettes. NicVape’s new line of “e-flavors” flavoring concentrate was tested for diacetyl and acetyl propionyl in July 2014. Diacetyl and acetyl propionyl was not detected in any of the new flavorings. NicVape continues to do quality assurance random testing to ensure our root flavorings do not have detectable diacetyl or acetyl propionyl.

Starting in October 2014 with our New e-liquid product lines, NicVape will begin testing every batch of final e-liquid product produced to provide access to the public as well as our wholesale & retail partners through our Online transparency application NicTrace : http://www.nicvape.com/Nictrace

Customers can go to the Nictrace System and enter the Batch ID from their NicVape product and see the 3 rd party testing results. For a sample report you can use batch id: “Sample e-liquid test report”

Our continued support of the community we love

At NicVape we are very active in the E-liquid community, and as part of this, we are strong supporters of the American E-liquid Manufacturers’ Standards Association. During the deeming FDA regulations NicVape responded with comprehensive comments. You can review the comments in their entirety here: https://drive.google.com/file/d/0B0JrO25MOsG5QVpmbEp4WkMzSWs/edit?usp=sharing

NicVape has always taken strides to demonstrate responsible manufacturing, including proper labeling, testing of ingredients and flavorings by implementing good manufacturing practices, and unprecedented levels of transparency.

Our mission is to provide the highest quality e-liquids and vaping products, while maintaining policies and procedures that set the standard for quality control, exacting production, and stellar customer service

E-liquids are now available in the following 3 collections.

To create these new lines NicVape has utilized the experience of a top 10 root-manufacturing company, and its 100-plus years’ of experience. These are offered in 15ml, 18ml and 30ml bottles coming in strengths of 0mg, 6mg, 12mg, and 18mg. Premium tobaccos will also be offered in 24mg.

ORIGINS


  • PET bottle with long nipple tip 18ml and 30ml
  • 50/50 PG/VG blend with the beginner customer in mind.
  • Flavors such as,
  • -Glacier
  • -Roots
  • -Adam’s Demise
  • -De-Vine
  • -Polar
  • -Big Bang
  • -Gaia

WILDSIDE

  • Amber Glass bottle, filled with more complex blends. 15ml and 30ml
  • 30/70 PG/VG blend Higher VG ratio is designed for enhanced experience with tanks, dripping and variable voltage devices.
  • Flavors such as,
  • -Red Venom
  • -Harlequin
  • - Cheshire
  • -Chaos Theory
  • -Mojito Loco
  • -Frost Bite





Tradewinds


  • 50/50 /VG blend a lineup of premium tobacco from different regions of the world. 15ml and 30ml
  • Cobalt Glass bottles
  • Flavors such as
  • -Tuscan Grape
  • -Carolina
  • -Carolina Cool
  • -Scandinavian Cured
  • -Havana
  • -Turkish
  • -Cameroon

Following the market trend and the buying habits of our customers we are discontinuing 10ml bottles. NicVape will only produce 15ml and 30ml bottles.

These changes will be implemented starting today. Pre orders are being accepted now and product will begin being shipped in mid-October.


[i] See FDA’s food additive regulations, 21 CFR § 184.1228 (2014) (“Diacetyl”); available online at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1278&SearchTerm=diacetyl. That regulation affirms the generally recognized as safe (GRAS) status of diacetyl as a direct human food ingredient when used as a flavoring agent and adjuvant at levels not to exceed current good manufacturing practice.

[ii] NIOSH, Diacetyl and 2,3-Pentanedione Criteria Document, “Occupational Exposure to Diacetyl and 2,3-Pentanedione,” External Review Draft at ix, (August 12, 2011) (hereinafter “NIOSH Criteria Document”), available online at: http://www.cdc.gov/niosh/docket/archive/pdfs/NIOSH-245/0245-081211-draftdocument.pdf.

[iii] See NIOSH Criteria Document at 12, 51.

[iv] Harber, P. et al. 2006. Diacetyl-Induced Lung Disease. Toxicol. Rev. 25(4): 261-272.

[v] Fjita, Y. et al. 2012. Pulmonary Actinomyces graevenitzii infection presenting as organizing pneumonia diagnosed by PCR analysis. J. Med. Microbiol. 61(8): 1156-1158.

[vi] Harber, P. et al. 2006. Diacetyl-Induced Lung Disease. Toxicol. Rev. 25(4): 261-272.

[vii] Sahakian, N., and Kreiss, K. 2008. Lung Disease in Flavoring and Food Production: Learning from Butter Flavoring. In Advances in Food and Nutrition Research , 163-192. Academic Press.

[viii] See NIOSH Criteria Document at 94, Table 4.1.

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