Over the course of the past 2 years, consumer demand for e-liquids and e-cigarettes has been on the rise. During this time period, there have been many concerns from the general public about how safe these e-liquids are and what ingredients they are comprised of.

Common ingredients in e-cigarettes and e-liquids include nicotine, vegetable glycerin, propylene glycol, water, natural and artificial flavoring. Flavoring either natural or artificial is commonly used in e-liquids to represent a food or specific flavors such as traditional tobacco, honey, cereal, mint, and more.

Nicotine-Containing Liquid Restrictions

EC must not contain more than 20 mg/ml of nicotine

Nicotine-containing liquid must be in dedicated refill containers not exceeding 10ml volume, and cartridges or tanks do not exceed a volume of 2ml

Additives are not prohibited but the nicotine-containing liquids cannot contain additives that are otherwise prohibited by the other Articles in the TPD

High purity ingredients must be used and substances other than those declared should only be present in trace quantities which are unavoidable during manufacture

Ingredients must not pose a risk to health either when heated or not heated

Nicotine doses must be delivered at consistent levels under normal conditions of use

Poducts are required to be child and tamper proof, protected against breakage and leakage and have a mechanism that ensures refilling without leakage

Products Must Include a Leaflet with Required Information

Instructions for use and storage of the product, including a reference that the product is not recommended for use by young people and non-smokers

Contra-indications

Warnings for specific groups

Possible adverse effects

Addictiveness and toxicity

Possible allergy information

Current E-Liquid Safety Concerns

The primary purpose of our analysis on e-liquid is for safety concerns and public health. Manufacturers and distributors of e-liquids (or e-juice) should be aware of what is in their product. Many safety concerns about contents of e-liquids have been constructed (and some fabricated). You should know what you’re selling to your customers.

Indoor Air Quality

Many studies have been performed for indoor air quality of e-cigarette vapor. A main question and voiced concern for the public is how second-hand vapor affects us. Please see the information below:

Comparison of the Effects of E-cigarette Vapor and Cigarette Smoke on Indoor Air Quality

http://informahealthcare.com/doi/abs/10.3109/08958378.2012.724728

Levels of selected carcinogens and toxicants in vapor from electronic cigarettes

http://tobaccocontrol.bmj.com/content/early/2013/03/05/tobaccocontrol-2012-050859.abstract

Does e-cigarette consumption cause passive vaping?

http://onlinelibrary.wiley.com/doi/10.1111/j.1600-0668.2012.00792.x/abstract

Electronic cigarettes: an evaluation of exposure to chemicals and fine particulate matter (PM)

http://www.ncbi.nlm.nih.gov/pubmed/22913171

Secondhand Exposure to Vapors From Electronic Cigarettes

http://ntr.oxfordjournals.org/content/early/2013/12/10/ntr.ntt203.short

What Am I Inhaling?

As mentioned above, there are common ingredients for most e-liquids. What adverse effects can be found from these substances?

Propylene Glycol

Propylene Glycol or (PG) is one of the primary ingredients in e-cigarettes. According to research studies dating back to the 1940’s, this ingredient has been used in inhalants for quite some time in devices such as asthma inhalers, air disinfectants in hospitals and restaurants, and entertainment centers as well such as theaters, bars, and restaurants. This substance is also a main ingredient of fog machines.

Is PG Safe? Should I be concerned?

“Propylene glycol is used in air sanitization and hard surface disinfection and dipropylene glycol is used in air sanitization.”

“Propylene glycol and dipropylene glycol were first registered in 1950 and 1959, respectively, by the FDA for use in hospitals as air disinfectants.”

“Indoor Non-Food: Propylene glycol is used on the following use sites: air treatment (eating establishments, hospital, commercial, institutional, household, bathroom, transportation facilities); medical premises and equipment, commercial, institutional and industrial premises and equipment; laundry equipment; hard non-porous surface treatments (bathroom facilities); automobiles; air conditioning filters; pet treatment, including cats, dogs, and caged birds; environmental inanimate hard surfaces; garbage containers/storage.”

“Target Pests: Odor-causing bacteria, Fleas, Mites, Red lice, Animal pathogenic bacteria (G- and G+ vegetative), Shigella bacteria, Pasteurella bacteria, Listeria bacteria, Herpes Simplex I and II, Animal viruses, Influenza Virus A2, Aspergillus Niger Fungus, Mold/Mildew, Pseudomonas SPP., Shigella Flexneri, Shigella Sonnei.”

General Toxicity Observations

“Upon reviewing the available toxicity information, the Agency has concluded that there are no endpoints of concern for oral, dermal, or inhalation exposure to propylene glycol and dipropylene glycol. This conclusion is based on the results of toxicity testing of propylene glycol and dipropylene glycol in which dose levels near or above testing limits (as established in the OPPTS 870 series harmonized test guidelines) were employed in experimental animal studies and no significant toxicity observed.”

Carcinogenicity Classification

“A review of the available data has shown propylene glycol and dipropylene glycol to be negative for carcinogenicity in studies conducted up to the testing limit doses established by the Agency; therefore, no further carcinogenic analysis is required.”

And there is much more information in the full document linked below:http://www.epa.gov/oppsrrd1/reregistration/REDs/propylene_glycol_red.pdf

Vegetable Glycerin

Vegetable Glycerin or (VG) is also one of the main component used in e-liquids. VG is the substance in an e-liquid that makes the liquid thicker. It is a carbohydrate that is usually derived from plant oils. This substance is used as a sweetener in many foods as well. Most e-liquid providers now use USP Grade VG rather than Food Grade.

VG is also used in place of alcohol for many extracts. See: http://www.wisegeek.com/what-is-vegetable-glycerin.htm

Products with Vegetable Glycerin can be found in various common items around your house. A few examples include:

Sugar substitute

Beauty products including makeup, mousse, shampoo, bubble bath, aftershave, and deodorant

Pet food

Soap

Skin and hand cream

Baked goods – increase moisture

As a thick gel for creams, gel capsule pills, rubs and jellies

Eye & ear drops, toothpastes, pastes, and many dental care products

How is glycerine classified?

Glycerine is classified by the U.S. Food and Drug Administration (FDA) as “generally recognized as safe” (GRAS) and complies with specifications for the Food Chemicals Codex (FCC), United States Pharmacopeia (USP), and European Pharmacopoeia (Ph. Eur. or EP) E244. It is manufactured according to current Good Manufacturing Practices (cGMP) and is shipped according to applicable Good Trade and Distribution Practices (GTDP). See: http://msdssearch.dow.com/PublishedLiteratureDOWCOM/dh_091a/0901b8038091a41a.pdf?filepath=productsafety/pdfs/noreg/233-00490.pdf&fromPage=GetDoc

What is the difference between “USP Grade” and “Pharmaceutical Grade”?

USP Grade materials allow for fillers and binders added during the manufacturing process, and the additives don’t have to be on the label per the FDA. Common fillers are things like corn sugars and Propylene Glycol. Pharmaceutical grade means the product was made using GMP, or Good Manufacturing Practices, and has to be 98-99.7% pure.

How Can Avomeen Help?

Avomeen’s laboratory performs a verity of e-liquid testing and development. Our chemical analysis can help you determine if your product is safe for consumption. Our labs include:

Determine e-liquid recipes through chemical reverse engineering (if you wish to have a competitive edge on other distributors)

Deformulation of e-liquid flavor profiles & identification of flavoring agents or additives used within a product’s formulation. We can help achieve the proper flavor with fewer additives.

Carcinogenic analysis including toxic ingredient analysis for Diacetyl, Propinyl Acetyl, and Acetoin

Analyze e-liquids for unknown ingredients and determine the purity and grade of its raw ingredients

Test your e-liquid for nicotine levels to formulate accuracy (USP Assay)

Metals VOC Analysis

VG/PG ratio

Safety Data Sheet

Toxicology Testing – Verify the safety of your product

Determine products shelf life under various storage conditions and give recommendations for storage and expiration for your customers

Develop new custom formulation of e-liquid recipes

These services are primarily utilized by and conducted for manufacturers and distributors of e-liquid products. If you manufacture or distribute e-liquid products and you would like analysis done for safety, legal, buy confidence or any other purposes, give us a call.