Friday, August 14, 2015

Unfiltered Thoughts on Warning Labels and Child-Resistant Packaging for E-Liquids

deep-skirt-closure
In Photo: A close-up of a child-resistant deep skirt closure clearly shows directions on how to open the bottle cap.


Well, what can I say? At least, the FDA is considerate enough to post an advance notice of proposed rule-making (ANPRM) to let everyone concerned know that they're going to make it harder and more expensive for e-juice vendors and manufacturers to sell their products.

Wow... Thank you so much, FDA!

But, let's face it. The Food and Drug Administration is going to regulate vaping, sooner or later. Pretty soon, the government will be limiting the nicotine concentrations of commercially available e-liquids to make them non-toxic to men, women and children, and even household pets.

Child-Resistant Closures for E-Liquid Bottles

As a preemptive measure, manufacturers have started using child-resistant caps and bottles for their nicotine-containing e-liquids. They seal-in the flavored e-juice into 10ml, 15ml and 30ml bottles that have water-tight and air-tight closures to keep in the liquid's freshness and flavor.

According to one manufacturer's website, there are four types of reclosable child-resistant closures for e-liquid bottles. Reclosable closures are "capable of being reclosed with a similar degree of security after they were initially opened and are capable of being used a sufficient number of times to dispense the total contents without loss of security."

A push-down-and-turn cap is a most effective type of child-resistant packaging because "children at the relevant age of 42 to 51 months are not fully capable of performing two movements - push and turn - at the same time and in a coordinated manner."

When using reclosable packaging, make sure you have "adequate directions for both opening and closing it. These instructions may appear in the form of words or graphics on the package itself, or be conspicuously placed elsewhere on the label."

child resistant caps for e-liquid bottles
In Photo: An array of child-resistant caps with droppers and closure tips for e-liquid bottles.

A CT or continuous thread closure, on one hand, features a cap with a built-in dropper that has a typical 15-mm closure tip. Other CT closures have longer and narrower tips. These caps are commonly used in refilling tanks and drips. Meanwhile, deep skirt closures are taller than average because they're designed to cover a longer, wider or taller sealing surface.

In comparison, the strap cap or hinged closure has a long, thin plastic cord that connects the top-half of the cap to the bottom-half portion at all times. Sometimes, this type of closure has the lower-half portion stuck to the bottle opening while the strap cap hangs from the neck. In other cases, a hinged closure would have a whole cap hanging from its plastic cord, which was kept in place by a small plastic hoop wrapped tightly around the bottle's neck.

Specific Information to Print on Warning Labels

The kind of information that a federal agency would want to see printed on the label of an e-liquid bottle is probably similar to those listed by the Electronic Cigarette Industry Trade Association (ECITA) on their website.

The ECITA has one caveat, however. E-liquids that have a nicotine concentration of between 0% and 2.49% each - irrespective of how they were sold or purchased - must display the following information on their labels.
  • Heading: "CAUTION:"
  • Text #1: "Keep out of the reach of children and pets."
  • Text #2: "Only for use in/with [delete as appropriate] electronic cigarettes."
  • Text #3: "Seek medical advice if you feel unwell."
  • Text #4: "May contain traces of [allergen]."
  • Nicotine concentration in weight per volume (w/v) percentage and/or milligrams per milliliter (mg/ml) must be displayed on the label.
  • The batch number must be displayed.
  • The 'Best Before End' date must be displayed.
  • Contact details must be displayed.
The FDA wanted a nicotine-exposure warning plastered on every e-juice bottle. A simple warning may be worded this way:
WARNING: This product contains nicotine extracted from tobacco. Nicotine is an addictive chemical. Possible side effects from continued use of this product include dizziness, nausea, sore throat, and dry mouth. DO NOT INGEST. Keep out of reach of children.
Or... You can put warning labels on your products with a detailed picture of what to expect from e-liquids that have too much nicotine in them, which is exactly what this chart from ECITA shows.

Screenshot Image via ECITA.org

How E-Liquids are Classified and Labeled in the U.K.

The Classification, Labelling and Packaging (CLP) Regulations of ECITA has a classification chart of e-liquids that included specific markings and warnings for each category. E-liquids are classified into four categories based on their nicotine level. Each group has a list of possible hazards and a corresponding list of precautionary measures.

The chart classifies e-liquids with a nicotine level of 2.5% and over as toxic, especially when the juice comes in contact with skin or when it's swallowed. Meanwhile, e-liquids with a nicotine concentration of 25% to 100% can be fatal to aquatic life and to humans, as well.

Not for Sale to Minors

I'm sure the FDA would want e-juice makers to include a short note to all underage vapers: Not for Sale to Minors. Along the road, you'll probably see a similar note on an APV packaging that says: "Not designed or intended primarily for use by minors 18 years of age or younger."

Although everyone knows that an electronic cigarette is NOT a children's product, clearly labeling a personal vaporizer as "for adult use" only puts it in the same class as a sex toy. Considering that current public policies on vaping have made out this fun and relaxing activity into something that's dirty and unhealthy when it's done in public, it's the perfect analogy.

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