FDA Regulations: Bottle Compliance Timeline
In 2016, after the FDA finalized its deeming rule for vaping products, the whole industry scrambled to work out what e-liquid bottles and labels would need. We dug and dug until we had a timeline for our bottles, and this post shared it.
Treat everything below as history. Packaging and labeling rules have moved on since then, and none of this is a checklist for today.
Short version: This was our reading of the rules in 2016, and it was never legal advice. If you make or sell e-liquid, work with a lawyer and check current requirements with the FDA.
What was on the timeline
- July 26, 2016: the deadline for child-resistant packaging on liquid nicotine containers, set by a separate federal law, the Child Nicotine Poisoning Prevention Act.
- August 8, 2016: the deeming rule took effect, bringing e-liquids and vaping devices under FDA tobacco rules. One of the most confusing parts was that a product changed after that date could count as a new product needing FDA review, and at the time we read that as covering both the e-liquid and its label.
- Sale only allowed in the United States: our understanding was that this statement had to appear on the bottle, even for a shop that also sold outside the US. We were still working to clarify that point.
- Batch numbering: at the time, it didn’t even have a due date.
We expected more dates and requirements to shift as information came down the pipeline, and many of them did.
The warning label
The rule also called for a nicotine warning on packaging: WARNING: This product contains nicotine. Nicotine is an addictive chemical. Our notes at the time covered how it had to look:
- Black text on a white background, or white text on a black background
- At least 12-point Helvetica Bold or Arial Bold
- Covering at least 30% of the main display area of the package
Where things stand now
A lot has changed since 2016. Every vaping product sold in the US now needs FDA premarket authorization through the PMTA process. The application deadline was September 2020, and many products are still under review. The federal minimum age for tobacco and vaping products has been 21 since December 2019, and flavor rules vary by state and city and change often. For current requirements, go to the FDA’s tobacco products site, and for more background, read our look back at the FDA’s deeming rule.
WARNING: This product contains nicotine. Nicotine is an addictive chemical. For adults 21+ only.