FDA Warning Label Requirements for every store owner
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August 10th, 2018 FDA Warning Label Requirements for ENDS (e Juices, e Liquids, Vape Devices, etc) go into effect.
What does this mean for you? What does it mean for manufacturers?
These are two important questions we'll cover in this weeks VapeRanger Blog post.
Warning Label Overview
- Warning label should appear on all packaging manufactured after August 10th.
- Stores with products manufactured prior to August 10th, 2018 can continue to sell these products and purchase them from distributors.
- Distributors may continue to sell their existing pre-August 10th stock.
- Manufacturers have until September 10th, 2018 to sell out of their pre-August 10th stock.
- Store owners and Distributors fall under the Deeming Regulations "Safe Harbor" provision; allowing them to clear pre-August 11th stock out.
- There is no timeline for stores and distributors to sell their pre-August 10th stock. (Page 22 VTA Webinar)
- Products that are too tiny to display the warning on the actual product may display the warning on their external packaging (see examples below)
Other Labeling Requirements
- Name and place of business of the manufacturer, packer or distributor
- Accurate statement of contents (weight, volume, count, ingredients)
- Example "30 ml of eLiquid"
- Amount of nicotine
- Example "This bottle contains 50 mg of nicotine per milliliter"
- Statement reading "Sale only allowed in the United States."
- Include revised Prop 65 warning for all products which contain nicotine.
- California Proposition 65 Warning:
- This product contains chemicals known to the state of California to cause cancer and birth defects or other reproductive harm.
Products without nicotine
- Can use alternative label
- This product is made from tobacco.
Product with Label Examples
Mad Hatter's I Love Salts is a perfect example of products too small to put a warning label but still go above and beyond to produce a compliant label on their exterior packaging and on the side of each small bottle.
The second example of perfect compliant warning label placement is Nitro's Cold Brew and Food Fighters eJuice
Another example of correct warning label placement on the actual eJuice bottle is Fresh Squeezed which displays the warning on the front of their 60 ml and 100ml e Liquid bottles.
Source: VTA Webinar "Deem Those Labels PDF
This blog post covers products that can fit a warning label on them. Products that are too small to display a label across the front have seperate guidelines. See the VTA Webinar for more information.
The information presented is for informational purposes only and not for the purpose of providing legal advice. You should contact your attorney to obtain advice with respect to any particular issue or problem.
