How FDA Regulations Will Affect Vaping in 2017
Here’s the deal:
Recent FDA regulations have changed the way the public views vaping. While this view has done little to the vaping community, our federal government has made significant changes to how vaporizers - such as vape pens and weed vaporizers - among many other tobacco products, are regulated.
What are these most recent changes? How will they affect manufacturers, retailers such as vape shops, importers, and lastly, the consumer?
Well, let’s take a look at these new changes.
As of 2016, the FDA, or better known as the U.S. Food and Drug Administration, recently made a rule into effect that would extend their regulatory authority to cover all tobacco products - which would include vaporizers, vape pens, hookah pens, electronic cigarettes (e-cigarettes), e-pipes, and all other related ENDS products.
As a side note, ENDS stands for Electronic Nicotine Delivery Systems.
These new FDA regulations will affect how ENDS are manufactured, imported, packaged, labeled, advertised, promoted, sold, and distributed.
However, one should note that products that are marketed to people who are trying to quit smoking, while still regulated by the FDA, are done so by the Center for Drug Evaluation and Research (CDER).
These regulations also affect certain components or parts related to ENDS products as well. Some of these parts include:
- Certain batteries
- Digital displays or lights to adjust settings
- Drip Tips
- Programmable Software
Regulations for Manufacturers
According to the FDA, if you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import ENDS products, you are a tobacco product manufacturer and must comply with certain requirements.
If you are considered a tobacco product manufacturer, here is a list of some of the requirements you are expected to follow according to these new regulations:
- Report user fee information
- Register your establishment and submit a list of all products including labeling and advertisements
- Provide ingredient listing
- Include required warning statements on packages and ads that include smokeless tobacco and cigars
- Submit a modified risk tobacco product application
Starting in 2018, all product packages and advertisements of all newly-regulated tobacco products must have the following warning statement:
“WARNING: This product contains nicotine. Nicotine is an addictive chemical.”
If the tobacco product doesn’t have any nicotine then this alternative statement would be used:
“This product is made from tobacco.”
Regulations for Retailers
A retailer, under the FDA, is a business that sells ENDS, e-liquids or other components or parts made from or used with tobacco products.
As of August 2016, these general rules pertain to ALL tobacco related products:
- Check ID for anyone under 27 who tries to purchase a tobacco product
- Don't sell tobacco products to anyone under 18 years of age
- Don’t sell tobacco products in vending machines unless it’s an adult facility
- Don’t give away samples of newly-regulated tobacco products, including parts
You might be wondering:
How does this affect devices like vaporizers?
The same rules as above apply with two new rules going into effect in August of 2018 which include:
- Don’t sell or distribute ENDS products without a health warning statement on the package
- Don’t display advertisements for ENDS products without a health warning statement
Regulations for Imported ENDS
According to the FDA, all tobacco products imported or offered for import into the United States have to abide by the requirements of the Food, Drug, and Cosmetic Act.
Importers who do not own or operate a private establishment that is involved in the manufacturing, preparing, compounding or processing of a tobacco product are not required to register their business or provide a product listing.
However, if you don’t meet this requirement, you are subject to the tobacco product manufacturer and retailer requirements under the new FDA regulations.
The goal of the FDA is to warn the public of the adverse health effects that come from smoking. However, they fail to distinguish between tobacco cigarettes and vaping products. By establishing these regulations, they are equalizing all tobacco products which will defeat the purpose of vaping products being used as a smoking alternative.
In my opinion, this shouldn’t be an issue for the vaping community.
You might be wondering though:
Will these new regulations affect dry herb vaporizers?
While there has been much speculation surrounding this question, it is safe to say that dry herb vaporizers will be affected by these new regulations. Likely, it will be assumed that the dry herb vaporizers can be used for tobacco, then they would be subject to the guidelines as above.
- Samantha Lee