New FDA Regulations on the vaping industry begin to take effect as of Monday August 8th 2016
As of Monday August 8th 2016, the Food and Drug Administration’s (FDA) tough new vaping regulations have gone into effect. Many within the vaping community feel that this could potentially be very harmful to the industry.
Among the list of regulations that have taken effect are:
- Must be 18 Years or Older to Purchase
- No Free Samples
- No Modification of Products
- New Vaping Product Must be Approved by the FDA
18 Years or Older to Purchase (21yo+ where applicable- CA, HI, NYC)
The first regulation on our list, is the requirement for vape shops to verify that purchasers are at least 18 years of age or older to purchase a vaping related product. Out of the 50 states in the USA 48 states already have laws on the books that prohibit vape retailers from selling products to minors and some states, like California, and Hawaii, including New York City even require purchasers to be 21 years of age or older. Out of the 50 states only two of them did not have any existing laws banning the sale of vaping products to minors, those states being Michigan and Pennsylvania. Overall owners of vapes shops have had no objection to this law and for the most part have supported and agree that minors should not be using vaping products.
No Free Samples
Vape shops are now prohibited from providing free samples of Ejuice to customers. Prior to this regulation taking effect, customers were able to try flavors for free before they made a purchase. Under the new FDA regulations, vape shops now have to charge a fee for those samples. The amount a vape shop charges for the samples will be up to the vape shops to determine.
No Modification of Products
Traditionally, vape shop employees have educated new customers about proper care and usage of a device by physically assisting the customer with setting up their device or actively troubleshooting problems. This includes tasks like connecting a tank to a battery, screwing in a coil, filling a tank with e-liquid, and also the rebuilding of coils across a variety of devices to the individual specification of the customer.
As of August 8th 2016, in the FDA’s view, these acts can no longer be performed by retailers — with very limited possible exceptions — because they constitute as “manufacturing.” Vape shop employees can continue to educate consumers on how to use the products safely, but employees cannot physically manipulate any product that is being sold.
New Vaping Product Must be Approved by the FDA
Any new vaping products must first be approved by the FDA before going on the market. The FDA has set an arbitrary predicate date of February 15, 2007, which means that any vaping products that have gone on the market after this date will be subject to approval by the FDA if they wish to remain on the market. This regulation is the most concerning to manufacturers and retailers of vaping products, as it may be a highly subjective process. A company submitting a product to the FDA for approval, does not even guarantee that product will even be reviewed by the FDA. In addition the cost associated with going through the bureaucratic mess of getting a vaping product approved for the market will be too costly for the majority of vape retailers or manufacturers, who reportedly make an average of $26,000 in monthly sales, which doesn’t leave much room for additional costs to be incurred. Some believe that this regulation will eliminate 99.9% or more, vaping products from the market.
The only light in this darkness may be that the new rules on the FDA’s approval of products that were released to the market after February 15th, 2007 is that vape retailers and manufacturers have until August 8, 2018, that is two years to obtain an approval from the FDA.
Since these regulations are just taking effect, we still are not completely sure how difficult the process of obtaining an approval will be, and we should find out more in the months to come. Anyone who is interested in learning more about these regulations or are interested in pushing back, can visit August8th.org for more info.