What does the FDA regulations mean for the e-cigarette industry?

Electronic cigarettes and vaporizers have become the new way of smoking for many people around the world. While regular cigarettes are still being sold in massive quantities, there has been an astonishing increase in the use of these vaporizers and E-cigs in just the past ten years. It comes as no surprise then that the Federal Government would start to regulate the industry.

In 2016, the Federal Department of Agriculture (FDA) brought many different types of Electronic Nicotine Delivery Systems (ENDS) under their jurisdiction. This includes vaporizers, vape pens, hook pens, and all types of electronic cigarettes. The FDA is now able to legally regulate how these individual items are manufactured, imported, packaged, labeled, advertised, promoted, sold, and distributed. This has caused a great deal of concerns with small business that are dependent on this industry, as well as the millions of consumers that buy these products and the accessories that go with them. The regulations are extremely harsh when it comes to small businesses and vendors of these devices, and the government is trying to shut the industry down through these regulations. Here are a few questions and answers concerning these new regulations.

What Does This Mean for Consumers?

For all intents and purposes, the industry is going to be treated just like the regular tobacco industry. Consumers will have a harder time finding the types of products that they like due to stricter regulations on distributors and businesses selling the products. Underage consumers (under the age of 18) will also find it as difficult to acquire these items as well. According to the FDA, about 16 percent of high school students used e-cigarettes, constituting more than 3 million underage users.

Consumers may also start to see more repressive tax measures placed on these devices. With the new federal regulation, federal tax revenues are a likely complement. Prices may also go up for consumers due to the additional costs now being placed at almost every level of the supply chain before the devices even get to the store.

What Does This Mean for Vendors?

Vendors will now have to face several new restrictions that they must abide by before selling these goods. Vendors are now legally obligated to check identification of anyone under the age of 27, as well as being unable to sell to those under the age of 18. Vendors are also prohibited from selling these devices and their accessories in self-service vending machines. Vendors are also no longer able to give away free samples of products in order to influence sales. These new regulations could mean that vendors lose out on business that they normally received by letting customers try the product before buying it.

Some vendors also mix certain products, such as certain vape shops. Businesses that are doing this must now follow both the regulations for vendors as well as those for manufacturers. This includes paying fees to the FDA, registering with the FDA, submitting ingredients listings, applying the appropriate labels to the products, including warnings on the packages, and many other compliance regulations that could affect the ability for these shops to do business. According to the FDA, submitting the appropriate reports can cost anywhere between $1,500 and $22,700 depending on the size of the establishment. These are just the costs to fill out a waiver for a small business. While the FDA Web site states that the application for submitting each individual new product is between $117,000 and $466,000, the actual costs for vendors associated with this process is estimated to be much higher. The FDA itself estimates that for large companies, labor could reach 1,700 hours for each new product to be approved. These are additional hours now required by the regulations. This means that with the labor and overhead, as well as the new application process, labeling, and packaging requirements for manufacturers, the cost to follow the new regulations for just one liquid could be over $1 million. Unfortunately for many shops (and even large companies), these expenses are extremely prohibitive. These regulations are truly meant to kill the industry.

What is All Affected by These New Regulations?

The following devices are the ones that are affected by the new regulations:
Vape pens
• Hookah pens
• Electronic cigarettes
• E-pipes
• Other electronic nicotine delivery systems

This also includes all of the components and parts of these devices as well. The FDA definition for “components and parts” is extremely wide-reaching, and includes E-liquids, a glass or plastic vial container of e-liquid, cartridges, atomizers, certain batteries, cartomizers and clearomizers, digital display or lights to adjust settings, tank systems, drip tips, flavorings for ENDS, programmable software, and more. This means that all of the devices and components are subject to the FDA regulation for manufacturing, distribution, and sale. Advertising and marketing are also included in the regulation. All of these items must also be fitted with warning labels and information about what is included in them.

Accessories are not included in this definition. Therefore, anything that is not part of the ENDS device should be safe from FDA regulation.

So What Does This All Mean?

In general, the regulations that are now being imposed on these devices are to make the possession of the devices more difficult for minors, as well as to ensure that any of the sales of the goods are safe. However, this does come at a high cost to the vendors and consumers of these products. Vendors now have to devote more resources to the sales of ENDS devices. They will also have to more actively market their items because they can no longer simply give samples to try and sell their products. Vape shops that are mixing their own liquids may now face legal action if they do so without following the strict federal guidelines set forth for manufacturers, and these guidelines can be so cost prohibitive that many small shops cannot afford to pay them. New required warning labels and packaging may also scare away prospective customers from these small shops, adding to the burdens of the new regulations.

For consumers, a price increase can be expected. Due to the large amounts of resources that the supply chain now has to devote to applications and following regulations with the FDA, costs are going to be passed on to the customer.

What Can the Community Do About This?

There is still a lot that can be done to try to fight back against these regulations. There are several Web sites that have started petitions to end the regulation of these products, or at the minimum to make the requirements for following them less strict and costly for the small vape shops that so many individuals frequent.

The Consumer Advocates for Smoke Free Alternatives Association (CASAA) is one of the most vocal groups about stopping these regulations. This non-profit, volunteer-run operation has over two-hundred thousand members and aims to provide smokers and non-smokers alike with the opportunity to experience less harmful alternatives to smoking cigars and cigarettes. The CASAA has started a petition on these new regulations and has gained a lot of support for it. Visit that site at CASAA.org.

Vaping and smoking E-cigarettes is a very important part of life for many people. They support the small businesses that are providing excellent service and products. With the new FDA regulations, these products could soon become cost prohibitive to provide. This not only hurts the manufacturer and vendor, but it also has repercussions on the consumer. If something is not done, many shops may go out of businesses, and prices will be on the rise.

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