share on twitter

When it comes to the FDA's regulation of vaping products, there have been concerns with how the rules affect the importing and exporting of products in and out of the US. With the history of the FDA's involvement in the vaping industry dating back to when the organization had no legal authority over vaping products, it's no wonder why vape shop owners and e-cig retailers are concerned.

How Do Vaping Regulations Affect Shipping?

Back in 2009, before having any authority over vaping products, the FDA began seizing e-cig shipments based on the claim that they had grounds to seize products for incorrect labeling. This infringement launched a massive lawsuit against the FDA from two major e-cig companies. In a court hearing, the judge ruled in favor of the vape companies and the FDA was told to cease seizing shipments; however, some e-cig companies claimed the FDA continued to seize e-cig shipments against the judge ruling, which resulted in another lawsuit. The second lawsuit was dropped when the FDA finally ceased seizing e-cig shipments and announced its intention to pursue authority over vaping products.

So how do the FDA's rules affect the shipping of vaping products today? That's a good question. We received a few questions about this during our DeMISTified webinar series. You can find these questions below with answers from industry experts.

Will e-liquids containing nicotine be allowed to be shipped via "delivery sales" via USPS, UPS, FEDEX, etc.?

Yes, as long as there is a warning label on the outside of the package starting May 10, 2018; however, state regulations may have different requirements, such as age-verification and signature at the time of delivery as seen in California. Another example of state laws affecting the shipping of e-cig products comes out of Utah. As of July 2016, the shipping of vape products into Utah is no longer permitted due to legislation that banned online e-cig sales. Other state laws are imposing tax hikes on vapor products, so be sure to keep up with proposed legislation in your state with CASAA's Calls to Action by State and do what you can to oppose unfair regulations.

↓ Watch the video explanation here ↓

Click to tweet: Starting May 10, 2018, a warning label must be on the outside of the packaging to ship #ecigs. #FDADeeming #Vaping

If we're a US-based manufacturer selling a product line for export, would the product line that is being exported be subject to the regulations?

Yes, manufacturers based in the US can export their vapor products overseas; however, they are required to follow the same processes as FDA-regulated products in the US. The FDA does require vape companies to maintain detailed records of the products you are exporting and must meet the following qualifications:

1) Meets with the foreign purchaser's specifications.

2) Does not conflict with the laws of the foreign country.

3) Is labeled on the outside of the shipping package that is intended for export.

4) Is not sold or offered for sale in the United States.

The exporter can also keep documentation, such as letters from the foreign government or notarized certifications from a US official, stating that the product does not have any issues being imported into the foreign country.

Can items still be imported from overseas?

Yes, vapor products can still be imported from overseas as long as they have the correct nicotine warning label on the packaging. According to the FDA, “Importers who import finished tobacco products for sale or distribution in the U.S. are considered tobacco product manufacturers” and must follow the deeming rules before distribution to consumers. Some of these requirements include:

Reporting ingredients, and harmful and potentially harmful constituents; Submitting an application for premarket review and receiving authorization from FDA before marketing new tobacco products; Complying with health warning requirements on product packages and advertisements; and Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by FDA.

The FDA's website also states that, “importers who own or operate a domestic establishment engaged in the manufacture, preparation, compounding or processing of a newly regulated tobacco product need to register the establishment and submit product listing to FDA by December 31, 2016.”. Visit the FDA website for more information on how to comply with the FDA regulations as a manufacturer.

Back To Understanding FDA Regulations Guide

The post FDA Vaping Regulations: Importing and Exporting appeared first on Electronic Cigarette Blog | White Cloud.

Wed, Dec 14, 2016
share on twitter

Ah product sampling. Remember the days when vape companies could go out to adult events to hand out free product to the smokers lining the streets? Or how about the promotion of vape product giveaways across social media channels? Or how about even just letting a potential new customer try out a flavor to find the right fit? Or how about being that potential new customer who is skeptical of vape flavors and thinks satisfaction can only be achieved if it tastes just like a cigarette, only to end up asking, “Why did I ever like the taste of a cigarette?” Well, those days will now be faded memories with the FDA's restrictions on product sampling.

No More Sampling Vape Products

If only every industry was like the automobile industry, at least in the sense that you can “try before you buy”. Who knows how many countless consumer dollars have gone to waste from buying products that just weren't…great. And when it comes to vaping, people are skeptical. There is always skepticism when it comes to the new and unknown. This is what made sampling vapor products great, both for the consumer and the vape company. Prior to FDA regulations, sampling was one of the best marketing practices for vape companies, as they could give consumers a hands-on demonstration of how vaping works and help them find a device, flavor and nicotine strength that worked the best for them; thus, the consumers had the benefit of trying different products and flavors so they could make an informed decision when making the commitment to give vaping a try.

Now that the FDA has taken authority over the vaping industry, product sampling has been thrown out the window. But still, there are some uncertainties as to what the FDA defines as “product sampling”. This is why we received a few questions about product sampling during our DeMISTified Webinar Series. Below you will find these questions with answers from the experts – or from the best research we could do on this gray area of FDA regulations.

What is the FDA ruling on sampling in store with or without nicotine?

There is no real distinction between sampling between nicotine-containing products versus nicotine-free products. Although nicotine-free products do not contain nicotine (hence the term “nicotine-free”), they are still subject to the rules in carrying a warning that states, “This product is made from tobacco.

The FDA's clarification on this is: If the intention of nicotine-free products is to be used with a tobacco product (mods, e-cigs, vape pens, etc.), then free product and/or sampling is strictly prohibited, regardless of whether or not the product in question contains nicotine.

↓ Watch the video explanation here ↓

“Free samples are banned as of the 8th, just take it away, free samples are banned.” – Cynthia Cabrera

Click to tweet: “Free samples are banned as of the 8th, just take it away, free samples are banned.” @cyncab #FDADeeming #ECigs

Do customer loyalty programs count as offering "free" product?

This is another gray area when it comes to the FDA's regulations. The rules specifically state that both product sampling and free product are prohibited; however, retailers can offer “product sampling” as long as they charge a fee. The FDA did not share specifics or a dollar amount with this fee, so we suggest you consult with your lawyer before moving forward with any form of product sampling.

As for loyalty programs, as long as no free product or sampling is involved, then retailers should be able to continue with loyalty programs. For example, White Cloud's Rewards Program allows customers to earn reward points based on purchases and other interactions. Customers may redeem their points for discounts towards future purchases and not for entirely free product.

What is the minimum amount that a vendor can charge for samples?

↓ Watch the video explanation here ↓

“There's no one solution or answer to how you should handle charging people for samples.” – Cynthia Cabrera

The FDA did not give a minimum amount for manufacturers and retailers to charge for samples. We recommend you consult an attorney for further direction.

We can speculate, along with the experts, that if manufacturers and retailers choose to charge $1.00 for the product, this may spark red flags for the FDA.

Click to tweet: “There's no one solution or answer to how you should handle the charging people for samples.” @cyncab

Back To Understanding FDA Regulations Guide

The post FDA Vaping Regulations: Product Sampling appeared first on Electronic Cigarette Blog | White Cloud.

Fri, Nov 18, 2016
share on twitter

One of the biggest concerns regarding the FDA's regulation of vapor products is the impact it will have on small vape shops. Most vape shops are privately owned, family-run businesses – what you might call “mom-and-pop shops”. Many of these smaller vapor product retailers built their shops from their life savings and simply cannot afford to comply with the FDA's onerous regulations. As a result, they will be forced out of business, despite the additional assistance being offered by the FDA (which does not help with cost). Even the larger e-cigarette manufacturers have concerns about the expensive PMTA process. As a matter of fact, one of the largest e-cigarette manufacturers declared bankruptcy shortly after the deeming regulations took effect, citing the costly PMTA process as one of the reasons they will be leaving the vaping industry.

How Do FDA Regulations Affect Vape Shops?

So, how do the FDA's Deeming Regulations affect smaller vape shops? This was one of the main topics discussed during our DeMISTified webinar series, as many of the attendees were actually vape shop owners. Below you will find questions about this topic with answers from industry experts.

If we change a coil, have we "modified" the product enough to be considered a "manufacturer"?

Yes, coils and modifications to coils are subject to FDA regulations. If you modify or change a coil, you will need to submit a PMTA, as the FDA's PMTA Guide states:

“Any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.”

The FDA states a “tobacco product manufacturer” is “any person, including any repackager or relabeler, who-

(A) manufactures, fabricates, assembles, processes, or labels a tobacco product; or

(B) imports a finished tobacco product for sale or distribution in the United States.”

According to the FDA, a vape shop is essentially an Electronic Nicotine Delivery System (ENDS) retailer that can do a variety of activities; therefore, they may be subject to tobacco retailer or tobacco manufacturer regulations, or both! The FDA considers these activities to be deemed as “tobacco product manufacturers”:

Vape shops selling a variety of ENDS products to consumers from devices to replacement pieces. Vape shops mixing different e-liquids for direct sale to consumers for use in ENDS.

↓ Watch the video explanation here ↓

Click to tweet: If you change a coil have you “modified” a product enough to be considered a “manufacturer”? Find out #Vape #ECigs

What are the critical dates that vape shop owners need to be aware of?

There are a number of critical dates vape show owners must be aware of in regards to the FDA's Deeming Regulations. The Vapor Technology Association (VTA) created a detailed FDA deeming regulations calendar to help vape shop owners and manufacturers.

How does photo identification for anyone 18 and over affect online sales of e-liquids and vaping devices?

According to the FDA regulations, retailers and manufacturers both online and in-store cannot sell, distribute or engage in the sale of tobacco products to users who are under the age of 18. Most e-cigarette manufacturers and vape shop owners have prepared for this by having employees physically check IDs in store or by using an electronic age verification device for online orders. For example: White Cloud uses a service called Lexis Nexus for vaping age verification before shipping our products to new customers. This age verification process was implemented long before the FDA's vaping regulations took effect.

The U.S. Postal Service and other carriers are not subject to penalties when they deliver a package; however, there are state laws set in place that have implemented restrictions on online e-cig sales, including California which requires a signature upon delivery, along with matching billing and shipping addresses.

Other local and state governments have also increased the tobacco purchasing age from 18 to either 19 or 21, so it's best to become familiar with the different age restrictions set in place when shipping vapor products.

↓ Watch the video explanation here ↓

“You need an independent third party that will verify the ID that's presented.” – Cynthia Cabrera

Click to tweet: What are the requirements for online #ecig retailers in verifying #vaping age? Find out: #FDADeeming #ECigs #Vape

Can shops custom mix on site per order after August 8, 2016?

As of August 8, 2016, vape shops cannot sell custom e-liquid mixes without an approved Premarket Tobacco Application (PMTA). Each individual e-liquid is subject to the regulations and must obtain PMTA approval to remain on the market. This includes every e-liquid flavor in every nicotine strength, as Dr. Michael Siegel stated during our webinar:

“Any combination of flavoring and nicotine strength is considered a separate product. So if you sell 10 e-liquids and each of them come in 3 different nicotine strengths, that's 30 different products.”

In a Regulatory Impact Analysis (RIA), the FDA estimated about 5,000 to 10,000 vape shops exist with 70% mixing their own e-liquid. This would mean that roughly 3,500 to 7,000 vape shops would be considered “tobacco product manufacturers”.

Consumers can still mix their own e-liquids, as long as it is used for personal consumption only. If they mix e-liquids with the intent to sell, then they are considered tobacco manufacturers and are subject to the regulations.

↓ Watch the video explanation here ↓

Click to tweet: Life after #FDADeeming: #Vape shops cannot sell custom #eliquid mixes as of August 8, 2016 – #ECigs #Vaping

Back To Understanding FDA Regulations Guide

The post FDA Vaping Regulations: Vape Shops appeared first on Electronic Cigarette Blog | White Cloud.

Wed, Nov 09, 2016