FDA Registration And Product Listing Deadline Looming, Vapor Product Manufacturers Must Comply By Dec 31

The Vapejoose international base of operations for the manufacturing, distribution, and sale of company-brand e-liquid.

The Vapejoose international base of operations for the manufacturing, distribution, and sale of company-brand e-liquid.

Under the Tobacco Control Act, every individual who owns or operates any “establishment” in the U.S. that is in the business of manufacturing, preparing or processing a “tobacco product” must register with the Food and Drug Administration (FDA) by Dec. 31 each year.

The FDA’s Deeming Rule has been in effect since August and established the government agency’s authority over vapor products, which are now considered to be regulated tobacco products. As such, manufacturers of these vapor products must also register with the FDA by the end of the year.

During registration vapor product companies, which include both hardware and e-liquid businesses, must “submit to FDA a detailed list of all products that are being manufactured, prepared, compounded, or processed for commercial distribution, along with copies of consumer information, all product labeling, and a representative sampling of advertisements,” according to The National Law Review.

The FDA encourages electronic submissions through the FDA Unified Registration and Listing Systems (FURLS). Companies can also file their establishment registrations “manually by filling out a Form FDA 3741 and mailing all of the necessary materials to CTP’s Document Control Center, or by packaging the files electronically using FDA’s eSubmitter software and submitting that package through the CTP Portal,” The National Law Review also reports.

Domestic manufacturers of finished tobacco products must register their facilities, and this includes vape shops that mix e-liquid in-house.

Those tobacco products produced that are not registered by the Dec. 31 deadline will be deemed “misbranded”, and through enforcement actions manufacturers could face fines, seizures or injunctions.

For more detailed information and links to forms and additional resources see “FDA’s Establishment Registration and Product Listing Deadline is Fast Approaching – Are You Prepared?”, an article that appeared in The National Law Review.

Philip Morris Hedges Its Bets, Plans Launch Of New Cigarette Alternative In U.S.

Marlboro_iQOSAs smoking rates continue to decline throughout much of the developed world, big tobacco companies have long been searching for a viable cigarette alternative to bolster sales in a market where vapor products have already carved out a healthy portion.

While big tobacco companies have acquired ownership over fledging vapor product companies like blu e-cigs, and have gone on to release products like the MarkTen and VUSE to compete in the already saturated vape market, these devices have had a hard time catching on with consumers.

To that end, tobacco giant Philip Morris International Inc. has tried for something new that could appeal more to the adult smoker, a concerted effort it hopes will be realized in its iQOS device.

The iQOS is a rechargeable electronic device that heats tubes of tobacco the company has dubbed “HeatSticks”, into an inhalable vapor. The HeatSticks bear a likeness to traditional tobacco cigarettes, and are part of a “heat not burn technology” that’s already been rolled out in test markets that include Italy, Japan and Switzerland.

The newest market that may see a release of the iQOS device is the U.S., with a product launch stateside that could happen as early as 2017, pending market approval by the Food and Drug Administrations (FDA).

For more on this story be sure to check out the Bloomberg Tech article here.

Deeming Regulations May Trigger Difficulties For Online Vape Vendors

Online_Shopping

Since the Food and Drug Administration (FDA) deeming regulations went into effect this summer, a good deal of confusion had swept through the industry.

Brick and mortar shops were bound by certain rules of compliance, which included prohibiting store employees from troubleshooting devices purchased by their customers, eliminating the practice of offering free samples, and submitting store clientele to more rigorous age verification at checkout.

Determining if someone is legally permitted to purchase vapor products in-store is a fairly straight-forward process, and only requires that the customer present a valid driver’s license. However, age verification for Internet purchases is a far trickier requirement for online vendors.

The FDA has regulated the online sale of traditional cigarettes by requiring retailers to take a number of steps in ensuring that these tobacco products cannot be purchased from websites by minors. It wasn’t until this year that online vape vendors had to submit to this rule, whereas before they operated completely abided just like any other e-commerce business.

With the introduction of the new regulations, both existing and new US online vaping businesses are likely to receive updated requirements from their credit card companies in line with the FDA’s actions that will require their compliance.

Failure to comply might mean that these online shops will be served with a termination notice withdrawing their credit card facility, according to reports issued by ECigIntelligence, a regulatory and market resource for the vapor product sector.

ECigIntelligence reports that for an online vape business to be able to accept credit cards under these new requirements, it must:

• Properly age-verify all transactions for any e-cigarette or vaping related product.

• Register with Visa and MasterCard via the merchant’s credit card processor and pay an annual $1,000 registration fee.

• Obtain an attorney’s letter stating that they are operating within existing applicable law sufficient to satisfy their credit card processor.

• Provide additional information, as requested by their credit card processor, to ensure they are operating within the new FDA regulations.

These requirements could mean trouble for online businesses. Market analysts suggest that rather than discussing how to comply, these businesses may instead be tempted to continue current market practices while putting their faith in the new rules being overturned—a gamble that may prove detrimental in ensuring their survival in a post-regulatory environment.

For more information click here for the ECigIntelligence article. Supporting information can be found by visiting Soar Payments at this link.

FDA Condemns Sale Of Online Vapor Products To Minors, Issues Warning Letters To Violators

Vaping_DarkSince banning the sale of vapor products to minors nearly seven weeks ago, the Food and Drug Administration (FDA) has flexed its regulatory muscle, and is closely monitoring illegal online tobacco sales involving underage shoppers.

The FDA has sent letters to at least 24 websites and 28 online e-cigarette retailers it suspects are in violation, warning them that the sale and marketing of tobacco products will not be tolerated, according to the Wall Street Journal, and that penalties will be issued if changes aren’t made to sites within 15 days.

The Journal also reports that while none of the violators were brick and mortar vape shops, rather gas stations and drug stores were the culprits, all retailers whether online or otherwise are bound by the same rules, and as such could be subject to $275 fines for repeat offenses.

Read more about this by visiting The Wall Street Journal, and by clicking here.

NJOY Files For Bankruptcy

NJOY_King_1

The Kings 2.0 vapor product failed to yield the profits that NJOY hoped for, which helped lead the company to bankruptcy.

Founded in 2006, with the mission of making combustible cigarettes a thing of the past, NJOY Inc., the country’s largest independent e-cigarette provider, has filed for bankruptcy.

The company filed a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code on Sept. 16 in Delaware federal court; much to the dismay of high-powered investors including Napster co-founder Sean Parker, PayPal founder Peter Thiel and pop singer Bruno Mars.

Those three joined other investors who put stake in NJOY and were part of a multi-million dollar capital round that placed the value of the company at $1 billion in 2013, the New York Post reports.

The legal news service Law360 pointed out that NJOY’s decision to file for bankruptcy protection came after the Arizona-based company reported significant losses following the 2013 release of its Kings 2.0 product, which was an updated version of its Kings disposable e-cigarette that ultimately failed to meet consumer expectations.

NJOY suffered this disastrous blow in the aftermath of the Food and Drug Administration’s first round of regulations that came to pass on August 8, at a time when the future of all other vapor product companies is uncertain.

You can read more about this story in the New York Post by clicking here.

New Product: ProVape Launches ProVari Radius

Photo by PRNewswire.com

Photo by PRNewswire.com

ProVape has launched its ProVari Radius, stating that it is ideal for vapers who demand an easy-to-use, powerful and lightweight product.

Features of the Radius include:

  • designed to fit the hand
  • box mod form that includes all of the features of the ProVari line
  • constructed of stainless steel and high-strength polycarbonate
  • patented Accuset and HotShot Boost technologies
  • battery monitoring, reverse battery protection, thermal monitoring
  • integrated and convenient micro-USB port
  • compatible with tanks and atomizers on the market
  • made in the United States
  • five programmable memory settings
  • available in four colors: Onyx Black, Midnight Blue, Cabernet Red and Ghost White.

For more information, visit www.provape.com.

New Products: Kamry K1000, Joyetech eCom, Cool Fire II, Pipe Style

 

The Kamry K1000 ePipe is a thumb fired mechanical mod that has a standard 510 connection. It comes in seven metallic satin finish colors with a silver firing button. It’s an excellent mod for one looking to get an ePipe. Batteries must be flat top 18350s as button tops do not fit. The K1000 ships with a full kit which includes the Battery Body, matching drip tip, 2 18350 IMR batteries, a K1000 atomizer, a charger and case. The kits retails for around $55.

 

 

Joyetech rolled out the eCom in very bold fashion. The eCom pen style, in either 650 mAh or 1000 mAh, has a proprietary thread that fits only Joyetech eCom atomizers. This pen style battery has a very sleek and modern look and sports variable voltage and variable wattage, which can be flipped with a switch. It has a USB charging port which doubles as a passthrough and battery indicator light. The 650mAh is $40 while the 1000mAh can be had for $45. Replacement atomizers are $20.

 

 

 

The Cool Fire II, Innokin’s newest mod in their artillery, is a grenade shaped and follows the weapon-like look of the 134, which took design cues from the M134 Minigun. Like the 134 the Cool Fire II has a rotational wheel that adjusts wattage in .5 increments from 7-12.5W.
It features reserve battery protection, short circuit protection, battery safe protection, low voltage warning, LED battery power display and a built in 7A fuse for protection and stability. It has a standard 510 connector to connect an assortment of attachments and will fit Innokin’s line of iClear devices. It retails for approximately $80.

 

 

 

 

The Pipe Style Telescopic, touted as a mechanical mod and cloned after the Ango R80, has a chromed brass stationary 510 center pin and telescopic tube to accommodate 18350/18500/18650 batteries, which are sold separately. It supports 510 and eGo threaded attachments and has a top-firing switch that can be thumb activated. It also comes with a 2.4 ohm chromed brass and polycarbonate mini clearomizer. It comes in metallic blue, black, copper, red and the pictured khaki. It can be purchased at fasttech.com for a mere $22.40.

 

 

 

 

Originally cloned after the AC9, the Smok RSST is very popular with rebuilders both for its ease of rebuilding and tank capacity. It has recently been updated with a much-needed Pyrex tank, so citrus and cinnamon vapers rejoice! It features a standard 510 connection, 4ml capacity, 1mm air hole, and stainless steel material. Rebuild this RBA with cotton, stainless steel mesh or silica with a little bit of Kanthal. It retails for about $25.

New Products: Billet Box, iTaste VTR, Efest LUC V4, VapeCrate

The Billet Box is a unique box made of a precision CNC milled 6061 t6 aluminum body and USA-made Dragon Plate Carbon Fiber. Its tank is machined DuPont Delrin plastic and it features a stainless steel ball bearing sliding lock. The 6.5 ml tank is 100 percent Food and Drug Administration approved material and has a quick refill function through the tank’s ball valve. It has 4 to 5.5 volt LDO variable output range and an easy to adjust engraved voltage dial​. The Billet Box comes with a 30-day warranty and replacement parts are available. It requires two 3.7 volt 16340 batteries, a punched 510 cartomizer, any 510 standard drip tip and juice. The Billet Box sells for $179. Image courtesy of billetboxvapor. Billetboxvapor.com

The iTaste VTR, manufactured by Innokin, is a variable voltage and variable wattage box mod. It features a rotational wheel to adjust voltage or wattage. The LED display details atomizer resistance and volts/watts output. It has 3-6 V and 3-15 W range, short circuit protection, low voltage warning and battery safe protection. It runs on 18650 unprotected batteries and features a standard 510/eGo connector that is sunken, against the mod body. It connects natively with the iClear 30, which sinks into the mod. Via the use of an adapter, other attachments like large cartomizer tanks and RBAs can be connected above the mod. The iTaste VTR retails for around $100. Image courtesy of Innokin. Innokin.com

Efest LUC V4 – Never be without power or constantly cycle batteries on and off the charger again. The LUC V4 has four built-in independent charging channels with reverse polarity protection, short circuit protection, over-current protection and Zero voltage activation function. The LCD displays the charge of the batteries and notifies when the battery is fully charged. It supports 10440 / 14500 / 14650 / 16340 / 16650 / 17650 / 17670 / 17350 / 18490/ 18500 / 18650 / 22650 / 25500 / 26650 batteries. It also has DC5V 1A USB to charge consumer electronics. Once the battery is connected to the LUC V4 it will stop charging when batteries are full. If the batteries are not taken off and the battery voltage drops below 3.9V the charger will resume charging. The LUC V4 retails for around $50. Image courtesy of Efest. Efest.com

The VapeCrate is a mod and accessory holder used to organize cluttered desks, cabinets or wherever you keep your vaping gear. Made of high-density polyethylene (HDPE) they are water and chemical resistant. They come in various configurations and colors. The smallest, the Desktop, holds two standard mods (Vamo, eVic, Provari, etc.) and one eGo battery while the largest, the Nicholas, will hold eight standard mods, a couple of box mods, several bottles of juice and a slew of attachments. The average vaper who has a lot of gear tucked away but needs something to organize his or her go-to area might consider the Trinity model.

It holds five standard mods, one eGo, two 30 ml bottles, three standard tanks, four mini tanks and six drip tips. They also have wooden configurations, less expensive than the HDPE, that you can purchase unfinished or finished. VapeCrates range in price from $14.95 to $79.95 for HDPE and $12.00 to $43.00 for the wood models. Image courtesy of VapeCrate. VapeCrate.com

New Products: SMOKTech S.I.D., eVic ECA, Sigelei’s Seats, iTaste 134

The SMOKTech S.I.D. is a mod with an eVic style body and Zmax guts and single button configuration. It comes in a variety of colors and sports variable voltage between three and six volts in .1 increments and variable wattage between three and 15 watts in .5 increments. It also has a side screen OLED, which requires the user to turn the device to read the menu, and a removable screw-off cap, similar to the eVic, which allows for easy cleaning. The S.I.D. has a standard 510 connection and is compatible with larger skirted devices like the Kanger and CE tanks. It can be used with a flat or button-top 18650 battery. The SMOKTech S.I.D. retails for approximately $50. Image courtesy of SMOKTech smoktech.com

 

The eVic ECA changeable atomizer from Joyetech is designed as the perfect complement to the best selling Joyetech eVic mod. It is designed to work with the eVic, giving the atomizer and mod a very streamlined look, but it does have a standard 510 connector so it will work on other ecigs. It is an atomizer and a plastic tank combo, reminiscent of the eGo-C, advertised as leak proof. It comes in longer type A or shorter type B variants and both have 3.5 milliliter capacities. The removable tank is filled via syringe and then placed into the housing, which contains the atomizer. The vaping is described as being similar to dripping. The ECA retails for $19.99 and has replaceable heads that cost approximately $5 per unit. Image courtesy of Joyetech joyetech.com

 

Sigelei's Atomizer Seats are useful for holding 510 devices like clearomizers, cartomizer tanks and RBAs. The large holders, typically made out of wood or plastic take up a lot of room, but these small seats would be perfect for keeping on your desk if you have a few attachments you swap out regularly. These would prevent devices from rolling around and keep RBAs upright so that they do not leak all over the place. They come in a variety of colors and retail for approximately $3 at various retailers. Image courtesy of Sigelei sigelei.com

 

Innokin's iTaste 134, with designed based on the M134 machine gun, is a microprocessor-controlled variable wattage mod that is adjusted by a rotating wheel and utilizes a single button for firing. This is a no screen display mod and it cannot display the resistance of attachments, but it is extremely easy to use and has been reviewed as an "eGo twist on steroids." It has a 6.5-12.5 watt incremental range on the rotating wheel with one watt increments between seven and 12. The 134 supports 18650 batteries and the capacity is displayed via green, yellow and red LED lights, with yellow meaning the battery is at half charge. It fits all of Innokin's iClear clearomizers including the iClear 10, 16 and 30 and supports a slew of other devices as it has a standard 510 connection. It sports 10-second cutoff, short circuit protection and reverse battery protection circuit. In the start kit is the 134 mod, an iClear 30 with a rotatable drip tip, and a beauty ring to clean up the look with other attachments. The iTaste 134 MSRP is $169, but kits can be found at a lower cost online. Image courtesy of Innokin innokin.com

 

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