https://vaping360.com/vape-news/110612/nicotine-toothpicks-regulations-market/
Nicotine Toothpicks Are a Bigger Story Than We Thought
Go ahead and laugh if you want, but nicotine toothpicks might be an important option for nicotine users looking for alternatives to smoking and vaping. Let’s face it, for many vapers in less-populated areas, finding the products they need is getting harder, and this is one nicotine product that isn’t subject to the shipping restrictions of the PACT Act.
There’s also an interesting regulatory story here. Like nicotine pouches and lozenges, toothpicks are a deemed tobacco product regulated by the FDA, even though they contain no actual tobacco. But one nicotine toothpick company might qualify as the only non-tobacco nicotine manufacturer to have a product grandfathered onto the market and not subject to FDA premarket authorization.
Nicotine toothpicks are an oral nicotine product that works for many smokers (and vapers) as an alternative to cigarettes. Keep reading if you’re curious about the products themselves, or the story of Zippix, the toothpick manufacturer that just might make history in the consumer nicotine space.
What are nicotine toothpicks and where can I buy them?
Nicotine toothpicks are wooden toothpicks containing nicotine and flavors.. Some manufacturers simply coat the toothpicks with a mixture of nicotine, flavorings and preservatives, while others use a high-tech vacuum chamber to evenly infuse the ingredients throughout the entire toothpick.
They come in a variety of flavors, and most deliver a similar amount of nicotine as lower-strength pouches: 2-3 mg each. They’re sold in packages of between 15 and 50 toothpicks.
While nicotine toothpicks are largely subject to the same rules as vapes and other consumer nicotine products, they are not banned from U.S. Mail delivery or included in the revised PACT Act, which only applies to vaping products and tobacco. That means that toothpick manufacturers that survive the difficult Premarket Tobacco Application (PMTA) process will be available for shipping anywhere in the country.
Sure, holding a toothpick isn’t exactly like holding a cigarette, but it’s not too far off.
We found five current U.S. nicotine toothpick manufacturers. One of these is made with synthetic nicotine. The other four are made with tobacco-derived nicotine. Of those, one submitted Premarket Tobacco Applications (PMTAs), two others did not, and the fourth, Zippix, is a regulatory story unto itself. More on that company below.
Crave Nicotine Toothpicks uses synthetic nicotine, which is not currently regulated by the FDA. The company, started by former Congrevape owner John Grefe, sells 3 mg toothpicks in eight flavors (currently), which come 50 to a package. Crave’s price per pick is lower than the other brands.
Grefe says that using synthetic nicotine allows him to take advantage of more subtle flavors that would be overwhelmed by the peppery sensation of organic nicotine. Synthetic nic frees him to approach the products in the same way as e-liquid, blending delicate flavors that might not stand up to a strong nicotine sensation, like Butterscotch Cake. Conversely, the toothpick medium allows his stronger flavors, like Sour Candy, to shine without being harsh.
“I approach it like vaping with a bigger opportunity to exploit the medium,” says Grefe. “With an e-liquid there a limit on sour that will come across in the vapor. But in a toothpick, I can crank sour through the roof.”
The company has hired a Washington, D.C. law firm to guide the process of gaining grandfathered status.
Pixotine, which launched in 2013, has submitted PMTAs for four of its flavors—Cinnamon, Original, Tobacco, and Winter Ice—in 3 mg strength. Pixotine toothpicks come in a pack of 15.
NicotinePicks sells eight flavors, which come in tubes of 20 (and cost less if you buy multiple packs). The company didn’t respond to our inquiries about PMTA submission, but doesn’t appear on the FDA’s list of products with submitted PMTAs.
Smart Toothpicks seems to be the only manufacturer that makes non-nicotine toothpicks in addition to its nicotine picks. According to an email from the company, Smart Toothpicks did not submit PMTAs due to the cost. Smart Toothpicks’ 3 mg nicotine toothpicks come in three flavors.
All of the toothpick manufacturers sell online. Some of them also have a presence in convenience stores and gas stations, although none appear to have deals with large tobacco product distributors.
Will Zippix avoid the FDA’s PMTA requirements?
The 2009 federal Tobacco Control Act gave the FDA authority over products made with nicotine derived from tobacco—but products that were on the market before Feb. 15, 2007 are exempt from the premarket authorization newer products must obtain to be legally sold.
That’s how most cigarettes and smokeless tobacco products remain on and continue to dominate the market, even though the FDA has never pronounced them “appropriate for the protection of public health” (the standard required for post-2007 products seeking PMTA acceptance). Manufacturers of those older products don’t have to do expensive toxicological testing or behavioral studies, like newer products (including all vapes) require.
Products that were marketed before Feb. 15, 2007 are considered “grandfathered,” and their manufacturers can continue selling them without jumping through the full set of FDA hoops. The FDA offers a formal grandfathered product determination, and has a database of products voluntarily submitted for that designation.
Needless to say, avoiding the PMTA requirement is a significant market advantage.
“We’re on our fourth round of supportive documentation sent to the FDA.”
According to the manufacturer of Zippix, the company’s nicotine toothpicks qualify as grandfathered products. Zippix owner Marcus Kruk told Vaping360 his toothpicks have been sold since 1993 by two companies owned by him. Zippix has applied to the FDA for formal recognition as a grandfathered product.
The company has hired a Washington, D.C. law firm to guide the process of gaining grandfathered status. “We’re on our fourth round of supportive documentation sent to the FDA,” says Kruk.
However, he points out that even without a formal FDA grandfathered product determination, his company can continue selling unless the FDA decides to challenge that status. Going to court against the FDA is never easy, but Zippix may have a good case.
Unlike vaping products, toothpicks will not be covered by the U.S. Postal Service delivery ban that will be announced any day now, and they aren’t included in the PACT Act.
Kruk’s original company, a compounding pharmacy, began making nicotine toothpicks in 1993. They were promoted to patients with breathing disorders by pulmonary physicians and respiratory therapists, but sold directly to patients over the phone. They marketed the products at medical equipment conventions, primarily in the southeast (Kruk is based in Alabama). However, Zippix never marketed the toothpicks as cessation products, or applied to the FDA as a drug delivery device (which could disqualify it as a grandfathered consumer product).
Whether the FDA will allow products that were not sold through typical consumer tobacco channels to be designated grandfathered tobacco products isn’t certain. But if they do, Zippix would be, as far as we can tell, the only consumer nicotine product made without leaf tobacco able to sell its products without enduring the onerous PMTA process.
The company sells nicotine toothpicks in six flavors—Cinnamon, Mocha, Peppermint Watermelon, Spice Island Clove, Sweet Whisky and Sweet Wood. The last two are 3 mg strength, and the other four are 2 mg. There are 20 picks in each package, and they’re primarily sold online. (Zippix also sells a toothpick containing vitamin B12 and caffeine.)
Where do nicotine toothpicks fit in the marketplace?
So-called “modern oral nicotine” products like nicotine pouches and lozenges—and nicotine toothpicks—are ideal choices for smokers looking to quit and vapers unable to get the products they want because of flavor bans or shipping restrictions.
Unlike vaping products, toothpicks will not be covered by the U.S. Postal Service delivery ban that will be announced any day now, and they aren’t included in the PACT Act. As with nicotine pouches, they may eventually attract negative attention from tobacco control activists, but it hasn’t happened yet.
According to Marcus Kruk, Zippix sales are booming, which seems to be the case for all non-combustible nicotine and tobacco products. People are looking for options, and they’re finding them with nicotine toothpicks, pouches and other oral nicotine products.
“With an e-liquid there a limit on sour that will come across in the vapor. But in a toothpick, I can crank sour through the roof.”
They’re ideal for times when you want nicotine but aren’t able to vape, like at work, in meetings or at sporting events. They’re tiny and easy to carry, and no one will notice that you’re using them.
Finally, nic toothpicks are the only consumer nicotine product aside from vapes that offer some connection to the hand-to-mouth rituals of smoking. Sure, holding a toothpick isn’t exactly like holding a cigarette, but it’s not too far off. You can pop it in your mouth, twist it around, pull it out and reverse it, or take a break and hold it between your fingers.
It’s important to have a wide variety of low-risk products available to give nicotine enthusiasts options. Nicotine toothpicks are another choice for people who don’t want to smoke.
Nicotine Toothpicks Are a Bigger Story Than We Thought
Go ahead and laugh if you want, but nicotine toothpicks might be an important option for nicotine users looking for alternatives to smoking and vaping. Let’s face it, for many vapers in less-populated areas, finding the products they need is getting harder, and this is one nicotine product that isn’t subject to the shipping restrictions of the PACT Act.
There’s also an interesting regulatory story here. Like nicotine pouches and lozenges, toothpicks are a deemed tobacco product regulated by the FDA, even though they contain no actual tobacco. But one nicotine toothpick company might qualify as the only non-tobacco nicotine manufacturer to have a product grandfathered onto the market and not subject to FDA premarket authorization.
Nicotine toothpicks are an oral nicotine product that works for many smokers (and vapers) as an alternative to cigarettes. Keep reading if you’re curious about the products themselves, or the story of Zippix, the toothpick manufacturer that just might make history in the consumer nicotine space.
What are nicotine toothpicks and where can I buy them?
Nicotine toothpicks are wooden toothpicks containing nicotine and flavors.. Some manufacturers simply coat the toothpicks with a mixture of nicotine, flavorings and preservatives, while others use a high-tech vacuum chamber to evenly infuse the ingredients throughout the entire toothpick.
They come in a variety of flavors, and most deliver a similar amount of nicotine as lower-strength pouches: 2-3 mg each. They’re sold in packages of between 15 and 50 toothpicks.
While nicotine toothpicks are largely subject to the same rules as vapes and other consumer nicotine products, they are not banned from U.S. Mail delivery or included in the revised PACT Act, which only applies to vaping products and tobacco. That means that toothpick manufacturers that survive the difficult Premarket Tobacco Application (PMTA) process will be available for shipping anywhere in the country.
Sure, holding a toothpick isn’t exactly like holding a cigarette, but it’s not too far off.
We found five current U.S. nicotine toothpick manufacturers. One of these is made with synthetic nicotine. The other four are made with tobacco-derived nicotine. Of those, one submitted Premarket Tobacco Applications (PMTAs), two others did not, and the fourth, Zippix, is a regulatory story unto itself. More on that company below.
Crave Nicotine Toothpicks uses synthetic nicotine, which is not currently regulated by the FDA. The company, started by former Congrevape owner John Grefe, sells 3 mg toothpicks in eight flavors (currently), which come 50 to a package. Crave’s price per pick is lower than the other brands.
Grefe says that using synthetic nicotine allows him to take advantage of more subtle flavors that would be overwhelmed by the peppery sensation of organic nicotine. Synthetic nic frees him to approach the products in the same way as e-liquid, blending delicate flavors that might not stand up to a strong nicotine sensation, like Butterscotch Cake. Conversely, the toothpick medium allows his stronger flavors, like Sour Candy, to shine without being harsh.
“I approach it like vaping with a bigger opportunity to exploit the medium,” says Grefe. “With an e-liquid there a limit on sour that will come across in the vapor. But in a toothpick, I can crank sour through the roof.”
The company has hired a Washington, D.C. law firm to guide the process of gaining grandfathered status.
Pixotine, which launched in 2013, has submitted PMTAs for four of its flavors—Cinnamon, Original, Tobacco, and Winter Ice—in 3 mg strength. Pixotine toothpicks come in a pack of 15.
NicotinePicks sells eight flavors, which come in tubes of 20 (and cost less if you buy multiple packs). The company didn’t respond to our inquiries about PMTA submission, but doesn’t appear on the FDA’s list of products with submitted PMTAs.
Smart Toothpicks seems to be the only manufacturer that makes non-nicotine toothpicks in addition to its nicotine picks. According to an email from the company, Smart Toothpicks did not submit PMTAs due to the cost. Smart Toothpicks’ 3 mg nicotine toothpicks come in three flavors.
All of the toothpick manufacturers sell online. Some of them also have a presence in convenience stores and gas stations, although none appear to have deals with large tobacco product distributors.
Will Zippix avoid the FDA’s PMTA requirements?
The 2009 federal Tobacco Control Act gave the FDA authority over products made with nicotine derived from tobacco—but products that were on the market before Feb. 15, 2007 are exempt from the premarket authorization newer products must obtain to be legally sold.
That’s how most cigarettes and smokeless tobacco products remain on and continue to dominate the market, even though the FDA has never pronounced them “appropriate for the protection of public health” (the standard required for post-2007 products seeking PMTA acceptance). Manufacturers of those older products don’t have to do expensive toxicological testing or behavioral studies, like newer products (including all vapes) require.
Products that were marketed before Feb. 15, 2007 are considered “grandfathered,” and their manufacturers can continue selling them without jumping through the full set of FDA hoops. The FDA offers a formal grandfathered product determination, and has a database of products voluntarily submitted for that designation.
Needless to say, avoiding the PMTA requirement is a significant market advantage.
“We’re on our fourth round of supportive documentation sent to the FDA.”
According to the manufacturer of Zippix, the company’s nicotine toothpicks qualify as grandfathered products. Zippix owner Marcus Kruk told Vaping360 his toothpicks have been sold since 1993 by two companies owned by him. Zippix has applied to the FDA for formal recognition as a grandfathered product.
The company has hired a Washington, D.C. law firm to guide the process of gaining grandfathered status. “We’re on our fourth round of supportive documentation sent to the FDA,” says Kruk.
However, he points out that even without a formal FDA grandfathered product determination, his company can continue selling unless the FDA decides to challenge that status. Going to court against the FDA is never easy, but Zippix may have a good case.
Unlike vaping products, toothpicks will not be covered by the U.S. Postal Service delivery ban that will be announced any day now, and they aren’t included in the PACT Act.
Kruk’s original company, a compounding pharmacy, began making nicotine toothpicks in 1993. They were promoted to patients with breathing disorders by pulmonary physicians and respiratory therapists, but sold directly to patients over the phone. They marketed the products at medical equipment conventions, primarily in the southeast (Kruk is based in Alabama). However, Zippix never marketed the toothpicks as cessation products, or applied to the FDA as a drug delivery device (which could disqualify it as a grandfathered consumer product).
Whether the FDA will allow products that were not sold through typical consumer tobacco channels to be designated grandfathered tobacco products isn’t certain. But if they do, Zippix would be, as far as we can tell, the only consumer nicotine product made without leaf tobacco able to sell its products without enduring the onerous PMTA process.
The company sells nicotine toothpicks in six flavors—Cinnamon, Mocha, Peppermint Watermelon, Spice Island Clove, Sweet Whisky and Sweet Wood. The last two are 3 mg strength, and the other four are 2 mg. There are 20 picks in each package, and they’re primarily sold online. (Zippix also sells a toothpick containing vitamin B12 and caffeine.)
Where do nicotine toothpicks fit in the marketplace?
So-called “modern oral nicotine” products like nicotine pouches and lozenges—and nicotine toothpicks—are ideal choices for smokers looking to quit and vapers unable to get the products they want because of flavor bans or shipping restrictions.
Unlike vaping products, toothpicks will not be covered by the U.S. Postal Service delivery ban that will be announced any day now, and they aren’t included in the PACT Act. As with nicotine pouches, they may eventually attract negative attention from tobacco control activists, but it hasn’t happened yet.
According to Marcus Kruk, Zippix sales are booming, which seems to be the case for all non-combustible nicotine and tobacco products. People are looking for options, and they’re finding them with nicotine toothpicks, pouches and other oral nicotine products.
“With an e-liquid there a limit on sour that will come across in the vapor. But in a toothpick, I can crank sour through the roof.”
They’re ideal for times when you want nicotine but aren’t able to vape, like at work, in meetings or at sporting events. They’re tiny and easy to carry, and no one will notice that you’re using them.
Finally, nic toothpicks are the only consumer nicotine product aside from vapes that offer some connection to the hand-to-mouth rituals of smoking. Sure, holding a toothpick isn’t exactly like holding a cigarette, but it’s not too far off. You can pop it in your mouth, twist it around, pull it out and reverse it, or take a break and hold it between your fingers.
It’s important to have a wide variety of low-risk products available to give nicotine enthusiasts options. Nicotine toothpicks are another choice for people who don’t want to smoke.
