Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products
2015-196 Nicotine Exposure Warnings Child-Resistant Packaging Liquid Nicotine, Nicotine-Containing E-Liquid(s) Other Tobacco Products Request for Comments open Advance notice of proposed rulemaking FD&C Act 2015-723 Bryant M. Godfrey or Courtney S. Smith, Center for Tobacco Products extension of comment period
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FDA-2015-N-1514-0274 FDA-2015-N-1514-0434 FDA-2015-N-1514-0320 FDA-2015-N-1514-0376 FDA-2015-N-1514-0435 FDA-2015-N-1514-0278 FDA-2015-N-1514-0408 FDA-2015-N-1514-0392 FDA-2015-N-1514-0336 FDA-2015-N-1514-0439
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https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0274 https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0434 https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0320 https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0376 https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0435 https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0278 https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0408 https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0392 https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0336 https://api.regulations.gov/v4/comments/FDA-2015-N-1514-0439
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RAI Services Company (RAIS) Comments: Docket No. FDA-2015-N-1514, 80 Fed. Reg. 37,555 (Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products; Request for Comments)  I am commenting on ANPRM Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products (Docket No. FDA-2015-N-1514)I am opposed to this FDA over-regulation of life saving products intended for adults only that wish to enjoy a facsimili of smoking without the harm associated with it. Ecigarettes are a consumer product, not a tobacco or drug product.  Created as an alternative way for consumers to enjoy their vices without the known dangers of other products that have been on the market.  The freedom to choose is my number one priority. I believe in the fair market, private property rights, business owners rights  individual rights to choose whats right for the individual.  The regulatory agency is repugnant to our Constitution.  I support the industrys mandates on child resistant caps, proper labels, use at your own risk warnings, and I respect their innovations that improve their products.  These are common sense rules, which are easily implanted state by state through the leadership of the industry  consumers.  Innovation should remain free and unimpeded by government over-reach such as this regulatory agency. Thank you for your conscience and concern.  As a pediatrician, I am writing to urge the U.S. Food and Drug Administration (FDA) to quickly develop and implement new regulations on e-cigarettes and their liquid nicotine refills.  I am concerned about children being poisoned by liquid nicotine, a highly toxic substance that can be ingested or absorbed through the skin, mouth, and eyes. An eye-dropper bottle containing 36 mg of nicotine per milliliter of liquid would be enough nicotine to kill four toddlers. Tragically, a one-year-old boy in New York died last December from accidental exposure to liquid nicotine.  If you go to stores liquid nicotine for e-cigarettes is seen in a variety of bright colors and flavors attractive to young children, including Cotton Candy and Grape Bubblegum, and is marketed using brightly colored labels depicting fruit, candy, and popular food items, increasing the likelihood that curious children will come in contact with the liquid.  It is often within arms reach of young children.  It is often shelved close to other more child friendly products.   When these materials come home they become even more available to young children.  Currently there is  no federal requirement that liquid nicotine containers have child-resistant packaging.  We know that child-resistant packaging is among the most effective methods for protecting children, and especially small children, from poisoning hazards.  The FDA has clear authority under the Family Smoking Prevention and Tobacco Control Act to regulate tobacco products to prevent child poisoning.   So please protect children by requiring child-resistant packaging, the use of graphics on warning labels, regulating the use of packaging and flavors attractive to children, and limiting the concentration and quantity of liquid nicotine per unit sold. Robert Gunther, MD MPH FAAP Unfortunately as we have seen the teen smoking rates in the US decline in the last few years, we have watched the significant increase in teen use of e-cigarettes.  Teen usage rates tripled between 2013 (4.5%) and 2014 (13.4%).  Despite the hard work of programs like the one I work with, Reality Check (anti-tobacco youth program in New York State) to raise awareness about the harms of smoking and tobacco use, with few regulations on e-cigarettes our youth see these products as a safer and less harmful alternative than traditional tobacco products.It is unfortunate that the e-cigarette makers can use the same aggressive and targeted tactics that traditional tobacco companies used for years to target our youth, without the regulations that have been placed on the big tobacco companies.Tobacco related illness is the leading cause of preventable death in the United States, tobacco control programs across the country have gotten so close to helping end this public health epidemic with smoking rates at an all-time low, our fight continues as we now have to tackle the unregulated e-cigarettes.  It would be due diligence to our youth and children to protect them through nicotine exposure warnings and child-resistant packaging and to treat these products in the same way as any other tobacco product, a hazard to public health. Has I long term smoker I found that quitting was hard to do until I started vaping. I work with a lot of people on a daily basis and when they ask if I smoke I tell them I quit and started vaping. Is it safer in the long run yes since I quit I have noticed that its easier to do things that was hard when I was smoking cigarettes. Now my question  is would you sit in front of a fog machine filled with all the chemicals in a cigarette or something that smells good, safer for everyone around you? Personally I cant stand the smell from a cigarette anymore!!! I know a couple of different makers of fluid and they are the safer then the tobacco industry. As a pediatrician, I urge the FDA to take swift action to protect children from liquid nicotine poisoning.I am concerned about children being poisoned by liquid nicotine, a highly toxic substance that can be ingested or absorbed through the skin, mouth, and eyes. An eye-dropper bottle containing 36 mg of nicotine per milliliter of liquid would be enough nicotine to kill four toddlers. Tragically, a one-year-old boy in New York died last December from accidental exposure to liquid nicotine.Liquid nicotine for e-cigarettes comes in a variety of bright colors and flavors attractive to young children, including Cotton Candy and Grape Bubblegum, and is marketed using brightly colored labels depicting fruit, candy, and popular food items, increasing the likelihood that curious children will come in contact with the liquid.E-cigarette use continues to increase dramatically, exposing more and more children to this alarming poisoning hazard. A recent study of people who use e-cigarettes and live in households with children showed just how ubiquitous these products have become and how easily accessible they are to children. 36% of those surveyed did not use child-resistant packaging or otherwise lock up liquid nicotine in containers that were difficult for children to access, and 13% reported storing liquid nicotine on an open counter. There is currently no federal requirement that liquid nicotine containers have child-resistant packaging.Child-resistant packaging is among the most effective and time-tested methods for protecting children, and especially small children, from poisoning hazards.The Food and Drug Administration (FDA) has clear authority under the Family Smoking Prevention and Tobacco Control Act to regulate tobacco products to prevent child poisoning. The FDA must publish a proposed rule as soon as possible requiring child-resistant packaging, including flow restrictors, and nicotine exposure warnings that specifically highlight the risk of harm to children on liquid nicotine containers. The FDA should also consider other measures to protect children from the harms of liquid nicotine poisoning, including the use of graphics on warning labels, regulating the use of packaging and flavors attractive to children, and limiting the concentration and quantity of liquid nicotine per unit sold. Please act quickly to prevent further harm to children. As an advocate for child health and well-being, I wholeheartedly support the potential FDA regulation of liquid nicotine packaging. Liquid nicotine is highly toxic; one 36 mg/mL bottle could kill four toddlers. The bright colors and flavors attract the young children to accidentally ingest the harmful substance. As liquid nicotine and e-cigarettes become more popular to adults trying to quit smoking, children will be at more risk. Support those who aim to quit smoking by protecting children from a new kind of harm.  I am commenting on ANPRM Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products (Docket No. FDA-2015-N-1514).  I am an ecigarette user, and this has allowed me to stay tobacco free since 12/31/2011.  This is the longest that I have not used tobacco since I was an adolescent (Age 11).  I am currently 47.  I do not consider myself a smoker any longer, and believe that it is a mistake by those that want to categorize me as a tobacco user.  I feel better, breathe better, and have maintained a healthy weight since stopping tobacco.  I tried several times to kick the habit before, and had not been successful until I tried ecigarettes.  It is unfortunate that much of what is said concerning these devices appears to have its origins from those that stand to lose money as a result of their use rather than relying upon evidence that is not slanted. Since I began, I have discovered a community of vapers and organizations that successfully advocate for safety.  CASAA (The Consumer Advocates for Smoke-free Alternatives Association) is an organization that also helps in not only advocating for our rights, but insist on safety.  Most every company I know (I do not belong, nor have I belonged to an ecig company) has warnings and has child resistant packaging.  These companies (Vapor Stores {I do not buy from convenience stores only vapor stores} also do not allow purchases by minors.Thank You As a pediatrician, I urge the FDA to take swift action to protect children from liquid nicotine poisoning.I am concerned about children being poisoned by liquid nicotine, a highly toxic substance that can be ingested or absorbed through the skin, mouth, and eyes. An eye-dropper bottle containing 36 mg of nicotine per milliliter of liquid would be enough nicotine to kill four toddlers. Tragically, a one-year-old boy in New York died last December from accidental exposure to liquid nicotine.Liquid nicotine for e-cigarettes comes in a variety of bright colors and flavors attractive to young children, including Cotton Candy and Grape Bubblegum, and is marketed using brightly colored labels depicting fruit, candy, and popular food items, increasing the likelihood that curious children will come in contact with the liquid.E-cigarette use continues to increase dramatically, exposing more and more children to this alarming poisoning hazard. A recent study of people who use e-cigarettes and live in households with children showed just how ubiquitous these products have become and how easily accessible they are to children. 36% of those surveyed did not use child-resistant packaging or otherwise lock up liquid nicotine in containers that were difficult for children to access, and 13% reported storing liquid nicotine on an open counter. There is currently no federal requirement that liquid nicotine containers have child-resistant packaging.Child-resistant packaging is among the most effective and time-tested methods for protecting children, and especially small children, from poisoning hazards.The Food and Drug Administration (FDA) has clear authority under the Family Smoking Prevention and Tobacco Control Act to regulate tobacco products to prevent child poisoning. The FDA must publish a proposed rule as soon as possible requiring child-resistant packaging, including flow restrictors, and nicotine exposure warnings that specifically highlight the risk of harm to children on liquid nicotine containers. The FDA should also consider other measures to protect children from the harms of liquid nicotine poisoning, including the use of graphics on warning labels, regulating the use of packaging and flavors attractive to children, and limiting the concentration and quantity of liquid nicotine per unit sold. Please act quickly to prevent further harm to children. No need for  child proof packaging . Been vaping for 5 months now. And never been more healthier. Bottles cone with a childproof cap already with warning labels. Just people need to be 18 years of age. Thats it