Deeming Tobacco Products To Be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products
ctp ctp20092 0910-AG38 open 2014-850 Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products Final rule Gerie Voss or Katherine Collins Office of Regulations Center for Tobacco Products 2015-660
2014-06-18 2014-06-13 2014-06-19 2014-06-26 2014-07-14
FDA-2014-N-0189-8056 FDA-2014-N-0189-3770 FDA-2014-N-0189-10852 FDA-2014-N-0189-28747 FDA-2014-N-0189-42853
04:00:00 04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2014-N-0189-8056 https://api.regulations.gov/v4/comments/FDA-2014-N-0189-3770 https://api.regulations.gov/v4/comments/FDA-2014-N-0189-10852 https://api.regulations.gov/v4/comments/FDA-2014-N-0189-28747 https://api.regulations.gov/v4/comments/FDA-2014-N-0189-42853
Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous
As a brick-and-mortar retail tobacconist, I would like to respond to the April 25, 2014, Notice of Proposed Rulemaking (NPRM) on the deeming of tobacco products under the Family Smoking Prevention and Tobacco Control Act. There are several aspects of the proposed deeming regulations that could have a devastating impact on my small business, Blue Havana II Cigars, located in Alpharetta, GA.  First, I oppose the arbitrary price point of $10 for a cigar to be deemed premium.  My inventory, all of which are premium cigars, range in price from $3 to $40 per cigar with the average selling price in the $5 to $7 range.  Additionally, as a retailer, wholesale price fluctuations, differing state tax rates, or a promotional event in my shop could cause a cigar to move from the premium category. Such inconsistencies in the marketplace could impose a significant regulatory burden on me as a small business owner.Secondly, I oppose the imposition of a costly pre-market review process for premium cigars. Pre-market review would be cost prohibitive for many manufacturers, effectively eliminating their ability to release special editions and seasonal blends. Such products are a distinctive aspect of the industry and a large part of my business.Thirdly, I oppose a ban on sampling. Product sampling is an integral part of the unique experience at a premium cigar shop. A sampling ban would prohibit consumers from being able to try new products in my shop and at cigar charity events, which drive consumer purchasing. Given the typical price point and celebratory nature of premium cigars, customers are less likely to purchase an unfamiliar product.For the aforementioned reasons, it is critical that the FDA consider the difference between premium cigars and other tobacco products when drafting the final regulations. Premium cigars are an adult product, without the habitual use patterns of mass-market tobacco products. Existing state law prohibits the sale of products to minors. As a small business owner, I take that obligation to my community very seriously.I urge you to exempt premium cigars from the final FDA regulations. Imposing one-size-fits-all regulations on a diverse suite of tobacco products is a step in the wrong direction for the FDA. Thank you for the opportunity to submit comment on the proposed deeming regulations.Sincerely,Jim Luftman, Member/ManagerBlue Havana II, LLC dba Blue Havana II Cigars I would like to point out the absolute economic disaster you are attempting to cause through these proposed regulations on, smokeless tobacco. Now the primary focus of this comment is on the issue of electronic cigarettes, but if we want to use correct terminology and not slang as you do we would call them, Personal vaporizers, or Advanced Personal vaporizers. The proposal you have made targets the entire e-cigarette industry, this is an obvious attempt to shut down the small business market that dominates the industry as of current. The whole idea of regulation of these products comes from a need for safety yes we all get it, but the FDA as well as everyone else knows that these regulations have a wide and sweeping range that aims to make it so only big pharmaceutical companies and big tobacco companies can afford to run the e-cigarette industry in order to maintain current government tax profits. The articles of this that I demand are changed are the requirement of new, nicotine gels (which is not a proper way to describe e-liquid) to be reviewed by the FDA. Doing so would be like making dove contact you every time they put a new scent in their soap. On top of this the requirement that all products after 2007 must be tested for the market is outrageous, I understand making all products after the regulations go into effect go through this process, but these products will have been on the market for 8 years already (every hear of ex-post facto law). Your regulations are to harsh on a product little is known about I believe that these proposed regulations on the electronic cigarette industry need to be lessened or pushed back to a later date until real scientific prof is given as to weather these products are harmful or not. E-cigs have saved people from smoking cigarettes weather the FDA wants to accept it or not the fact is that with these regulations you are assisting in the deaths of tens of thousands of Americans. Its time that the Food and Drug administration stands by facts and science not common misconception and rumor over these products. Until real evidence is given to the general public regarding these products the FDA is committing a major ethical violation by regulating the whole industry. If you will not hear our voice now then be ready be cause the CASAA is fight you at every turn and for once THE PEOPLE will take the power god has given to them which is exemplafied in the Federal Constitution of the United States of America and stand up for their right to vape, and I promise you if you dont work with us and compromise you are only adding another nail to this countries ever closing coffin. AEMSAs PRA submission to OMB As an adult who enjoys premium cigars, I urge the FDA to remove the $10 price definition, and any other price requirements from the definition of premium cigars. Premium cigars should be defined only by their construction and composition, and not by their price. Cigars priced $10 and above currently represent a very small fraction of the premium cigar industry and this arbitrary number would result in serious damages to an industry and a hobby thats very important to me and millions of other Americans. If regulation of this 1,000-year-plus pastime is absolutely necessary, I ask only for fair and rational requirements. A $10 minimum price point is neither fair nor rational. Thank you for your consideration of my concerns.  As a premium cigar consumer, I urge the Food and Drug Administration (FDA) to exempt premium cigars from the proposed deeming regulations issued on April 24, 2014. The new proposed regulations will infringe on my rights as a cigar consumer: the freedom to enjoy a variety of premium cigars; The freedom to patronize small businesses across America who will now find their livelihood at risk; The freedom to assemble with fellow cigar enthusiasts because of intrusive government intervention into an adult pursuit.  These devastating new restrictions on premium cigars and the businesses that manufacture and sell premium cigars, must recognize that premium cigars, are not what Congress intended with the Family Smoking Prevention and Tobacco Control Act.  I urge the FDA to consider the following:I personally enjoy cigars and tobacco pipes, but besides my personal enjoyment of these products, my income relies on these products. I work at a small tobacco store in Greenville, SC and I absolutely love what I do and the people I interact with on a daily basis. I pray that you will take me and all of the individuals who will be affected into consideration as you seek to further the involvement into premium tobacco. Most of all, I plead to you NOT TO RAISE PRICES in any capacity. I meet so many people from different walks of life in my shop and other shops when I travel. People, who just like me, enjoy a good cigar and the camaraderie it brings. Please do not interfere with our personal enjoyment of premium tobacco. People like being together, and premium cigars are also an important part of the moments of solitude that we all need in life.The federal government should not be interfering with that type of camaraderie, fellowship, and personal pursuit. Thank you for considering my opinions and my voice on this matter.