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Showing content with the highest reputation on 07/13/2018 in all areas

  1. Tam

    Concern.

    Much like smoking cigarettes when they first came out, there isn't any long term studies on the effects of vaping so we won't know if there will be any adverse consequences down the road. If you're not a smoker trying to quit smoking cigarettes, and you're only wanting to start vaping to fit in with your co-workers or because it looks "cool." I would strongly recommend you find a different hobby, other co-workers who might have similar interests as you, and stay away from something that, although we believe it's safer than smoking, we still don't know the full effects it could have in the future. That's my two cents. :)
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  2. Hey Vapor Talkers, So as most of you have probably heard by now the FDA has release their deeming regulations for electronic cigarettes. It's extremly broad and a potential devastating blow to the industry. Especially for small to medium sized vape shops that produce their own hardware or e-liquids. I'll leave my own opinion out of the top post and reserve this for the most current information. There seems to be a lack of simplified summaries so I'll do my best, with what we know so far, to explain the situation. UPDATED 7-1-2016 Hi folks SFATA provided a great breakdown that makes things very easy to understand. You can view that document - HERE Here is a summary for everyone: The U.S. Food and Drug Administration (“FDA” or “the Agency”) issued a prepublication version of its final Deeming Rule on May 5, 2016. This Rule extends FDA’s authority to all tobacco products, products derived from tobacco, and devices used with tobacco products (except accessories). With this action, and as of the Rule’s effective date, the FDA will or could have authority over the following products: ● Liquids containing nicotine (products without nicotine are not under FDA’s authority) ● Batteries ● Tank systems ● Cartomizers ● Atomizers ● Digital Displays ● Device Software The Rule was published in the May 10, 2016 edition of the Federal Register. The Rule’s effective date is 90 days from publication in the Federal Register ( i.e. , August 8, 2016). Once the Rule is published in the Federal Register, it starts the clock ticking on a number of dates. The Deeming Rule also creates a distinction among businesses in the industry: retailers and manufacturers. Retailers: Means any person who sells tobacco products to individuals for personal consumption, or who operates a facility where vending machines or selfservice displays are permitted. Manufacturers: Means any person, including any repacker and/or relabeler, who manufactures, fabricates, assembles, processes, or labels a finished tobacco product. As explained below, if an establishment mixes or prepares eliquids, or creates or modifies aerosolizing apparatuses for direct sale to consumers, such a firm would be a tobacco product manufacturer. A manufacturer could also be any business that rebuilds coils or devices beyond simple repairs. Depending on number of employees and annual revenues, it is possible that a manufacturer could qualify as a “small scale tobacco product manufacturer.” Qualifying for this designation will not reduce the compliance requirements, but will afford such firms with additional time to comply with certain requirements under the Rule. Under the Rule, a “smallscale tobacco product manufacturer” is a manufacturer of any regulated tobacco product that employs 150 or fewer fulltime equivalent (“FTE”)employees and has annual total revenues of $5,000,000 or less. FDA considers a manufacturer to include each entity that it controls, is controlled by, or is under common control with such manufacturer. In other words, if a firm employs 150 or less FTE employees and has $5,000,000 or less in annual total revenues, but is controlled by, controls, or under common control with another manufacturer that puts them over the 150 FTE/$5,000,000 revenue thresholds, they would no longer be considered a smallscale tobacco product manufacturer. IMPORTANT DATES: May 10, 2016 - The Deeming Rule is officially published and will be effective 90 days thereafter. August 8, 2016 - The Deeming Rule is effective, as it is 90 days after the Rule is published in the Federal Register. This starts the clock on the various premarket pathway options and it also implements some key changes in the near term. December 31, 2016 - As a result of The Deeming Rule manufacturers will now need to submit a list of all products twice a year December and June of each year. Because the Rule will go into effect August 8 th December of this year will be the first time that vapor product manufacturers have to submit this information. February, 2017 - Manufacturers will need to submit an ingredient list of all products that are manufactured in February of 2017. It is not clear at this time what items the FDA will be expecting although we do expect that the level of detail required will be significant. As we know more, we will provide updates. August 8, 2018 - Premarket tobacco product application (“PMTAs”) are due. August 8, 2019 -Three years after the Rule’s effective date. By this time, all products on the market must have been grandfathered or the subject of an FDA marketing authorization order. How Suppliers must obtain FDA authorization Manufacturers of newlydeemed products that are "new tobacco products” will be required to obtain premarket authorization of their products through one of three pathways: (1) substantial equivalence (SE): This will require a manufacturer to show that a new product is substantially equivalent to a product on the market as of February 15, 2007. As I'm sure most of you know, It is unlikely that many products will be able to demonstrate SE given both the lack of comparable products on the market in February 2007 and the differences between products then and now. These submissions are due 18 months after the effective date (Anyone remember the old pen style 801's? Yikes...) (2) exemption from SE; This pathway is intended primarily for cigars and is unlikely to be an avenue for vapor products. These applications are due 12 months after the effective date. (3) premarket tobacco product application (PMTAs): This will be the path that almost all vapor products will need to follow. Manufacturers for both eliquids and devices will have 24 months to submit a PMTA application. After an application has been submitted, manufacturers will have an additional 12 months to market products. At the close of these compliance periods, products will be subject to FDA enforcement unless they are grandfathered or are the subject of a marketing authorization order. It should be noted that the administrative costs of compiling a PMTA will cost at least a few hundred thousand dollars PER product. This conservative estimate does not account for the testing that will be required to generate data sufficient to inform a PMTA submission. Such testing could cost at least $1 million per product. Short Term: Nothing will significantly change the way you operate your business until August 8 th . Beginning on August 8 th , the FDA can and likely will, to some degree, begin to enforce the following requirements: ∙ Products may not be sold to persons under the age of 18 (both in person and online); ∙ Age verification required by photo ID; You've no doubt run across a few suppliers already requests age verification documents. These are suppliers getting ahead of the curve, expect this to become more normal. Vapor Talk Quite a few members have PM'd me asking how this will affect Vapor Talk and what our stance is. (.... the PR firm kindly requested I refrain from using the exact words I'd like to express. But I'm sure you can take an educated guess if you know my history here!) First, the forum will always remain! No doubt forums are a gateway to the most current information. Secondly, I've taken back a large controlling share of Vapor Talk. We've just closed a joint, multi-million dollar venture and I can assure you, we're in this for the long haul (PR Release will be available at the end of the month). Vapor Talk started in 2008 and since then we've gone through early year bans, border seizures, California state ban (then reversed by good ol' Arnold) and much more. We've been doing this well before many of the new vapers arrived. I'll be working to expand the Vapor Talk online store, get the forum backup to spec (Many updates and bug fixed have been applied to the forum today.) as well as open new locations. VT is currently managed by the Whitney Group out of New Jersey but we'll be reopening offices in Los Angeles, a new office in Beijing (I'm flying out in two weeks so be sure to check the VT blog!) and finally England (Location TBA). Many of you have supported not just me personally but Vapor Talk as a company and community for a long time. As such we plan to stay for many, many years to come.
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