FDA Regs

When Herbert A. Gilbert filed a patent for his idea of an electronic smokeless device in 1963, he couldn’t have known how big of an impact it would have on the world 50 years later. From his idea the amazing and ever changing eCig Industry has been developed, Vaper Communities all over the world have been formed and it has helped millions of people make the switch to vaping.

It’s very likely that the FDA will propose to ban all PEVUs, Tanks, Attys, Clearomizers, Tips, Wicks, and of course ALL E-liquids. For this reason, we are urging all Vapers, Vape Shops, retailers and ecig supporters to voice your opinion and submit your comments as soon as possible. The deadline to comment is 11:59 pm (EST), August 8, 2014 and if you have not commented, please do so right away. The number of comments received by the FDA about our issue is critical to how the FDA will decide to treat our products.

Consumers:

Click here for the Call to Action issued by The Consumer Advocates for Smoke-free Alternatives Association (CASAA). CASAA is a volunteer, consumer organization, not an industry representative.

Already submitted a comment? Urge others to submit their comments by using the social share buttons below to share with all friends, family and e-cig supporters to help the eCig Industry.

Business Owners:

Below you’ll find guidance for your submission as a business owner.

The FSPTCA of 2009 was designed to stem the harms caused by the tobacco industry and to establish tremendous hurdles in the event that the tobacco industry attempted to ever introduce a new product. Those who innovated and have been touched by the vapor industry know vapor products are the anti-tobacco product.  It is important to convey this message when preparing your comments for submission.

  1. Click here to leave your comments.
  2. Comments longer than 5000 should be uploaded as an attachment.
  3. Please include the following format in your comments:
  • From: [your name]
  • To: FDA Center for Tobacco Products
  • RE: FDA, Docket No. FDA-2014-N-0189, Regulatory Information Number (RIN) 0910- AG38

In your opening comments be sure to include: 


  • Years in operation

  • Number of Employees

  • Number of former smokers in your employ

  • Number of locations 

Continue with your comments and address, in your own words, the significant and problematic issues below:

  1. The vapor industry was initiated and innovated by small business owners and entrepreneurs; and thus many aspects of the proposed deeming regulations are troubling, starting with the February 15, 2007 grandfather date.  This cutoff date will require that products marketed after 2007 submit either a costly “new tobacco product” application, or a Substantial Equivalency application (“SE”), approving it is equivalent to a predicate product marketed before 2007 (non-existent for most e-cigarettes).
  • Explain how dis-similar your products are to the cig-alike products being sold on February 15, 2007, including industry advances in technology.

 

  1. In the absence of being able to meet SE, manufacturers will have to file a Pre Market Tobacco Application (PMTA) for every SKU not marketed in 2007 (“new tobacco product”).  These applications require costly public health studies (estimated to cost between $1M and $4M per SKU) yet do not address actual health, safety, or quality control issues and provide absolutely no benefit to consumers.
  • Calculate the number of SKUs you have to estimate how much it would cost your business to comply.
  1. Potential public health benefits could be lost if innovation of vapor products is stifled.
    • In its efforts to reduce the harm caused by tobacco products the FDA should support the continued innovation and pursuit of the best products available and regulate all products based on the 'continuum of risk'  (Section III - Continuum of Nicotine Delivering Products).  The FDA has the opportunity to develop a more workable approach for dealing not only with products currently on the market, those being 'deemed', but also new products that may be developed.
    • Request that the FDA strike the Proposed Rule as it applies to e-cigarettes and move towards a more rational/science-based approach to the regulation of all products based on risks, relative risks, and intended uses. The tobacco, nicotine and alternative products environment changes rapidly and will continue to do so in the coming months and years, therefore the FDA must be able to make the necessary adjustments. 

Once you’ve addressed the concerns above in your own words, offer viable solutions and concessions to address legitimate concerns:

  1. We understand the need for reasonable regulation and therefore support separate and more appropriate regulation of vapor products potentially based, at most in part, on the “self-executing provisions of the Tobacco Control Act”.  As a business I support:
    • Enforcement authority against products determined to be adulterated and misbranded
    • Provision and enforcement of good manufacturing practices (GMP), if appropriately tailored to address manufacturing of e-cigarettes and distinct from manufacturing of tobacco products
    • Requiring submission of ingredient listing and reporting of harmful constituents
    • Requiring registration and product listing for all e-cigarette products
    • As there is no reliable evidence that flavors have long-term effects on public health or are likely to initiate cigarette and/or dual use, including use by minors we support marketing of products and flavors exclusively to adults.