FDA exempts most vaping gear from regulations

Discussion in 'Vaping News' started by Anthony_Vapes, Apr 18, 2018.

  1. Anthony_Vapes

    Anthony_Vapes Staff Member Moderator 3 year member reviewer Weekly Referral Winner

    Jul 19, 2017
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    In a Guidance For Industry paper issued by the U.S. Food & Drug Administration (FDA), the agency’s fifth revision of Ingredients guidance for tobacco products has taken a major positive step with regard to non-combustible and non-consumable components of Electronic Nicotine Delivery Systems and other deemed “tobacco products.” This revision reads, in part:

    “At this time, with regard to components and parts either sold separately as finished products or as components or parts of other finished products, FDA intends to enforce the ingredient listing submission requirement of section 904(a)(1) only with respect to those components or parts: (1) made or derived from tobacco, or (2) containing ingredients that are burned, aerosolized or ingested during tobacco product use. For example, cigarette paper is burned during use of a cigarette and produces constituents that are inhaled by the smoker, therefore, ingredients in cigarette paper should be submitted to the agency.”

    When it comes to vapor products, this essentially applies exclusively to e-liquid, since it is the only component in a “finished tobacco product” which is inhaled by the user. The FDA further clarifies:

    “Examples of components or parts for which FDA does not intend to enforce the ingredient listing submission requirement of section 904(a)(1) at this time include, but are not limited to, the following:

    • Electrical components including, but not limited to, batteries, charging systems, circuit boards, wiring, and connectors
    • System software
    • Digital display, lights, and buttons to adjust settings
    • Connection adapters
    • Cartomizers
    • Coils
    • Wicks
    • Tanks
    • Mouthpieces”
    This is a welcome revision from the FDA, and one we very much hope will remain cemented in the agency’s policy going forward.
  2. shawn.hoefer

    shawn.hoefer Member

    Jul 25, 2017
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    Your headline is a bit misleading. The gear is NOT exempted from regulation. They don't have to submit ingredients... Exempted from one requirement of the regs. The regs still exist.

    Sent from my LG-H931 using Tapatalk
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  3. VapeNMirrors

    VapeNMirrors New Member

    Jul 19, 2017
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    I'd actuality like to know "ingredients" of coils/wire and wicks and reasonable assurances there aren't flakes/oxides/leaching of materials into the vape. I'd like TCR curves on labeling too!
    Anthony_Vapes likes this.
  4. Whitesoxfan2579

    Whitesoxfan2579 3 year member

    Jul 19, 2017
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    So the way I'm reading this is that it will mainly pertain to e liquids?
    shawn.hoefer and Anthony_Vapes like this.
  5. marcus0263

    marcus0263 New Member

    Mar 5, 2018
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    Yep, the 2007 grandfather still applies. Essentially we're still fucked.

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