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FDA Regulations Update 2018

FDA Regulations Update 2018

June 13, 2018. Steven Bustrin, H2 Digital Marketing



For many, the confusion of rumors going around in the FDA regulations have made everything but clarity on what is actually going on in the vape industry. Some companies are going out of business, some producing new flavors, and others are so confused. Instead of throwing out a mix of different regulations and complicated information, let’s make this simple and give you the timeline of regulations that are in place from 2016, currently, and some coming up.


August 8th, 2016

  • No new products (or changes to existing products) can be introduced to the market until the FA authorizes such sales through a “marketing order” based on successfully completing either the SE or PMTA pathways.
  • You can only sell to customer age 18 or older and you need to check a photo ID of everyone under age 27.
  • You are no longer allowed to give away free samples.
  • You are no longer allowed to sell products in a vending machine.
  • You must prevent “product adulteration” by operating your facility in a sanitary manner to avoid contamination (of manufactured or shopped products) that could pose a risk to public health beyond the risk of the product itself.
  • You must avoid any and all misbranding of products as the FDA will start enforcement on false or misleading labeling and advertising. This includes “modified risk claims”
  • This applies to retailers, manufacturers, importers, and distributors.

December 31st, 2016

  • You must register your business if you prepare, manufacture, compound, repackage, relabel or process tobacco products.
  • You must list all your products, in detail.

February 8th, 2017

  • If you are a large-scale manufacturer, you must submit your ingredients, by quantity, brand, and sub-brand.
  • If you are a large-scale manufacturer, you must submit your Tobacco Health Documents (developed after June 22, 2009) relating to “health, toxicological, behavioral, or physiologic effects” of products, constituents (including smoke constituents), ingredients, components and additives.

August 8th, 2017

  • Your Substantial Equivalence Exemption Requests are due.
  • If you are a small-scale manufacturer, you must submit your ingredients, by quantity, brand, and sub-brand.
  • If you are a small-scale manufacturer, you must submit your Tobacco Health Documents relating to “health, toxicological, behavioral, or physiological effects” of products, constituents, ingredients, components and additives.
  • You are not allowed to use “modified risk” language on your labels.

February 8th, 2018

  • Your Substantial Equivalency (SE) Applications are due.

May 10th, 2018

  • You have to comply with labeling and advertising requirements.

August 8th, 2018

  • Your Premarket Tobacco Applications (PMTA) are due for all products that were on the market as of August 8th, 2016.

August 8th, 2019

  • You have to report Harmful and Potentially Harmful Constituents (HPHC).






*Source via FDAREGS.INFO