Bates Responds to “Bizarre Restrictions”

Posted 23rd April 2019 by Dave Cross
The Food and Drug Administration (FDA) has issued its draft guidance for proposals to change the market approval system for vaping products. Clive Bates explains the nonsensical system that would render reduced harm products more difficult to get hold of than tobacco products.

“Caught in its auto-induced moral panic about the teen vaping epidemic,” writes Clive Bates, “the FDA has decided that it would be better if certain vaping products were harder to get hold of than cigarettes, and the ones that were easiest to get hold of should be the ones most like cigarettes – tobacco and menthol flavour.”

“This seems entirely mad to me and riddled with the potential for unintended consequences that would increase smoking in both adults and adolescents.”

The FDA has published “Modifications to Compliance Policy for Certain Deemed Tobacco Products” online. The guidance document details changes to the compliance policies for premarket review requirements for “certain deemed tobacco products”, the process by which vape products are authorised for sale.

The FDA writes that it, “describes how we intend to prioritise our enforcement resources with regard to the marketing of certain deemed tobacco products that do not have premarket authorisation.”


The move is underpinned by the bogus teen epidemic the organisation has invented: “Data from the 2018 National Youth Tobacco Survey (NYTS), as described throughout this guidance, has documented a significant increase in youth use of ENDS products and revealed the magnitude of the problem. These data have prompted FDA to revise its compliance policies with respect to the continued marketing of deemed tobacco products that have not obtained premarket authorisation, and to call on industry to do more to keep their products out of the hands of minors.”

Clive states: “The FDA intends to prioritise enforcement for lack of a marketing authorisation against (in practice this means ‘prohibit’) flavoured ENDS products (other than tobacco-flavoured, mint-flavoured, and menthol-flavoured ENDS products).”

This encompasses:

  • Products sold in locations that minors are able to enter at any time – so that would include all regular shops, convenience stores, gas stations
  • Products sold through retail establishments and online retail locations that have sold to minors after issuance of the guidance
  • Products sold online with no limit on the quantity that a customer may purchase within a given period of time
  • Products sold online without independent, third party age and identity-verification services that compare customer information against third party data sources, such as public records

Clive’s full response can be read on his blog.




 Dave Cross
Article by Dave Cross
Freelance writer, physicist, karateka, motorbikes, and dog walker
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