America Let Down By The FDA

Date:

Last week, the American Food and Drug Administration (FDA) was due to deliver a decision on whether Juul were allowed to continue to sell their pods in the United States.

Dithering, it failed to announce anything other than saying it needed more time. Meanwhile, it took action to ban thousands of other products from the marketplace.

A joint statement from Janet Woodcock, the FDA’s Acting Commissioner of Food and Drugs, and Mitch Zeller, Director of the FDA’s Centre for Tobacco Products, said the organisation was facing the “unprecedented task of reviewing applications for over 6.5 million ‘deemed’ new tobacco products”.

In summary, the FDA has:

  • Refused to accept 4.5 million applications
  • Rejected 946,000 applications
  • Approved 0 applications

They say they have acted on 93% of submitted PMTAs (premarket tobacco product applications), “issuing Marketing Denial Orders (MDO) for more than 946,000 flavoured ENDS products because their applications lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.”

Read full article here.

Dave Cross – Planet of the Vapes – 2021-09-14.

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