FDA forming nicotine group

The US Food and Drug Administration says that it is forming a Nicotine Steering Committee to help develop and implement nicotine policy and regulation.

This development is said to be in support of the agency’s comprehensive new tobacco regulatory plan announced in July.

And it is said to be aimed at addressing what the FDA describes as ‘the public health crisis of addiction to tobacco products in this country’.

‘The committee, which will include senior leadership from the Center for Tobacco Products [CTP], Center for Drug Evaluation and Research, and Office of the Commissioner, will focus on nicotine replacement therapies (NRTs), which are designed to help people quit smoking,’ the CTP said in a press note. ‘The committee will examine the evolving science behind the agency’s evaluation of these NRTs, including the types of safety and efficacy studies FDA requires and how these products are used and labeled.

‘As the committee’s first action, it will hold a public hearing for FDA to obtain feedback on public health, scientific, regulatory, and legal considerations relating to NRT products and their use for cessation.’

The hearing is scheduled for January 26 at the FDA’s White Oak Campus in Silver Spring, Maryland. Registration for attending or presenting at the hearing is required by January 2. But electronic or written comments will be accepted after the public hearing until February 15.

More information is available at: https://www.federalregister.gov/documents/2017/11/30/2017-25671/the-food-and-drug-administrations-approach-to-evaluating-nicotine-replacement-therapies-public.