FDA Releases Long Awaited Deeming Regulations

Today the FDA announced a proposal to extend its authority to additional tobacco products. The FDA’s proposal would extend its’ list of regulated products (cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) to include other currently unregulated products including:

E-Cigarettes

Pipe Tobacco

Nicotine Gels

Waterpipe Tobacco

Dissolvables

Cigars

FDA This proposal is a landmark event for the future of tobacco control, as extending the list of restricted products increases the potential to “make the next generation tobacco free,” according to Health and Human Services Secretary Kathleen Sebelius.

The proposed rule brings these additional products like e-cigarettes under regulations that apply to currently regulated products. Makers of these products nation-wide will be required to:

register with the FDA and report ingredients,
market new products only after FDA review,
halt the distribution of free samples, and
only make claims of reduced risk if the FDA confirms them through scientific evidence.

Under the proposal these products will also be subject to:

a minimum age for purchase and ID requirements,
health warnings on the labels, and
will be prohibited from being sold in vending machines, unless the facility is age restricted

1904246_10152330919752299_8222115739515258608_n All of the proposed restrictions extend the FDA’s authority to protect the health of the public, even as the tobacco industry evolves with the legislation. Tobacco control efforts over the last fifty years significantly diminished the potential tobacco-related death and disability, yet the product continues to be the leading preventable cause of death. New policies to restrict the sale and promotion have the potential to reduce death and disability even further. While communities around the nation have made strides in tobacco control for e-cigarettes and other products, the FDA’s proposal would make regulations nation-wide.

The proposal was released at a time when tobacco control advocates are rallying around new regulations, especially for e-cigarettes. A congressional report released earlier this month called out the industry for its youth marketing tactics, a strategy that will be limited under new FDA authority. In light of recent advocacy for e-cigarette regulations at the POS, CounterTobacco.org created an evidence summary on the topic.

The proposed rule is available for public comment for 75 days.

At the point-of-sale, requiring a minimum age and ID to purchase, along with a restriction for vending machines, will reduce youth exposure to harmful products and minimize initiation. This link is especially important given the recent inundation of new products into the retail environment. The FDA proposed a rolling timeline with the various provisions, and as more news comes out about implementation CounterTobacco.org is committed to relaying that information.