ATR Supports Change in Predicate Date for New Tobacco and Vapor Products

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Posted by Paul Blair on Tuesday, November 24th, 2015, 4:04 PM PERMALINK

Today, Americans for Tax Reform sent a letter to members of Congress urging them to change the predicate date at which new tobacco and tobacco-derived products like premium cigars and electronic cigarettes must undergo expensive and unnecessary regulatory hurdles imposed by the Food and Drug Administration (FDA).

Without Congressional action, the FDA will require all products that have hit the market since February of 2007 to undergo a Pre-Market Tobacco Applications (PMTA) process that could cost upwards of several million dollars per product simply to undergo review.

In 2009, the Tobacco Control Act (TCA) established a predicate date of February 15, 2007 at which all new tobacco and tobacco-derived products must establish “substantial equivalence” to products sold before then in order to avoid an expensive and lengthy pre-approval process by the FDA.

Because of the speed at which innovation has occurred with vapor products since that time, essentially all products currently being sold to consumers fall into this regulatory trap. The process of obtaining FDA approval to continue to be sold isn’t only expensive; it may not actually be possible given the lack of clarity and available data being demanded of each business for each product.

Congress must act to permit innovation to continue for these smoking cessation products that stand to save millions of lives and billions of tax dollars resulting from harm reduction associated with smokers making the transition to tobacco-free alternatives like e-cigarettes.


Below is a full text of the letter:

Dear Member of Congress,

I write today in support of efforts to save the thousands of small businesses in the United States who are selling tobacco-free technology products to adult consumers trying to kick their smoking habit. Though reliant on the sale of tobacco products for billions of tax dollars annually, Congress should help facilitate all efforts by the free market to accomplish what stiff regulations and taxes never could, getting smokers to quit for good.

Unfortunately, without Congressional action, an overreaching Food and Drug Administration (FDA) will proceed with an arbitrary bureaucratic hurdle for the sale of vapor products more akin to prohibition than reasonable regulation. Unable to regulate tobacco products until 2009, the Tobacco Control Act (TCA) established a predicate date of February 15, 2007 at which all new tobacco or tobacco-derived products must establish “substantial equivalence” to products sold before then in order to avoid an expensive and lengthy pre-approval process by the FDA.

Without Congressional action, the FDA pre-approval process will cost upwards of several million dollars per product, a cost affordable to none other than the large tobacco companies, for products already being sold to consumers. Since 2007, significant innovation in the electronic cigarette and vapor product category has occurred, meaning nearly 99% of the life-saving vapor products on the market will cease to exist.

This burdensome regulatory hurdle also stands to harm producers and retailers of cigars, pipe tobacco and dissolvable tobacco.

Amending the predicate date established in the Tobacco Control Act for new products will do nothing to impede upon the FDA’s general efforts to regulate this product category. In fact, grandfathering in all of the products currently being sold to consumers, will save the agency at least two year’s worth of paperwork and allow them to focus on encouraging good manufacturing practices, among other things.

A predicate date change to the date of FDA deeming regulation enactment will simply allow innovation to continue, without decimating an entire market of smoking cessation products and the consumers who use them.

In testimony to the Senate Commerce Committee last June, Matthew Myers of the Campaign for Tobacco-Free Kids explained, “Responsibly marketed and properly regulated, e-cigarettes could benefit public health if they help significantly reduce the number of people who smoke conventional cigarettes and become sick and die as a result.” He explained further that if properly regulated, “I don’t think there is any doubt that there would be a reduction in harm,” from smokers who switched to e-cigarettes. He is absolutely right on this point.

A recent Centers for Disease Control (CDC) survey suggests that there are more than 9 million adult consumers of vapor products in the United States. This represents the greatest accomplishment in public health in decades and is due entirely to the free market. This rise corresponds with a significant decline in smoking rates among Americans and is no coincidence.

That is why I support a change in the 2007 predicate date, which would permit products currently being used by consumers to quit smoking to continue to be sold. This very reasonable step has been put in legislative language authored by Rep. Tom Cole (R-Okl.) in the form of H.R. 2058 and exists in similar form in an amendment made to the House Appropriations Rural Development, Food and Drug Administration and Related Agencies agriculture appropriations bill earlier this year.

Unlike smokers, adult vapor product consumers are becoming single-issue voters who correctly attribute their switch from combustible tobacco products to smoke free alternatives like e-cigarettes to saving their lives. To crush this new and emerging industry would reverse decades of efforts to get people to quit smoking.

I urge Congress to amend the Tobacco Control Act predicate date for the tobacco-derived products in the electronic cigarette and vapor product category in an effort to protect public health and protect American jobs. Such a change in the predicate date would not interfere with the short-term goals of responsibly regulating the products; it would simply help avoid the looming economic and public health disaster associated with status quo prohibition.


Grover G. Norquist ​

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