Trump’s FDA Guidance to Combat Unauthorized Tobacco Products Commended

Current and former lawmakers and law enforcement have commended President Donald Trump’s Food and Drug Administration (FDA) guidance to combat unauthorized tobacco products.

The FDA said in May that it is doubling down on combatting unauthorized tobacco products in the country. On May 8, the agency issued a document titled “Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization.”

The guidance describes enforcement policies with regard to marketing of Electronic Nicotine Delivery Systems (ENDS) and nicotine pouch products that do not have premarket authorization. The guidance states:

Accordingly, all new tobacco products, including those that are ENDS and nicotine pouch products, on the market without authorization are illegally marketed products. This guidance document describes certain enforcement policies with regard to the marketing of certain electronic nicotine delivery systems and nicotine pouch products that do not have premarket authorization.

Many in Congress have fought to combat illicit tobacco imports.

Last week Rep. Ashley Hinson (R-IA) introduced the Eliminating Nefarious Distribution of Smuggled Chinese Vapes Act, or the ENDS Chinese Vapes Act, to stop the “flood of illegal, unregulated, Chinese products that are targeting America’s youth.” Sen. Tom Cotton (R-AR) introduced the companion legislation in the Senate.

Hinson said in a statement:

China is flooding our country with illegal vape products designed to hook our kids, and as a mom to teenage boys, I refuse to sit back and let that happen. These illegal vapes contain dangerous chemicals and shockingly high amounts of nicotine, yet China is pushing them on American kids while banning them at home. That cannot continue. This bill ramps up enforcement and ensures bad actors that are targeting American kids face serious consequences.

The ENDS Chinese Vapes Act would establish heightened civil penalties for anyone who imports or attempts to import illegal vapes into the United States:

• $500 per vape unit for violations involving ordinary negligence
• $1,000 per vape unit for violations involving gross negligence
• $5,000 per vape unit for violations involving fraud or knowing mislabeling.

Hinson and other lawmakers in March urged the Trump administration to crack down on the illicit Chinese vapes.

Former Sen. Richard Burr (R-NC) told Breitbart News in an interview, “This was needed for some time because the illicit market was created because of inaction on the enforcement side, and in part due to the lack of clarity to the marketplace as to what could be sold, so you know it’s sort of a double-edged sword. But make no mistake about it, the illicit market grew and became probably the biggest part of the market, simply because of the lack of enforcement. And, I think what FDA has done now is they have made it clear that they’ve provided guidance on what can be sold at retail, and I think made a commitment to target on a priority basis illicit product, and in many cases the illicit product, in most cases it comes out of China.”

Burr explained that the government should focus on harm reduction, such as moving from combustible tobacco products to less harmful alternatives.

He said, “I think we can’t forget the fact that this is all the byproduct of what we did in Congress in 2000, the Tobacco Control Act, which was a conscious effort to say we can reduce harm if companies will invest in reduced harm technologies, so Congress not only gave FDA authority, but we also gave instructions, and the industry spent millions of dollars creating new technologies, and we’ve seen many iterations over a couple of decades, and I remember RJ Reynolds first had smoke no burn product, you lit the end, but it never burned tobacco, which was the biggest carcinogen, it was the combustible product of tobacco. So, every iteration has been a less harmful product and the coalition is trying to promote reduced harm products, and with every iteration from at least the reputable companies. In fact, that’s what’s accomplished, is that we get reduced harm, which provides what was always my intent when I was there, which is increased options for adults to choose.”

Diane Goldstein, a retired police lieutenant and the executive director of Law Enforcement Action Partnership, said in an interview, “I think that there’s a lot of very interesting complexities here, right? It’s that strategically we cannot enforce our way out of this illicit market. And, so enforcement without the other stools, the other legs of the stool means it’s unbalanced, and so my focus is always strategic enforcement at the highest level, which was just conducted.”

She added, “We’re only getting a small percent of the products that are entering our borders, and it’s not about border security. It’s that consumers are driving this issue, and so until the FDA authorizes as many products as we have as combustible nicotine enforcement is only a partial solution.”

Goldstein continued, “We can’t change the market unless we have enough products out there that are safe and regulated, and once we have enough products out there, and I would suggest that the FDA should do, you know, at least as many combustible products that are already there. So, in the United States, I think we have something like over 12,000 tobacco products that the FDA has approved, but not of that. There’s only like a small percentage of nicotine products. I think it’s like over 4000 combustible nicotine products that are actually authorized, and what we know, it’s the combustible nicotine that causes cancer, right, until we accept that e-cigarettes are risk reduction and actually provide better public health outcomes, until we get at least 4000 products out there, we’re not going to make a dent on the illicit market.”