Category: Regulation

Maryland will become the first state to ban the flavored disposable e-cigarettes that are exempt under U.S. President Trump’s federal flavor ban. Tobacco and menthol flavors are excluded from Maryland’s measure.

Trump’s flavor ban went into effect last week, removing flavored pod products from the market, but it exempts single-use disposable products as well as open tank systems.

“I will not stand idly by letting kids get addicted to nicotine and hurt by these unregulated products that are marketed directly towards them,” Maryland Comptroller Peter Franchot said in a statement.

Franchot’s office sent a notice to the state’s tobacco retailers and wholesalers, warning that they will be disciplined if caught selling flavored disposable products.

The Trump administration wants to remove the Center for Tobacco Products (CTP) from the U.S. Food and Drug Administration’s (FDA) authority.

In his 2021 budget proposal, released on Monday, President Donald Trump envisions the CTP as a stand-alone agency with a Senate-approved director.

The budget proposal states that making the CTP its own agency would allow the FDA to “focus on its traditional mission of ensuring the safety of the nation’s food and medical products supply” while “a new agency with the singular mission on tobacco and its impact on public health would have greater capacity to respond strategically to the growing complexity of new tobacco products.”

Public health advocates reacted strongly against the proposal, saying it would roll back any forward motion the FDA has had in terms of regulating tobacco products. Creating “a new stand-alone agency to handle tobacco regulation is the wrong idea at the wrong time,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids.

Public health advocates already feel that Trump’s recently enacted flavor ban is too weak because it allows for single-use disposable flavored products to remain on the market, which they believe youth will gravitate toward in the absence of other flavored products. The ban removes flavored pod products with the exception of tobacco and menthol flavors from the market.

Some fear that having a Senate-approved director of this new agency would politicize the regulation of the industry—it could “greatly politicize its management and activities,” said Eric N. Lindblom, senior scholar at the O’Neill Institute for National and Global Health Law at Georgetown Law and a former director of the FDA CTP’s Office of Policy.

The FDA was granted oversight of tobacco in 2009 under the Obama administration. The CTP was then created within the FDA to regulate the industry. The CTP would remain under the Department of Health and Human Services under the new budget proposal.

Health Canada and its Quebec counterpart are investigating a vaping ad by Imperial Tobacco to see if it violates advertising laws, reports CBC.

The ad warns of “an epidemic of disinformation” and “hypocrisy” surrounding vaping.

The Tobacco and Vaping Products Act states that it is illegal to “promote a vaping product, including by means of the packaging, by comparing the health effects arising from the use of the product or from its emissions with those arising from the use of a tobacco product or from its emissions.”

Imperial’s “Facts not Fear” website appears to violate that section of the law on the home page and at least seven times on the three pages accessible from the main site, according to Health Canada.

“Everything we do, from our point of view, is legal,” said Eric Gagnon, head of corporate and regulatory affairs for Imperial. “We’ll never do anything illegal. I can assure you that the advertisement, the campaign ahead of publishing looked at every detail, and we consider the advertisement to be legal.”

Imperial appears to have made slight changes to the website recently, removing references to its Vype vapor device.

“Inspectors are currently reviewing the ad and the associated websites,” the federal health minister’s office said.

The U.S. Food and Drug Administration (FDA) sent a warning letter to Smart Toothpicks for several violations of the Federal Food, Drug and Cosmetics Act.

Smart Toothpicks is a company in Arizona that sells dissolvable tobacco products, including peppermint ice nicotine toothpicks.

The FDA’s warning letter cited the company for three violations: selling a tobacco product to a minor through the company’s website; selling unauthorized modified-risk tobacco products; and failing to include required nicotine warning statements on both packaging and advertising. The FDA is requiring the company to respond in writing within 15 days outlining its plan for corrective actions and compliance with the Food, Drug and Cosmetics Act.

Stephen Hahn, the new U.S. Food and Drug Administration (FDA) commissioner, defended the Trump administration’s partial e-cigarette ban but said he would take more actions to stop teen vaping if necessary.

The vaping ban will take effect on Feb. 6 and will ban the sale of most flavored cartridge-based vapor products, with the exception of menthol and tobacco flavors and single-use disposable products. Critics of the ban say it is too weak and fear youth will simply switch to the nonbanned products.

In his first interview with a national media outlet since his confirmation in December, Hahn told the Washington Post that the sales restrictions will target the products most popular with youth but that the FDA will closely monitor the situation, and if minors do switch to menthol-flavored products, the agency will take further action to curb vaping.

“The good thing about this policy is we have the ability without jumping through a lot of hoops to change our enforcement prioritization based on the data we are getting in,” Hahn said.

Advocates on both sides expressed skepticism at the FDA’s ability to quickly assess and respond to changing patterns in youth vaping. “There is zero percent chance the FDA can quickly respond to what they view as the risks associated with vaping because in three years, they have failed to implement sensible regulations,” said Paul Blair, director of strategic initiatives for Americans for Tax Reform.

“The agency’s record of monitoring the marketplace in real time is troubling,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids. “There have been enormous changes with no evidence of their knowing it.”

The U.S. Food and Drug Administration (FDA) filed for scientific review modified-risk tobacco product (MRTP) applications from Philip Morris Products (PMP) for its IQOS heat-not-burn system and three types of HeatStick products on May 24, 2017.

Due to the large size of these applications, the FDA is posting the application documents in installments on a rolling basis as they were redacted in accordance with applicable laws. The FDA completed posting the originally submitted applications on Nov. 28, 2017.

The latest set of application materials from PMP was added on Jan. 24, 2020.

The publicly available modules are located on the FDA’s website.

New Jersey lawmakers voted on Monday to ban flavored vapor products in an effort to reduce youth tobacco use. The bill now awaits approval from Governor Phil Murray.

The legislation also prohibits the use of coupons or discounts to purchase tobacco or vapor products, and it would bar menthol-flavored products, as well as fruit and candy flavors, but would allow tobacco flavors.

If approved, New Jersey would follow Massachusetts as the only other state with a statewide ban on flavors, though other states have enacted emergency regulations on the sales of flavored products.

Murray has not indicated whether he will sign the legislation into law.

Shares in British American Tobacco (BAT) and Imperial Brands rose on Friday after the U.S. Food and Drug Administration (FDA) exempted menthol and tobacco from a list of e-cigarette flavors that it has banned under new guidelines.

“Following a significant period of disruption and uncertainty, this regulatory clarity is a welcome step towards returning the U.S. vapor market to stability,” BAT wrote in a statement.

The new FDA guidelines would also allow tobacco makers to bring back some of the banned flavors if their marketing applications passed a substantive review by the FDA.

“In addition to exempting menthol, the FDA guidance is clear that flavored products will return to the market once they have been approved through the premarket tobacco product application (PMTA) process,” said Simon Evans, spokesman for Imperial Brands.

BAT submitted a marketing application for its Vuse Solo e-cigarette to the FDA in November while Imperial Brands said it would submit its applications for its Blu e-cigarettes before May.

The Campaign for Tobacco-Free Kids (CTFK), however, said the Trump administration had broken its promise to eliminate the flavored e-cigarettes that are driving youth nicotine addiction.

“By leaving menthol flavored e-cigarettes widely available and completely exempting liquid flavored products, this policy will not stop the youth e-cigarette epidemic,” said Matthew L. Myers, president of the CTFK.

By contrast, Michael Siegel, a professor at the Boston University School of Public Health, described the decision to exempt open system products from the ban as a huge victory for public health.

“By allowing vape shops to continue selling flavored vape liquids, the FDA is preventing hundreds of thousands of ex-smokers from being forced to return to smoking,” he said.

But Robin Koval, CEO and president of the Truth Initiative, said that the argument that flavored e-cigarettes and vape shops are necessary for smokers to switch from cigarettes ignores the data.

“The data show that the majority of adult e-cigarette users either never previously used cigarettes or continue to smoke, thereby undermining any potential public health benefit,” she said.

Vapor industry representatives, meanwhile, expressed concern about the FDA’s determination that makers of the nicotine liquids are manufacturers and thus required to submit PMTAs for their products by the court-ordered deadline of May 12.

According to Gregory Conley, president of the American Vaping Association, there has been little “chatter” about liquid manufacturers actually filing such applications.

If they fail to do so by the deadline, many small vapor shops dependent on large nicotine liquid makers could begin closing in mid-May from lack of product from legal sources.