Category: Regulation

Today, the U.S. Food and Drug Administration issued a proposed rule to set forth requirements related to the content, format and FDA’s review and communications procedures for premarket tobacco product applications (PMTAs).

When finalized, this proposed rule will help to ensure that PMTAs contain sufficient information for evaluation such as details regarding the physical aspects of a tobacco product and information on the product’s potential public health benefits and harms. It also would codify the procedures by which the agency would review PMTAs and establish the requirements for manufacturers to maintain records related to the legal marketing status of their tobacco products.

“Our review of premarket product applications will help evaluate the public health benefits and harms of a tobacco product to ensure that those authorized for marketing are appropriate for the protection of public health,” said Acting FDA Commissioner Ned Sharpless. “This will include understanding the likelihood that those who do not use tobacco products – such as kids – will start using them, as well as the likelihood that tobacco users will stop. And as I’ve said before, responsible manufacturers certainly don’t need to wait to act. We encourage industry to use available FDA resources as a guide for their submissions to the agency.

“This proposed rule follows our announcement last week that we intend to finalize a compliance policy in the coming weeks that would prioritize enforcement to clear the market of unauthorized, non-tobacco-flavored e-cigarette products. These important regulatory actions are part of our ongoing oversight of e-cigarettes and other tobacco products that is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine addiction and tobacco-related disease and death.”

Under the PMTA pathway, manufacturers or importers must demonstrate to the agency, among other things, that marketing of the new tobacco product(s) would be appropriate for the protection of the public health. That statutory standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products. The agency’s evaluation also includes reviewing a tobacco product’s components, ingredients, additives, constituents, toxicological profile and health impact, as well as how the product is manufactured, packaged and labeled.

In July, a U.S. District Court judge in Maryland issued an order requiring that manufacturers submit premarket applications by May 12, 2020, for deemed tobacco products, including e-cigarette products, that were on the market as of Aug. 8, 2016. Manufacturers may refer to available resources such as the final guidance issued this past June for manufacturers of e-cigarettes and other electronic nicotine delivery systems who will need to prepare PMTA applications. The agency will continue to work efficiently to issue a final rule in a timely manner; however, the final rule need not be in place for manufacturers to continue submitting PMTAs to the agency.

In addition to content and format requirements, the proposed rule would codify the general procedures the FDA would follow when evaluating PMTAs, including application acceptance, application filing and inspections. Additionally, the proposed rule would establish PMTA-related requirements for filing amendments to an application, the time for review, withdrawal of applications, changes in ownership, post-market reporting and maintenance of records, FDA communications with an applicant, FDA’s disclosure procedures and electronic submission requirements.

This proposed rule also explains how applicants may submit a supplemental PMTA or a resubmission, which would reduce the burden of submitting and reviewing a standard PMTA in certain situations. A supplemental PMTA could be submitted when an applicant is seeking authorization for a new tobacco product that is a modified version of a tobacco product for which they have already received a PMTA marketing order. In addition, an applicant could resubmit a PMTA when seeking to address application deficiencies following the issuance of a “No Marketing Order.”

The proposed rule also establishes certain recordkeeping requirements for manufacturers regarding the legal marketing status of certain tobacco products without a PMTA, such as documents showing that a tobacco product is not required to undergo premarket review (grandfathered) or has previously received premarket authorization.

The proposed rule will be open for public comments for 60 days through Nov. 25, 2019.

South Korea plans to ban the advertising of e-cigarettes, reports The Korea Herald.

The Ministry of Health and Welfare said on Monday it would revise the National Health Promotion Act. The amendment will take effect six months after the bill is passed in the National Assembly.

The proposed revision prohibits not only promotions of e-cigarettes, but any kind of marketing that could induce consumption of tobacco products.

Manufacturers will also be prohibited from providing free goods or services relating to nicotine products.

Commercial postings online about experiences using e-cigarettes or related products are also prohibited.

Violators will be fined between KRW3 million ($2,533) and KRW5 million.

Manufacturers of electronic cigarettes in the Philippines have until Oct. 24 to secure an operating license from the country’s Food and Drug Administration (FDA), an FDA official said on Sept. 11.

Anton Javier, the FDA’s project manager for product research and standards development, said the measure is intended to ensure the e-cigarettes sold in the Philippines are free from substances that have been proven to be harmful to health.

According to Javier, there has been strong resistance to the requirement, which manufacturers fear will affect the flavor of their products.

Javier noted that only one company, which he did not identify, has applied for registration so far.

Governor Andrew M. Cuomo of New York will pursue emergency regulations this week to ban the sale of flavored e-cigarettes, reports The New York Times. Tobacco-flavored and menthol-flavored products would not be covered by the ban, the governor said, noting that menthol products could assist in helping people to stop smoking traditional cigarettes.

If New York outlaws flavored e-cigarettes, it would become the second state to move toward such a ban following Michigan, which announced earlier this month that it would prohibit such products.

Cuomo’s action comes days after President Trump announced an effort to ban similar vapor products at the federal level.

Health officials around the U.S. have been grappling with an outbreak of a severe lung disease linked to vaping. At least six deaths and hundreds of hospitalizations have been reported.

New York state has had 64 cases of the lung disease linked to vaping.

Though the specific substance or product causing the vaping illnesses remains unclear, the New York State Department of Health has linked many cases of the illness to cannabis products that contain high levels of vitamin E acetate, a thickening agent for vaping liquid.

The U.S. Food and Drug Administration (FDA) says it will prioritize the agency’s enforcement of the premarket authorization requirements for non-tobacco-flavored e-cigarettes, including mint and menthol, clearing the market of unauthorized, non-tobacco-flavored e-cigarette products.

“The Trump Administration is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools and communities,” said Health and Human Services Secretary Alex Azar. “We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth.”

Today’s announcement comes as preliminary numbers from the National Youth Tobacco Survey show a continued rise in the rates of youth e-cigarette use, especially through the use of non-tobacco flavors. In particular, the preliminary data show that more than a quarter of high school students were current (past 30 day) e-cigarette users in 2019 and the overwhelming majority of youth e-cigarette users cited the use of popular fruit and menthol or mint flavors.

“We appreciate President Trump and Secretary Azar’s continued support of the agency’s efforts to prevent youth use of e-cigarettes, including the bold approach we’re announcing today,” said Acting FDA Commissioner Ned Sharpless.

“Once finalized, this compliance policy will serve as a powerful tool that the FDA can use to combat the troubling trend of youth e-cigarette use. We must act swiftly against flavored e-cigarette products that are especially attractive to children. Moreover, if we see a migration to tobacco-flavored products by kids, we will take additional steps to address youth use of these products.”

Read the full FDA statement.