Tobacco Products

CTPConnect—March 2019

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This newsletter serves as a digest of the latest announcements and stories out of CTP. It is a complement to our Spotlight on Science newsletter and CTP News e-blasts.

In This Issue…

“The FDA has repeatedly affirmed our collective view that e-cigarettes may have promise as a tool for helping currently addicted adult smokers quit smoking. But, with the staggering data on youth trends, we’re struggling to preserve these opportunities for adults while addressing the youth epidemic. I simply won’t allow their sale to come at the expense of addicting a generation of kids to nicotine.”

FDA’s Commissioner made these remarks following the February release of National Youth Tobacco Survey data elaborating on a distressing surge observed between 2017 and 2018 in youth use of tobacco, and e-cigarettes, in particular. As detailed in the Commissioner’s statement, NYTS authors suggested that the rise in e-cigarette use between 2017 and 2018 was due to the recent popularity of certain types of e-cigarettes, such as JUUL. Youth e-cigarette users also used them more frequently and more youth used flavored products in 2018 than in the previous year.

As evidence points to the need for additional actions, including policy refinements, to protect kids and reduce death and disease from tobacco products, FDA is taking action for public health protection.


Here, we provide highlights of current FDA initiatives. Specifically, in this CTP Connect, read about…

Data Affirms Staggering Rise in Youth E-Cig Use, FDA Carries On Forceful Actions to Keep Tobacco Products Out of Kids’ Hands

FDA Issues Compliance and Enforcement Guidance

Compliance Deadline Updates: Warning Requirements for Cigars and Pipe Tobacco, Harmful and Potentially Harmful Constituents Reporting

CTP Updates Portal for Reporting Tobacco Product Safety Issues

Tobacco Prevention Resources Available!

Did You Know? April Is…


Data Affirms Staggering Rise in Youth E-Cig Use, FDA Carries On Forceful Actions to Keep Tobacco Products Out of Kids’ Hands

National Youth Tobacco Survey Confirms Youth E-Cigarette Epidemic

Elaborating on initial results from November 2018, National Youth Tobacco Survey (NYTS) data released Feb. 11 by the Centers for Disease Control and Prevention (CDC) and FDA shows a sharp increase in youth use of tobacco products. According to the data, published in the Morbidity and Mortality Weekly Report article “Vital Signs: Tobacco Product Use Among Middle and High School Students—United States, 2011–2018,” about 4.9 million middle and high school students were current users of any tobacco product in 2018, up from 3.6 million in 2017.

From 2017-2018, e-cigarettes were the primary driver of the increase in current use of any tobacco product among students.

According to the NYTS findings, the increase in youth tobacco use was driven by a surge in e-cigarette use. More than 3.6 million middle and high school students were current e-cigarette users in 2018, a dramatic increase of more than 1.5 million students in a single year. The recent National Institutes of Health “Monitoring the Future” study found comparable results.

“The epidemic use of e-cigarettes among children is one of the biggest public health challenges currently facing FDA,” the agency’s commissioner said in a statement on the day the NYTS findings were released. To address this issue, the agency is taking various steps under its Comprehensive Plan for Tobacco and Nicotine Regulation and Youth Tobacco Prevention Plan. The agency’s actions are designed to significantly reduce tobacco-related disease and death in the U.S., by protecting youth while the agency also works to help addicted smokers quit.

The NYTS authors suggest the rise in e-cigarette use between 2017 and 2018 is likely due to the recent popularity of certain types of e-cigarettes, such as JUUL. Youth who use e-cigarettes have also been found to be using them more frequently and more youth have been using flavored products.

Research recently published in JAMA Network Open also sheds light on potential risks to youth e-cigarette users. The research shows that, compared to non-users, youth who use e-cigarettes are more likely to start smoking conventional cigarettes—risking a lifetime of addiction to smoking and, in turn, facing potential disease and death related to smoking.

The agency is taking ongoing steps to address youth appeal of, and access to, flavored tobacco products, which appear to be at the core of the youth tobacco use problem. To remain up-to-date on FDA’s continuing efforts to reduce disease and death from tobacco, visit CTP’s Comprehensive Plan for Tobacco and Nicotine Regulation and Youth Tobacco Prevention Plan webpages.

New Agency Actions Focus on Both Retailers and Manufacturers

As part of the agency’s enduring commitment to stem youth access to tobacco products, FDA has recently taken several actions focused on retailers and manufacturers, under its Youth Tobacco Prevention Plan. Among these actions, the agency has:

  • Initiated enforcement action against certain retail locations of Walgreen Co. and Circle K Stores Inc. for repeated violations of restrictions on the sale and distribution of tobacco products, including sales of cigars and menthol cigarettes to minors.
  • The agency also sent a letter to the corporate management of Walgreen Co., requesting a meeting to discuss whether there is a corporate-wide issue related to its stores’ repeat violative sales of tobacco products to kids. “We all share the important responsibility of keeping harmful and addictive tobacco products out of the hands of kids,” according to a Feb. 7 statement from the FDA Commissioner, which went on to say that retailers, in particular, “are on the front lines of these efforts and must take that legal obligation seriously.”

The Commissioner announced additional forceful actions to combat youth access to tobacco products in a March 4 statement.

As summarized in the Commissioner’s remarks, these were among FDA’s additional actions:

  • Identified 14 more national retail chains whose rates of violative inspections exceed 15 percent of their total inspected stores since the inception of FDA’s retailer compliance check inspection program in 2010.

  • Sent letters to more than 40 companies seeking information about whether more than 50 products—including a variety of flavored e-cigarette products—are being marketed illegally and outside of the agency’s current compliance policy.

  • Sent the first warning letters to several companies for, among other things, selling electronic nicotine delivery systems (ENDS) products and a waterpipe tobacco product with labeling and/or advertising that failed to include the required nicotine warning statement.

More information is available in the FDA Commissioner’s March 4 statement.

Read Statement

FDA Issues Compliance and Enforcement Guidance

Draft Guidance: “Modifications to Compliance Policy for Certain Deemed Tobacco Products”

FDA has issued a draft guidance titled “Modifications to Compliance Policy for Certain Deemed Tobacco Products” as part of the agency’s commitment to limit youth access to, and appeal of, tobacco products. The agency has proposed to end the 2017 compliance policy regarding premarket review requirements for certain deemed tobacco products—specifically, for flavored electronic nicotine delivery system (ENDS) products (other than tobacco-, mint-, and menthol-flavored ENDS) and flavored cigars (other than tobacco-flavored cigars).

“Evidence shows that youth are especially attracted to flavored e-cigarette products, and that minors are able to access these products from both brick-and-mortar retailers and online,” according to the FDA Commissioner’s statement about the draft guidance. “We also continue to be concerned about cigar use among youth—flavored cigars, in particular—which our enforcement work shows are also being illegally sold to minors,” the Commissioner added. “With these concerns in mind, today, we’re advancing our policies aimed at preventing youth access to, and appeal of, flavored e-cigarettes and cigars.”

Comments on the “Modifications to Compliance Policy for Certain Deemed Tobacco Products” draft guidance may be submitted to the open docket with the same title on Regulations.gov. Comments must be received by April 15, 2019 to ensure that FDA considers them while working on the final guidance.

As detailed in the draft guidance, beginning 30 days after issuance of the final guidance–which will be released at a later date—all flavored ENDS products covered by the new policy would no longer be subject to FDA’s enforcement discretion outlined in the current compliance policy. This current policy gives manufacturers of ENDS products on the market as of Aug. 8, 2016 until Aug. 8, 2022 to submit a premarket application. Also as of 30 days after the guidance is finalized, all manufacturers and retailers would be subject to FDA enforcement for selling flavored ENDS products that lack marketing authorization.

FDA is proposing to prioritize enforcement of the policy by focusing on flavored (other than tobacco-, mint-, and menthol-flavored) ENDS products that are offered for sale in ways that pose a greater risk for minors to access the products, and those that are targeted to minors or likely to promote use of ENDS by minors. Importantly, the new draft guidance details FDA’s expectation that manufacturers of flavored ENDS products covered by the new policy—but that remain on the market—submit their premarket applications by Aug. 8, 2021, which is one year earlier than the agency previously proposed.

The many aspects of the policies are outlined in the draft guidance.

Read Draft Guidance

Draft Guidance: “Enforcement Policy for Certain Marketed Tobacco Products”

FDA has published the draft guidance “Enforcement Policy for Certain Marketed Tobacco Products,” which explains the agency’s policy for manufacturers, importers, or distributors of certain marketed tobacco products that receive a not substantially equivalent (NSE) order and the sell-off time allowed, as well as the enforcement policy for retailers with such products in their inventory. These certain marketed tobacco products include “provisional” tobacco products and new tobacco products created by modifying the quantity of a provisional tobacco product in a pending substantial equivalence report.

When finalized, this guidance will supersede the “Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent” guidance issued in September 2015.

Comments on the draft guidance may be submitted on Regulations.gov by searching for “Docket No. FDA-2018-D-3244.”

The Federal Food, Drug, and Cosmetic Act permits a provisional tobacco product to remain on the market pending FDA’s review of the substantial equivalence report for that product. According to the new draft guidance, FDA does not intend to take enforcement action against a manufacturer, importer, or distributor of a product that has received an NSE order for at least 30 calendar days from the date of the NSE order. The agency also does not intend to take enforcement action against a retailer for at least 30 calendar days from the date the NSE order is posted on FDA’s Misbranded and Adulterated NSE Tobacco Products webpage. FDA encourages retailers to contact their supplier or manufacturer to discuss possible options for the misbranded and adulterated product they may have in their inventory.

Read the guidance for additional information about FDA’s enforcement policy for affected tobacco products.

Read Draft Guidance

Final Guidance: Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain FD&C Act Requirements to Vape Shops

FDA has published the final guidance titled "Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops."

Under section 903(a)(2)(C) of the Food, Drug, and Cosmetic Act, a tobacco product in package form is misbranded if its label does not include an accurate statement of the percentage of tobacco used in the product that is foreign-grown and domestic-grown. This guidance clarifies FDA’s interpretation of this as applying only to tobacco products that are made or derived from tobacco. Tobacco products (such as components, parts, and accessories) that are not made or derived from tobacco would not be required to bear the statement.

Additionally, at this time, FDA does not intend to enforce this requirement for certain products, including tobacco-derived liquid nicotine, e-liquid made or derived from tobacco, cigars, smokeless tobacco, and waterpipe tobacco. FDA is providing this compliance policy as the agency recognizes the current scientific and technical difficulties of quantifying the percentage of foreign and domestic tobacco used in these products.

The guidance also clarifies vape shops that are tobacco product manufacturers are subject to the requirements in section 904(a) and (c) of the FD&C Act, including the requirements to provide ingredient listings, report Harmful and Potentially Harmful Constituents, and submit health documents. Those vape shops that modify a product so that it is a new tobacco product are required to comply with the premarket authorization requirements. Vape shops that engage in the manufacture, preparation, compounding, or processing of tobacco products are required to comply with the establishment registration and product listing requirements in section 905 of the FD&C Act.

The final guidance explains certain activities which modify a product, and which would subject the vape shop to the requirements of the Act that apply to manufacturers and includes a compliance policy for limited circumstances for which FDA does not intend to enforce these requirements. For more information on these certain activities and the limited circumstances under which FDA does not intend to enforce compliance, read the final guidance and FDA In Brief.

Read Guidance


Compliance Deadline Updates: Warning Requirements for Cigars and Pipe Tobacco, Harmful and Potentially Harmful Constituents Reporting

FDA has revised the “Extension of Certain Tobacco Product Compliance Deadlines to the Final Deeming Rule” guidance and the related Small Entity Compliance Guide, “FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements.” The revision to these documents extends the harmful and potentially harmful constituents (HPHCs) reporting compliance date to a date that is six months after publication of a final guidance regarding HPHC reporting under section 904(a)(3) and, for small tobacco product manufacturers, nine months after publication of the final guidance. For products entering the market after the publication date of the final guidance, manufacturers must report on HPHCs 90 days prior to marketing the products.

In the preamble to the final deeming rule, FDA indicated its intention to issue guidance regarding HPHC reporting (and later a testing and reporting regulation under section 915) with enough time for manufacturers to report, given the three-year compliance period. At this time, FDA has not published a final HPHC reporting guidance; therefore, we are providing a revised compliance date that is based on when we issue a final HPHC reporting guidance.

Read Revised Guidance


CTP Updates Portal for Reporting Tobacco Product Safety Issues

CTP has updated the Safety Reporting Portal (SRP) for consumers, health care professionals, manufacturers, and researchers submitting safety issues with tobacco products. The introductory section was enhanced to better educate users about which issues to report using the SRP and which to report elsewhere. Additional changes offer more response options for gender and health care professional identities. And, for those submitting voluntary reports, the system now requires input as to whether nonusers were affected by the problem and asks how many people were affected, as well as the setting in which the problem occurred.

For tobacco product researchers, the SRP now allows you to input a list of email addresses to be notified when a report is submitted, and there is a new requirement (was previously optional) to enter an FDA-assigned protocol number.

Anyone may report a problem with a tobacco product, such as a health or safety issue, to FDA via the Safety Reporting Portal. If you or someone you know had a reaction to, or was hurt by, a tobacco product, please visit the SRP and provide as much information as possible. Although consumers and health care professionals may report anonymously, including a way for us to contact you allows FDA the option to find out more about your experience. FDA reviews all tobacco-related SRP reports to identify new or concerning issues.

Safety Reporting Portal

Tobacco Prevention Resources Available! Download or order youth tobacco education materials in English and Spanish!

Do you educate teens about the dangers of smoking?

Find free youth smoking prevention posters from FDA in English and Spanish, with the themes “Be Shareable,” “So What If I Do?” and “Smoking Can Make It Happen.” You can access our bilingual materials through CTP’s online Exchange Lab, where you can download and order these and other tobacco-related resources such as fact sheets, infographics, and web content.

 

Exchange lab prevention poster
Exchange lab prevention poster in Spanish

 

Find Free Resources

Find feature articles on CTP’s website!

Check out these and other recent feature articles on tobacco-related topics…


Did You Know? April Is…

National Stress Awareness Month

People who quit smoking and stay smoke-free feel less stress than people who continue to smoke (Cohen S, Lichtenstein E. Perceived stress, quitting, and smoking relapse. Journal of Health Psychology. 1990; 9(4):466-78). At smokefree.gov, find support, tips, tools, and expert advice on quitting smoking, including information on “Coping With Stress Without Smoking.”



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