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2018-174 Youth Tobacco Enforcement OrdinancesDate: November 30, 2018 Report No. 2018-174 INFORMAL STAFF REPORT TO MAYOR AND CITY COUNCIL SUBJECT Provide additional information regarding smoking regulations and age restrictions, including a recent ordinance approved by the City of San Antonio, and a recent Food and Drug Administration (FDA) announcement about limiting the use of tobacco products and electronic cigarettes by minors. BACKGROUND Following requests from the City Council, staff provided two Informal Staff Reports under reference numbers 2018-141 and 2018-157. The two reports discuss current policies and background information regarding smoking and electronic cigarette regulations. More specifically, the reports outlined:  No. 2018-141: History of the City’s Smoking Ordinance No. 2015-121  No. 2018-157: Information on current laws and policies in the City which regulate the sale and usage of electronic cigarettes. This includes the City’s Smoking Ordinance, State Statutes for School Districts, and Denton ISD’s Policy. A Council Member recently requested additional information about the tobacco ordinance approved by the City of San Antonio1. Additionally, the FDA recently issued an announcement about tobacco and e-cigarette use by minors which staff wanted to update Council with since it is relevant to the issue. DISCUSSION San Antonio’s Tobacco 21 Ordinance The San Antonio ordinance (Attachment 1), also known as the “Tobacco 21 Ordinance”, took effect on October 1, 2018 and increased the minimum age for the sale of tobacco products from 18 years of age to 21 years of age. The Tobacco 21 Ordinance defines the term “tobacco products” to include “… any product that is made from or derived from tobacco, and is intended for human consumption or is likely to be consumed, whether smoked, heated, chewed, absorbed, dissolved, inhaled or ingested by any other means including but not limited to, a cigarette, a cigar, pipe tobacco, chewing tobacco, snuff, snus, or an electronic smoking device or liquids used in electronic smoking devices.” Enforcement of the Tobacco 21 ordinance is carried out by the San Antonio Metropolitan Health District (“Metro Health”), the public health agency that is designated by State law, City code, and 1 January 11, 2018, the City of San Antonio passed Ordinance 2018-01-11-0001 which amended Chapter 36 of the San Antonio City Code and increased the age for sale of tobacco products to 21 years of age. The amendment also defines the term “tobacco products” to include electronic smoking devices, prohibits providing tobacco products to anyone under 21 years of age, and provides criminal penalties for violating the ordinance. Date: November 30, 2018 Report No. 2018-174 County resolution with the responsibility for providing public health programs in San Antonio. Metro Health is a City/County organization but administrative control is under the City of San Antonio and is operated as a City department. Violations of the Tobacco 21 ordinance will be enforced by Metro Health as class “C” misdemeanors and can result in a fine up to $500. It is important to note that the Tobacco 21 ordinance only addresses the selling, distributing, or providing tobacco products to someone who is under 21; in other words the in-store retailers in the City of San Antonio could be fined for selling to someone under 21. The Tobacco 21 ordinance does not apply to the individuals under 21 who purchase, use, or is possess a tobacco product. These individuals would be addressed under Texas State tobacco laws which provide individuals under 18 who purchase, use, or possess tobacco can be fined up to $250 and required to attend a tobacco awareness program.2 Before starting Citywide enforcement, a nine month grace period is in place to allow Metro Health to provide education to the public to raise awareness of the new law and to educate tobacco retailers and staff on the changes. For reference, Attachment 2 is a presentation given to the San Antonio City Council on January 11, 2018 outlining the Tobacco 21 ordinance and associated research. Also attached is a timeline (Attachment 3), education and implementation overview (Attachment 4), and a question and answer (Attachment 5). Food and Drug Administration Announcement Staff also wanted to share some relevant information regarding proposed policy changes at the federal level. On Thursday, November 15, 2018, the Food and Drug Administration (“FDA”) announced that it will begin the process to ban menthol in cigarettes, ban flavor in cigars, and limit the sales of flavored electronic cigarettes to youths. In a news release, the FDA released the findings from the National Youth Tobacco Survey (NYTS) that showed that more than 3.6 million middle and high school students were current users of electronic cigarettes in 2018, an increase of 1.5 million over the previous year. Scott Gottlieb, Commissioner of the FDA, laid out proposed new steps in a statement (Attachment 6) and directed the FDA’s Center for Tobacco Products to revisit the compliance policy by having “all flavored products, including all flavors other than tobacco, mint and menthol, sold in age-restricted, in-person locations and, if sold online, under heightened practices for age verification.” While there has been no change in policy or federal law, the directives set forth in a statement from Gottlieb are meant to speed up FDA action to limit the sale of flavored electronic cigarette products to minors both in stores and online. This directive is the first step in the long process of banning menthol in cigarettes, banning flavors in cigars, and limiting sales of flavored electronic cigarettes to youths. 2 See Texas Health & Safety Code § 161.252 which prohibits individuals under 18 from possessing, purchasing, consuming, or accepting a cigarette, e-cigarette, or tobacco product. Date: November 30, 2018 Report No. 2018-174 ATTACHMENTS 1. San Antonio Ordinance (“Tobacco 21 Ordinance”) 2. San Antonio Tobacco 21 Presentation 3. Tobacco 21 Timeline 4. Tobacco 21 Education and Implementation Plan 5. Tobacco 21 Question and Answer 6. FDA Statement Regarding Youth Access to Tobacco and Electronic Cigarettes STAFF CONTACT: Stuart Birdseye Management Analyst 940-349-8009 stuart.birdseye@cityofdenton.com Sarah Kuechler Director of Public Affairs 940-349-8356 sarah.kuechler@cityofdenton.com LEGAL: Stephanie N. Neal Assistant City Attorney 940-349-8333 Stephanie.neal@cityofdenton.com 1 ur County Tobacco 21 Colleen M. Bridger, MPH, PhD Director City Council A Session January 11, 2018 2 Tobacco •Leading cause of preventable disease, disability, and death in the United States. •Every day, nearly 2,100 young people under the age of 21 become daily cigarette smokers. •Nicotine is highly addictive and the adolescent brain is more susceptible to it. 2 3 Why Raise the Age? •95% of adult smokers began smoking before they turned 21. 3 •Only 2% of tobacco sold is purchased by 18-20 year olds, but that 2% supplies 90% of the addictive tobacco to younger people. 4 Increasing the Sale Age to 21 A Public Health Solution 4 •Delay age of first tobacco use and reduce risk of becoming regular smoker. •Help keep tobacco out of schools. •Younger teens have harder time passing themselves off as 21. 5 Where is T21 already in place? 5 25% of Americans covered 6 Timeline Dates Activity August 24th Introduced T21 to Community Health & Equity Committee Sept. 15th – Oct. 23rd Community Survey October 26th T21 presentation to Community Health & Equity Committee November 3rd Mailed letter & town hall invite to over 1,600 local tobacco retailers November 13th T21 Supporter / Stakeholder Meeting November 16th Town Hall Meeting December 6th City Council B Session January 11th City Council A Session Proposed implementation timeline: January – Sept. 2018 Educate retailers and community on ordinance and enforcement October 1, 2018 Tobacco sale age raised from 18 to 21 6 7 Local Survey Results 5,447 individuals responded to our Tobacco 21 survey that asked the question: Do you believe that the minimum tobacco sales age should be raised from 18 to 21? 77.5% answered Yes Yes 77.5% No 22.3% Blank 0.2% 7 8 Economic data Concern Response Will this program save lives? Just under 500 San Antonio 18-20 year old lives will be saved each year from implementing T21. Is this program cost effective? The Texas DSHS estimated $406 million saved in health care spending on pre-term birth and low birth weight related expenses alone for statewide implementation. Is this program bad for business? Since implementation in Needham, MA in 2005, no convenience stores have gone out of business. Smokers cost employers almost $6,000 more per year than non smokers. 8 9 Needham Case History 9 10 Concerns Raised at B Session 10 Concern raised in December Addressed by Proposed method of selecting stores for unannounced compliance checks Will use random sampling Enforcement on 18-20 year olds purchase, use and possession Have dropped enforcement on 18-20 year olds; retaining enforcement on retailers 11 Draft Ordinance 11 Age group Tobacco Retailers (sale) Youth (PUP) < 18 years of age State law Violations of sale – misdemeanor, with max. fine of $500. State law Violations of youth PUP – misdemeanor, with max. fine of $250. 18-20 years of age COSA Ordinance Mirror state law, but will raise age restriction to 21 COSA Ordinance No enforcement 12 Implementation Plan •Nine month grace period – effective October 1, 2018 •Provide education to youth and families to ensure awareness of new law and educate tobacco retailers and staff on changes in law. •Metro Health will lead enforcement •Random sampling used to determine locations of unannounced compliance checks at tobacco retailers 12 13 Fiscal Impact •Minimal fiscal impact •As proposed, the fine is up to $500 for the sale of tobacco products to someone under 21 years of age. •Revenues from these fines will be deposited in the General Fund. 13 14 Recommendation Staff recommends City Council approve the proposed changes to Chapter 36 of the City Code, titled Smoking 14 15 Thank you. Any Questions? Colleen M. Bridger, MPH, PhD Director 15 Legend Completed In Progress Target Month(s) Jan-18FebruaryMarchAprilMayJuneJulyAugustSeptemberOctober NovemberDecemberJan-19Metro Health Activities Create Metro Health web page to inform community and tobacco retailers on T21 (www.sanantonio.gov/tobacco21) Provide updates on Metro Health's T21 web page Mail T21 letter to San Antonio tobacco retailers regarding passage of Tobacco 21 Ordinance Create T21 Ordinance Fact Sheet for tobacco retailers Distribute T21 Ordinance Fact Sheet to tobacco retailers Create T21 retailer education kit Distribute T21 retailer education kit to tobacco retailers (in-person, mail, online, social media). Continue outreach to Tobacco Retailers Send out and share invitations for T21 Stakeholder Meetings to community and tobacco retailers (mail, email, social media, media interviews) Host T21 Stakeholder Group Meeting A: March 29, 6 PM at Central Library Host T21 Stakeholder Group Meeting B: April 11, 10 AM at Central Library Host T21 Stakeholder Group Meeting C: April 11, 6 PM at Central Library Send out and share invitations for T21 Stakeholder Meetings to the community and tobacco retailers (mail, email, social media, media interviews) Host T21 Stakeholder Meeting 1: August 8, 5:30 PM at Forest Hills Library (West) Host T21 Stakeholder Meeting 2: August 13, 3 PM at Carver Library (East) Host T21 Stakeholder Meeting 3: August 27, 10:30 AM at Tobin Library (North) Host T21 Stakeholder Meeting 4: September 4, 6 PM at Mission Library (South) Present T21 to Greater Bexar County Council of Cities (Includes Mayors of local municipalities) Present T21 to Bexar County Suburban Cities Council (Includes Mayors of local municipalities) Continue T21 outreach to other municipalitiesOther Cities Tobacco 21 (T21) Implementation - As of August 31, 2018 Retailer Education/ OutreachWeb PageRetailer and Community MeetingsPage 1 of 2 Legend Completed In Progress Target Month(s) Jan-18FebruaryMarchAprilMayJuneJulyAugustSeptemberOctober NovemberDecemberJan-19Metro Health Activities Tobacco 21 (T21) Implementation - As of August 31, 2018 Create T21 community education materials Distribute T21 community education materials (schools, universities, colleges, events, military, faith-based, non-profits, social media, online) Create 30 second T21 video for young adults 20 and younger Share T21 video on social media and with universities, colleges, schools and other organizations Present T21 to the Joint Base San Antonio (JBSA) / Metro Health Public Health Briefing Work with the JBSA leadership to obtain support and approval for a communication plan to include Lackland, Randolph, Fort Sam Houston, the Air Force Basic Trainees, students at the Medical Education and Training Campus, and dependents. Present T21 to JBSA Student Commanders leading the Medical Education and Training at Fort Sam Houston for the Army, Navy, Air Force, Marines and Coast Guard Present T21 at the Fort Sam Houston (FSH) Community Information Forum open to the entire FSH community Work with community partners to create tobacco use surveys for both high school teens and young adults ages 18-20 to measure current rates of youth tobacco use in San Antonio Seek approval to administer both youth tobacco use surveys Conduct both youth tobacco use surveys Analyze youth tobacco use surveys and produce report Issue press release and conduct media interviews announcing T21 will take effect October 1, 2018 October 1, 2018 - San Antonio T21 Ordinance becomes effective; Hold press briefing Recruit 18-20 year old adults for T21 Decoy Compliance Visits Health Inspectors begin annual T21 inspections on October 1, 2018 Provide T21 Decoy Compliance Training to selected 18-20 yr. old young adults Health Inspectors & young adults (18-20) begin annual T21 Decoy Compliance Visits on January 1, 2019 (100 per year by random selection)Community Educ.Military Educ.SurveysComplianceMediaPage 2 of 2 Page 1; updated [1/26/18] Tobacco 21 Education and Implementation Overview Raising the minimum legal sale age for tobacco from age 18 to 21 will have a substantial positive impact on public health and will save lives. To be effective, education, implementation and enforcement will be critical elements in the City of San Antonio’s Tobacco 21 (T21) initiative and Ordinance. The Ordinance will take effect nine months after passage. The San Antonio Metropolitan Health District (Metro Health) will focus its efforts, on T21 education throughout the San Antonio community and providing signage and resources to tobacco retailers. The information and resources will require minimal funds supported by Metro Health’s current operating budget. T21 Education (January – September 2018) Metro Health will collaborate with the San Antonio Tobacco 21 Coalition, the San Antonio Council on Alcohol and Drug Abuse (SACADA), Tobacco Retailers and others such as the Region 20 Education Service Center, local school districts, charter & private schools, and other City of San Antonio departments, including Parks and Recreation, Human Services, Library, and the Office of Equity, to provide T21 education in the San Antonio community. Tobacco Retailer Education:  In the first nine months of passage of a T21 Ordinance, tobacco retailers will receive education and resources to comply with T21.  Retailers will be able to participate in an educational session on T21 and the local Ordinance.  Retailers will receive signage from Metro Health at no cost to comply with the T21 Ordinance to display in their establishments.  Retailers will receive T21 information from Metro Health at no cost to train their employees on the new minimum sale age, types of tobacco products listed in the Ordinance, fines, and a listing of local tobacco cessation programs.  Those selling tobacco products will be required to maintain the current standard of verifying the age of people wanting to purchase tobacco products who appear to be under the age of 27.  Retailers will also be able to download T21 information from the City of San Antonio’s<Metro Health website, www.sanantonio.gov/health. Youth & Families:  City of San Antonio departments who work with youth and families will provide them with bilingual information on T21.  San Antonio youth focused institutions and organizations will receive bilingual T21 educational information to share with the youth and families they serve.  Organizations will be encouraged to include T21 information in their tobacco prevention curricula and prevention programs.  Youth focused institutions, organizations, parents and youth will be able to download T21 information from the City of San Antonio’s Metro Health website.  T21 information will also be disseminated via Social Media. Page 2; updated [1/26/18] T21 Implementation Philosophy The overarching philosophy for implementation of this Ordinance is education and partnership with retailers to achieve compliance with the new sale age. As well, the implementation philosophy emphasizes educating youth about the dangers of tobacco addiction and access to tobacco cessation services. Retailers and youth will be educated about the new law and every effort will be made for retailers to achieve voluntary compliance. However, for those retailers who fail to comply with the Ordinance, the following processes will apply as outlined below (please also see a flow chart 1 beginning on page 3 of the implementation and enforcement processes). According to the Texas Comptroller’s Office, currently less than 10% of retailers sell to underage individuals, but non-compliance is unacceptable given the addictiveness of tobacco and the health consequences to youth. Enforcement Authority Principal enforcement of the proposed T21 Ordinance will be by Metro Health’s Sanitarians. Currently Metro Health Sanitarians have the capacity to fulfill the T21 enforcement authority role since the majority of tobacco retailers already receive a routine inspection once per year. The addition of a T21 compliance check to verify T21 signage and training requirements will add minimal time to the current routine inspection. In addition, any person may register a complaint with the City of San Antonio by calling 311 to report violations of this Ordinance. Metro Health Sanitarians also currently follow up on complaints made by the community through the 311 process. If fines for violations of the Ordinance generate additional revenue, it will be collected by the General Fund. Retailers: Signage and Training Compliance (Beginning October 1, 2018)  If a violation is identified during an education visit after the nine month education period, the tobacco retailer will be issued a warning and asked to immediately rectify the violation (i.e., post appropriate signage) and information will be forwarded to the Metro Health Sanitarians.  The Metro Health Sanitarians will subsequently conduct an unannounced compliance visit within 30 days of the violation to verify that signage and/or training violations have been corrected.  Continued violations will result in a citation. Tobacco Sales to Under 21 Compliance (Beginning January 1, 2019)  If the retailer is suspected of selling tobacco products to minors (either due to 311 complaints or signage and/or training violations), Metro Health may check compliance by sending in a person under 21 to see if the retailer will sell to them.  At least once per year, Metro Health will coordinate sales compliance checks in retail establishments based upon received complaints and simple random sampling. Metro Health will use random sampling to select 10 retailers from each Council District. Page 3; updated [1/26/18]  If a tobacco retailer violates the T21 Ordinance by selling to a person under the age of 21, the Metro Health Sanitarian will issue a citation.  The penalty for the sale of tobacco products to someone under 21 years of age is a maximum fine of $500. Chart 1: T21 Implementation and Enforcement Processes Community and Retailer Education (January – September 2018)  Metro Health will collaborate with stakeholders and partners to provide T21 education throughout the San Antonio community.  Metro Health will provide signage, training and additional resources to tobacco retailers. Signage and Training Compliance (Beginning October 1, 2018) Metro Health and tobacco education staff through community partners will conduct T21 compliance checks to verify signage and training through routine visits to tobacco retailers. No Was there a violation? Yes No additional signage/training compliance check for current year Retailer asked to immediately address the violation and issued a warning. Information forwarded to the T21 Enforcement Team. Enforcement Team conducts unannounced compliance visit within 30 days to verify no further signage or training violations. Was there a violation? No Yes No additional compliance check Issue citation Continued on next page Page 4; updated [1/26/18] Tobacco Sales to Under 21 Compliance (Beginning January 1, 2019) Sales compliance checks are done by the Metro Health Sanitarians who will monitor the sale of tobacco to a person known to be under the age of 21. Retailers are selected for Tobacco Sales enforcement through:  311 complaint process  Signage and training violations  Simple random sampling (10 retailers per Council District per year) No Was there a violation? Yes No additional compliance check Issue citation 06-05-18 Questions & Answers • When does the Tobacco 21 Ordinance go into effect? October 1, 2018. • Where does the City of San Antonio Tobacco 21 Ordinance go into effect? It goes into effect within the boundaries of the City of San Antonio. • How do I know if my store is within the City of San Antonio (the City) boundaries? Email us at samhd@sanantonio.gov with your store address and we will let you know. • What does the City’s Tobacco 21 Ordinance cover? The City’s Tobacco 21 Ordinance covers all Tobacco Products meeting the following description: any product that is made from or derived from tobacco, and is intended for human consumption or is likely to be consumed, whether smoked, heated, chewed, absorbed, dissolved, inhaled or ingested by any other means, including, but not limited to, a cigarette, a cigar, pipe tobacco, chewing tobacco, snuff, snus, hookahs or an electronic smoking device or liquids used in electronic smoking devices. o The City’s Tobacco 21 Ordinance does not include drugs, devices or combination products authorized for sale as tobacco cessation aids by the U.S. Food and Drug Administration, such as nicotine patches. • Are synthetic tobacco products, tobacco free liquids, and CBD Oils (Cannaboid oils) included in the City’s Tobacco 21 Ordinance? Yes. (The City’s Tobacco 21 Ordinance follows state law; Health and Safety Code, Chapter 161.081). • Within the City, can e-cigarette replacement parts be sold to those under 21 years of age? No. (Tobacco 21 ordinance follows state law; Health and Safety Code, Chapter 161.081). • Does the City’s Tobacco 21 Ordinance apply to the sale of rolling paper for hand-rolled cigarettes to those under the age of 21? No - unless the rolling paper is made of tobacco. • If my store sells tobacco products, what do I need to do to be in compliance? Starting on October 1, 2018, tobacco retailers within the City will need to: o Verify that customers who ask for cigarettes, other tobacco products or electronic cigarettes are at least 21 years old. If a customer looks to be under 27 years old, retailers must ask for proof of age. Any of these documents constitute proof of age;  A valid photo driver’s license or non-driver ID card issued by a state or other U.S. government agency.  A valid passport  A photo ID issued by the armed forces of the United States. o ID cards issued by employers, schools, or colleges are NOT acceptable forms of ID. o Post Tobacco 21 signage in a location that is conspicuous (visible) to all employees and customers and that is close to the place at which the cigarettes, e-cigarettes, or tobacco products may be purchased. o Ensure employees are educated on the City’s Tobacco 21 Ordinance. 06-05-18 o Ensure employees have signed the City’s Tobacco 21 Employee Notification- Acknowledgement Form and these forms are kept accessible for inspection. • Can my store remove the Texas Tobacco Law sign? No. The state’s signs must still be displayed. Texas Tobacco Law still applies – No sale to minors under 18 years of age. Individuals under the age of 18 who purchase, use or are in possession of a tobacco product can be fined up to $250. • Where can I find the City’s signage and the City’s Tobacco 21 Employee Notification- Acknowledgement Form? Metro Health will provide these Tobacco 21 materials to tobacco retailers in the City before October 1, 2018. The materials will also be posted on www.sanantonio.gov/tobacco21. • What are the City’s fines for selling or distributing tobacco products to someone who is under 21 within the City? The sale or distribution of tobacco products to someone who is under 21 within the City of San Antonio is a Class C misdemeanor, and upon conviction, can result in a fine up to $500. • Will there be a fine within the City for someone who is 18, 19 or 20 years old who purchases, uses or is found in possession of a tobacco product? No. • Does the City’s Tobacco 21 Ordinance apply to cigarette/tobacco vending machines? Yes. Cigarette vending machines within the City may not be situated in a premise or workplace where persons under 21 are allowed entry and / or are employed. • Within the City, regarding hookahs, if the person who purchases the hookah set up at the business is 21 years of age or older, can people under 21 share the hookah set up with that individual? No. • Does the City’s Tobacco 21 Ordinance regulate online sales and delivery? No. • Can Vape shops within the City work on or repair an e-cigarette unit for an 18, 19 or 20 year old who purchased it legally before October 1, 2018? Yes, a repair is allowed, however, giving the device back to someone who is under 21 is not allowed under the City’s Tobacco 21 Ordinance. • Vape shops allow sampling without purchases. Would someone under 21 years of age be allowed to sample within the City? No. • Can clerks at stores within the City knowingly sell to someone who will be providing the product to someone under the age of 21? No. FDA Statement Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes For Immediate Release November 15, 2018 Statement Español (/NewsEvents/Newsroom/ComunicadosdePrensa/ucm626115.htm) As a physician who cared for hospitalized cancer patients, I saw first-hand the devastation that smoking-related diseases had wrought on the lives of patients and their families, and dedicated myself to helping ease this suffering. As a cancer survivor myself, I understand too well the uncertainty, grief and struggle that accompanies a cancer diagnosis. And as a father of three young children, I hear daily from parents and teachers worried about the epidemic use of electronic cigarettes and nicotine addiction among kids. When I pledged last year to reduce addiction to nicotine, I was driven by the fact that, in the U.S., tobacco use remains the leading cause of preventable death and disease. Combustible cigarettes cause the overwhelming majority of tobacco-related disease. When used as intended, they are responsible for the death of half of all long- term users. Today, I’m pursuing actions aimed at addressing the disturbing trend of youth nicotine use and continuing to advance the historic declines we’ve achieved in recent years in the rates of combustible cigarette use among kids. These actions are grounded in hard evidence. But they also are deeply personal. When I first announced (/NewsEvents/Speeches/ucm569024.htm) our comprehensive tobacco framework plan in July 2017, I recognized my opportunity – an almost unprecedented opportunity – to use the tools that the FDA had been given in the Family Smoking Prevention and Tobacco Control Act to bring about meaningful, lasting change to dramatically alter this cycle of disease and death. I envisioned a world in which cigarettes lose their addictive potential through reduced nicotine levels. I envisioned a regulatory paradigm that focused on nicotine and evaluated the diverse nicotine delivery mechanisms along a continuum of risk. On one end, there are combustible tobacco products. At the other end, there are medicinal nicotine products sold as gums and patches. And there is an array of products in between. I saw the opportunity to advance new technologies like electronic nicotine delivery systems (ENDS) as an alternative to cigarettes for adults who still seek access to satisfying levels of nicotine, without all the deadly effects of combustion. I believed then – and I continue to believe – that we must recognize the potential for innovative, less harmful products that can efficiently deliver satisfying levels of nicotine to adults who want them. But as I said at that time, as I said at my confirmation hearing, as I said in my first remarks to the professional staff of the FDA three days after being confirmed as the FDA’s Commissioner in May of 2017, and as I’ve said dozens of times in the months that followed: any policy accommodation to advance the innovations that could present an alternative to smoking – particularly as it relates to e-cigarettes – cannot, and will not, come at the expense of addicting a generation of children to nicotine through these same delivery vehicles. This simply will not happen. I will take whatever steps I must to prevent this. Today, I’m announcing proposals to help reverse these trends, with the unwavering support of HHS Secretary Alex Azar, who shares my deep commitment to protecting the health of our nation’s children. Today, we advance our efforts to combat youth access and appeal with a policy framework that firmly and directly addresses the core of the epidemic – flavors. The data show that kids using e-cigarettes are going to be more likely to try combustible cigarettes later. This is a large pool of future risk. The policies I’m outlining now strives to strike a careful public health balance between our imperative to enable the opportunities to transition to non-combustible products to be available for adults; and our solemn mandate to make nicotine products less accessible and less appealing to children.The data make unmistakably clear that, if we’re to break the cycle of addiction to nicotine, preventing youth initiation on nicotine is a paramount imperative. Almost all adult smokers started smoking when they were kids. Nearly 90 percent started smoking before the age of 18, and 95 percent by age 21. Only about 1 percent of cigarette smokers begin at age 26 or older. When I announced the FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation (/TobaccoProducts/NewsEvents/ucm568425.htm) in July 2017, I made clear my concerns about kids’ use of e- cigarettes, especially those products marketed with obviously kid-appealing flavors. At the time, however, the trends in youth use appeared to be changing in the right direction – reported e-cigarette use among high school students, which peaked at 16.0 percent in 2015, had decreased to 11.3 percent in 2016 and held steady in 2017. What I did not predict was that, in 2018, youth use of e-cigarettes and other ENDS products would become an epidemic. Today, the FDA and the Centers for Disease Control and Prevention are publishing data from the 2018 National Youth Tobacco Survey (NYTS). The data from this nationally representative survey, conducted of middle and high school students, show astonishing increases in kids’ use of e-cigarettes and other ENDS, reversing years of favorable trends in our nation’s fight to prevent youth addiction to tobacco products. These data shock my conscience: from 2017 to 2018, there was a 78 percent increase in current e-cigarette use among high school students and a 48 percent increase among middle school students. The total number of middle and high school students currently using e-cigarettes rose to 3.6 million — that’s 1.5 million more students using these products than the previous year. Additionally, more than a quarter (27.7 percent) of high school current e-cigarette users are using the product regularly (on 20 or more days in the past month). More than two-thirds (67.8 percent) are using flavored e-cigarettes. Both these numbers have risen significantly since 2017. These increases must stop. And the bottom line is this: I will not allow a generation of children to become addicted to nicotine through e-cigarettes. We won’t let this pool of kids, a pool of future potential smokers, of future disease and death, to continue to build. We’ll take whatever action is necessary to stop these trends from continuing. Over the past months, the FDA has worked aggressively to address youth use of e-cigarettes. We deployed a range of our regulatory tools. We launched a multi-pronged Youth Tobacco Prevention Plan (/TobaccoProducts/PublicHealthEducation/ProtectingKidsfromTobacco/ucm608433.htm). We escalated enforcement (/NewsEvents/Newsroom/PressAnnouncements/ucm620184.htm) against retailers who illegally sell ENDS products to minors. We partnered (/NewsEvents/Newsroom/PressAnnouncements/ucm618169.htm) with the Federal Trade Commission to target e-liquid manufacturers whose products used misleading, kid-appealing imagery that mimicked juice boxes, lollipops and other foods. We worked with eBay to remove listings for these products on their websites. We launched innovative campaigns, including “The Real Cost” Youth E-Cigarette Prevention Campaign, to educate teens (/NewsEvents/Newsroom/PressAnnouncements/ucm620788.htm) about the consequences of addiction to e-cigarettes. And I made clear – in speeches, in statements and in interviews – that we were closely watching what appeared to be disturbing trends. I repeatedly said that, although we continue to believe that non-combustible tobacco products may provide an important opportunity to migrate adult smokers away from more harmful forms of nicotine delivery, these opportunities couldn’t come at the expense of addicting a generation of kids to nicotine. I told the manufacturers of e-cigarettes that the youth use of their products was an existential threat to this innovation. In short, over the past year we weren’t sitting still. And we weren’t quiet about our concerns. And yet these deeply disturbing trends continued to build. In September, after receiving the raw data from the NYTS survey, I took additional action. I called on manufacturers to step up (/NewsEvents/Newsroom/PressAnnouncements/ucm620185.htm), to take voluntary actions to prevent youth access to these products and to take meaningful steps to curb their youth appeal. Some manufacturers have already responded to these requests and pledged to take some meaningful voluntary steps to curb youth access and appeal to their products. I also said that the FDA would be re-evaluating our own policy approach and that all options would be considered. Given the startling and disturbing youth use rates in the 2018 NYTS data being released today, it’s clear that we must do more – specifically, several policy changes to target what appear to be the central problems – youth appeal and youth access to flavored tobacco products. Some of these changes would involve revisiting the FDA’s compliance policy, issued in 2017, which extended the dates by which manufacturers of deemed tobacco products that were on the market as of Aug. 8, 2016, were expected to submit premarket applications to the FDA for review (after receipt of an application, the FDA reviews the application and determines if the product meets the applicable statutory standard to be marketed). Under that policy of enforcement discretion, the premarket application compliance date for newly regulated combustible tobacco products, including certain cigars and pipe tobacco, was extended to August 2021. The premarket application compliance date for newly regulated non-combustible tobacco products was extended to August 2022. This applied to most ENDS or e-cigarettes. Today, I’m directing the FDA’s Center for Tobacco Products (CTP) to revisit this compliance policy as it applies to deemed ENDS products that are flavored, including all flavors other than tobacco, mint and menthol. The changes I seek would protect kids by having all flavored ENDS products (other than tobacco, mint and menthol flavors or non- flavored products) sold in age-restricted, in-person locations and, if sold online, under heightened practices for age verification. These changes will not include mint- and menthol-flavored ENDS. This reflects a careful balancing of public health considerations. Among all ENDS users, data suggests that mint- and menthol-flavored ENDS are more popular with adults than with kids. One nationally representative survey showed that, among ENDS users aged 12-17 years old, 20 percent used mint- and menthol-flavored ENDS while, among adult ENDS users, 41 percent used mint- and menthol-flavored ENDS. Any approach to mint- and menthol-flavored ENDS must acknowledge the possibility that the availability of these flavors in ENDS may be important to adult smokers seeking to transition away from cigarettes. Moreover, I recognize that combustible cigarettes are still sold in menthol flavor, including in convenience stores. I don’t want to create a situation where the combustible products have features that make them more attractive than the non-combustible products. Or a situation where those who currently use menthol- flavored cigarettes might find it less attractive to switch completely to an e-cigarette. This is a difficult compromise that I’m trying to strike, recognizing the public health risk posed by cigarettes still being available in menthol flavor. But at the same time, I’m deeply concerned about the availability of menthol-flavored cigarettes. I believe these menthol-flavored products represent one of the most common and pernicious routes by which kids initiate on combustible cigarettes. The menthol serves to mask some of the unattractive features of smoking that might otherwise discourage a child from smoking. Moreover, I believe that menthol products disproportionately and adversely affect underserved communities. And as a matter of public health, they exacerbate troubling disparities in health related to race and socioeconomic status that are a major concern of mine. Although I’m not proposing revisions to the compliance policy for the mint- and menthol flavors in e-cigarettes at this time, we need to address the impact that menthol in cigarettes has on the public health. I’m also aware that there are potentially important distinctions even between mint- and menthol-flavored e-cigarette products. I’m particularly concerned about mint-flavored products, based on evidence showing its relative popularity, compared to menthol, among kids. So, I want to be clear that, in light of these concerns, if evidence shows that kids’ use of mint or menthol e-cigarettes isn’t declining, I’ll revisit this aspect of the current compliance policy. In addition, I’m directing CTP to revisit the compliance policy for all flavored ENDS products (other than tobacco, mint and menthol flavors or non-flavored products) that are sold online without additional, heightened age- verification and other restrictions in place. As part of that effort, I’m directing CTP to publish additional information regarding best practices for online sales. My aim is to have these best practices available soon, so sites can quickly adopt them to help prevent youth access to these flavored products. Of course, no tobacco products, including non- flavored ENDS products or those with tobacco, mint and menthol flavors, should be sold to kids. For this reason we’ll continue to enforce the law whenever we see online sales of these products to minors and will closely monitor online sales of mint and menthol ENDS products. If youth trends don’t move in the right direction, we will revisit all of these issues. I hope I’ll soon see manufacturers of ENDS products preparing, with the FDA input as appropriate, premarket tobacco product applications (PMTAs) to demonstrate that their products meet the public health standard in the Tobacco Control Act. In the coming months, CTP plans to issue additional policies and procedures to further make sure that the process for reviewing these applications is efficient, science-based and transparent. We’ll also explore how to create a process to accelerate the development and review of products with features that can make it far less likely that kids can access an e-cigarette. Other considerations of our policy framework would apply to traditional forms of combustible tobacco products. I noted that the popularity of menthol cigarettes with youth is especially troubling. In fact, youth smokers are more likely to use menthol cigarettes than any other age group. More than half (54 percent) of youth smokers ages 12-17 use menthol cigarettes, compared to less than one-third of smokers ages 35 and older. Prevalence of menthol use is even higher among African-American youth, with data showing that seven out of 10 African-American youth smokers select menthol cigarettes. And, unlike menthol-flavored ENDS, there’s no evidence to suggest that menthol-flavored cigarettes may play a role in harm reduction for adult smokers. We will advance a Notice of Proposed Rulemaking that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars, informed by the comments on our Advanced Notice of Proposed Rulemaking (ANPRM) (https://www.federalregister.gov/documents/2018/03/21/2018-05655/regulation-of- flavors-in-tobacco-products). Finally, to ensure that we’re taking a comprehensive approach, we must evaluate our regulatory approach to flavored cigars. Flavors are added to cigars and other tobacco products for various reasons, such as reducing the harshness, bitterness and astringency of tobacco products during inhalation and to soothe irritation during use. Research shows that, compared to adults (25 or older) who smoke cigars, a higher proportion of youth who smoke cigars use flavored cigars. These data also indicate that eliminating flavors from cigars would likely help prevent cigar initiation by young people. Accordingly, I am also outlining policy goals to address the presence of flavors in cigars – including those that were subject to the compliance policy for newly deemed products, and those that were “grandfathered.” Specifically, I propose a policy through appropriate means to ban flavors in cigars. The bottom line is that these efforts to address flavors and protect youth would dramatically impact the ability of American kids to access tobacco products that we know are both appealing and addicting. This policy framework reflects a re-doubling of the FDA’s efforts to protect kids from all nicotine-containing products. They also reflect a very careful public health balance that we’re trying to achieve. A balance between closing the on-ramp for kids to become addicted to nicotine through combustible and non-combustible products, while maintaining access to potentially less harmful forms of nicotine delivery through ENDS for adult smokers seeking to transition away from combustible tobacco products. This policy framework is an important step toward reversing the epidemic that is underway and that is confirmed by the data from the NYTS. I could take more aggressive steps. I could propose eliminating any application enforcement discretion to any currently marketed ENDS product, which would result in the removal of ALL such products from the marketplace. At this time, I am not proposing this route, as I don’t want to foreclose opportunities for currently addicted adult smokers. But make no mistake. If the policy changes that we have outlined don’t reverse this epidemic, and if the manufacturers don’t do their part to help advance this cause, I’ll explore additional actions. We’ve already seen some positive steps announced voluntarily by manufacturers. Responsible manufacturers certainly don’t need to wait for the FDA to finalize these policies to act. They can stop certain marketing and sales practices — the ones we believe are part of the youth access and youth appeal problem — right now. We hope that within the next 90 days, manufacturers will choose to remove flavored ENDS products from stores where kids can access them and from online sites that do not have sufficiently robust age-verification procedures. The FDA continues to take aggressive action to protect the public health, especially among kids at risk of nicotine addiction and tobacco use. As part of our Comprehensive Plan (/TobaccoProducts/NewsEvents/ucm568425.htm), in addition to issuing the ANPRMs to hear the public’s input on the role of flavors in tobacco products, and on cigars, we also issued an ANPRM on lowering nicotine in cigarettes. We have expedited the review of many of the comments, and spent hours, days and months taking close consideration of the questions raised and evidence presented by the public and various stakeholders. This policy framework reflects the FDA’s consideration of available data and information to get the most complete picture possible of the causes of the epidemic rise in youth use of ENDS. We’ll continue to base our actions on the best available science. And when it comes to protecting our youth, we’ll continue to actively pursue a wide range of prevention and enforcement actions. We’ll leave no stone unturned. This is one of our highest priorities. The tobacco marketplace has changed dramatically in the past year when it comes to youth use of ENDS. And the vision for public health achievements from reduced use of combustible products and reduced nicotine addiction is at risk. But with implementation of the forceful and far-reaching actions that are outlined today, and with the commitment of tobacco manufacturers to take additional, voluntary actions to reduce youth access to their products, we can reverse these trends. As I said after becoming Commissioner, I can think of no more impactful action the FDA could possibly take on my watch to help American families. Here are additional details regarding the policy framework that I seek to advance: 1. Flavored ENDS products that are not sold in an age-restricted, in-person location. Have all flavored ENDS products (other than tobacco, mint and menthol flavors or non-flavored products) sold in age-restricted, in-person locations. All ENDS products, including e-liquids, cartridge-based systems and cigalikes, in flavors except tobacco, mint and menthol, would be included. For instance, the proposed policy would apply to flavors such as cherry, vanilla, crème, tropical, melon and others. To advance this goal, the FDA is revisiting the compliance policy on PMTA authorization for such flavored products sold in physical locations where people under the age of 18 are permitted. The FDA is not revisiting the compliance policy with respect to ENDS products sold exclusively in age- restricted locations – for instance, a stand-alone tobacco retailer (such as a vape shop) that adequately prevents persons under the age of 18 from entering the store at any time; or, a section of an establishment that adequately prevents entry of persons under the age of 18 and the flavored ENDS products are not visible or accessible to persons under the age of 18 at any time. At this time, ENDS products with tobacco, mint or menthol flavors, as well as any non-flavored ENDS products, sold in any location, would not be included in any policy revisions. This distinction among flavors seeks to maintain access for adult users of these products, including adults who live in rural areas and may not have access to an age-restricted location, while evidence of their impacts continues to develop. It also recognizes that combustible cigarettes are currently available in menthol in retail locations that are not age- restricted. This approach is informed by the potential public health benefit for adult cigarette smokers who may use these ENDS products as part of a transition away from smoking. The FDA, however, will not ignore data regarding the popularity of mint- and menthol-flavored ENDS among kids. We will continue to use all available surveillance resources to monitor the rates and use patterns among youth and adults for these products, and we will reconsider our policies with respect to these products, if appropriate. 2. Flavored ENDS products (other than tobacco, mint and menthol flavors or non-flavored products) that are sold online. In addition, we will seek to curtail the sale of applicable flavored ENDS products that are sold online without heightened age verification processes. The FDA will be working to identify these heightened measures for age verification and other restrictions to prevent youth access via online sales. These best practices would be available soon, so sites can quickly adopt them. Because no tobacco products should be sold to kids (including non-flavored ENDS products or those with tobacco, mint and menthol flavors), the FDA will continue to enforce the law whenever we see online sales of these products to minors and will closely monitor online sales of mint and menthol ENDS products. 3. Flavored cigars. Research shows that, compared to adults (25 or older) who smoke cigars, a higher proportion of youth who smoke cigars use flavored cigars. This data also indicates that eliminating flavors from cigars would likely help prevent cigar initiation by young people. Given these public health concerns, I believe flavored cigars should no longer be subject to the extended compliance date for premarket authorization — regardless of the location in which the products are sold. The FDA’s proposal to revisit the compliance policy for flavored cigars that are new tobacco products does not apply to the entire product category, as some products were considered “grandfathered.” Accordingly, the FDA intends to propose a product standard that would ban flavors in all cigars. In July, the comment period for our ANPRM on flavors in tobacco products (https://www.federalregister.gov/documents/2018/03/21/2018-05655/regulation-of-flavors-in-tobacco- products) closed. The FDA has expedited review and analysis of these comments, and we intend to proceed with developing a proposed regulation. As included in the most recent Unified Agenda, the FDA intends to prioritize the issuance of this proposed rule. 4. ENDS products that are marketed to kids. The FDA will pursue the removal from the market of those ENDS products that are marketed to children and/or appealing to youth. This could include using popular children’s cartoon or animated characters, or names of products favored by kids like brands of candy or soda. 5. Menthol in combustible tobacco products. Informed by the comments from our ANPRM, the FDA will advance a Notice of Proposed Rulemaking that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars. The FDA started this process several years ago with an ANPRM. That ANPRM issued alongside the FDA’s preliminary scientific evaluation, which suggested menthol use is likely associated with increased smoking initiation by youth and young adults. Now, armed with the additional years of data, comments from the public – and with the perspective of our Comprehensive Plan and its implementation – the FDA will accelerate the proposed rulemaking process to ensure that our policies on flavored tobacco products protect public health across the continuum of risk. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. ### Inquiries Media   Michael Felberbaum (mailto:michael.felberbaum@fda.hhs.gov)   240-402-9548 Consumers   888-INFO-FDA Follow FDA Follow @US_FDA (https://twitter.com/US_FDA) (/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm) Follow FDA (https://www.facebook.com/FDA) (/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm) Follow @FDAmedia (https://twitter.com/FDAMedia) (/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm)    2017 (/NewsEvents/Newsroom/PressAnnouncements/2017/default.htm) 2016 (/NewsEvents/Newsroom/PressAnnouncements/2016/default.htm) More in Press Announcements (/NewsEvents/Newsroom/PressAnnouncements/default.htm)