Deleted Tweets From Scott Gottlieb, R-D.C.

Last week we announced a proposal to end our current compliance policy as it applies to certain flavored ENDS products (except tobacco-, mint-, or menthol-flavored) https://t.co/nwxDyOoh2M, and we issued a draft guidance outlining our proposed enforcement priorities. https://t.co/3BwKq2NF2D

Last week’s action is another step in preventing youth use and access to e-cigs - but it doesn’t end there.

Recent evidence indicates that tobacco, mint and menthol flavored ENDS are more preferred by adults than minors, and adults may be using these products to cease use of combustible tobacco. Thus, we’re not currently proposing to change the compliance policy for these products. https://t.co/QIY28o4ynN

Our draft guidance also states that #FDA expects manufacturers of flavored ENDS products (other than tobacco, mint and menthol) to submit premarket applications by Aug. 8, 2021 – a year earlier than expected under our previous policy.

The 2019 National Youth Tobacco Survey begins this month. To ensure the survey addresses youth who don’t think JUUL, or similar products, are e-cigs, we have worked with the CDC to ask kids what product brands they use, including JUUL. We’ll be closely monitoring the results.

If youth use spikes again in 2019, the #FDA will have to consider additional regulatory steps, including action to require flavored pod-based e-cigs to come off the market until they have successfully completed the application process. These are the product kids are using.

The #FDA will not allow a generation of children to become addicted to nicotine. This effort will carry on after I leave the agency. These efforts are embedded in the public health DNA of this agency and strongly supported by @SecAzar and the White House. https://t.co/iUoGjPh5xY

Later this year we’ll also expand “The Real Cost” E-Cig Prevention Campaign to television to further reach youth about the dangers of e-cigarette use. I urge others to consider stepping up their efforts to educate and protect children as well. https://t.co/ekdn8rdjFM

If youth use rises again in 2019, whatever redeeming public health value this category of pod-based products may have for adult smokers, that potential benefit will be fully offset by the youth use. These products are on the market only out of enforcement discretion by #FDA.

E-cig use among kids is so widespread, so pervasive, that we risk addicting an entire generation of children on nicotine and watching the dramatic gains we’ve made in reducing smoking rates be reversed. https://t.co/JKrLfF1m09

#FDA will hold a public meeting on April 17 to discuss draft guidance on complying with and implementing the intentional adulteration rule to protect food. The meeting runs from 8:30 AM - 2:00 PM at our College Park campus. To register, visit: https://t.co/XTPCUN6Bj0 https://t.co/0odoVWb7mP

RT @FDAfood: Trying to eat healthier when eating out? Compare calorie and nutrition info before you order, then make the choice… https://t.co/LScY6lKv3b

#FDA finalized two guidance documents to support the development of antiretroviral drug products for treatment of HIV in pediatric patients and to aid the development of systemic drugs for prevention of HIV-1 infection. https://t.co/Xf6jjQguTv

RT @SecAzar: At #NHPC2019 this morning, I was glad to announce that @US_FDA is releasing final versions of guidances to support development… QT @SGottliebFDA: Part of #FDA's commitment to HIV focuses on efforts to advance development of life-saving treatments to vulnerable/… https://t.co/8XAaVVifI7)

RT @NBCNewsHealth: FDA issues warning to two breast implant makers over safety concerns https://t.co/TYc1ZcDxnM

RT @FDAOncology: To address the question of whether treatment beyond progression has clinical benefit, CDER researchers pooled data… https://t.co/CQ9SJ6h1Vy

RT @FDAOncology: FDA takes new steps to broaden patient participation in #cancer #clinicaltrials, advancing policies to promote incl… https://t.co/MFW6ct19wa

RT @FDASpox: Flag: FDA issued warning letters to two breast implant manufacturers for deficiencies in their required post-approv… https://t.co/M4vlpX9oVe

RT @PostOpinions: The future of e-cigarettes depends on the industry’s willingness to protect teens, write @HHSgov's @SecAzar and… https://t.co/aFoCBAg8dn

My Op Ed with @SecAzar in @washingtonpost today - The potential opportunity for e-cigs to be a useful tool for currently addicted adult smokers hangs in the balance if we cannot reduce the epidemic of youth use of these products. https://t.co/aDoOOJF4rM

RT @SecAzar: We are at a critical point in the history of e-cigarettes. Read my op-ed with @SGottliebFDA on why we can’t afford… https://t.co/V3U7PwMeL7

RT @FDAJobs: Waving�Wednesday: Meet Linley Cohen, she started as a student at #FDA in 2008 and now serves as a Communication Spe… https://t.co/i6zwHW4DqC

RT @SGottliebFDA: My Op Ed with @SecAzar in @washingtonpost today - The potential opportunity for e-cigs to be a useful tool for curr… https://t.co/GanyJdxVEl

After carefully considering benefits and risks to patients we think it’s critical patients have access to the drugs while impurity-free losartan is manufactured. We believe this will NOT meaningful increase risks over the time it will take to get impurity-free losartan to market

THREAD: Update on the recent ARB recalls: This week, we announced the agency will not object to certain losartan medications containing very limited amounts of impurities temporarily continuing to be distributed to patients. https://t.co/HZb3YT0060

We strongly believe risks (such as stroke) of abruptly discontinuing these important medicines far outweighs the low risk associated with continuing the medications.

We’ll keep working with manufacturers to eliminate these impurities from the drug supply, but we recognize that we also need to ensure patients who need ARBs have access now. We’ll continue to prioritize our investigation and give frequent updates on this important safety issue.

RT @FrankYiannasFDA: We must invest to prevent problems from happening by solidifying the agency’s tools under FSMA. We must also embrac… https://t.co/MalOkHbv5A

As HHS CoS and then Deputy on DPC, Lance Leggitt helped #FDA advance a historic modernization of the Office of New Drugs, CURES implementation, efforts to combat kids tobacco use, and generic competition. His #FDA knowledge and commitment to our mission leaves a lasting imprint.

RT @BrookingsEcon: #ICYMI: watch @SGottliebFDA as he reflects on his tenure as Commissioner of @US_FDA , featuring @davidmwessel and… https://t.co/1DnO8cO8nj

Many companies making/selling FDA-regulated products comply with #FDA rules to protect the public. But some firms willfully disregard them, prompting us to take action. In today’s #FDA #SundayTweetorial, I’ll highlight a # of FDA’s key enforcement actions during my 2-year tenure. https://t.co/Edk6HTzyEt

@TheJusticeDept FDA has many tools to use against bad actors, depending on the violation: warning letters (WLs) that cite violations and seek corrective actions, mandatory recall (for some products), seizure, injunction, civil penalties, and criminal prosecution. And we’re not shy to use them! https://t.co/PErgQUcfjC

@TheJusticeDept We’ve pursued a series of escalating actions against these outfits, culminating in federal cases for permanent injunctions to stop two stem cell clinics from marketing their products without #FDA approval and for major deviations from CGMP requirements https://t.co/05r2joAsFC https://t.co/DKIYmdV8l8

@TheJusticeDept Enforcement is a priority. #FDA worked together to confront numerous health fraud scams and worked on the successful prosecution of companies and individuals who marketed dietary supplements with dangerous ingredients during the last two years https://t.co/6PsCNB89P4. https://t.co/XPCnzMbZVg

@TheJusticeDept Consider these stats from FY 2018: FDA issued 14,285 WLs, oversaw 7,562 recalled products, initiated 14 injunctions and 1 product seizure, issued 231 import alerts to detain potentially violative products and made 317 criminal arrests. We also make sure to publicize bad actors.

@TheJusticeDept We consider enforcement - protecting consumers from those who would prey on them with bogus claims and fraudulent products - to be the cornerstone of our consumer protection mission. We’ve dedicated new resources to this work https://t.co/4usiypxrWo. https://t.co/w5wNAs0Fws

@TheJusticeDept Our aggressive actions against bogus stem cell clinics, where bad actors have been leveraging the scientific promise of cell-based regenerative medicine to peddle unapproved treatments that risk patient’s health and even harm them, provides a good example of our efforts. https://t.co/TLJ1ZMUnog

@TheJusticeDept As part of our new risk-based enforcement approach to drug products labeled as homeopathic, we’ve taken action against companies marketing such unapproved products with claims they can treat addiction and chronic pain and/or other conditions https://t.co/wVyeDA0L1V. https://t.co/0JJQDu3ygu

@TheJusticeDept Most recently we sent 17 WLs to companies illegally marketing Alzheimer’s disease products, often sold on websites and social media platforms. Such health fraud preys on vulnerable populations, wastes money and often delays proper medical care https://t.co/2IVt6RghMM. https://t.co/QJTu4VZe9Y

@TheJusticeDept We’ve also taken action against companies marketing pills and capsules labeled as dietary supplements with unproven drug claims about protecting consumers from harms that come from sun exposure https://t.co/l0Qk7I7GLy. They put consumer’s health at risk and provide false security https://t.co/lLTvSlqUKh

@TheJusticeDept And we’ve been vigilant in going after companies that market fraudulent cancer products, issuing > a dozen WLs in 2017, including 4 WLs to companies marketing unproven products purporting to contain cannabidiol (CBD) claiming to treat/cure cancer https://t.co/DZXFLHmSZK. https://t.co/2nZQgdEuUN

@TheJusticeDept The company had marketed their neurovascular device for unapproved and potentially dangerous surgical uses, gave sales reps quotas and bonuses for selling the device for such uses and trained their reps to instruct physicians on the unapproved use of these devices.

@TheJusticeDept #FDA has also sought to protect the public from online pharmacies that purport to sell cheaper versions of drugs from Canada, Britain or Australia but may actually get drugs from other countries, increasing the risk consumers may buy counterfeit drugs https://t.co/sJoeNo9pWX. https://t.co/RauigIbxtt

@TheJusticeDept Congress responded by updating our authority for overseeing compounders (who provide medications to patients when there is no FDA-approved drug). Since 2012, we’ve issued more than than 220 WLs, overseen > 230 recall events and have continued going after the industry’s bad actors https://t.co/fB3WPJmCMK

@TheJusticeDept In 2012, 750 people developed fungal meningitis across multiple states and over 60 died after they were injected with contaminated compounded steroid drugs. Enforcement was an integral part of our approach to this tragedy and it remains integral in our work with compounders. https://t.co/HHCRfxlJxl

@TheJusticeDept A key part of #FDA’s efforts to promote safe and effective medical devices is our enforcement work related to unsafe practices and bad actors. In December, an FDA criminal investigation resulted in a guilty plea & fines for medical device maker ev3 Inc https://t.co/nEzbwZJcDm https://t.co/a7c4Mh3eEy

@TheJusticeDept This month, working with #DOJ, we obtained a permanent injunction against a company for making supposedly sterile injectable drugs in insanitary conditions whose eye injections resulted in impaired vision https://t.co/cee6olPDhj. https://t.co/hNwYagQog8

@TheJusticeDept #FDA has moved to block the flow of opioid drugs on the web, recently warning 23 networks operating > 450 websites illegally marketing potentially dangerous, unapproved, and misbranded opioid medications, including tramadol and oxycodone https://t.co/80bZNAznjm. https://t.co/VHvRvzFWfu

@TheJusticeDept Enforcement has been an essential tool in tackling the opioid epidemic, especially illicit opioids, which are accounting for a sharply increasing percentage of the total exposure to these drugs and fueling a growing addiction crisis https://t.co/5aTCwmo8gb https://t.co/ny1RQJORxh

@TheJusticeDept We’ve increased our interdiction at the nation’s 9 International Mail Facilities where illegal counterfeit and unapproved drugs flow in https://t.co/eqQDXEzO32 and have begun implementing new authority making it easier for us to stop illegally imported drug articles https://t.co/gjpgrCHAhS

Last week we announced a proposal to end our current compliance policy as it applies to certain flavored ENDS products (except tobacco-, mint-, or menthol-flavored) https://t.co/nwxDyOoh2M, and we issued a draft guidance outlining our proposed enforcement priorities. https://t.co/3BwKq2NF2D

Last week’s action is another step in preventing youth use and access to e-cigs - but it doesn’t end there.

Recent evidence indicates that tobacco, mint and menthol flavored ENDS are more preferred by adults than minors, and adults may be using these products to cease use of combustible tobacco. Thus, we’re not currently proposing to change the compliance policy for these products. https://t.co/QIY28o4ynN

Our draft guidance also states that #FDA expects manufacturers of flavored ENDS products (other than tobacco, mint and menthol) to submit premarket applications by Aug. 8, 2021 – a year earlier than expected under our previous policy.

The 2019 National Youth Tobacco Survey begins this month. To ensure the survey addresses youth who don’t think JUUL, or similar products, are e-cigs, we have worked with the CDC to ask kids what product brands they use, including JUUL. We’ll be closely monitoring the results.

If youth use spikes again in 2019, the #FDA will have to consider additional regulatory steps, including action to require flavored pod-based e-cigs to come off the market until they have successfully completed the application process. These are the product kids are using.

The #FDA will not allow a generation of children to become addicted to nicotine. This effort will carry on after I leave the agency. These efforts are embedded in the public health DNA of this agency and strongly supported by @SecAzar and the White House. https://t.co/iUoGjPh5xY

Later this year we’ll also expand “The Real Cost” E-Cig Prevention Campaign to television to further reach youth about the dangers of e-cigarette use. I urge others to consider stepping up their efforts to educate and protect children as well. https://t.co/ekdn8rdjFM

If youth use rises again in 2019, whatever redeeming public health value this category of pod-based products may have for adult smokers, that potential benefit will be fully offset by the youth use. These products are on the market only out of enforcement discretion by #FDA.

E-cig use among kids is so widespread, so pervasive, that we risk addicting an entire generation of children on nicotine and watching the dramatic gains we’ve made in reducing smoking rates be reversed. https://t.co/JKrLfF1m09

#FDA will hold a public meeting on April 17 to discuss draft guidance on complying with and implementing the intentional adulteration rule to protect food. The meeting runs from 8:30 AM - 2:00 PM at our College Park campus. To register, visit: https://t.co/XTPCUN6Bj0 https://t.co/0odoVWb7mP

RT @FDAfood: Trying to eat healthier when eating out? Compare calorie and nutrition info before you order, then make the choice… https://t.co/LScY6lKv3b

#FDA finalized two guidance documents to support the development of antiretroviral drug products for treatment of HIV in pediatric patients and to aid the development of systemic drugs for prevention of HIV-1 infection. https://t.co/Xf6jjQguTv

RT @SecAzar: At #NHPC2019 this morning, I was glad to announce that @US_FDA is releasing final versions of guidances to support development… QT @SGottliebFDA: Part of #FDA's commitment to HIV focuses on efforts to advance development of life-saving treatments to vulnerable/… https://t.co/8XAaVVifI7)

RT @NBCNewsHealth: FDA issues warning to two breast implant makers over safety concerns https://t.co/TYc1ZcDxnM

RT @FDAOncology: To address the question of whether treatment beyond progression has clinical benefit, CDER researchers pooled data… https://t.co/CQ9SJ6h1Vy

RT @FDAOncology: FDA takes new steps to broaden patient participation in #cancer #clinicaltrials, advancing policies to promote incl… https://t.co/MFW6ct19wa

RT @FDASpox: Flag: FDA issued warning letters to two breast implant manufacturers for deficiencies in their required post-approv… https://t.co/M4vlpX9oVe

RT @PostOpinions: The future of e-cigarettes depends on the industry’s willingness to protect teens, write @HHSgov's @SecAzar and… https://t.co/aFoCBAg8dn

My Op Ed with @SecAzar in @washingtonpost today - The potential opportunity for e-cigs to be a useful tool for currently addicted adult smokers hangs in the balance if we cannot reduce the epidemic of youth use of these products. https://t.co/aDoOOJF4rM

RT @SecAzar: We are at a critical point in the history of e-cigarettes. Read my op-ed with @SGottliebFDA on why we can’t afford… https://t.co/V3U7PwMeL7

RT @FDAJobs: Waving�Wednesday: Meet Linley Cohen, she started as a student at #FDA in 2008 and now serves as a Communication Spe… https://t.co/i6zwHW4DqC

RT @SGottliebFDA: My Op Ed with @SecAzar in @washingtonpost today - The potential opportunity for e-cigs to be a useful tool for curr… https://t.co/GanyJdxVEl

After carefully considering benefits and risks to patients we think it’s critical patients have access to the drugs while impurity-free losartan is manufactured. We believe this will NOT meaningful increase risks over the time it will take to get impurity-free losartan to market

THREAD: Update on the recent ARB recalls: This week, we announced the agency will not object to certain losartan medications containing very limited amounts of impurities temporarily continuing to be distributed to patients. https://t.co/HZb3YT0060

We strongly believe risks (such as stroke) of abruptly discontinuing these important medicines far outweighs the low risk associated with continuing the medications.

We’ll keep working with manufacturers to eliminate these impurities from the drug supply, but we recognize that we also need to ensure patients who need ARBs have access now. We’ll continue to prioritize our investigation and give frequent updates on this important safety issue.

RT @FrankYiannasFDA: We must invest to prevent problems from happening by solidifying the agency’s tools under FSMA. We must also embrac… https://t.co/MalOkHbv5A

As HHS CoS and then Deputy on DPC, Lance Leggitt helped #FDA advance a historic modernization of the Office of New Drugs, CURES implementation, efforts to combat kids tobacco use, and generic competition. His #FDA knowledge and commitment to our mission leaves a lasting imprint.

RT @BrookingsEcon: #ICYMI: watch @SGottliebFDA as he reflects on his tenure as Commissioner of @US_FDA , featuring @davidmwessel and… https://t.co/1DnO8cO8nj

Many companies making/selling FDA-regulated products comply with #FDA rules to protect the public. But some firms willfully disregard them, prompting us to take action. In today’s #FDA #SundayTweetorial, I’ll highlight a # of FDA’s key enforcement actions during my 2-year tenure. https://t.co/Edk6HTzyEt

@TheJusticeDept FDA has many tools to use against bad actors, depending on the violation: warning letters (WLs) that cite violations and seek corrective actions, mandatory recall (for some products), seizure, injunction, civil penalties, and criminal prosecution. And we’re not shy to use them! https://t.co/PErgQUcfjC

@TheJusticeDept We’ve pursued a series of escalating actions against these outfits, culminating in federal cases for permanent injunctions to stop two stem cell clinics from marketing their products without #FDA approval and for major deviations from CGMP requirements https://t.co/05r2joAsFC https://t.co/DKIYmdV8l8

@TheJusticeDept Enforcement is a priority. #FDA worked together to confront numerous health fraud scams and worked on the successful prosecution of companies and individuals who marketed dietary supplements with dangerous ingredients during the last two years https://t.co/6PsCNB89P4. https://t.co/XPCnzMbZVg

@TheJusticeDept Consider these stats from FY 2018: FDA issued 14,285 WLs, oversaw 7,562 recalled products, initiated 14 injunctions and 1 product seizure, issued 231 import alerts to detain potentially violative products and made 317 criminal arrests. We also make sure to publicize bad actors.

@TheJusticeDept We consider enforcement - protecting consumers from those who would prey on them with bogus claims and fraudulent products - to be the cornerstone of our consumer protection mission. We’ve dedicated new resources to this work https://t.co/4usiypxrWo. https://t.co/w5wNAs0Fws

@TheJusticeDept Our aggressive actions against bogus stem cell clinics, where bad actors have been leveraging the scientific promise of cell-based regenerative medicine to peddle unapproved treatments that risk patient’s health and even harm them, provides a good example of our efforts. https://t.co/TLJ1ZMUnog

@TheJusticeDept As part of our new risk-based enforcement approach to drug products labeled as homeopathic, we’ve taken action against companies marketing such unapproved products with claims they can treat addiction and chronic pain and/or other conditions https://t.co/wVyeDA0L1V. https://t.co/0JJQDu3ygu

@TheJusticeDept Most recently we sent 17 WLs to companies illegally marketing Alzheimer’s disease products, often sold on websites and social media platforms. Such health fraud preys on vulnerable populations, wastes money and often delays proper medical care https://t.co/2IVt6RghMM. https://t.co/QJTu4VZe9Y

@TheJusticeDept We’ve also taken action against companies marketing pills and capsules labeled as dietary supplements with unproven drug claims about protecting consumers from harms that come from sun exposure https://t.co/l0Qk7I7GLy. They put consumer’s health at risk and provide false security https://t.co/lLTvSlqUKh

@TheJusticeDept And we’ve been vigilant in going after companies that market fraudulent cancer products, issuing > a dozen WLs in 2017, including 4 WLs to companies marketing unproven products purporting to contain cannabidiol (CBD) claiming to treat/cure cancer https://t.co/DZXFLHmSZK. https://t.co/2nZQgdEuUN

@TheJusticeDept The company had marketed their neurovascular device for unapproved and potentially dangerous surgical uses, gave sales reps quotas and bonuses for selling the device for such uses and trained their reps to instruct physicians on the unapproved use of these devices.

@TheJusticeDept #FDA has also sought to protect the public from online pharmacies that purport to sell cheaper versions of drugs from Canada, Britain or Australia but may actually get drugs from other countries, increasing the risk consumers may buy counterfeit drugs https://t.co/sJoeNo9pWX. https://t.co/RauigIbxtt

@TheJusticeDept Congress responded by updating our authority for overseeing compounders (who provide medications to patients when there is no FDA-approved drug). Since 2012, we’ve issued more than than 220 WLs, overseen > 230 recall events and have continued going after the industry’s bad actors https://t.co/fB3WPJmCMK

@TheJusticeDept In 2012, 750 people developed fungal meningitis across multiple states and over 60 died after they were injected with contaminated compounded steroid drugs. Enforcement was an integral part of our approach to this tragedy and it remains integral in our work with compounders. https://t.co/HHCRfxlJxl

@TheJusticeDept A key part of #FDA’s efforts to promote safe and effective medical devices is our enforcement work related to unsafe practices and bad actors. In December, an FDA criminal investigation resulted in a guilty plea & fines for medical device maker ev3 Inc https://t.co/nEzbwZJcDm https://t.co/a7c4Mh3eEy

@TheJusticeDept This month, working with #DOJ, we obtained a permanent injunction against a company for making supposedly sterile injectable drugs in insanitary conditions whose eye injections resulted in impaired vision https://t.co/cee6olPDhj. https://t.co/hNwYagQog8

@TheJusticeDept #FDA has moved to block the flow of opioid drugs on the web, recently warning 23 networks operating > 450 websites illegally marketing potentially dangerous, unapproved, and misbranded opioid medications, including tramadol and oxycodone https://t.co/80bZNAznjm. https://t.co/VHvRvzFWfu

@TheJusticeDept Enforcement has been an essential tool in tackling the opioid epidemic, especially illicit opioids, which are accounting for a sharply increasing percentage of the total exposure to these drugs and fueling a growing addiction crisis https://t.co/5aTCwmo8gb https://t.co/ny1RQJORxh

@TheJusticeDept We’ve increased our interdiction at the nation’s 9 International Mail Facilities where illegal counterfeit and unapproved drugs flow in https://t.co/eqQDXEzO32 and have begun implementing new authority making it easier for us to stop illegally imported drug articles https://t.co/gjpgrCHAhS