Indiana political choices this fall

https://upload.wikimedia.org/wikipedia/commons/c/c9/Mike_Pence%2C_official_portrait%2C_112th_Congress.jpg

John Gregg 2012.jpg

Unfortunately this fall Indiana has to choose between two ATTORNEYS for governor. Gov Pence is trying to run on his record of increased employment in the state… So far during his TV campaign I have not seen where he is bragging about Indiana being one of the top meth producers in the country, has the most pharmacy robberies, rehab centers are full of former chronic pain pts that have either been tossed to the curb by raids on pain clinics and who has resorted to Heroin and other street drugs trying to control their unrelenting chronic pain. Untold number of chronic pain pts that are being forced into urine testing because AG Zoeller “strong armed” the Medical Licensing Board to pass EMERGENCY REGULATION. Many physicians’ practices adopted the rule and then the ACLU took the board to court and won that their emergency regulation was a violation of the FOURTH AMENDMENT…  unreasonable search and seizure… but .. the practice are allowed to voluntarily implement such testing.. since if a pt is not happy.. they can find a new doctor.

A recent quote from Zoeller … Zoeller’s office has no control over medical licenses, but often the solution is taking away a doctor’s prescribing license which is monitored by federal government. He said he has ways of getting around the fact he doesn’t control prescribing licenses but it doesn’t always work out.  

AG Zoeller: can always use a “work around” to get at doc’s license ?

Indiana has a population of abt 6.6 million.. and using average statistics would suggest that there are some TWO MILLION chronic pain pts. In the last election abt 2.4 million votes were cast for governor with abt 80,000 between winner and loser.

When small Scott county had a epidemic of HIV + & Hep B&C… Pence resisted creating a “clean needle ” program.. and initially conceded to a 30 day program and then relented and granted a ONE YEAR clean needle program.  In the ensuing year.. only a handful of other Indiana counties have been granted the funding to create a clean needle program.

I recently told about a rehab center in central Indiana that had 30 pts census and 2 were recovering from alcoholism and the other 28 were in there because their were chronic pain pts and had been tossed out of raided practice or for some other reason could no longer get their necessary pain medication and had resorted to going to the street to get Heroin and other drugs to help them deal with their untreated chronic pain.

To me, it is clear… that Gov Pence and AG Zoeller are all about the black/white of the law.. when it comes to those who suffer from addictive personality disorder and those who have a medical necessity for the use of opiates.

How many people suffering from subjective diseases have been abused during the first term of these two… how many more are at risk of being abused if there is a second term ?  The law of probability may have missed you during the last four years.. will you be that lucky during the next four years ?

 

Those pt information printouts are given to you for a reason

stevemailboxI was recently contacted by a Mother caring for her young adult son. The son was a chronic pain pt and was on a long acting and short action opiate that was not adequately controlling his pain. The prescriber decided to try 100mcg Fentanyl patches to help improve his pain management.

When the Mother took this new Rx to her local chain store.. the female Pharmacist refused to fill because it would “kill her son”..

I showed the Mother the conversion formulas that suggested that using “morphine equivalents” that the increase using the 100 mcg Fentanyl patches was “modest” and given her son’s opiate tolerance. I personally did not see much of a risk of to her son’s well being.

I asked the Mom if they had been advised of the slow on set of Fentanyl patches and that the transition could be rather rough for the first week or two.. NOPE…

I advised the Mom about the half life of the two opiates that he had been on before and that they may have to be taken during the transition.  As I anticipated, the transition started out rather badly… I believe without proper counseling… the son would have stopped the patches and never figured out if these patches would improve his pain management..

The transition was “bumpy” but progress was made and then one day about one week into the transition.. everything went “south”. Once again the Mom reached out to me… I asked if the patches had been exposed to some heat source ?  A day or so later, she responded that the son had decided to put a HEATING PAD over the patches.. While that would have caused the patches to transfer medication faster.. the medication is very heat sensitive and would have started DESTROYING the medication in the patch and thus the son would get less medication and would have been thrown into WITHDRAWAL.

Basically, the son had to start over with the transition… but the good news is that the intensity of his pain is now improving/lowering.  I am sure that the pt information printouts furnished with the patches would have warned about using a external heat source (heating pad, hot tub) while using the patches. This is a good example of why pt should read those informational printouts when getting new medications.

More “feel good” regulations that goes UNENFORCED ?

stevemailboxBureaucrats that never fail to disappoint

I got a email from a FL Pharmacist that works for one of the BIG BOYS. It would seem that Pharmacist was told by  supervisors that the Rx dept where she/he was PIC was buying/selling too many opiates and had to CUT BACK. It wasn’t as if this Rx dept had a number of “questionable pts”… this particular Pharmacist had cultivated a sizeable chronic pain pt following.

Back in 2015 the FL Board of Pharmacy (BOP) passed new regulations that stated that Pharmacists were to start looking for a reason to fill a controlled Rx rather than start looking for a reason not to fill a controlled Rx.

The effective date of this new regulation was the end of 2015. At the time, I questioned if this new regulation was just another “feel good regulation”… the BOP could point to what they had accomplished and that there would be very little action on enforcement.  FL Pharmacists were required to have two hours of continued education (CE) by the end of 2017. The FL BOP decided that they could “educate ” common sense into Pharmacists as to why they should fill legit controlled Rxs for chronic pain pts.   IMO, I figured that the FL BOP would “sit on their hands” until all the Pharmacists had the opportunity to meet the mandatory CE requirement. Given the FL BOP abt TWO YEARS in which they would have to DO NOTHING in regards to enforcement of this new regulation.

This particular FL Pharmacist felt that the instructions from HQ to reduce the dispensing of controlled Rxs was in violation of the Pharmacist’s professional discretion as provided under the Pharmacy Practice Act and would cause this Pharmacist to refuse to fill legit controlled Rxs and in conflict with the new regulation.

This Pharmacist reached out to the FL BOP and filed a complaint over this issue. Apparently, this Pharmacist’s complaint was not filed using the “proper format” or “proper channel”… so the complaint was IGNORED.

The primary charge of the Boards of Pharmacy is to protect the health/safety of the general public.  According to the FL BOP website:

floridaspharmacy.gov/the-board/

The Florida Board of Pharmacy consists of nine members appointed by the Governor and confirmed by the Senate.

Does anyone suspect that political contributions to election campaigns has a lot to do with who is appointed to the BOP ? The last time that I looked at the make up of the FL BOP.. the lowest ranking non-practicing Pharmacist on the board was a DISTRICT MANAGER for one of the major chain pharmacies.

So much for the FL BOP’s charge of protecting the public’s health and safety ???

 

Another “OPIATE RELATED DEATH”

Pa. couple found in botched, bloody suicide pact

http://www.pennlive.com/news/2016/05/pa_couple_found_in_botched_blo.html

It was a tragic, bloody attempted end for an elderly couple in western Pennsylvania, who authorities say tried to end their lives in an apparent suicide pact.

The victims are identified as Wilma Friday, 82, and Edward Friday, 80, of Rostraver Township, Westmoreland County, according to KDKA in Pittsburgh.

However, both survived the initial, botched suicide attempt. And now, the sole surviving spouse may face homicide charges in the case for allegedly helping his wife to die.

Wilma Friday was found alive in a pool of blood Saturday evening flown to UPMC Presbyterian Hospital, KDKA writes, adding:

Police believe she attempted to slit her own throat, and when she failed, her husband tried to help her. Wilma finally died of her injuries Wednesday morning.

PA-woman-dies-in-bothched-suicide-pact-with-husband.jpgWilma Friday, 82, was found alive in a pool of blood Saturday evening, only to die Wednesday of her injuries. 

Meanwhile, Edward Friday took 20 OxyContin pills and was found with cuts to his wrist. But he also survived and is recovering from his injuries, KDKA reports.

And because he assisted his wife in her suicide, police are now said to be conducting their ongoing probe as a homicide investigation, KDKA notes.

No charges have been filed in the case as yet

Has pt care become more about BUSINESS & PROFITS than real concern abt pts ?

profits2Walgreens forged ahead with Theranos deal despite lingering doubts: WSJ

http://www.fiercemedicaldevices.com/story/walgreens-forged-ahead-theranos-deal-despite-lingering-doubts-wsj/2016-05-26

Walgreens Boots Alliance ($WBA) had doubts about Theranos‘ proprietary blood testing technology when it partnered with the company a few years ago. But Walgreens forged ahead with a deal anyway and that decision has come back to bite it–big time.

The drugstore giant agreed to put Theranos blood-testing centers in thousands of its drugstores across the U.S. without ever fully validating the startup’s technology or its capabilities, The Wall Street Journal reports. Walgreens repeatedly asked Theranos for more information but then backpedaled, partly because execs were worried that Theranos would choose a different chain as a partner.

Walgreens also considered calling it quits on the deal but held back because it was worried that Theranos might sue for breach of contract and claim billions of dollars in damages. Walgreens has lost $50 million by investing in the blood-testing outfit and it doesn’t expect to get that money back, according to the WSJ story.

In 2012–a year before Walgreens and Theranos announced their partnership–two Walgreens execs and Paul Rust, a retired executive from Quest Diagnostics ($DGX), visited Theranos. “It was a very strange situation,” Rust told the newspaper about the one-day rendezvous.

Rust “was never allowed to go into the lab” and had “no idea that the results I saw were run on the Edison devices or not.” He was “led to believe that they were being run on the Edison,” Rust said.

And “much to my surprise, the Walgreens people themselves had not been in the lab,” Rust said. It turned out that Theranos was using its Edison machines for just a small fraction of its tests and used traditional lab equipment instead, former Theranos employees have said.

Walgreens prior to its deal with Theranos also said that it would pay Johns Hopkins to evaluate the company’s technology. Theranos CEO Elizabeth Holmes and former president Sunny Balwani agreed to send one of the company’s proprietary devices to the Hopkins lab. But Theranos never delivered the device, which left Walgreens unable to compare results from Theranos’ machine with commercially available tests, according to the WSJ story,  

Now, Walgreens is trying to sweep up the broken pieces. In October, the Deerfield, IL-based company froze its partnership with Theranos. Earlier this year, the company closed one blood-testing center in California after a federal inspection of Theranos’ Newark, CA-based lab found that Edison devices often did not satisfy the company’s own accuracy requirements.

When it didn’t look like Theranos was moving fast enough to correct the issues, Walgreens issued the company an ultimatum. The company also asked its lawyers to see if there was a way to force Theranos to close the 40 blood-testing clinics that it set up at Walgreens’ Arizona drugstores, The Financial Times reported earlier this year.

Walgreens declined to comment to the WSJ about its decision to partner with Theranos. Theranos is staying characteristically enigmatic about the companies’ deal. “We value our partnership with Walgreens and look forward to continuing to work together,” Theranos spokeswoman Brooke Buchanan told the newspaper.

Alcohol replacing “DRUG OF CHOICE” to abuse.. replacing opiates ?

ewrewr4353sf43.jpgEveryone in the world is drinking less alcohol, besides Americans

http://www.foxnews.com/leisure/2016/05/23/everyone-in-world-is-drinking-less-alcohol-besides-americans/?intcmp=hpffo&intcmp=obnetwork

For the first time in nearly 15 years years, everyone around the globe is drinking less alcohol.

Except for people in the U.S.

According to new research released by Euromonitor International, worldwide consumption of alcoholic beverages declined by 0.7 percent in 2015. It’s the first time the firm has tracked a decrease in global alcohol sales since it began monitoring figures in 2001.

Ukraine recorded the biggest decline worldwide, buying 17 percent less alcohol in 2015 than it did in 2014. China, which represents the world’s largest alcoholic drinks market, saw a decline of 3.5 percent.

But not everyone is buying less booze.

 

North America is the one notable exception. In 2015, the U.S. bought 30.6 billion liters of alcohol—up from 29.8 billion liters in 2014. Compared to other continents, North America has had a stronger economy. The popularity of microbreweries and the craft beer movement has given alcohol sales a big boost in the states, too, said Euromonitor International’s senior alcoholic drinks analyst Spiros Malandrakis.

Says Malandrakis, “While terms such as authenticity and craftsmanship are losing traction, the trajectories of sophistication, moderation, perceived exotic credentials, accessibility and restrained yet grounded aspirational attributes remain the key driving forces fuelling pockets of buoyancy.”

Across the globe, people are looking for more premium quality, complex spirits—even if they’re drinking less.

Sales of tequila and mezcal grew to about 275 million liters in 2015 from about 263 million liters in 2014, and sales of bourbon and other U.S. whiskey grew to 335 million liters from 322 million liters. Sales of cognac grew to almost 104 million liters from about 99 million liters. Global sales of wine grew to 27.9 billion liters from about 27.4 billion liters.

Whiskey in the U.S. is experiencing one of its biggest growth periods in history. According to state revenue data and the Kentucky Distillers’ Association, Kentucky bourbon production increased 44 percent over the past year—filling 1.9 million barrels in 2015, an all-time high over the last 48 years.

So what aren’t people drinking nowadays?

Sales of vodka fell to about 3.2 billion liters in 2015 from about 3.3 billion liters in 2014, and sales of rum fell to 1.36 billion from about 1.38 billion liters. Despite losing market share, vodka is still the world’s most consumed spirit.

 

Imagine this: Federal courts protecting the (illegal ?) actions of the DEA ?


Menominee Indian Tribes Lawsuit agaisnt the DEA Dismissed

http://www.nbc26.com/news/menominee-indian-tribes-lawsuit-agaisnt-the-dea-dismissed

MENOMINEE COUNTY, Wis – The Menominee Indian Tribe’s Lawsuit against the Drug Enforcement Administration and Department of Justice was dismissed by a federal court in Green Bay. DEA and DOJ agents raided Menominee Tribal land last October. The government says it took tens of thousands of high-grade marijuana plants. But the Tribe maintains it was industrial hemp protected under the farm bill.

The Menominee Indian Tribe released this statement today in response, “The Tribe is disappointed with this recent setback that challenges our sovereignty as a Tribal Nation and inhibits our ability to pursue research initiatives exploring the viability of this versatile and sustainable crop.  The Tribe is currently reviewing the decision to determine what options it may or may not pursue.”

I’m from the government… and don’t worry about getting screwed

screwed1Why victims of deadly meningitis outbreak haven’t been compensated

https://www.washingtonpost.com/world/national-security/everybody-has-dropped-the-ball-why-victims-of-the-deadliest-meningitis-outbreak-in-us-history-havent-been-compensated/2016/05/24/a7f2c37c-1ea1-11e6-8c7b-6931e66333e7_story.html

Kathy Pugh quit her job when her mother got sick from a tainted medication, and now Pugh spends her days helping the once-vibrant 85-year-old get out of bed, shower and dress. If her mom ever were compensated for what she endured, Pugh said she would like to install laminate flooring — which would make it easier to move around in a wheelchair — and maybe buy a handicap van.

Evelyn Bates-March, Pugh’s mother, is one of hundreds of victims of a 2012 outbreak of fungal meningitis that federal investigators traced to a batch of contaminated steroid injections manufactured by the New England Compounding Center. A civil fund of more than $200 million was created after victims sued the compounding center and companies with which it did business. The federal government also has money available to compensate crime victims.

But the 85-year-old, like all the others affected by the outbreak, has yet to see a dime to help her cope with how her life has changed since she was given a tainted shot.
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[Federal prosecutors charge 14 in deadly meningitis outbreak]

Ongoing negotiations with the Centers for Medicare and Medicaid Services over what portion that agency, which paid some of the medical bills, should receive have stalled any payments to victims from the civil fund.
Kathy Pugh, right, sits with her mother, Evelyn Bates-March, who fell ill after receiving a tainted steroid shot in 2012. (Photo courtesy of Kathy Pugh)

Prosecutors — who charged two leaders of the compounding center with racketeering and second-degree murder — separately have advocated making federal victim-assistance money available to the victims, though their request has been waylaid by a dispute in the top levels of the Justice Department, people familiar with the case said.

“It’s been devastating,” Pugh said. “Everybody has dropped the ball.”

The case illustrates how the court system, the Justice Department and other parts of the federal bureaucracy can slow or even stop crime victims from obtaining financial assistance that most would agree they deserve.

Wyn Hornbuckle, a Justice Department spokesman, said in a statement, “We are still exploring funding options for the NECC victims,” but he declined to provide any specific information about what that exploration entailed. A spokeswoman for the U.S. attorney’s office in Boston, which is prosecuting the criminal case, reiterated that “no final determination has been made.”

“We will continue to do all that we can to ensure compensation for the victims in this case,” said the spokeswoman, Christina Sterling.

The 2012 meningitis outbreak had a devastating impact. According to federal prosecutors and the U.S. Centers for Disease Control and Prevention, more than 750 people got a fungal infection after receiving injections from the New England Compounding Center, and at least 64 people died — making it the deadliest meningitis outbreak in U.S. history.

In 2014, federal prosecutors alleged the incident was criminal. They charged 14 people in a 131-count indictment, alleging employees at the New England Compounding Center knew they were producing medication in an unsafe and unsanitary way and shipping it to customers anyway. Owner and head pharmacist Barry J. Cadden and supervisory pharmacist Glenn A. Chin were charged with 25 acts of second-degree murder and are scheduled to go on trial later this year.
Lyn Laperriere in 2006, six years before he was killed by a deadly meningitis outbreak. His wife, Penny Laperriere, is now among hundreds unsuccessfully seeking compensation as crime victims from the Justice Department. (Photo courtesy of Penny Laperriere)

[Compounding pharmacy linked to meningitis outbreak knew of mold, bacteria contamination]

Lawyer Stephen J. Weymouth, who represents Chin, said his client, who has pleaded not guilty, “wants people to be compensated financially from as many different sources as can be possibly financed.” An attorney for Cadden did not immediately return phone and email messages seeking comment.

Penny Laperriere, 59, of Sterling Heights, Mich., said her husband, Lyn, began to struggle within a few weeks of having a shot with the tainted medication in 2012. A bowler whose average topped 200 a game, Lyn suddenly began to struggle with balance and couldn’t finish a practice, she said. Then came the splitting headaches, which caused pain so severe he had to be hospitalized, she said.

Laperriere said doctors traced Lyn’s symptoms to a contaminated shot, but the treatment — anti-fungal medication with nasty side effects — failed. One night, when Lyn’s parents and sister were in town visiting, Laperriere said doctors called to say her husband, a retired General Motors machine repairman who would travel the country racing cars, had “flat-lined.” She said doctors revived him but “I knew he was brain-dead.”

In October 2012, the family took him off life support. He was six days shy of his 62nd birthday.

Laperriere said she had to sell her home because it required too much maintenance, and she had to put her and her husband’s dogs up for adoption because their vet and other bills were too high. She said she does not think she will see any money in compensation after lawyers and others take their cut.

“Which is really sad,” Laperriere said. “My husband died, and his pain and suffering is worth nothing?”

There are two pools of money from which victims might be paid: federal funds and funds from the civil lawsuits. Kimberly Dougherty, a Boston lawyer representing 100 victims, said each victim has been sent a letter stating how much he or she is eligible to receive from the civil fund, but payouts have been stalled while lawyers negotiate with the Centers for Medicare and Medicaid Services, which covered some of the victims’ medical care and has liens on the payouts. Dougherty said the victims share “a sense of frustration, particularly when they know there’s money sitting in a bank account that they can’t access.”

A spokesman for the Centers for Medicare and Medicaid Services said in a statement that Medicare “paid for medical care associated with” the outbreak and was “required by law to recover those payments from settlements like the NECC settlement.”

“We understand that many NECC settlement recipients who are Medicare beneficiaries are concerned about the distribution of the settlement money,” the spokesman said. “Medicare routinely works to make sure that, in similar situations, beneficiaries are able to keep a portion of their settlement.”

Separately, federal prosecutors in Boston and the Justice Department’s Office for Victims of Crime have advocated that victims be compensated using funds from the Antiterrorism and Emergency Assistance Program, which sets aside $50 million from the federal government’s $9 billion Crime Victims Fund for victims of terrorism or mass violence. But the Office of Justice Programs’ Office of General Counsel determined that the injuries sustained by the victims were not the result of an “intentional violent criminal act,” as the program requires and, thus, were not eligible for funds from it, according to officials familiar with the matter.

Though Justice Department officials say other funding mechanisms are being discussed, victims say they think they are being treated unfairly.

Willard Mazure Jr., 55, of Jackson, Mich., said before he received the tainted shot, he was a heavy-equipment operator who would hunt and fish regularly. Now he lives off disability and his wife’s income, unable to work because his short-term memory is virtually gone and even modest physical activity can leave his legs feeling as if they’re being prodded with pins and needles.

The compensation for each victim from Justice Department funds, which are administered through the state, might be minimal. Massachusetts law likely limits the payouts for most to $25,000, though those with “catastrophic” injuries could receive as much as $50,000. The victims say even that would help, and they have waged an aggressive campaign to persuade government officials to free up the money. Officials estimate that as much as $25 million might be needed for all those affected.

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Eighteen members of Congress from both political parties recently wrote to Shaun Donovan, the director of the Office of Management and Budget, asking that the decision to keep money from the victims be reversed. A spokeswoman for that agency said in a statement that the issue was “still being considered by the Department of Justice and has not yet been referred to the Office of Management and Budget.”

“If and when it is, we will move swiftly to make a determination,” the spokeswoman said.

Mazure said although financial compensation would be welcome, it would not undo the damage the shots inflicted on him.

“Every cent will help,” Mazure said, “but nothing will make me whole.”

Adam Goldman contributed to this report.

Telemedicine…trade off of convenience over proper diagnosis ?

telemedicineStudy Finds Misdiagnosis, Prescription Errors In Teledermatology

http://www.healthitoutcomes.com/doc/study-finds-misdiagnosis-prescription-errors-in-teledermatology-0001

Research reveals virtual visits may be less than effective in treating patients.

By Christine Kern, contributing writer

A study of 16 online telemedicine companies published by JAMA Dermatology revealed some online physicians misdiagnosed skin cancer, herpes, and syphilis and also prescribed medication without taking a patient’s medical history.

The article, Choice, Transparency, Coordination, and Quality Among Direct-to-Consumer Telemedicine Websites and Apps Treating Skin Disease, asserts that, while evidence supports the use of teleconsultation to increase patient access to dermatological services, “Little is known about the quality of rapidly expanding direct-to-consumer (DTC) telemedicine websites and smartphone apps diagnosing and treating skin disease.”

The study sought to assess the performance of these DTC teledermatology services and found while telemedicine has the potential to expand access to high-value healthcare, there are serious concerns regarding the quality of skin disease diagnosis and treatment provided by many DTC websites. The authors concluded, “Ongoing expansion of health plan coverage of these services may be premature. Until improvements are made, patients risk using healthcare services that lack transparency, choice, thoroughness, diagnostic and therapeutic quality, and care coordination.”

As part of the study, researchers created several fake skin condition scenarios and downloaded stock photos of them with prepared medical histories of “patients” if the physicians asked for them. Diagnoses were provided in 48 of 62 completed online visits and 31 prescribed medications, but only 10 patients were advised about potential risks or side effects. Less than 30 percent of the sites allowed users to select their own clinician.

“The services failed to ask simple, relevant questions of patients about their symptoms, leading them to repeatedly miss important diagnoses,” said Jack Resneck, a dermatologist with the University of California, San Francisco, and lead author of the study.

The Wall Street Journal reported DTC telemedicine services have seen a recent growth in popularity, and the American Telemedicine Association anticipates there will be more than one million virtual medical visits this year alone. But while telemedicine is being touted as convenient and inexpensive, and as a way to expand coverage to those in underserved areas, there is also growing concern among some physician groups the services are undermining doctor-patient relationships deteriorating the quality of care and undermining the healthcare system as a whole.

Another study published by JAMA Internal Medicine questioned the effectiveness of telemedicine, especially in the synchronous variety of telemedicine found in video and phone consults. Variation in Quality of Urgent Health Care Provided During Virtual Visits found these methods of providing virtual care to patients often fail to adhere to clinical best practices.

FDA takes significant steps to protect Americans from dangers of tobacco through new regulation

FDA takes significant steps to protect Americans from dangers of tobacco through new regulation

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm499234.htm

Today, the U.S. Food and Drug Administration finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. This historic rule helps implement the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009 and allows the FDA to improve public health and protect future generations from the dangers of tobacco use through a variety of steps, including restricting the sale of these tobacco products to minors nationwide.

“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction,” said HHS Secretary Sylvia Burwell. “Today’s announcement is an important step in the fight for a tobacco-free generation – it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions.”

Tobacco use is a significant public health threat. In fact, smoking is the leading cause of preventable disease and death in the United States and responsible for 480,000 deaths per year. While there has been a significant decline in the use of traditional cigarettes among youth over the past decade, their use of other tobacco products continues to climb. A recent survey supported by the FDA and the Centers for Disease Control and Prevention shows current e-cigarette use among high school students has skyrocketed from 1.5 percent in 2011 to 16 percent in 2015 (an over 900 percent increase) and hookah use has risen significantly. In 2015, 3 million middle and high school students were current e-cigarette users, and data showed high school boys smoked cigars at about the same rate as cigarettes. Additionally, a joint study by the FDA and the National Institutes of Health shows that in 2013-2014, nearly 80 percent of current youth tobacco users reported using a flavored tobacco product in the past 30 days – with the availability of appealing flavors consistently cited as a reason for use.

Before today, there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco or cigars to people under age 18. Today’s rule changes that with provisions aimed at restricting youth access, which go into effect in 90 days, including:

  • Not allowing products to be sold to persons under the age of 18 years (both in person and online);
  • Requiring age verification by photo ID;
  • Not allowing the selling of covered tobacco products in vending machines (unless in an adult-only facility); and
  • Not allowing the distribution of free samples.

The actions being taken today will help the FDA prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, as well as communicate their potential risks.

Today’s rule also requires manufacturers of all newly-regulated products, to show that the products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The tobacco product review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

Under staggered timelines, the FDA expects that manufacturers will continue selling their products for up to two years while they submit – and an additional year while the FDA reviews – a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise, the product will face FDA enforcement.

For decades, the federal government and the public health community have fought to protect people from the dangers of tobacco use. Since the first Surgeon General’s report on Smoking and Health in 1964, which warned Americans about the risks associated with smoking, significant progress has been made to reduce smoking rates among Americans. In fact, tobacco prevention and control efforts have saved at least 8 million lives in the last 50 years, according to the 2014 Surgeon General’s Report on the Health Consequences of Smoking. In 2009, Congress took a historic step in the fight for public health by passing the bipartisan Family Smoking Prevention and Tobacco Control Act (TCA) giving the FDA authority to regulate the manufacturing, distribution and marketing of tobacco products to protect the public health.

Today’s action marks a new chapter in the FDA’s efforts to end preventable tobacco-related disease and death and is a milestone in consumer protection.

“As a physician, I’ve seen first-hand the devastating health effects of tobacco use,” said FDA Commissioner Robert M. Califf, M.D. “At the FDA, we must do our job under the Tobacco Control Act to reduce the harms caused by tobacco. That includes ensuring consumers have the information they need to make informed decisions about tobacco use and making sure that new tobacco products for purchase come under comprehensive FDA review.”

Today’s actions will subject all manufacturers, importers and/or retailers of newly- regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated under the TCA since 2009.

These requirements include:

  • Registering manufacturing establishments and providing product listings to the FDA;
  • Reporting ingredients, and harmful and potentially harmful constituents;
  • Requiring premarket review and authorization of new tobacco products by the FDA;
  • Placing health warnings on product packages and advertisements; and
  • Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.

“This final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates, like e-cigarettes, cigars and hookah tobacco, that had gone largely unregulated,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “The agency considered a number of factors in developing the rule and believes our approach is reasonable and balanced. Ultimately our job is to assess what’s happening at the population level before figuring out how to use all of the regulatory tools Congress gave the FDA.”

To assist the newly-regulated tobacco industry in complying with the requirements being announced today, the FDA is also publishing several other regulatory documents that provide additional clarity, instructions and/or the FDA’s current thinking on issues specific to the newly-regulated products.

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.