The U.S. Food and Drug Administration issued a final rule containing a
broad set of federal requirements designed to significantly curb access
to and the appeal of cigarettes and smokeless tobacco products to
children and adolescents in the United States. Published March 19, 2010,
the new rule becomes effective June 22, 2010, and has the force and
effect of law.
Titled Regulations Restricting the Sale and Distribution of Cigarettes
and Smokeless Tobacco to Protect Children and Adolescents, the new rule
restricts the sale, distribution, and promotion of these products to
make them less accessible and less attractive to kids. Among other
things, the rule prohibits the sale of cigarettes or smokeless tobacco
to people younger than 18, prohibits the sale of cigarette packages with
less than 20 cigarettes, prohibits distribution of free samples of
cigarettes, restricts distribution of free samples of smokeless tobacco,
and prohibits tobacco brand name sponsorship of any athletic, musical or
other social or cultural events. The entire rule can be found at
www.fda.gov/protectingkidsfromtobacco.
"This ruling is a critical piece of a coordinated effort to save lives,
lower costs, and reduce suffering from heart disease, cancer and other
tobacco-related illness," said HHS Secretary Kathleen Sebelius. "Today,
we're addressing a larger public health effort to prevent our children
from becoming the next generation of Americans to die early from
tobacco-related disease. This is a great step toward a healthier
America."
"Every day nearly 4,000 kids under 18 try their first cigarette and
1,000 kids under 18 become daily smokers. Many of these kids will become
addicted before they are old enough to understand the risks and will
ultimately die too young. This is an avoidable personal tragedy for
those kids and their families as well as a preventable public health
disaster for our country," said FDA Commissioner Margaret A. Hamburg,
M.D. "Putting these restrictions in place is necessary to protect the
health of those we care most about: our children."
Enforcement of the new rule will begin once it becomes effective on June
22, 2010. FDA will work closely with States and Territories to ensure
that retailers comply with the rule. FDA will also work with the retail
community over the coming months to educate them about the new
requirements and assist them in understanding how to comply with them
and help protect our children and adolescents from these addictive
products.
Manufacturers and retailers who do not comply with the rule may be
subject to enforcement action.
The rule was originally crafted in the 1990s by the Food and Drug
Administration. After being set aside by the Supreme Court, it was
included as a key provision of the 2009 Family Smoking Prevention and
Tobacco Control Act.
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Thursday, March 18, 2010
FDA Committed to Addressing Growing National Overdose Problem
The U.S. Food and Drug Administration (FDA) recognizes the five-fold increase in unintentional drug overdose deaths noted by the Centers for Disease Control and Prevention between 1990 and 2006 as a serious public health concern. Much of this increase follows from increases in the deaths from the use of opioid drugs, which in 2006 accounted for more overdose deaths than heroin and cocaine combined. The agency is also concerned about misuse of benzodiazepines (e.g., Valium and Xanax), which accounted for 272,000 emergency department visits in 2008 (compared to 306,000 for opioids).
FDA is pursuing a variety of programs and initiatives in an effort to strike the right balance between ensuring patients access to important pain medications and mitigating the risks. These efforts include:
* The Safe Use Initiative: The mission of the Safe Use Initiative is to create and facilitate public and private collaborations within the healthcare community. Its goal is to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with partners who are committed to safe medication use (see http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm1). Collaborations of this kind are essential for drugs like opioids, given the diverse factors that influence their use (e.g., legal, social, medical) and the many stakeholders working to assure they are used safely and effectively.
* Risk Evaluation and Mitigation Strategies (REMS) for Opioid Drugs: In 2007, Congress provided FDA with the authority to require REMS if that was necessary to ensure that the benefits of a drug outweigh its risks. These can include, for example, requirements for prescriber, pharmacist, and patient education about the risks and appropriate use of a drug, or other tools to better manage a drug’s risks On February 6, 2009, FDA sent letters to manufacturers of certain opioid drug products, indicating that these drugs will be required to have a REMS. The affected opioid drugs include long-acting and extended-release brand name and generic products that contain the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone (see http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm2). FDA held a series of public stakeholder meetings in 2009 and opened a docket to receive public comments. FDA continues to accept public comments on the Agency’s approach to opioid REMS and plans to hold a public advisory committee meeting in the summer of 2010 to discuss proposals for this important safety program.
* Efforts on Acetaminophen: Every year in the United States, about 30,000 people are hospitalized with overdoses associated with acetaminophen – approximately half of which are unintentional. In June 2009, FDA convened an advisory committee meeting to provide expert input on options to reduce harm while maintaining access to this effective medication for pain. Potential strategies are currently under review.
* Strategies for the safe disposal of drugs: Certain medicines may be especially harmful and, in some cases, fatal in a single dose if they are accidentally taken. For this reason, FDA lists 26 drugs, including a number of potent opioids, that have special disposal directions indicating they should be flushed down the sink or toilet after the medicine is no longer needed. If disposed of down the sink or toilet, they cannot be accidently used by children, pets, or anybody else (Learn More: Disposal by Flushing of Certain Unused Medicines: What You Should Know3).
* Evaluating the abuse potential of drugs: FDA has entered into a research collaboration with the National Institute on Drug Abuse (NIDA) to assess particular drugs for their abuse potential. The results of this research are provided to the Drug Enforcement Administration (DEA).
* Supporting efforts to identify safer pain medications. Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research recently reviewed this area in the New England Journal of Medicine. See http://content.nejm.org/cgi/content/full/361/22/21054.Exit Disclaimer5
Through these efforts and others, FDA will join with sister agencies, medical professionals, health care institutions, patient organizations and others to reduce the number of overdose deaths.
-----
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FDA is pursuing a variety of programs and initiatives in an effort to strike the right balance between ensuring patients access to important pain medications and mitigating the risks. These efforts include:
* The Safe Use Initiative: The mission of the Safe Use Initiative is to create and facilitate public and private collaborations within the healthcare community. Its goal is to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with partners who are committed to safe medication use (see http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm1). Collaborations of this kind are essential for drugs like opioids, given the diverse factors that influence their use (e.g., legal, social, medical) and the many stakeholders working to assure they are used safely and effectively.
* Risk Evaluation and Mitigation Strategies (REMS) for Opioid Drugs: In 2007, Congress provided FDA with the authority to require REMS if that was necessary to ensure that the benefits of a drug outweigh its risks. These can include, for example, requirements for prescriber, pharmacist, and patient education about the risks and appropriate use of a drug, or other tools to better manage a drug’s risks On February 6, 2009, FDA sent letters to manufacturers of certain opioid drug products, indicating that these drugs will be required to have a REMS. The affected opioid drugs include long-acting and extended-release brand name and generic products that contain the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone (see http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm2). FDA held a series of public stakeholder meetings in 2009 and opened a docket to receive public comments. FDA continues to accept public comments on the Agency’s approach to opioid REMS and plans to hold a public advisory committee meeting in the summer of 2010 to discuss proposals for this important safety program.
* Efforts on Acetaminophen: Every year in the United States, about 30,000 people are hospitalized with overdoses associated with acetaminophen – approximately half of which are unintentional. In June 2009, FDA convened an advisory committee meeting to provide expert input on options to reduce harm while maintaining access to this effective medication for pain. Potential strategies are currently under review.
* Strategies for the safe disposal of drugs: Certain medicines may be especially harmful and, in some cases, fatal in a single dose if they are accidentally taken. For this reason, FDA lists 26 drugs, including a number of potent opioids, that have special disposal directions indicating they should be flushed down the sink or toilet after the medicine is no longer needed. If disposed of down the sink or toilet, they cannot be accidently used by children, pets, or anybody else (Learn More: Disposal by Flushing of Certain Unused Medicines: What You Should Know3).
* Evaluating the abuse potential of drugs: FDA has entered into a research collaboration with the National Institute on Drug Abuse (NIDA) to assess particular drugs for their abuse potential. The results of this research are provided to the Drug Enforcement Administration (DEA).
* Supporting efforts to identify safer pain medications. Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research recently reviewed this area in the New England Journal of Medicine. See http://content.nejm.org/cgi/content/full/361/22/21054.Exit Disclaimer5
Through these efforts and others, FDA will join with sister agencies, medical professionals, health care institutions, patient organizations and others to reduce the number of overdose deaths.
-----
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Wednesday, March 17, 2010
"All Black People" Asked to Leave S. Jersey Wal-Mart
Wal-Mart officials are looking at security tapes after an announcement was made for "all black people'' to leave a store in South Jersey.
http://www.nbcphiladelphia.com/news/local-beat/All-Black-People-Asked-to-Leave-South-Jersey-Walmart-88118157.html
http://www.nbcphiladelphia.com/news/local-beat/All-Black-People-Asked-to-Leave-South-Jersey-Walmart-88118157.html
Saturday, March 13, 2010
Electronic Cigarettes Are Tobacco Products, States AAPHP
/PRNewswire/ -- The American Association of Public Health Physicians submitted a petition to the US Food and Drug Administration on February 23rd in response to their official stance concerning electronic cigarettes. They cite many concerns, including legal, ethical, epidemiological, medical, and the impact on public health the products could have in the future.
The AAPHP's recent petition dealt with their request that the FDA reclassify the products from a "drug-device combination" to a "tobacco product." They are currently urging all supporters of electronic cigarettes to leave the FDA comments on the docket for their petition so the will of the people may be made known . The AAPHP believes in and promotes harm reduction, unlike other mainstream health organizations who reject the concept.
According to the AAPHP, all tobacco products are "nicotine delivery devices" and that the largest portion of illness and death from conventional cigarettes is due to the products of the combusted tobacco, not the chemicals and other substances found in tobacco cigarettes. The carcinogens are not what cause the majority of the health problems; the smoke causes it when it is inhaled deeply into the lungs and held there.
"E-cigarettes, more than any other tobacco or tobacco-related product, satisfies both the habituation and nicotine addiction," says the organization in their petition. They state that they believe that many smokers struggle with a second addiction to smoking, which is the habit of carrying a pack of cigarettes and lighter, holding the cigarette when it is lit, and the act of smoking it. It is said in their report that there is a significant number of electronic cigarette users who have been successful in switching over to e-cigarette liquid which contains no nicotine while they continue to perform the ritual of "smoking."
Continuing on through the petition, they state that electronic cigarettes, unlike conventional cigarettes, produce no sidestream smoke; that is, smoke that is emitted from a cigarette when it is not being puffed on. The fact that electronic cigarettes also have no combustion is mentioned again, this time in reference to the amount of property damage done every year due to fires caused by lit cigarettes.
The AAPHP states that classifying electronic cigarettes as tobacco products would enable the FDA to impose manufacturing quality regulations, much in the same way pharmaceutical companies are expected to produce their products.
"Objections to FDA approval of e-cigarettes as tobacco products are speculative and largely based on misinformation," states the petition.
-----
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The AAPHP's recent petition dealt with their request that the FDA reclassify the products from a "drug-device combination" to a "tobacco product." They are currently urging all supporters of electronic cigarettes to leave the FDA comments on the docket for their petition so the will of the people may be made known . The AAPHP believes in and promotes harm reduction, unlike other mainstream health organizations who reject the concept.
According to the AAPHP, all tobacco products are "nicotine delivery devices" and that the largest portion of illness and death from conventional cigarettes is due to the products of the combusted tobacco, not the chemicals and other substances found in tobacco cigarettes. The carcinogens are not what cause the majority of the health problems; the smoke causes it when it is inhaled deeply into the lungs and held there.
"E-cigarettes, more than any other tobacco or tobacco-related product, satisfies both the habituation and nicotine addiction," says the organization in their petition. They state that they believe that many smokers struggle with a second addiction to smoking, which is the habit of carrying a pack of cigarettes and lighter, holding the cigarette when it is lit, and the act of smoking it. It is said in their report that there is a significant number of electronic cigarette users who have been successful in switching over to e-cigarette liquid which contains no nicotine while they continue to perform the ritual of "smoking."
Continuing on through the petition, they state that electronic cigarettes, unlike conventional cigarettes, produce no sidestream smoke; that is, smoke that is emitted from a cigarette when it is not being puffed on. The fact that electronic cigarettes also have no combustion is mentioned again, this time in reference to the amount of property damage done every year due to fires caused by lit cigarettes.
The AAPHP states that classifying electronic cigarettes as tobacco products would enable the FDA to impose manufacturing quality regulations, much in the same way pharmaceutical companies are expected to produce their products.
"Objections to FDA approval of e-cigarettes as tobacco products are speculative and largely based on misinformation," states the petition.
-----
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Friday, March 12, 2010
CDC uses shopper-card data to trace salmonella
As they scrambled recently to trace the source of a salmonella outbreak that has sickened hundreds around the country, investigators from the Centers for Disease Control and Prevention successfully used a new tool for the first time — the shopper cards that millions of Americans swipe every time they buy groceries.
With permission from the patients, investigators followed the trail of grocery purchases to a Rhode Island company that makes salami, then zeroed in on the pepper used to season the meat.
Never before had the CDC successfully mined the mountain of data that supermarket chains compile.
http://news.yahoo.com/s/ap/20100311/ap_on_sc/us_shopper_card_sleuths
Me:
OK, there's good and bad in this one... tracking salmonella, good... potentially tracking me and my habits, bad.
I hesitated for a long time before finally getting one of those grocery cards. I didn't like the idea that my food preferences could be tracked or that I'd be getting a lot of targeted junk mail. I got over it. I love my little Kroger card.
However, I'm still not thrilled with the idea that someday the food police could come after me. Can you imagine how these cards COULD be used?
Let's say I develop diabetes. The new Obamacare is passed and my doctor wants to make sure I'm eating right, my insurance wants to make sure I'm doing what the doctor ordered... So I'm buying Twinkies for the kids when they come over, not for me Mr. Doctor... Ah, but you know that you are creating an unhealthy environment for yourself and you are contributing to the obesity of a minor. Slap, slap.
Who knows where this could go...
I feel fairly safe 'cause I gave 'em all incorrect information when I got my card. I do that as a rule on everything I sign up for these days. Yep, I am one of those bad types who's skewing all the data. To make it even worse, I have two different cards for some stores, hee hee, ha ha... You should see my key chain.
Just as an aside, I understand giving bad info is a good idea. I read somewhere, in passing, that it's possible for crooks to somehow use those cards to find you or do some nasty stuff to you or your credit or something. I'd have focused a bit more on that one if I happened to have been affected.
Someday that last paragraph may come back to haunt me. If the food police, Obamacare, and our government all come together in a potential 1984 scenario, I'm up a creek. Of course, given my propensity to blog against Big Brother, Obamacare, and similar, I'll probably be in a gulag somewhere already so my little handy-dandy cost-saving shopping cards won't matter anyway.
- jmd
---
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---
With permission from the patients, investigators followed the trail of grocery purchases to a Rhode Island company that makes salami, then zeroed in on the pepper used to season the meat.
Never before had the CDC successfully mined the mountain of data that supermarket chains compile.
http://news.yahoo.com/s/ap/20100311/ap_on_sc/us_shopper_card_sleuths
Me:
OK, there's good and bad in this one... tracking salmonella, good... potentially tracking me and my habits, bad.
I hesitated for a long time before finally getting one of those grocery cards. I didn't like the idea that my food preferences could be tracked or that I'd be getting a lot of targeted junk mail. I got over it. I love my little Kroger card.
However, I'm still not thrilled with the idea that someday the food police could come after me. Can you imagine how these cards COULD be used?
Let's say I develop diabetes. The new Obamacare is passed and my doctor wants to make sure I'm eating right, my insurance wants to make sure I'm doing what the doctor ordered... So I'm buying Twinkies for the kids when they come over, not for me Mr. Doctor... Ah, but you know that you are creating an unhealthy environment for yourself and you are contributing to the obesity of a minor. Slap, slap.
Who knows where this could go...
I feel fairly safe 'cause I gave 'em all incorrect information when I got my card. I do that as a rule on everything I sign up for these days. Yep, I am one of those bad types who's skewing all the data. To make it even worse, I have two different cards for some stores, hee hee, ha ha... You should see my key chain.
Just as an aside, I understand giving bad info is a good idea. I read somewhere, in passing, that it's possible for crooks to somehow use those cards to find you or do some nasty stuff to you or your credit or something. I'd have focused a bit more on that one if I happened to have been affected.
Someday that last paragraph may come back to haunt me. If the food police, Obamacare, and our government all come together in a potential 1984 scenario, I'm up a creek. Of course, given my propensity to blog against Big Brother, Obamacare, and similar, I'll probably be in a gulag somewhere already so my little handy-dandy cost-saving shopping cards won't matter anyway.
- jmd
---
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage
www.ReadMyLipstickNetwork.com
Twitter: @readmylipstick
www.ArtsAcrossGeorgia.com
www.Hummingbird-Hollow.com
Twitter: @hhpotterystudio
---
Tuesday, March 02, 2010
Time to start thinking seriously about money in the mattress?
Citibank's recent notice to customers is causing quite a rucus across the spectrum:
People are wondering whether this is their way of getting ready for a potential run on the bank due to a major depression around the corner.
Here's a statement from Citibank:
I gather from some limited reading that the rule / law this is based on goes back to the 30s, and that it was expanded in 2006 to include on-line banking.
Cape Bank in New Jersey also has a similar notice on their site:
A lot of folks have huge concerns about the status of their money in banks. You can't turn on the television or the radio without hearing an advertisement for gold or silver it seems.
Who hasn't experienced a problem with trying to get their money out of a bank? My sister recently received a large check from her insurance company as a result of flood damage. She had workers fixing her house, getting it "livable" again. The bank put an extensive hold on her check, which had already been delayed due to normal insurance procedures.
Some banks now require that you pay a fee to cash a check written on their bank if you're not a customer. I kid you not. My son took a check to the bank it was written on wanting to cash it rather than deposit it in his account at another bank. They wanted $6 to cash it. When he pitched a fit about paying they said he could open up an account for $6. If he closed the account within a specified time they'd take the money. He finally opened an account when they gave him a $100 incentive to open an account (again, the money had to stay there). The catch? He had to make a certain number of transactions and keep a minimum balance. At the end of his 3 months he's outta that bank.
I read recently that the powers that be in Washington are looking at our IRAs and 401ks. They're thinking about taking the money, using it and then doling it back out to us. Not sure how that one will fly, but it is rather scary thinking that the government is eyeing the billions we have in our various savings plans.
Most, if not all, banks have a cap on how much money you can withdraw via an ATM during a day or over a period of time. From scanning it looks like it's $1,000 per day or $2,500 in a 7-day period.
With banks failing all over the place, the government taking over many, the uncertainty of our financial stability and the very intrusive regulations by the banking system and the government, maybe it is time to consider taking our money and putting it under the mattress.
What do I think? Do your research and keep a close eye on things. Make contingency plans but don't panic.
Update: Citigroup Says Feds Ordered 7 Day Restriction On Bank Withdrawals
http://dailypaul.com/node/126537
A new advisory being sent by America’s third largest bank to its account holders has stoked fears that major financial institutions could be preparing for old fashioned bank runs if the economy takes a turn for the worse.
http://www.datehookup.com/Thread-421559.htm
http://www.federalreserve.gov/boarddocs/supmanual/cch/200601/int_depos.pdf
“Effective April 1, 2010, we reserve the right to require seven (7) days advance notice before permitting a withdrawal from all checking accounts. While we do not currently exercise this right and have not exercised it in the past, we are required by law to notify you of this change.”
People are wondering whether this is their way of getting ready for a potential run on the bank due to a major depression around the corner.
Here's a statement from Citibank:
“When Citibank moved to unlimited FDIC coverage in 2009, we had to reclassify many checking accounts to allow for immediate withdrawals in order to ensure all customers qualified for the additional coverage. When we moved back to standard FDIC coverage with most major banks in 2010, Citibank decided to reclassify those accounts back to make them eligible again for promotional incentives. To do so, Federal Reserve Reg D requires these accounts, called NOW accounts, to reserve the right to require a 7-day notice of withdrawal. We recently communicated this technical requirement to our customers. However, we have never exercised this right and have no plans to do so in the future."
I gather from some limited reading that the rule / law this is based on goes back to the 30s, and that it was expanded in 2006 to include on-line banking.
Cape Bank in New Jersey also has a similar notice on their site:
The Bank reserves the right to require you to give seven (7) days prior written notice to the Bank of an intention to withdraw. This requirement is in accordance with Federal Regulations and payment by the Bank without requiring the seven (7) days notice does not constitute a waiver by the Bank of the right to require the notice. http://www.capebankonline2.com/site/account_agreements.html
A lot of folks have huge concerns about the status of their money in banks. You can't turn on the television or the radio without hearing an advertisement for gold or silver it seems.
Who hasn't experienced a problem with trying to get their money out of a bank? My sister recently received a large check from her insurance company as a result of flood damage. She had workers fixing her house, getting it "livable" again. The bank put an extensive hold on her check, which had already been delayed due to normal insurance procedures.
Some banks now require that you pay a fee to cash a check written on their bank if you're not a customer. I kid you not. My son took a check to the bank it was written on wanting to cash it rather than deposit it in his account at another bank. They wanted $6 to cash it. When he pitched a fit about paying they said he could open up an account for $6. If he closed the account within a specified time they'd take the money. He finally opened an account when they gave him a $100 incentive to open an account (again, the money had to stay there). The catch? He had to make a certain number of transactions and keep a minimum balance. At the end of his 3 months he's outta that bank.
I read recently that the powers that be in Washington are looking at our IRAs and 401ks. They're thinking about taking the money, using it and then doling it back out to us. Not sure how that one will fly, but it is rather scary thinking that the government is eyeing the billions we have in our various savings plans.
Most, if not all, banks have a cap on how much money you can withdraw via an ATM during a day or over a period of time. From scanning it looks like it's $1,000 per day or $2,500 in a 7-day period.
With banks failing all over the place, the government taking over many, the uncertainty of our financial stability and the very intrusive regulations by the banking system and the government, maybe it is time to consider taking our money and putting it under the mattress.
What do I think? Do your research and keep a close eye on things. Make contingency plans but don't panic.
Update: Citigroup Says Feds Ordered 7 Day Restriction On Bank Withdrawals
http://dailypaul.com/node/126537
A new advisory being sent by America’s third largest bank to its account holders has stoked fears that major financial institutions could be preparing for old fashioned bank runs if the economy takes a turn for the worse.
http://www.datehookup.com/Thread-421559.htm
http://www.federalreserve.gov/boarddocs/supmanual/cch/200601/int_depos.pdf
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