/PRNewswire/ -- Some bath salts – with names like Ocean Burst and Ivory Wave – aren't really for bathing. Rather, they are the latest high for naive teens and young adults as well as established drug abusers.
"Fake cocaine and fake meth are laced in bath salts and sold legally on the Internet and in convenience stores, gas stations, truck stops and head shops in most states. This newest boutique chemical substance is being used for a narcotic effect and often sends users to emergency rooms," warns Greg L. Jones, M.D., addiction medicine physician at Willingway Hospital, an alcohol and drug abuse treatment center in Statesboro, Ga.
According to Dr. Jones, manufacturers are using engineered molecules similar to controlled substances in the fake bath salts, which are labeled 'not for consumption,' to skirt the law. The molecules are derivatives of two controlled substances –MDPV (methylenedioxypyrovalerone, which is similar to Ritalin, but more potent) and mephedrone (an amphetamine-like drug). Also known as party salts and party powders, fake bath salts are snorted or ingested to create a stimulant, narcotic effect like that of cocaine.
"Users are snorting and ingesting the fake bath salts as a stimulant, to create a sense of euphoria and to stay up and party longer," Dr. Jones explains. "However, it can increase pulse and blood pressure to dangerous levels and cause delirium and confusion."
People using the bath salts as a narcotic have been treated for paranoia, hallucinations, agitation, hypertension, chest pain and headaches.
"Drug-naive teens and college students are showing up in ERs across the country because they purchased and used these products. They probably think that since they didn't buy them from a drug-dealer that they aren't as dangerous as the real thing, so they load up on them and reach a toxic state," Dr. Jones said.
As attention is being drawn to this latest drug abuse fad, Dr. Jones predicts that, as Willingway Hospital is now doing, facilities will be adding questions about use of party powders and fake bath salts to their drug and alcohol history questionnaires. And, more prevalent use is leading to a ban of these products, such as in Louisiana where two weeks ago, Governor Bobby Jindal announced that the so-called bath salts are now defined as illegal narcotics under State of Louisiana law.
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Showing posts with label drug. Show all posts
Showing posts with label drug. Show all posts
Tuesday, January 18, 2011
Wednesday, January 12, 2011
Survey: Exposure to Anti-Drug Messages Among Teens Drops Dramatically by Two-Thirds as Drug Use Goes Up
/PRNewswire/ -- The University of Michigan's Monitoring the Future study (MTF) – the largest survey on teen drug abuse tracking over 46,000 8th, 10th and 12th graders – found a huge falloff in teens' recalled exposure to drug abuse prevention messages over the past seven years. The new data from the MTF study have been released at a time when teens themselves report finding the drug-prevention messages to be effective.
Comparing 2003, the year in which kids and teens' recalled exposure to drug prevention messages from the White House Office of National Drug Control Policy (ONDCP)'s National Youth Anti-Drug Media Campaign (NYADMC) peaked, to today, the proportion of 8th graders that reported daily/or more often exposure dropped from 54 percent to 18 percent, a dramatic decrease of two-thirds among the youngest group surveyed. Similar declines occurred among 10th graders (50 percent in 2003 to 17 percent in 2010) and 12th graders (32 percent to 10 percent). According to Lloyd Johnston, the principal investigator of the study, the rates of teens' recalled exposure of drug abuse prevention messages are lower in 2010 than they have been since his research team began tracking all three grades nearly two decades ago.
"At a time when teen drug use is at relatively low levels, historically, and children are not learning as much through the news media about the health consequences of using many dangerous drugs, it is important that we get that information to them by other means – through prevention ads, in schools and through their families," said Johnston. "If they don't get those messages, teens will come to view drug use as less dangerous than their predecessors did and that misconception will leave them vulnerable to having their own epidemics of drug abuse. In fact, we are already seeing these signs beginning to happen now for teen use of drugs like marijuana, Ecstasy and LSD."
Support for prevention programs like the state grants portion of the Safe and Drug-Free Schools and Communities Program, which was zeroed out in the 2011 budget, and the federal NYADMC, has dwindled significantly over the past decade. In fiscal year 2003, which marked the peak year for recalled exposure of drug abuse prevention messages among teens, federal support of the NYADMC was $145 million, compared to only $45 million for fiscal year 2010. The kinds of extracurricular activities – programs in sports, civics and the arts – that states and localities have funded to engage kids' positive energies and help prevent substance abuse continue to collapse under relentless budgetary pressure.
"Our prevention infrastructure is disappearing before our eyes and the result of all this is not fair, but it's undeniable: the additional burden is increasingly falling on the shoulders of parents and caregivers," said Steve Pasierb, President of The Partnership at Drugfree.org. "The slashing of funds and lack of support, coupled with the discussion of further cuts for effective prevention programs, are going to have a direct impact on the 35 million American families with children at risk of abusing drugs or alcohol."
Teens Seeing/Hearing Less Drug-Prevention Messages, But Find Them Effective
While recalled exposure among teens is down significantly, perceived effectiveness of the drug-prevention messages did not reflect the same dramatic drops and, for the most part, remained constant. Between 2003 and today, the proportion of 8th, 10th, and 12th graders that agreed "the commercials made them, to a great extent, less favorable toward drugs" remained fairly stable. Among 8th graders, 42 percent in 2003 and 36 percent in 2010; among 10th graders, 26 percent in 2003 and 23 percent in 2010; and among 12th graders 22 percent in 2003 and 21 percent in 2010.
Similarly, the percentage of teens who agreed that drug-prevention messages made them less likely to use drugs in the future also remained stable, although they reported they are exposed to fewer messages.
"There is evidence of a correlation between decreased drug use among teens and their exposure to drug abuse prevention messages," said Pasierb. "The alarming drops in the number of messages teens are seeing or hearing today is especially disturbing because the kids themselves report these messages are effective in keeping them from using drugs."
Increases in Teen Use of Illicit Drugs Correlate with Decreased Support for Anti-Drug Messages
The MTF survey also measures teen attitudes about drug and alcohol use, including perceived harmfulness and disapproval, factors that can predict future substance abuse. The perception among teens that regular marijuana use is harmful decreased among 10th and 12th graders, but declined the most among the youngest group of 8th graders. The study also confirmed a new uptick in teen Ecstasy use, especially, among 8th and 10th graders, following drastic declines of this drug of abuse over the past decade. As teen anti-drug attitudes erode and move in the wrong direction, increases in drug use are sure to follow.
"While we recognize the current constraints on the federal budget, we urge Congress to fund ONDCP's National Youth Media Campaign at the highest possible level and restore the funding cuts that have eroded the impact of this program and have most likely contributed to increases in teen drug abuse," said Pasierb. "We would welcome the opportunity to work with Congress and the Administration to increase the frequency with which teens receive anti-drug messages, while demanding full accountability for the program and its outcomes."
The National Youth Anti-Drug Media Campaign, administered by ONDCP, is aimed at reducing drug use among American teens. The Partnership at Drugfree.org assists in facilitating the creative development of the drug abuse prevention messages used by the NYADMC.
To learn more about how to help parents prevent, intervene in and find treatment for drug and alcohol use by their children, please visit drugfree.org
-----
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Comparing 2003, the year in which kids and teens' recalled exposure to drug prevention messages from the White House Office of National Drug Control Policy (ONDCP)'s National Youth Anti-Drug Media Campaign (NYADMC) peaked, to today, the proportion of 8th graders that reported daily/or more often exposure dropped from 54 percent to 18 percent, a dramatic decrease of two-thirds among the youngest group surveyed. Similar declines occurred among 10th graders (50 percent in 2003 to 17 percent in 2010) and 12th graders (32 percent to 10 percent). According to Lloyd Johnston, the principal investigator of the study, the rates of teens' recalled exposure of drug abuse prevention messages are lower in 2010 than they have been since his research team began tracking all three grades nearly two decades ago.
"At a time when teen drug use is at relatively low levels, historically, and children are not learning as much through the news media about the health consequences of using many dangerous drugs, it is important that we get that information to them by other means – through prevention ads, in schools and through their families," said Johnston. "If they don't get those messages, teens will come to view drug use as less dangerous than their predecessors did and that misconception will leave them vulnerable to having their own epidemics of drug abuse. In fact, we are already seeing these signs beginning to happen now for teen use of drugs like marijuana, Ecstasy and LSD."
Support for prevention programs like the state grants portion of the Safe and Drug-Free Schools and Communities Program, which was zeroed out in the 2011 budget, and the federal NYADMC, has dwindled significantly over the past decade. In fiscal year 2003, which marked the peak year for recalled exposure of drug abuse prevention messages among teens, federal support of the NYADMC was $145 million, compared to only $45 million for fiscal year 2010. The kinds of extracurricular activities – programs in sports, civics and the arts – that states and localities have funded to engage kids' positive energies and help prevent substance abuse continue to collapse under relentless budgetary pressure.
"Our prevention infrastructure is disappearing before our eyes and the result of all this is not fair, but it's undeniable: the additional burden is increasingly falling on the shoulders of parents and caregivers," said Steve Pasierb, President of The Partnership at Drugfree.org. "The slashing of funds and lack of support, coupled with the discussion of further cuts for effective prevention programs, are going to have a direct impact on the 35 million American families with children at risk of abusing drugs or alcohol."
Teens Seeing/Hearing Less Drug-Prevention Messages, But Find Them Effective
While recalled exposure among teens is down significantly, perceived effectiveness of the drug-prevention messages did not reflect the same dramatic drops and, for the most part, remained constant. Between 2003 and today, the proportion of 8th, 10th, and 12th graders that agreed "the commercials made them, to a great extent, less favorable toward drugs" remained fairly stable. Among 8th graders, 42 percent in 2003 and 36 percent in 2010; among 10th graders, 26 percent in 2003 and 23 percent in 2010; and among 12th graders 22 percent in 2003 and 21 percent in 2010.
Similarly, the percentage of teens who agreed that drug-prevention messages made them less likely to use drugs in the future also remained stable, although they reported they are exposed to fewer messages.
"There is evidence of a correlation between decreased drug use among teens and their exposure to drug abuse prevention messages," said Pasierb. "The alarming drops in the number of messages teens are seeing or hearing today is especially disturbing because the kids themselves report these messages are effective in keeping them from using drugs."
Increases in Teen Use of Illicit Drugs Correlate with Decreased Support for Anti-Drug Messages
The MTF survey also measures teen attitudes about drug and alcohol use, including perceived harmfulness and disapproval, factors that can predict future substance abuse. The perception among teens that regular marijuana use is harmful decreased among 10th and 12th graders, but declined the most among the youngest group of 8th graders. The study also confirmed a new uptick in teen Ecstasy use, especially, among 8th and 10th graders, following drastic declines of this drug of abuse over the past decade. As teen anti-drug attitudes erode and move in the wrong direction, increases in drug use are sure to follow.
"While we recognize the current constraints on the federal budget, we urge Congress to fund ONDCP's National Youth Media Campaign at the highest possible level and restore the funding cuts that have eroded the impact of this program and have most likely contributed to increases in teen drug abuse," said Pasierb. "We would welcome the opportunity to work with Congress and the Administration to increase the frequency with which teens receive anti-drug messages, while demanding full accountability for the program and its outcomes."
The National Youth Anti-Drug Media Campaign, administered by ONDCP, is aimed at reducing drug use among American teens. The Partnership at Drugfree.org assists in facilitating the creative development of the drug abuse prevention messages used by the NYADMC.
To learn more about how to help parents prevent, intervene in and find treatment for drug and alcohol use by their children, please visit drugfree.org
-----
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www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
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Twitter: @artsacrossga, @softnblue, @RimbomboAAG @FayetteFP
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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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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Tuesday, December 29, 2009
FDA Warns Public of Continued Extortion Scam by FDA Impersonators
/PRNewswire/ -- The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam.
The criminals call the victims -- who in most cases previously purchased drugs over the Internet or via "telepharmacies" -- and identify themselves as FDA special agents or other law enforcement officials. The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards.
The criminals always request the money be sent by wire transfer to a designated location, usually in the Dominican Republic. If victims refuse to send money, they are often threatened with a search of their property, arrest, deportation, physical harm, or incarceration.
"Impersonating an FDA official is a violation of federal law," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment."
FDA special agents and other law enforcement officials are not authorized to impose or collect criminal fines. Only a court can take such action, with fines payable to the U.S. Treasury.
Anyone receiving a telephone call from a person purporting to be an FDA or other law enforcement official who is seeking money to settle a law enforcement action for the illegal purchase of drugs over the Internet should refuse the demand and call the FDA's Office of Criminal Investigations Metro Washington Field Office at (800) 521-5783 to report the crime.
In addition to posing as FDA officials, criminals have posed as special agents of the DEA, FBI, U.S. Secret Service and U.S. Customs Service as well as U.S. and Dominican prosecutors and judges. In response, the FDA, in conjunction with various federal, state, and local agencies, is actively pursing criminal charges.
The FDA also reminds consumers to use caution when purchasing prescription drugs over the telephone or the Internet. In addition to the increased risk of purchasing unsafe and ineffective drugs from Web sites operating outside the law, there is the danger that personal data can be compromised. For more on FDA's concerns about unlawful drug sales on the Internet, see http://www.fda.gov/oc/buyonline/faqs.html.
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The criminals call the victims -- who in most cases previously purchased drugs over the Internet or via "telepharmacies" -- and identify themselves as FDA special agents or other law enforcement officials. The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards.
The criminals always request the money be sent by wire transfer to a designated location, usually in the Dominican Republic. If victims refuse to send money, they are often threatened with a search of their property, arrest, deportation, physical harm, or incarceration.
"Impersonating an FDA official is a violation of federal law," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment."
FDA special agents and other law enforcement officials are not authorized to impose or collect criminal fines. Only a court can take such action, with fines payable to the U.S. Treasury.
Anyone receiving a telephone call from a person purporting to be an FDA or other law enforcement official who is seeking money to settle a law enforcement action for the illegal purchase of drugs over the Internet should refuse the demand and call the FDA's Office of Criminal Investigations Metro Washington Field Office at (800) 521-5783 to report the crime.
In addition to posing as FDA officials, criminals have posed as special agents of the DEA, FBI, U.S. Secret Service and U.S. Customs Service as well as U.S. and Dominican prosecutors and judges. In response, the FDA, in conjunction with various federal, state, and local agencies, is actively pursing criminal charges.
The FDA also reminds consumers to use caution when purchasing prescription drugs over the telephone or the Internet. In addition to the increased risk of purchasing unsafe and ineffective drugs from Web sites operating outside the law, there is the danger that personal data can be compromised. For more on FDA's concerns about unlawful drug sales on the Internet, see http://www.fda.gov/oc/buyonline/faqs.html.
-----
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Thursday, July 10, 2008
HHS Announces New International Programs to Enhance Drug and Food Safety Joint Inspections with European Union and Australian Regulators
HHS Announces New International Programs to Enhance Drug and Food Safety Joint Inspections with European Union and Australian Regulators; Third-Party Certification Program Are Latest Steps toward Implementing New Import Strategy
U.S. Health and Human Services (HHS) Secretary Mike Leavitt today announced two groundbreaking programs designed to enhance the safety of food and medical products exported to the United States.
"These programs will significantly increase our collaboration with international and private sector partners to enhance the safety of imported food and medical products," Secretary Leavitt said. "Working together, we intend to offer expedited access to those products shown to
meet our standards and to focus more of our resources on those products that present higher risks."
Secretary Leavitt made the announcement in a speech to hundreds of industry leaders at an Import Safety Summit in Washington. He described the twin initiatives as the latest steps in a fundamental, government-wide shift to implement the Interagency Import Safety Action Plan finalized in November 2007. Historically, U.S. authorities have primarily relied on intervening at the border to intercept unsafe goods.
The new strategy calls for actively working with trading partners to help ensure they build quality into every step of a product's life cycle, targeting critical points where risk is greatest, and focusing attention and resources on these areas.
The first initiative is a pilot project the HHS Food and Drug Administration (FDA) is undertaking with its counterparts in the European Union and Australia to jointly plan, allocate for and conduct inspections of drug-manufacturing facilities. The project will initially focus on makers of active pharmaceutical ingredients. If successful, this program could expand to include other types of manufacturing facilities. The novel collaboration will allow HHS/FDA to
more fully take advantage of information gathered by trusted inspection and regulatory systems in other countries.
The second initiative is a third-party certification pilot program involving aquacultured (farm-raised) shrimp. HHS/FDA is seeking the participation of certification bodies that currently certify foreign processors of aquacultured shrimp for compliance with the FDA's seafood regulations. The project is designed to help HHS/FDA learn how to evaluate third-party certification programs and implement them in the field -- a key part of leveraging the additional resources of the private sector and other regulators.
U.S. Health and Human Services (HHS) Secretary Mike Leavitt today announced two groundbreaking programs designed to enhance the safety of food and medical products exported to the United States.
"These programs will significantly increase our collaboration with international and private sector partners to enhance the safety of imported food and medical products," Secretary Leavitt said. "Working together, we intend to offer expedited access to those products shown to
meet our standards and to focus more of our resources on those products that present higher risks."
Secretary Leavitt made the announcement in a speech to hundreds of industry leaders at an Import Safety Summit in Washington. He described the twin initiatives as the latest steps in a fundamental, government-wide shift to implement the Interagency Import Safety Action Plan finalized in November 2007. Historically, U.S. authorities have primarily relied on intervening at the border to intercept unsafe goods.
The new strategy calls for actively working with trading partners to help ensure they build quality into every step of a product's life cycle, targeting critical points where risk is greatest, and focusing attention and resources on these areas.
The first initiative is a pilot project the HHS Food and Drug Administration (FDA) is undertaking with its counterparts in the European Union and Australia to jointly plan, allocate for and conduct inspections of drug-manufacturing facilities. The project will initially focus on makers of active pharmaceutical ingredients. If successful, this program could expand to include other types of manufacturing facilities. The novel collaboration will allow HHS/FDA to
more fully take advantage of information gathered by trusted inspection and regulatory systems in other countries.
The second initiative is a third-party certification pilot program involving aquacultured (farm-raised) shrimp. HHS/FDA is seeking the participation of certification bodies that currently certify foreign processors of aquacultured shrimp for compliance with the FDA's seafood regulations. The project is designed to help HHS/FDA learn how to evaluate third-party certification programs and implement them in the field -- a key part of leveraging the additional resources of the private sector and other regulators.
Friday, December 28, 2007
FDA Warns Consumers Not to Use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular (also known as Shangai
Toxic Note: I know that none of OUR readers would EVER buy or use any of these products, you're too smart to try unregulated drugs off the Internet without checking 'em out first. But, just on the off-chance someone out there is considering it (after all, someone must be buying it or they wouldn't be making it to sell...), here's the info from the FDA:
These products are illegal drugs and contain undeclared active ingredients in prescription erectile dysfunction drugs
The U.S. Food and Drug Administration (FDA) is advising consumers not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular, also marketed as Shangai Chaojimengnan, products.
These products, which originate in China, are being marketed for the treatment of erectile dysfunction (ED) and for sexual enhancement. Although labeled as dietary supplements, these products do not qualify as dietary supplements because they contain undeclared active ingredients of FDA-approved prescription drugs for erectile dysfunction. The products are thus drugs that are illegal because they lack FDA approval.
The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, they may seek out products like these because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of these ingredients can not be validated.
"Products like these put consumers at considerable risk because they contain undeclared active ingredients in FDA approved drugs that require a prescription to obtain," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research (CDER). "An unsuspecting consumer with underlying medical issues may buy and take these products without knowing that they can cause serious drug interactions."
FDA performed chemical testing of the products that revealed that Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, and Lady Shangai contain sildenafil, the active ingredient in Viagra, an FDA-approved drug for erectile dysfunction. Shangai Regular, also marketed as Shangai Chaojimengnan, contains an unapproved substance with a structure similar to sildenafil that may cause similar side effects and drug interactions. Neither sildenafil nor the analog of sildenafil is listed as an ingredient on the label of any of these products.
FDA advises consumers who have used any of these products to discontinue use and consult their health care providers if they have experienced any adverse events that they feel are related to the use of these products. Consumers and health care professionals can report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm. FDA recommends that consumers should talk to their health care provider about FDA-approved treatments for erectile dysfunction. FDA may take further regulatory actions to protect consumers from these illegal products.
The products are packaged and distributed by Shangai Distributor, Inc. of Coamo, Puerto Rico.
These products are illegal drugs and contain undeclared active ingredients in prescription erectile dysfunction drugs
The U.S. Food and Drug Administration (FDA) is advising consumers not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular, also marketed as Shangai Chaojimengnan, products.
These products, which originate in China, are being marketed for the treatment of erectile dysfunction (ED) and for sexual enhancement. Although labeled as dietary supplements, these products do not qualify as dietary supplements because they contain undeclared active ingredients of FDA-approved prescription drugs for erectile dysfunction. The products are thus drugs that are illegal because they lack FDA approval.
The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, they may seek out products like these because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of these ingredients can not be validated.
"Products like these put consumers at considerable risk because they contain undeclared active ingredients in FDA approved drugs that require a prescription to obtain," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research (CDER). "An unsuspecting consumer with underlying medical issues may buy and take these products without knowing that they can cause serious drug interactions."
FDA performed chemical testing of the products that revealed that Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, and Lady Shangai contain sildenafil, the active ingredient in Viagra, an FDA-approved drug for erectile dysfunction. Shangai Regular, also marketed as Shangai Chaojimengnan, contains an unapproved substance with a structure similar to sildenafil that may cause similar side effects and drug interactions. Neither sildenafil nor the analog of sildenafil is listed as an ingredient on the label of any of these products.
FDA advises consumers who have used any of these products to discontinue use and consult their health care providers if they have experienced any adverse events that they feel are related to the use of these products. Consumers and health care professionals can report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm. FDA recommends that consumers should talk to their health care provider about FDA-approved treatments for erectile dysfunction. FDA may take further regulatory actions to protect consumers from these illegal products.
The products are packaged and distributed by Shangai Distributor, Inc. of Coamo, Puerto Rico.
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