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 a continued 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 and/or incarceration.

"Impersonating an FDA official is a violation of federal law," said Dara Corrigan, the FDA's associate commissioner for regulatory affairs. "FDA special agents and other law enforcement officials are not authorized to impose or collect criminal fines. Only a court can take such action."

In most instances, victims of extortion-related calls have also received telephone solicitations for additional pharmaceutical purchases from other possibly related, illegal entities located overseas. The extortionists use customer lists complete with extensive personal information provided through previous purchase transactions. These include names, addresses, telephone numbers, Social Security numbers, dates of birth, purchase histories and credit card account numbers.

Typically, these criminals use telephone numbers that change constantly and make it appear as though their calls originate in the United States.

No known victim has been approached in person by a law enforcement impersonator associated with this scheme.

The FDA's Office of Criminal Investigations, with the U.S. Drug Enforcement Administration, and the U.S. Immigrations and Customs Enforcement, Homeland Security Investigations, with the support of various U.S. Attorneys, are pursuing multiple national and international criminal investigations.

Arrests have been made and additional prosecutions are pending; however, the scheme is likely to continue. The FDA has issued similar warnings in the past:

* FDA Warns Public of Extortion Scam by FDA Impersonators (11/12/2008)
* FDA Warns Public of Continued Extortion Scam by FDA Impersonators (12/29/2009)


Victims of this scheme who have suffered monetary loss through the payment of funds in response to an extortion call, or 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 may obtain a victim questionnaire by contacting the FDA's Office of Criminal Investigations and clicking "Report Suspected Criminal Activity."

Anyone receiving a purported official document on agency letterhead may verify its authenticity by contacting that organization directly via a publicly available phone number. Additionally, all federal agencies use email addresses with a "gov" email extension.

The FDA also reminds consumers that pharmaceutical products offered online and by telephone by sources of unknown origin can pose a substantial health risk. Products recovered during this investigation that were purchased from online or telephone sources have been found to contain trace amounts of heroin, other undisclosed and potentially harmful active pharmaceutical ingredients, or no active ingredient at all. Purchases should only be made from licensed pharmacies located in the United States. In addition to the increased risk of purchasing unsafe and ineffective drugs from websites operating outside the law, personal data may be compromised.

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Deaths prompt CPSC, FDA warning on infant sleep positioners

The U.S. Consumer Product Safety Commission (CPSC) and the U.S. Food and Drug Administration (FDA) today warned consumers to stop using infant sleep positioners. Over the past 13 years, CPSC and the FDA have received 12 reports of infants between the ages of 1 month and 4 four months who died when they suffocated in sleep positioners or became trapped and suffocated between a sleep positioner and the side of a crib or bassinet.

Most of the infants suffocated after rolling from a side to stomach position. In addition to the reported deaths, CPSC has received dozens of reports of infants who were placed on their backs or sides in sleep positioners, only to be found later in potentially hazardous positions within or next to the sleep positioners.

“The deaths and dangerous situations resulting from the use of infant sleep positioners are a serious concern to CPSC,” said CPSC Chairman Inez Tenenbaum. “We urge parents and caregivers to take our warning seriously and stop using these sleep positioners, so that children can have a safer sleep.”

The two main types of infant sleep positioners are flat mats with side bolsters or inclined (wedge) mats with side bolsters.

Flat Mat Infant Sleep Positioner Inclined Wedge Infant Sleep Positioner
FLAT MAT INCLINED/WEDGE

Both types of sleep positioners typically claim to help keep infants on their backs and reduce the risk of Sudden Infant Death Syndrome (SIDS). The FDA has never cleared an infant sleep positioner to prevent or reduce the risk of SIDS. In addition, CPSC and the FDA are unaware of any scientific studies demonstrating that infant positioners prevent SIDS or are proven to prevent suffocation or other life-threatening harm.

“To date, there is no scientifically sound evidence that infant sleep positioners prevent SIDS,” said Dr. Joshua Sharfstein, FDA Principal Deputy Commissioner and a pediatrician. “We want to make sure parents, health care professionals, and childcare providers understand the potential risk of suffocation and stop using infant sleep positioners.”

Sleep positioners also typically claim to do one or all of the following: aid in food digestion to ease colic or the symptoms of gastroesophageal reflux disease (GERD); and prevent flat head syndrome (plagiocephaly). In light of the new safety data, FDA believes any benefit from using these devices to ease GERD or prevent plagiocephaly is outweighed by the risk of suffocation.

CPSC and the FDA are warning parents and child care providers to:

* STOP using sleep positioners. Using a positioner to hold an infant on his or her back or side for sleep is dangerous and unnecessary.
* NEVER put pillows, infant sleep positioners, comforters, or quilts under a baby or in a crib.
* ALWAYS place an infant on his or her back at night and during nap time. To reduce the risk of SIDS, the American Academy of Pediatrics recommends placing infants to sleep on their backs and not their sides.


The American Academy of Pediatrics does not support the use of any sleep positioner to prevent SIDS.

Manufacturers of infant sleep positioners with medical claims that have not been reviewed by the FDA should stop marketing those products until they submit, and the FDA clears, appropriate premarket review submissions, including necessary safety and effectiveness data.

FDA has informed manufacturers of cleared devices of the agency's serious concern and has requested that they submit clinical data showing the benefits of their products outweigh the risk of suffocation or other serious harm.

Prompt reporting of adverse events can help the FDA and CPSC identify and better understand the risks associated with infant sleep positioners. If you have had a problem with an infant sleep positioner, the agencies encourage you to file a report through FDA’s MedWatch program, at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.

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FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now

The U.S. Food and Drug Administration today issued a public health advisory to alert patients, caregivers and health care professionals to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after Dec. 31, 2008.

CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface.

Three HFA-propelled albuterol inhalers have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. In addition, an HFA-propelled inhaler containing levalbuterol, a medicine similar to albuterol, is available as Xopenex HFA Inhalation Aerosol.

"Concern about the environment stimulated the need to phase out CFCs," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "The FDA wants to emphasize that HFA-propelled albuterol inhalers are safe and effective replacements for CFC-propelled albuterol inhalers."

Albuterol inhalers are used to treat bronchospasm (wheezing) in patients with asthma and chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema. Patients use albuterol inhalers to deliver medicine directly into the lungs.

The FDA is urging patients to talk with their health care professionals now about switching to HFA-propelled albuterol inhalers. These products are safe and effective replacements for CFC-propelled albuterol inhalers.

Manufacturers have been increasing production of HFA albuterol inhalers, so an adequate supply is available now.

HFA-propelled albuterol inhalers may taste and feel different than the CFC-propelled albuterol inhalers. The spray of an HFA-propelled albuterol inhaler may feel softer than that of a CFC-propelled albuterol inhaler. Patients must also prime and clean HFA-propelled albuterol inhalers. Doing so prevents buildup of the drug in the inhalation device, and buildup can block the medicine from reaching the lungs. Each HFA-propelled albuterol inhaler has different priming, cleaning, and drying instructions, and patients should read and understand the instructions first before using the inhaler.

The phaseout of CFC-propelled inhalers is the result of the Clean Air Act and an international environmental treaty, the Montreal Protocol on Substances that Deplete the Ozone Layer. Under this treaty, the United States has agreed to phase out production and importation of ozone depleting substances including CFCs. No CFC-propelled albuterol inhalers may be produced, marketed or sold in the United States after Dec. 31, 2008.