The Food and Drug Administration (FDA) has issued a reminder to consumers that drinking fruit and vegetable juices that have not been treated to kill harmful bacteria can pose serious health risks.

The FDA continues to receive reports of serious outbreaks of foodborne illness caused by untreated juices. Bacteria often contaminate fruits and vegetables as they are juiced and can be harmful if the juice is not treated to destroy them.

Healthy people’s immune systems can usually fight foodborne bacteria but for children, the elderly, and people with weakened immune systems there are significant risks including serious illnesses or even death.

Symptoms of foodborne illness usually include vomiting, diarrhea, and abdominal pain; or flu-like symptoms such as fever, headache, and body ache. Although symptoms can occur within 20 minutes or up to six weeks after ingesting the affected food source, sickness usually develops in one to three days.

As a protective measure, since 1999, the FDA has required juice manufacturers to place warning information about the health risks of drinking untreated juice or cider on product containers.

Almost all juices sold in supermarkets, including refrigerated juices and products sold in boxes and containers are treated for bacteria.
Untreated products are required to have the following warning label:

WARNING: This product has not been pasteurized and therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems.

The FDA warning label requirements do not apply to fresh-squeezed juices and juices bought by the glass at farmers’ markets, roadside stands, or in juice bars.
 
Consumers should note that untreated juice is most likely to be sold in the refrigerated section of a grocery store. When in doubt, FDA advises consumers to ask if a juice product is treated, especially for juices purchased in health food stores, cider mills, or farmers’ markets.

For more information on handling food safely, contact: The U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Food Information Line at 1-888-SAFEFOOD (toll-free), 24 hours a day. Or visit the FDA’s Food Safety Web site at: cfsan.fda.gov

Jennifer R. Clason, Jeffrey A. Kilbride, and James R. Schaffer have been accused of sending numerous span emails advertising pornographic websites.

The three were indicted by a federal grand jury in Arizona (U.S.) and accused of violating the CAN-SPAM Act of 2003 and other crimes.

According to the Justice Department, the pornographic Web sites that were being promoted would pay the trio for directing internet traffic to their sites.

The unsolicited spam emails generated by the three were ranked in the top 200 largest sources of spam on the Internet according to the Internet anti-spam monitor The Spamhaus Project.

The Department of Justice stated that America Online received more than 600,000 complaints between late January and early June 2004 related to spam from this particular operation. It is estimated that tens of millions of users may have received the email.

The spam operation functioned by buying large amounts of Internet bandwidth from major service providers along with which came large blocks of IP addresses, a small number of which could be used for spamming.
They used these addresses until they were blocked by anti-spam systems or were terminated by their ISP. At that point they would find a new ISP and repeat the process.

Each of the three indicted individuals is charged with two counts of fraud and one count of criminal conspiracy. Kilbride and Schaffer face an additional two counts of interstate transportation of pornographic material via the internet, two counts of interstate transportation of obscene material for the purpose of sale or distribution, and one count of money laundering.

In addition, Schaffer has one count of operating three pornographic Web sites without including required statements regarding the performers.

The three face long prison sentences if convicted for the crimes contained in the indictments. Kilbride and Schaffer face a maximum of 25 years in prison for money laundering and obscenity charges.

The spamming and criminal conspiracy charges carry maximum sentences of five years each. Schaffer also faces up to two years on the charge of improper pornographic record keeping.

Andrew Ellifson, a fourth individual implicated in the group’s activities pleaded guilty to a violation of the CAN-SPAM act and one count of criminal conspiracy. His role was creating, managing, and operating the computer network used for spamming.

Ellifson’s sentencing will occur on September 26 and he could serve up to a total of 15 years in prison if convicted on all three counts of the indictment.  In a plea bargain he agreed to relinquish the profits he made through the spam emails.

Carrington Labs of Irving, Texas, has issued a voluntary recall of Medline labeled alcohol-free mouthwash. As a result of this recall, Medline Industries, Inc. Mundelein, Illinois, is initiating a voluntary recall of Personal Hygiene Admission kits containing the same alcohol-free mouthwash.

The FDA has been apprised of this action.

The recall includes Alcohol-Free Mouthwash, Medline Label, 2 oz. reorder number MDS095029 and Alcohol-Free Mouthwash, Medline Label, and 4 oz. reorder number MDS095030. The product was distributed to hospitals, medical centers, and long-term care facilities nationwide.

The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The Centers for Disease Control and Prevention (CDC) has confirmed hospital illnesses in two states associated with the use of the affected mouthwash.

B. cepacia poses little medical risk to healthy people. However, people with certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF), may be more susceptible to infections with B. cepacia.

B cepacia is a known cause of infections in hospitalized patients. B. cepacia bacteria are often resistant to common antibiotics. The effects of B. cepacia on people vary widely, ranging from no symptoms at all, to serious respiratory infections, especially in patients with CF.

Product lot numbers beginning 0503 through 0508 are affected. Affected product can be identified by checking the lot code stamped on the bottom of the bottle.

Additionally, affected product can be identified by checking for the identification code RA05CRR on the lower portion of back display panel of the product label.

The mouthwash may also be found packed in certain Medline Personal Hygiene Hospital Admission Kits. If you received mouthwash labeled for Medline Industries, Inc. from your healthcare provider please check to see if the reorder number on the label matches the recalled reorder numbers listed above, then check to see if the lot number matches the recalled lot number(s).

Customers who have Medline labeled alcohol free mouthwash which is being recalled should stop using the product and contact Medline Industries, Inc. for instructions.

Medline Industries, Inc. is notifying their customers via overnight mail and is arranging for all products to be returned for credit. For a complete list of admission kits involved, go to www.medline.com or call Medline Industries at 1-800-MEDLINE for details.

Following an emergency hearing before the Massachusetts Board of Registration in Medicine, Dr. Michael R. Brown, a Cape Cod physician, has lost his medical license on the grounds that he wrote an incredible number of prescriptions for the powerful painkiller, OxyContin.

The doctor is also facing criminal drug possession charges for allegedly buying back painkillers he had prescribed to a patient.

Dr. Brown, who became known as “Dr. Feel Good,” wrote so many prescriptions for OxyContin in 2004 that it is estimated he single-handedly accounted for approximately 300,000 of the 923,000 tablets sold in the entire state for the year. Many of the prescriptions deemed to be excessive were to children. 

OxyContin is an FDA approved medication for the relief of chronic pain and is often used by cancer patients. The drug, however, also has a dark side and has become a widely abused and addictive “street” drug that offers a quick heroin-like high.

Nancy Achin Audesse, executive director of the Board, said that although Brown had been required in 2001 to take courses in pain management, he continued to over-prescribe OxyContin. This resulted in the emergency action by the Board which believed Dr. Brown posed "an immediate and serious threat to the public safety and welfare."

The doctor can appeal the suspension, which will remain in effect indefinitely.

On Tuesday, Brown, 52, pleaded innocent to 13 counts of illegal drug possession within intent to distribute. The doctor has also been accused of buying back painkillers he had prescribed to a patient. 

According to California’s Attorney General, Bill Lockyer, the state’s Medicaid program was bilked out of hundreds of millions of dollars by drug makers that inflated their prices.

As the number of defendants in the federal lawsuit increased to 39, Lockyer has made it clear that he believes Medi-Cal, California’s health insurance program for the poor, elderly, and disabled was the victim of price gouging by these companies which provided false and misleading drug pricing information to the state.

By engaging in these practices and defrauding the state into paying inflated reimbursement rates, the drug companies created an artificial incentive for doctors and pharmacies to prescribe their products.

Under California’s False Claims Act, the companies could be liable for treble (triple) damages and penalties of up to $10,000 per false claim. This could expose each of the companies sued to liability awards of up to $40 million.

Several other states have already filed similar suits and they have been consolidated in the United States District Court in Boston. This litigation could also cause the federal government to step up its own ongoing investigations into the matter of price gouging.

All of this litigation stems from a 1998 whistleblower lawsuit filed by Ven-A-Care, a small pharmacy that alleged Medi-Cal had based its drug reimbursement rates on false and misleading (inflated) drug-pricing information provided by the pharmaceutical companies.

In 2003, the state intervened in the Ven-A-Care lawsuit and the case was removed from state court and consolidated with the federal litigation pending in Boston.

The companies being targeted by the lawsuit maintain that they did nothing wrong and were in full compliance with law and all applicable guidelines.

The CPSC has announced the voluntary recall of Maptangle™ World Edition Floor Mat Map Games made in Taiwan by Team WorldWide Corp., of Taipei City, Taiwan (floor mat only) and distributed by Hidden Hills Productions Inc., of Westlake Village, California. Customers should stop using the product immediately.

Although only some 140 units are involved, the recall is a serious one because of the danger posed to children from lead exposure. Here, the orange paint on the floor mat maps contains excess levels of lead. Lead poisoning is associated with behavioral problems, learning disabilities, hearing problems and growth retardation. To date no injuries have been reported.

The floor map game consists of a 6-foot by 5.5-foot vinyl Maptangle™ floor mat that has various multicolored geographic locations and landmarks painted on the floor mat and a set of 103 playing cards consisting of corresponding geographic locations and landmarks.

The object of the game is for a team of players to locate, and place their feet on all of the landmarks and geographic locations. The game is age-graded for children 7 years and up. This recall pertains only to the floor mat, and does not include any other components of the game. Floor mat map games with manufacture date codes are not subject to this recall.

The games were sold at educational, book, museum, and specialty toy stores nationwide from February 2005 through June 2005 for about $25.

Consumers are advised to immediately stop using the recalled game maps, and contact Hidden Hills Productions Inc. for information on returning the recalled maps and receiving a free replacement map or refund.

Contact Hidden Hills Productions Inc. at (800) 641-9996 between 9 a.m. and 5 p.m. PT Monday through Friday, or visit the company’s Web site at http://www.borderlinegames.com

As more testing is done on bullet proof police vests containing a fiber known as Zylon, it is becoming clear that they simply do not do what they are supposed to do, which is to stop bullets.

In the latest study conducted by the Justice Department 103 Zylon vests performed so poorly that there were immediate changes made to federal safety guidelines. At least one of six bullets fired at each vest penetrated 60 of the 103 tested (58%).

Even when the vests were not penetrated, 91% sustained damage that was extensive enough to have caused blunt-force trauma to the officers who would have been wearing them. Such damage was regarded as completely unacceptable by the director of the justice institute.

Previous tests showed that Zylon deteriorated quickly, especially when exposed to light, heat, and moisture. The test results released this weak only served to emphasize the questionable value of the product and the potential risks it exposes law enforcement officers to when they wear it.

The New York City Police Department uses vests made of Kevlar, a material which has shown no sign of failure and has protected numerous police officers from multiple gunshots which would have serious injured or killed them. No such glowing endorsements are associated with Zylon.

In an article that appeared in our July 5 edition we reported on the claims that Zylon’s manufacturer was aware of the product’s shortcomings and with respect to the related lawsuit brought by the Justice Department. At that time we wrote the following:

Few defective products could be more dangerous to their users than bulletproof vests that turn out not to be bulletproof. That would be bad enough. But, what if the manufacturer and the supplier of the bullet-resistant material actually knew about the problem before the vests were sold thereby consciously exposing thousands of law enforcement officers to serious injuries or death? That would be unconscionable.

Unfortunately, this is precisely what appears to have happened in the case of some 230,000 or more bulletproof vests manufactured by Second Chance Body Armor Inc. (Second Chance) of Central Lake, Michigan, with bullet-resistant fiber supplied by Toyobo Co. (Toyobo) of Japan.

Last November 15, the Wall Street Journal (WSJ) reported Second Chance was aware of test results that “cast doubt on the vests’ effectiveness” for at least two years before one California police officer was killed and a Pennsylvania officer was seriously wounded by bullets that pierced the “bulletproof” vests they were wearing.

The WSJ stated that the test results were withheld “because executives feared bad news might hurt plans for an initial public stock offering.” Aaron J Westrick, a whistle-blower who was once the research director at Second Chance, has claimed (and testified) the company was aware (in 2001) that the strength of the Zylon (the fiber made by Toyobo) deteriorated much more quickly than the five-year warranty.

Test results from Toyobo in 2001 showed the resilience of the Zylon fibers was weakened when exposed to high temperature and humidity. Research by Second Chance on used vests then showed more rapid loss of bullet-resistance than expected. A second report by Toyobo later that year showed an even sharper decrease in Zylon’s effectiveness over time. 

According to the WSJ, depositions and other documents filed as part of ongoing civil litigation reveal during 2001 and 2002 there was considerable internal conflict at Second Chance over what to do about the mounting evidence that the vests were seriously flawed in terms of long-term resilience. The company continued to conceal the problem and avoided any recall or warning.

At least one Second Chance official claims to have told the executive committee in 2002 that it had two choices. It could do nothing “until a customer is injured or killed” or until the problem is discovered and then “make excuses as to why we didn’t recognize and correct the problem,” or it could notify customers and stop selling the 100% Zylon vests. There are allegations that the company attempted to destroy all copies of the memo of that meeting.  

Mr. Westrick says “he was told to keep the results quiet because company executives stood to lose as much as $20 million if the company didn’t launch an IPO.”

In September 2003 Second Chance announced it would upgrade and replace 130,000 potentially defective vests. Thereafter, the company filed for bankruptcy under Chapter 11 (October 2004) citing the cost of replacing those vests and mounting legal fees.

Now, the Justice Department has joined the fray by filing its own civil suit against Second Chance and Toyobo on behalf of several federal agencies that bought thousands of Zylon vests. The complaint alleges that between 1998 and 2001, the two companies “kept silent as to the ever-mounting information in their possession that the Zylon fabric degraded substantially faster than expected.”    

Second Chance now appears to be blaming Toyobo for the entire problem while Toyobo claims the failure of Second Chance to share critical information about vest-failure tests with Toyobo, the public, and investigating authorities makes Second Chance the “bad actor.”

The Justice Department claims that from as early as 1998, test results showed Zylon fiber deteriorated “rapidly” when exposed to visible and fluorescent light. Moreover, a document prepared by Second Chance and given to Toyobo stated the two companies “must avoid even the perception of a possible problem.” Finally, the additional testing in 2001 showed the vests bullet-resistance broke down upon exposure to high temperatures and humidity.

The federal government purchased 40,000 vests made with Zylon in 1998. The WSJ reports that, last week, Second Chance recommended an additional 98,000 vests made with Zylon be replaced citing new research that showed they “may fail to perform and result in serious injury or death.”

Officials are still in the process of investigating the death of 5-year-old Abubakar Tariq Nadama to determine why he went into cardiac arrest and died following chelation therapy on August 24.

Chelation therapy is a treatment that involves an intravenous injection of a synthetic amino acid known as ethylene diamine tetra-acetic acid that attaches to heavy metals and then leaves the body through urine. The child had just received his third such treatment when he went into cardiac arrest at the Advanced Integrative Medicine Center in Portersville, Pennsylvania.

Although the Food and Drug Administration (FDA) has approved the treatment only for acute heavy-metal poisoning that has been confirmed by blood tests, some believe the therapy can help autistic children based upon the belief that autism is linked to mercury or lead exposure.

Some experts regard using the treatment for this purpose to be risky. In fact, the Advisory Board on Autism-Related Disorders claims it was just a matter of time before a death would be linked to the therapy.

In the world of pharmaceuticals, a “blockbuster” is the term reserved for a prescription drug which has annual sales in the billion-dollar plus range (with the emphasis on “plus”).

While annual sales in the $500 million range are nothing to sneeze at, the many drugs that attain that level are looked upon as revenue producers. The blockbusters are looked upon as king-makers.

Thus, when drug has the potential to attain the elusive “10-figure” status, some very questionable marketing strategies take place. These include:

•    Failing to disclose or report negative test or clinical trial results;
•    Failing to report adverse reactions;
•    Failing to finalize post-approval testing or reporting;
•    Spending more on advertising a drug than on developing and testing it;
•    Withholding negative information from doctors or using questionable incentives to encourage the writing of prescriptions for a specific drug;
•    Indirectly engineering a campaign to stimulate (while not actually promoting) one or more “off-label” uses of a drug that may actually generate more income for that drug than the approved uses. (The “off-label” market will be described below.)

These revenue-driven strategies do not make a drug better or safer. In fact, every case is little more than marketing winning out over science, safety, and even ethical considerations. In the case of Natrecor nothing good can be said concerning the manner in which the drug was promoted and marketed.

Natrecor, or nesiritide, was approved by the FDA in 2001 to treat congestive heart failure or acute decompensating heart failure in which patients experience shortness of breath and the heart fails to adequately pump blood to other organs in the body.  The drug works by mimicking a hormone-like molecule that dilates vessels to prevent blood from gathering in the heart and lungs thereby allowing the patient to breathe.

 Natrecor is manufactured by Scios, a company which was bought by Johnson & Johnson in 2003.  As many as 600,000 patients have been treated with the drug since its approval.

Natrecor was, and still is, supposed to be used for the sole purpose of treating hospitalized patients with the aforementioned heart conditions. Despite this express limitation on its approved use; Natrecor has become an increasingly popular option in outpatient clinics nationwide where it is used for far longer periods than it was originally approved for. 

Some outpatient clinics even administer Natrecor twice weekly for up to 12 weeks.  This type of use is considered to be extremely dangerous as no study has been conducted to confirm whether long-term use is either safe or effective. 

This “off-label” use of Natrecor has lead to the discovery of severe side-effects and a subsequent push from medical experts and consumer advocates for the manufacturer to conduct further large-scale, longitudinal studies of the drug.

The off-label prescribing of drugs beyond the scope of their approval by the FDA has become a serious concern in recent years. Dosage levels, medical conditions, and treatment durations for which drugs were never intended or tested make the entire area of off-label use problematic at best. At its worst, the practice can be downright deadly.

It is for this reason that the FDA regularly discourages and even warns against such uses of drugs. This has been especially true in the case of powerful drugs like antipsychotics, heart medications, and antidepressants.

The incredibly strange thing about off-label use, however, is that doctors may prescribe drugs to treat conditions for which the FDA has even denied approval. Thus, while a manufacturer cannot market a drug for an unapproved off-label use, a doctor may prescribe the drug for that use.    

Thus, if a pharmaceutical company is able to subtly (or, even not so subtly) stimulate off-label use of one of its drugs, the return in unanticipated profits can be quite significant. In fact, a clever marketing scheme can turn a restricted approval drug with limited sales potential into a billion-dollar blockbuster.

Many times, off-label use of a drug is stimulated by doctors themselves who are acting more like marketing agents than as responsible health professionals.

Dr. Jonathan Sackner-Bernstein, a cardiologist at North Shore University Hospital in New York and an avid opponent of the overuse of Natrecor, co-wrote several journal articles that provide data which links Natrecor to kidney problems and elevated death rates. 

Sackner-Bernstein’s patients taking Natrecor were 80% more likely to die within the next 30 days than patients who had received other treatments such as diuretics or vasodilators. 

The issues relating to kidney safety were known prior to and during the process of FDA approval of the drug and are specifically noted in the drug’s labeling. Yet the increased risk of mortality was not entirely known or appreciated until the drug became widely used in outpatient clinics for extended periods of time. 

Although Scios argued that the Sackner-Bernstein paper included studies done at higher doses than are advised on the drug’s label, those higher doses are precisely what patients are being exposed to when they receive the treatment outside of hospitals.
 
Natrecor was never approved to be used as frequently as it is being used in outpatient clinics.  Sackner-Bernstien and other experts, including fellow cardiologist Keith Aaronson, have attempted to show that Natrecor should not be administered in outpatient settings and that the drug’s label should indicate the serious problems associated with unrestricted off-label usage.

In the July 14 edition of the New England Journal of Medicine, Dr. Eric Topol of the Cleveland Clinic was highly critical of the way in which Scios was marketing Natrecor and he even went so far as to state that the drug should be off the market because the FDA was never given sufficient data upon which to have based its approval. 

Natrecor has been aggressively marketed with sales of the drug now reaching almost $700 million this year.  This is because Natrecor is an expensive option, costing nearly 50 times more than standard therapy options. 

Natrecor is billed to insurance companies at up to $700 per session.  When used in hospitals for emergency situations, as intended, the cost, while high, is controllable.  However, when patients are receiving this treatment dozens of times in outpatient clinics, the cost quickly spirals out of control. 

In addition to other questionable marketing strategies, Scios provided doctors with promotional materials advising them on how to bill Medicare for Natrecor uses that are clearly not approved by the FDA. 

The Scios reimbursement guide, also available through a toll-free number, told doctors to use Medicare codes that treat Natrecor like chemotherapy allowing them to bill for lager Medicare reimbursements.

As a result, Medicare managers became concerned that reimbursements for Natrecor treatments in outpatient clinics would skyrocket as a result of the information that Scios has been giving to medical professionals.

In May 2005, Johnson & Johnson announced that in compliance with the FDA, it would revise the labeling for Natrecor to include data indicating an increased risk of mortality within 30 days for Natrecor patients compared with patients taking a placebo or other treatments. 

This was a good start but doctors and other medical professionals were still advocating further studies of Natrecor to determine the health risks associated with the drug.  Milton Packer, a cardiologist at the University of Texas, Southwestern, is concerned that Scios, like Vioxx maker Merck, has not done adequate studies to make sure that its drug is safe.  Although the FDA approved the drug in 2001, many doctors argue that today the vote might be closer and Natrecor would probably wind up with a tougher label.

Then, in May of this year, an independent expert panel, convened by Johnson & Johnson itself, recommended that Natrecor be restricted to severely ill hospitalized patients.  Most experts also agreed that a large-scale clinical trial is needed in order to determine the risks of Natrecor.   

Although a spokesperson for Scios argued that the company could not control how doctors prescribe the drug, Scios itself greatly contributed (or even created) the problem by affirmatively providing doctors with information on how to maximize their billing of Natrecor for off-label uses. 

Many experts consider it ethically irresponsible for a pharmaceutical company to promote an off-label (and potentially harmful) use of a medication for no other apparent reason than financial gain.

Such questionable conduct could have caused significant problems for Scios and Johnson & Johnson if the drug does prove to be as dangerous as it appears to be and it continued to be prescribed in outpatient settings as opposed to hospital situations where it is a life-or-death situation. 

In June, the panel of cardiologists convened by Johnson & Johnson and headed by the highly respected heart researcher, Harvard’s Dr. Eugene Braunwald, recommended strict limitations on Natrecor, including not using it for scheduled “tune-ups” or even administering it outside the hospital.

The panel specifically recommended that Natrecor only be used in cases of an acute type of heart failure when the patient actually shows up at the hospital; that it should not be used in place of diuretics, the first-line treatment for heart failure; and never used for outpatients, scheduled appointments, or to improve kidney function. 

Furthermore, the panel believed that: “Scios should immediately undertake a proactive educational program to inform physicians regarding the conditions and circumstances in which [Natrecor] should and should not be used.”

A member of the panel, Barry Massie (professor of medicine at University of California in San Francisco) also expressed disapproval of the manner in which doctors flagrantly engage in the off-label prescribing of drugs. He believes it is important for doctors to take responsibility for their actions and only prescribe drugs for their approved uses. “It shouldn’t all be blamed on the pharmaceutical companies, no matter what they do to encourage unproven indications.”

On July 20, Johnson & Johnson acknowledged it had received a subpoena from the United States Attorney’s office in Boston requesting documents related to the sales and marketing of Natrecor.

As a result of this virtual tidal wave of disapproval concerning the questionable tactics associated with the marketing of Natrecor, Johnson & Johnson added a clear disclaimer to its hotline used by doctors seeking information on how to charge Medicare and insurance carriers for the drug. The disclaimer clearly seeks to discourage the heretofore rampant off-label use of Natrecor. 

The disclaimer warns of the “lack of clinical data” regarding off-label use of the drug and that Scios “does not recommend Natrecor for this use.” Johnson & Johnson now plans to follow up on the panel’s suggestions.

Fortunately, in the case of Natrecor, the often ineffective checks and balances in the healthcare system finally worked to forever deprive Natrecor of the blockbuster status its manufacturers had so desperately attempted to achieve.

Unsubstantiated online marketing claims by Emerson Direct Inc. about their anti-smoking product, Smoke Away, have lead to a $1.3 million settlement between the Florida company and the Federal Trade Commission (FTC).

The FTC complaint against Emerson Direct, Inc. (doing business as the Council on Natural Health) of Naples, Florida, and its owner Michael J. Connors charged that the company could not support claims that the product made quitting smoking easy and did so without cravings or side effects.

The FTC also alleged the credentials of doctors were misused and that one chiropractor did not have the expertise he was claimed to have.

Also implicated in the complaint were Thomas De Blasio, M.D., a physician from Manalapan, New Jersey, and Sherry Bresnahan, D.C., a chiropractor from Algonquin, Illinois, who were involved in advertisements endorsing the product.

The FTC disputed a number of statements made about Smoke Away in a variety of advertisements including a national television infomercial, 60- and 120-second national television ads, 60-second radio spots, and on Web sites.

The company claimed Smoke Away enables smokers: to quit smoking in seven days or less; to quit smoking quickly, effortlessly, and permanently; to eliminate nicotine cravings; and that the product caused no withdrawal symptoms or side-effects such as weight gain, insomnia, or tension.

Claims were also made that Smoke Away is more effective than nicotine patches, nicotine gum, and prescription medications for smoking cessation.

The FTC charged that these claims were false or unsubstantiated and that Connors also misrepresented the company’s policy of giving prompt refunds to dissatisfied consumers.

In addition to the significant settlement, the company is prohibited from making any claims about the benefits, performance, efficacy, safety, or side-effects of Smoke Away or any other smoking cessation product or program unless those claims are true, non-misleading, and substantiated.  Distributors and sales agents must also be notified about the settlement.

Likewise, the defendants are prohibited from making any claims about the benefits, performance, or efficacy of any food, drug, or dietary supplement unless those claims are backed by scientific evidence. Doctor’s claiming to be experts must have actually tested the product.