We totally disagreed with Pensar Medical legal reasoning in not requiring a FDA 510K clearance on a npwt foam dressing kit. We are very familiar with the guidance document example Exhibit A.(see document link). This letter addresses 3 changes; foam from gauze, wound inlet flange and extension of a tube. The later 2 have flowchart responses to that were created internally by Pensar to lead them to a decision not to submit. However, there is no flowchart response on the changing of gauze to foam, which raises a red flag considering they are two different materials, new colorants(leachables) that unless tested, possesses a possible over all molecular structure change when sterilized, that which can pose a huge risk. Currently right now the FDA has only identified 2 medical devices that have an approved list of colorants; contact lenses and surgical sutures. Anything outside these two, the FDA’s position on color additives is considered unsafe, and thereby adulterated, unless the color additive is proven to be safe via extensive testing and reporting to the FDA. No company internally can determine the safety of a component and or medical device. FDA 510K submission is mandatory for PENSAR Medical products.
|For Immediate Release
October 5, 2015
|United States Department of Justice
Southern District of California
SAN DIEGO – United States Attorney Laura E. Duffy announced today that David Arthur, the manufacturer of an unapproved medical device, was sentenced by United States District Judge Roger T. Benitez to serve 18 months in custody for his role in the distribution of the Energy Wave. The Energy Wave, a so-called Rife machine, consisted of a micro-current frequency generator with a digital readout and keypad, and two stainless steel cylinders and personal application plates with connections to ports on the generator. Users were provided with an operating manual and list of Auto Codes that set forth hundreds of digital device settings for treatment of specific medical conditions, including AIDS, diabetes, stroke, ulcer, and worm infection. Users were directed to punch in the digital code for the condition to be treated, and touch the cylinders or plates to the body for a recommended amount of time to treat the desired condition. Arthur sold hundreds of the Energy Wave devices, for $750 each, to individuals who distributed them via the internet, during the period from November, 2011, to March of 2014, earning $372,000.
Arthur had been previously warned by FDA agents in 2010 that the devices that he was manufacturing were not approved by the FDA and were therefore considered to be illegal medical devices which could not be marketed without FDA approval and his registration as a manufacturer. In 2010, Arthur had been manufacturing The Detox Box, another so-called Rife machine, being marketed by a company known as CNGI, Inc. In February of 2011, CNGI pled guilty to a felony for selling unapproved medical devices, and paid a penalty of $150,000. After the conviction of CNGI, Inc., Arthur stopped making the devices for a few months. Finding no lawful employment as lucrative, Arthur began manufacturing the device again in November of 2011, simply changing the name to The Energy Wave.
In addition to being sentenced to serve 18 months in custody, Arthur was also fined $3,000 and ordered to forfeit $30,000.
Arthur sold the device to David Perez, of Carlsbad, California, and Beth Campbell, of Salt Lake City, Utah, who marketed it via the internet. Both Perez and Campbell, charged in the related Criminal Case No. 15cr0360-BEN, have entered pleas of guilty in that case. Campbell is set to be sentenced on November 2, 2015, at 9:00 a.m., and Perez is scheduled to be sentenced on January 11, 2016, both before Judge Benitez.
U.S. Attorney Duffy stated that “This case demonstrates our commitment to protecting the sick and vulnerable from those who would prey upon them and offer expensive miracle cures which have not been proven to be safe and effective for use.”
Postal Inspector in Charge of the Los Angeles Division, Robert Wemyss stated, “This sentence sends a strong message that the U.S. Postal Inspection Service remains steadfast in protecting consumers against unscrupulous marketers of medical quackery. The American public can be assured that Postal Inspectors are committed to removing such potentially dangerous medical devices from the nation’s mail system.”
“This investigation uncovered a serious public health threat and should serve as a warning to those who put consumers at risk for their own financial gain,” said Dave Shaw, special agent in charge for HSI San Diego. “HSI agents will continue to work with our law enforcement partners, both here and abroad, to investigate medical-related fraud over the Internet, especially when it involves an online marketing scam, such as this case in which unregulated medical devices were sold under false pretense.”
Criminal Case No. 14cr2264-BEN
David Arthur Age: 50
Huntington Beach, California
SUMMARY OF CHARGES
Introduction into Interstate Commerce of Unapproved Medical Devices – Title 21, U.S.C., Sections 331(a), 333(a)(2) and 351(f)
Maximum penalty: Three years in prison and $250,000 fine
U.S. Food and Drug Administration, Office of Criminal Investigations; Postal Inspection Service; Homeland Security Investigations
<iframe width=”560″ height=”315″ src=”https://www.youtube.com/embed/KsPlwKbGxE8″ frameborder=”0″ allowfullscreen></iframe>
Rife Machine Operator Sued by Quackwatch
Stephen Barrett, M.D.
The Attorneys General of Wisconsin and Minnesota have sued to stop an unlicensed woman, Shelvie Rettmann, of Prior Lake, Minnesota, from representing that she can cure cancer.
In December 1997, Wisconsin Attorney General James Doyle announced that a Wisconsin resident who was diagnosed with advanced colon and liver cancer used Rettmann’s services after being told that she could cure the woman’s cancer . Although medical doctors had recommended chemotherapy, Rettmann had advised her otherwise.
At their first meeting, Rettmann allegedly photographed the woman and her daughter with a Polaroid camera and put the photos in a cup attached to a radionics machine. After telling the mother that she had colon and blood cancer and the daughter that she had breast cancer, Rettmann allegedly advised both to have treatments with a Rife Frequency Generator, a special diet, dietary supplements, a regimen of baths, and foot zoning (a type of foot massage claimed to break up accumulated deposits at the end of foot nerve endings in order to help heal the body).
Both women underwent multiple treatments. The mother paid Rettmann a total of $1,778.85, and the daughter paid $495.30. At their final meeting, Rettmann told the mother that she had been cured. Within a month, however, the mother experienced severe pain that caused her to see a physician. She was told that her cancer had progressed considerably and that the prognosis was hopeless. She died soon after that assessment. The daughter was subsequently examined by her personal physician and told that she did not have breast cancer.
Rettmann allegedly conducted seminars about her products in Ellsworth. Consumers who used her services were allegedly told that she had successfully treated as many as 1,000 patients.
According to Doyle, Rettmann told patients that the government did not want to cure cancer and did not understand what she was doing. She also allegedly provided her customers books and videotapes which claimed that there was a conspiracy to keep the Rife generator from being approved by the FDA and that the government was wrong at Waco and the Oklahoma City bombing. She had been selling the Rife device for about $3,500 and the radionics machine for $1,700. She also sold the nutritional supplements she recommended.
In September 1998, Minnesota Attorney General Hubert Humphrey III announced that his office had obtained a judgment against Rettmann . The Scott County District Court found that Rettmann had violated state laws prohibiting deceptive trade practices and consumer fraud by selling medical devices without FDA approval and telling consumers she could cure cancer with a “Rife generator” machine, a “radionics” device, “foot-zoning” treatments, and various vitamins and supplements. During a hearing, the FDA provided support and expert testimony confirming that the devices Rettmann sold were illegal.
The judge concluded: (a) Rettmann had sold over $7,000 worth of bogus medical devices, treatments and products to an Anoka, Minnesota, man with pancreatic and liver cancer; (b) Rettmann promised she could cure the consumer’s cancer faster if he stopped taking chemotherapy treatments; (c) relying on Rettmann’s promise, the man stopped chemotherapy after a single session and died four months later; and (d) Rettmann also violated Minnesota consumer laws by saying she was licensed to practice “foot zoning” (essentially foot massage) and she could cure cancer through “foot zoning” treatments. Minnesota does not license the practice of “foot zoning.” The judge prohibited Rettmann from providing health care services or products, ordered refunds upon request to injured consumers, and imposed civil penalties of $50,000 plus the state’s attorney fees and costs.
Rettmann filed for bankruptcy in July 1998. However, the court ruled that the State was still entitled to obtain a judgment. Consumers who paid Rettmann for health care services or products since June 25, 1991 should contact the Minnesota Attorney General’s Office by calling , or , TYY (651) 297-7206 or . Because Rettmann is in bankruptcy there is no assurance of refunds. However, contacting the Attorney General’s Office will preserve that possibility.
In 2001, the FDA warned Bioray, Inc., of Birmingham, Alabama, that it was illegal to sell the BioRay Light and Sound Generator as a diagnostic or therapeutic device . Some sellers of the device became more cautious about claims on the Internet, but the device is still marketed today.
Radionics is a pseudoscience based on the notion that diseases can be diagnosed and treated by tuning in on radio-like frequencies allegedly emitted by disease-causing agents and diseased organs. The theory behind it originated with Albert Abrams, M.D. (1864-1924), who developed thirteen devices claimed to detect such frequencies and/or cure people by matching their frequencies. Abrams made millions leasing his devices and was considered by the American Medical Association to be the “dean of gadget quacks.” He claimed:
- All parts of the body emit electrical impulses with different frequencies that vary with health and disease.
- Illnesses—as well as age, sex, religion, and location—could be diagnosed by “tuning in” on patient’s blood or handwriting samples with one of his devices.
- Diseases could be treated by feeding proper vibrations into the body with another of his devices.
During the 1950s, an FDA investigation showed that some of Abrams’s devices produced magnetism from circuits like that of an electric doorbell, whereas others had short-wave circuits resembling those of a taxicab transmitter . Similar devices have been produced by many others and are still marketed today.
One of Abrams’s many imitators was Royal Raymond Rife (1888-1971), an American who claimed that cancer was caused by bacteria. During the 1920s, he claimed to have developed a powerful microscope that could detect living microbes by the color of auras emitted by their vibratory rates. His Rife Frequency Generator allegedly generates radio waves with precisely the same frequency, causing the offending bacteria to shatter in the same manner as a crystal glass breaks in response to the voice of an opera singer. The American Cancer Society has pointed out that although sound waves can produce vibrations that break glass, radio waves at the power level emitted a Rife generator do not have sufficient energy to destroy bacteria .
The bottom line is that radionics devices have no value for diagnosing or treating anything.
Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
October 16, 2015
United States Department of Justice
Northern District of Indiana
HAMMOND – United States Attorney for the Northern District of Indiana, David Capp, announced that Vahan Kelerchian, 56, of Richboro, Pennsylvania, doing business as Armament Services International “ASI”, was found guilty of a multitude of charges relating to the acquisition of machineguns and restricted laser aiming sites, late Thursday evening after a two-week jury trial.
According to evidence presented at trial, Kelerchian conspired with Joseph Kumstar and Ronald Slusser, two now former Lake County Police Officers, to knowingly make false statements relating to the acquisition of firearms. Kumstar and Slusser, who have plead guilty, used their positions as sworn law enforcement officers in coordination with Kelerchian using his position as a Class 3 Federal Firearms Licensee to acquire approximately 71 fully automatic machineguns in the name of the Lake County Sheriff’s Department knowing that the Lake County Sheriff’s Department was not going to be the true owner of these weapons. Kelerchian, Kumstar and Slusser conspired to use law enforcement letter head to create letters which falsely represented that the machineguns were going to be used by the Lake County Sheriff’s Department to carry out its law enforcement responsibilities since machineguns manufactured after 1986 can only be acquired by law enforcement agencies and not individual officers. The machineguns were purchased for a cost of $1200 and $1600 and then when received by the Sheriff’s Department, transported offsite to be parted out. The barrels (also known as the “upper”) were split with the officers and some were sent back to Kelerchian. The “uppers” sold between $3000 and $3600 due to post-1986 parts not being available to the public because only law enforcement agencies or the military can acquire these weapons.
Kelerchian also used his company to assist Kumstar and Slusser to acquire 74 restricted laser aiming sights again using law enforcement letterhead from the Lake County Sheriff’s Department and the Lowell Police Department. These laser sights were restricted by the Food and Drug Administration because they were class 3b lasers. These lasers were designed, per a variance from FDA, to be used for law enforcement and military use only because they did not have the audible or manual safety locks as required for class 3b lasers. The laser aiming sights had a visible laser that could be seen in excess of 50 feet and an invisible laser that could be used for targeting with infrared goggles in excess of 1 mile. Kelerchian along with the officers used their positions to acquire these devices and sell them to the general public or keep the devices for themselves.
In addition to the charges above, Kelerchian was also found guilty of money laundering and false statements to the Bureau of Alcohol, Tobacco, Firearms and Explosives regarding false demonstration letters involving high powered belt-fed machine guns. Kelerchian was also charged with bribery but was found not guilty of that accusation.
This case is a result of an investigation by the Bureau of Alcohol, Tobacco, Firearms and Explosives; Department of Defense Criminal Investigative Services; Federal Bureau of Investigation; Food and Drug Administration, Office of Criminal Investigations; and the Internal Revenue Service, Criminal Investigation Division. This case was prosecuted by Assistant United States Attorneys Philip C. Benson and Thomas M. McGrath.
# # #
Pensar Medical Wound Pro Sting Ray NPWT Wound Dressing: Buyers Beware
Make Sure To Conduct Due Diligence on a Medicare PDAC and FDA 510K approval on Pensar Medical WoundPro Dressing Foam Kits.
Before doing business with Pensar Medical, make sure that Pensar Medical has the proper FDA 510K clearance to sell and market its WoundPro Dressing Kits. According to the FDA 510K Search Data Base, Pensar Medical DOES NOT have a FDA 510K clearance for its WoundPro Dressing kit.
Check the FDA 510K Search Data Base:
Call the FDA and Check :
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA1-888-INFO-FDA FREE (1-888-463-63321-888-463-6332 FREE)
Make sure to report this to the FDA immediately
Before doing business with Pensar Medical, make sure that Pensar Medical has the proper Medicare PDAC approval. According to the Noridian, Medicare Pricing Data Analysis and Coding office, Pensar Medical DOES NOT have Medicare PDAC approval for its WoundPro Dressing Kit.
Check the Noridian Search Data Base:
Call Noridian and Check:
PO Box 6757
Fargo ND 58108-6757
877.735.1326877.735.1326 FREE Toll Free
Email a compliant to Noridian immediately:
Proprietary Name: Alaira; Apex Wound Pro
Classification Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
Product Code: OMP
Device Class: 2
Regulation Number: 878.4780
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: Pensar Medical, LLC
Registered Establishment Number: 3007793449
Premarket Submission Number: K100823
Owner/Operator: Pensar Medical
Owner/Operator Number: 10043309
Manufacturer; Remanufacturer; Specification Developer; U.S. Manufacturer of Export Only Devices
|Proprietary Name:||Alaira; Apex Wound Pro, Pensar Wound Pro|
|Classification Name:||NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP|
|Medical Specialty:||General & Plastic Surgery|
|Registered Establishment Name:||Pensar Medical, LLC|
|Registered Establishment Number:||3007793449|
|Premarket Submission Number:||K100823|
|Establishment Operations:||Manufacturer; Remanufacturer; Specification Developer; U.S. Manufacturer of Export Only Devices|
Health fraud is the deceptive sale or advertising of products that claim to be effective against medical conditions or otherwise beneficial to health, but which have not been proven safe and effective for those purposes.
In addition to wasting billions of consumers’ dollars each year, health scams can lead patients to delay proper treatment and cause serious—and even fatal—injuries.
Since the 1990s, peddlers of fraudulent “health” products have used the Internet as a primary tool to hawk their wares. This has kept the U.S. Food and Drug Administration (FDA) and other agencies busier than ever in protecting the public from health fraud.
Since June 2008, FDA has warned consumers not to use bogus cancer-treatment products marketed online by 28 U.S. companies. These products include tablets, teas, tonics, salves, and creams sold under more than 180 different brand names.
And since December 2008, FDA has warned about more than 70 weight loss products containing unapproved pharmaceutical ingredients and chemicals not listed on the labels. Some of these ingredients present serious health risks when taken in dosages recommended on the product label.
Common Types of Health Fraud
Cancer fraud: Among the many long-running cancer scams is the Hoxsey Cancer Treatment, an herbal regimen that has no proven benefit. Another scam involves products called black salves. These are offered with the false promise of drawing cancer out from the skin, but they are potentially corrosive to tissues.
Cancer requires individualized treatment by a specialized physician. No single device, remedy, or treatment can treat all types of cancer.
Patients looking to try an experimental cancer treatment should enroll in a legitimate clinical study. For more information, visit the National Cancer Institute Clinical Trials Web site.
HIV/AIDS fraud: There are legitimate treatments that can help people with the human immunodeficiency virus (HIV). While early treatment of HIV can delay progression to AIDS, there is currently no cure for the disease.
Relying on unproven products and treatments can be dangerous and cause delays in seeking legitimate medical treatments that have been proven in clinical trials to improve quality of life.
Safe, reliable testing to determine whether you have HIV can be done by a medical professional.
To date, there is one FDA-approved testing system that allows individuals to test themselves at home. It is an HIV collection system that tests only for HIV-1, which is the cause of the majority of the world’s HIV infections.
The test, sold either as The Home Access HIV-1 Test System or The Home Access Express HIV-1 Test System, allows blood samples to be sent to a laboratory for testing with an FDA approved HIV-1 test.
Arthritis fraud: The U.S. Federal Trade Commission says consumers spend about $2 billion annually on unproven arthritis remedies that are not backed by adequate science.
For current, accurate information on arthritis treatments and alternative therapies, visit the Arthritis Foundation Web site.
Fraudulent “diagnostic” tests: Doctors often use in vitro diagnostic (IVD) tests—in tandem with a physical examination and a medical history—to get a picture of a patient’s overall health.
These tests involve blood, urine, or other specimen samples taken from the body. They help diagnose or measure many conditions, including pregnancy, hepatitis, fertility, HIV, cholesterol, and blood sugar.
It’s rare that the use of only one of these tests can provide a meaningful diagnosis. You can buy IVD tests in stores, through the mail, or online. Many of these tests are regulated by FDA and sold legally. However, many others are marketed illegally and do not meet FDA’s regulatory requirements. These tests may not work or may be harmful.
To find out whether FDA has cleared or approved an IVD test for a particular purpose, call FDA at (888) 463-6332, or your local FDA district office.
Bogus dietary supplements: The array of dietary supplements—including vitamins and minerals, amino acids, enzymes, herbs, animal extracts and others—has grown tremendously.
Although the benefits of some of these have been documented, the advantages of others are unproven. For example, claims that a supplement allows you to eat all you want and lose weight effortlessly are false.
Claims to treat diseases cause products to be considered drugs. Firms wanting to make such claims legally must follow FDA’s premarket New Drug Approval process to show that the products are safe and effective.
Weight loss fraud: Since 2003, FDA has worked with national and international partners to take hundreds of compliance actions against companies pushing bogus and misleading weight loss schemes.
FDA has recently enhanced efforts to stop sales and importation of—and to warn consumers about—weight loss products that contain dangerous prescription drug ingredients that are not listed on the label.
Sexual enhancement product fraud: FDA has warned consumers about numerous illegal drugs promoted and sold online for treating erectile dysfunction and for enhancing sexual performance.
Although they are marketed as “dietary supplements,” these products are really illegal drugs that contain potentially harmful ingredients that are not listed on the label.
Diabetes fraud: FDA has taken numerous compliance actions against sales of fraudulent diabetes “treatments” promoted with bogus claims such as
- “drop your blood sugar 50 points in 30 days”
- “eliminate insulin resistance”
- “prevent the development of type 2 diabetes”
- “reduce or eliminate the need for diabetes drugs or insulin”
Influenza (flu) scams: Federal agencies have come across contaminated, counterfeit, and subpotent influenza products.
FDA, with U.S. Customs and Border Protection, has intercepted products claimed to be generic versions of the influenza drug Tamiflu, but which actually contained vitamin C and other substances not shown to be effective in treating or preventing influenza.
Don’t Be a Victim
It’s ultimately up to the buyer to beware of potential health fraud. Know of the potential for health fraud and learn about the common techniques and gimmicks that fraudulent marketers use to gain your attention and trust.
For instance, testimonials from people who say they have used the product may sound convincing, but these can easily be made up. These “testimonials” are not a substitute for scientific proof.
Also, never diagnose or treat yourself with questionable products. Always check with your health care professional before using new medical products.
Be wary of these red flags:
- claims that a product is a quick, effective cure-all or a diagnostic tool for a wide variety of ailments
- suggestions that a product can treat or cure diseases
- promotions using words such as “scientific breakthrough,” “miraculous cure,” “secret ingredient,” and “ancient remedy”
- text with impressive-sounding terms such as: “hunger stimulation point” and “thermogenesis” for a weight loss product
- undocumented case histories by consumers or doctors claiming amazing results
- limited availability and advance payment requirements
- promises of no-risk, money-back guarantees
- promises of an “easy” fix
- claims that the product is “natural” or “non-toxic” (which doesn’t necessarily mean safe)
Don’t be fooled by professional-looking Web sites. Avoid Web sites that fail to list the company’s name, physical address, phone number, or other contact information. For more tips for online buying, visit Buying Medicines and Medical Products Online.
If you find a person or company that you think is illegally selling human drugs, animal drugs, medical devices, biological products, foods, dietary supplements, or cosmetics, report it to FDA.
To report problems with FDA-regulated products, call your local FDA Consumer Complaint Coordinator.
To report unlawful sales of medical products on the Internet, visit Reporting Unlawful Sales on Internet.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
6 Tip-offs to Rip-offs: Don’t Fall for Health Fraud Scams
Bogus product! Danger! Health fraud alert!
You’ll never see these warnings on health products, but that’s what you ought to be thinking when you see claims like “miracle cure,” “revolutionary scientific breakthrough,” or “alternative to drugs or surgery.”
Health fraud scams have been around for hundreds of years. The snake oil salesmen of old have morphed into the deceptive, high-tech marketers of today. They prey on people’s desires for easy solutions to difficult health problems—from losing weight to curing serious diseases like cancer.
According to the Food and Drug Administration (FDA), a health product is fraudulent if it is deceptively promoted as being effective against a disease or health condition but has not been scientifically proven safe and effective for that purpose.
Scammers promote their products through newspapers, magazines, TV infomercials and cyberspace. You can find health fraud scams in retail stores and on countless websites, in popup ads and spam, and on social media sites like Facebook and Twitter.
Health fraud scams can do more than waste your money. They can cause serious injury or even death, says Gary Coody, R.Ph., FDA’s national health fraud coordinator. “Using unproven treatments can delay getting a potentially life-saving diagnosis and medication that actually works. Also, fraudulent products sometimes contain hidden drug ingredients that can be harmful when unknowingly taken by consumers.”
Coody says fraudulent products often make claims related to:
- weight loss
- sexual performance
- memory loss
- serious diseases such as cancer, diabetes, heart disease, arthritis and Alzheimer’s.
Fraudulent products not only won’t work—they could cause serious injury. In the past few years, FDA laboratories have found more than 100 weight-loss products, illegally marketed as dietary supplements, that contained sibutramine, the active ingredient in the prescription weight-loss drug Meridia. In 2010, Meridia was withdrawn from the U.S. market after studies showed that it was associated with an increased risk of heart attack and stroke.
Fraudulent products marketed as drugs or dietary supplements are not the only health scams on the market. FDA found a fraudulent and expensive light therapy device with cure-all claims to treat fungal meningitis, Alzheimer’s, skin cancer, concussions and many other unrelated diseases. Generally, making health claims about a medical device without FDA clearance or approval of the device is illegal.
“Health fraud is a pervasive problem,” says Coody, “especially when scammers sell online. It’s difficult to track down the responsible parties. When we do find them and tell them their products are illegal, some will shut down their website. Unfortunately, however, these same products may reappear later on a different website, and sometimes may reappear with a different name.”
FDA offers some tip-offs to help you identify rip-offs.
- One product does it all. Be suspicious of products that claim to cure a wide range of diseases. A New York firm claimed its products marketed as dietary supplements could treat or cure senile dementia, brain atrophy, atherosclerosis, kidney dysfunction, gangrene, depression, osteoarthritis, dysuria, and lung, cervical and prostate cancer. In October 2012, at FDA’s request, U.S. marshals seized these products.
- Personal testimonials. Success stories, such as, “It cured my diabetes” or “My tumors are gone,” are easy to make up and are not a substitute for scientific evidence.
- Quick fixes. Few diseases or conditions can be treated quickly, even with legitimate products. Beware of language such as, “Lose 30 pounds in 30 days” or “eliminates skin cancer in days.”
- “All natural.” Some plants found in nature (such as poisonous mushrooms) can kill when consumed. Moreover, FDA has found numerous products promoted as “all natural” but that contain hidden and dangerously high doses of prescription drug ingredients or even untested active artificial ingredients.
- “Miracle cure.” Alarms should go off when you see this claim or others like it such as, “new discovery,” “scientific breakthrough” or “secret ingredient.” If a real cure for a serious disease were discovered, it would be widely reported through the media and prescribed by health professionals—not buried in print ads, TV infomercials or on Internet sites.
- Conspiracy theories. Claims like “The pharmaceutical industry and the government are working together to hide information about a miracle cure” are always untrue and unfounded. These statements are used to distract consumers from the obvious, common-sense questions about the so-called miracle cure.
Even with these tips, fraudulent health products are not always easy to spot. If you’re tempted to buy an unproven product or one with questionable claims, check with your doctor or other health care professional first.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
- Consumers can subscribe to the FDA RSS feed that will send information on fraudulent products to your smart phone or computer and help you from being duped or hurt by these products.
- To report a health product that you suspect is fraudulent, call your local FDA Consumer Complaint Coordinator.
September 15, 2015: Rhode Island Businessman Pleads Guilty to Marketing and Selling Unapproved Remedies for Cancer Mitigation and Treatment, Tax Evasion
PROVIDENCE, R.I. – James Feijo, 68, owner and operator of Daniel Chapter One, a Portsmouth, R.I., based company, pleaded guilty in federal court in Providence to marketing and selling products not approved by the U.S. Food and Drug Administration (FDA) as cancer mitigation and treatment options, and failing to pay more than $218,000 in employment taxes due the IRS, announced United States Attorney Peter F. Neronha, Michael Mangiacotti, Resident Agent in Charge of the FDA Office of Criminal Investigations, and William P. Offord, Special Agent in Charge of IRS Criminal Investigation.
Appearing before U.S. District Court Judge John J. McConnell, Jr., Feijo pleaded guilty to one count of introduction of a new unapproved drug and one count of tax evasion.
At the time of his guilty plea, Feijo admitted to the court that he engaged in the marketing, sale and distribution of unapproved health products and supplements, 7 Herb Formula, Bio Shark and GDU, which were not generally recognized as safe and effective for use by the FDA. Additionally, the products, as marketed, were not generally recognized as safe and effective by qualified experts for the cure, mitigation, treatment, or prevention of cancer. The products were marketed and sold through various websites, in-store advertisements, a call center, on the Feijos’ daily radio program, and through the use of promotional materials and publications.
In addition, at the time of his guilty plea, Feijo admitted to the court that from 2006 through 2011, he falsely represented to Daniel Chapter One employees that they were independent contractors, when in truth they were employees of Daniel Chapter One. During that time, Feijo failed to issue IRS Wage and Tax Statements, Forms W-2, accounting for employees’ wages and taxes withheld. Feijo admitted that through 2011, Daniel Chapter One employees were paid by checks written out to cash, and that for at least sixteen quarters he failed to collect, account for and pay over employment taxes due the IRS totaling $218,408.04.
Feijo is scheduled to be sentenced by U.S. District Court Judge John J. McConnell, Jr., on January 12, 2016.
The case is being prosecuted by Assistant U.S. Attorney Terrence P. Donnelly.
The matter was investigated by the Rhode Island FDA Task Force and by IRS Criminal Investigation.
FDA Criminal Investigation
September 9, 2015: Owner Of Dietary Supplement Company Sentenced To 40 Months In Prison For Multimillion-Dollar Scheme To Adulterate Dietary Supplements
EWARK, N.J. – The owner and president of a dietary supplement manufacturing company in Flanders, New Jersey, was sentenced today to 40 months in prison for directing the sale of diluted and adulterated dietary ingredients and supplements sold by his company, U.S. Attorney Paul J. Fishman announced.
Barry Steinlight, 70, of Hackettstown, New Jersey, previously pleaded guilty before U.S. District Judge Esther Salas to a one-count information charging him with conspiring to commit wire fraud. Judge Salas imposed the sentence today in Newark federal court.
“Consumers expect labels that accurately describe the products they ingest,” U.S. Attorney Fishman said. “Steinlight deceived his customers as part of a four-year scheme in which he delivered bogus, mislabeled products. Today he was appropriately punished for his crime.”
“The Justice Department has increased its attention on supplement sellers like Barry Steinlight who sell products that are not what they claim to be,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “We will investigate and prosecute companies and individuals that sell supplements that threaten the health of the American public and drain their bank accounts with misrepresented products.”
“Today’s announcement demonstrates that those who sell adulterated dietary supplements and purposely subvert the regulatory functions of the FDA by providing false and misleading information will be held accountable for their actions,” stated Jeffrey J. Ebersole, Acting Special Agent in Charge, FDA Office of Criminal Investigations’ New York Field Office. “We commend the efforts of the Department of Justice for vigorously pursuing the prosecution of this matter.”
According to documents filed in this case and statements made in court:
Steinlight was the president and owner of Raw Deal Inc., a dietary supplement manufacturing facility. From at least 2009 through November 2013, Steinlight instructed Raw Deal employees to add “fillers,” including maltodextrin, viobin cocoa replacer and rice flours to the dietary ingredients and supplements packaged for, and sold to, Raw Deal’s customers. These “fillers” were added without customer consent or knowledge. Steinlight also directed Raw Deal employees not to list the “fillers” as ingredients on the certificates of analysis (COAs) issued to its customers as proof of the identity of the ingredients contained in the products.
In addition to directing the dilution and adulteration of Raw Deal’s products, Steinlight also directed Raw Deal employees to create COAs that falsely certified that certain of Raw Deal’s products were kosher or organic. Also, during an FDA inspection of Raw Deal in February 2012, Steinlight instructed employees to alter a document before providing it to the FDA.
Raw Deal’s executive vice president, Catherine Palmer, 38, of Budd Lake, New Jersey, admitted that during the 2012 FDA inspection, she ordered a subordinate to falsify an ingredient list of a dietary supplement product before submitting it to the FDA. In addition, she admitted instructing a Raw Deal employee not to run blenders during the 2012 inspection so that the FDA would not see “fillers” being added to customer orders.
In addition to the prison term, Judge Salas sentenced Steinlight to one year of supervised release. During his plea hearing, Steinlight admitted that Raw Deal’s gross profits during the scheme were between $7 million and $20 million. As part of his plea agreement, Steinlight must forfeit $1,036,834 in profits from the scheme.
Palmer pleaded guilty yesterday to a one-count information charging her with obstructing an FDA investigation. The obstruction charge carries a maximum potential sentence of five years in prison and a $250,000 fine, or twice the gain or loss caused by the offense. Her sentencing is scheduled for Dec. 21, 2015.
The government is represented by Assistant U.S. Attorney Joseph Mack, Deputy Chief of the U.S. Attorney’s Office’s Health Care and Government Fraud Unit, Special Assistant U.S. Attorney Shannon M. Singleton from the FDA’s Office of Chief Counsel, and Trial Attorneys Patrick Runkle and David Sullivan of the Civil Division’s Consumer Protection Branch.
U.S. Attorney Fishman reorganized the health care fraud practice at the U.S. Attorney’s Office for the District of New Jersey shortly after taking office, including creating a stand-alone Health Care and Government Fraud Unit to handle both criminal and civil investigations and prosecutions of health care fraud offenses. Since 2010, the office has recovered more than $635 million in health care fraud and government fraud settlements, judgments, fines, restitution and forfeiture under the False Claims Act, the Food, Drug, and Cosmetic Act and other statutes.
Health fraud scams refer to products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective for those uses.
Health fraud scams waste money and can lead to delays in getting proper diagnosis and treatment.They can also cause serious or even fatal injuries.
Watch this video to learn more.
CDC, FDA urge providers to adhere to device sanitation protocols
The CDC and FDA are urging health care facilities and providers to review cleaning, disinfecting and sterilizing protocols for reusable medical devices after recent media accounts reported that patients may have been exposed to infection due to lapses in basic sanitation practices.
According to the CDC’s health advisory, nonadherence to cleaning procedures involved failure to follow reprocessing instructions for medical devices, such as surgical instruments and endoscopes, provided by manufactures.
“Recent infection control lapses due to noncompliance with recommended reprocessing procedures highlight a critical gap in patient safety,” the advisory said. “Health care facilities should arrange for a health care professional with expertise in device reprocessing to immediately assess their reprocessing procedures. This assessment should ensure that reprocessing is done correctly, including allowing enough time for reprocessing personnel to follow all steps recommended by the device manufacturer.”
The CDC and FDA recommend that health care facilities:
- train all new staff members who reprocess medical devices and provide follow-up training at least once a year and when new devices or instructions are introduced;
- require staff members to demonstrate competency in device cleaning before reprocessing devices on their own;
- maintain current documentation of trainings and reprocessing activities, including maintenance records for reprocessing equipment, sterilization records, and records confirming disinfectants were tested and properly replaced;
- verify that any hired contractor has an appropriate training program;
- have copies of manufacturers’ instructions readily available to staff and inspectors;
- regularly monitor adherence to cleaning, disinfection, sterilization and device storage procedures in all areas where reprocessing is conducted, including prompt cleaning before disinfection or sterilization procedures, disinfecting devices in accordance with manufacturers’ instructions and monitoring sterilizer and endoscope reprocessor performance;
- provide feedback to staff regarding their competency in sterilization procedures;
- allow adequate time for reprocessing to ensure all steps recommended by the devices’ manufacturers have been followed;
- consider scheduling procedures to ensure there is enough time for reprocessing;
- train health care personnel to be able to readily identify properly reprocessed devices that are ready for patient use;
- outline policies and procedures to identify, notify and follow patients in the event of a reprocessing error or failure; and
- follow manufacturer recommendations for maintenance and repair of medical devices.