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Tag: FDA

  • 4 Charged Amid Allegations ‘Industrial Bleach’ Was Sold On Internet As ‘Miracle Cure’ For Flu, Arthritis And Cancer; Web Chatter References Pro Advocate Group, Same Enterprise Linked To Bizarre Claims In AdSurfDaily Saga

    A YouTube video apparently in support of “Project GreenLife” superimposes an image of FDA Commissioner Dr. Margaret Hamburg against the backdrop of a height chart -- an apparent bid to suggest that Hamburg should be booked at a police station.
    A YouTube video apparently in support of “Project GreenLife” superimposes an image of FDA Commissioner Dr. Margaret Hamburg against the backdrop of a height chart — an apparent bid to suggest that Hamburg should be booked at a police station.

    The PP Blog first told you about “Miracle Mineral Supplement,” also known as “Miracle Mineral Solution” or MMS, in August 2010. The FDA warned that serious harm could come to human beings who consumed it, saying MMS produced industrial bleach when used as directed.

    “Multiple independent distributors” sold the product online, the FDA said.

    Now, the U.S. Department of Justice has announced that four people — two from Oregon and two from Washington state — have been charged criminally.

    Named defendants were Louis Daniel Smith, 42, and Karis Delong, 38, both of Ashland, Ore. Also charged were Chris Olson, 49, and Tammy Olson, 50, of Nine Mile Falls, Wash.

    “Our most vulnerable citizens need real medicine — not dangerous chemicals peddled by modern-day snake oil salesmen,” said Stuart F. Delery, principal deputy assistant Attorney General for the Justice Department’s Civil Division.

    Smith and Delong operated a business known as “Project GreenLife” or PGL, the Justice Department said.

    A dissolved Nevada corporation known as PGL International LLC lists “Daniel Smith” as its managing member. A website styled ProjectGreenLife.com now appears to be parked at GoDaddy. Meanwhile, there are references online to ProjectGreenLife purportedly having been a “1st and 14th Amendment Private Membership Association.”

    At least one website that makes the claim makes a companion claim that Daniel Smith used “the help and counsel of the ProAdvocate Group” when contacting the FDA about MMS-related matters. “Daniel based his inquiry on a good-faith understanding of U.S. Supreme Court case law as it pertained to the activities of a private association,” the site claims. “Daniel told the FDA unless they objected within ten days he would assume they had no objection.”

    Pro Advocate Group reportedly was the Texas-based entity that assisted the AdViewGlobal HYIP scam form a “private association” in 2009 in which AVG appears to have tried to insulate itself from examination by the U.S. government by purporting to operate from Uruguay. In April 2012, federal prosecutors in the District of Columbia linked AVG to the $119 million Ponzi scheme operated by Andy Bowdoin of AdSurfDaily.

    Along with hawking purported private associations, Pro Advocate Group claims on its website that it offers “Pro Se Litigation with Super Appeal” and other services.

    A Justice Department news release yesterday on the charges flowing from Project GreenLife and the sale of MMS did not reference Pro Advocate Group.

    Smith, Delong and Tammy Olson were charged with one count of conspiracy, four counts of interstate sales of misbranded drugs and one count of smuggling. Chris Olson was charged with one count of conspiracy, one count of the interstate sale of a misbranded drug and one count of smuggling.

    The Justice Department said that “PGL provided consumers directions to combine MMS with citric acid to create Chlorine Dioxide, and the instructions told consumers to drink this mixture to cure numerous illnesses. Chlorine Dioxide is a potent agent used to bleach textiles, among other industrial applications. In humans, Chlorine Dioxide is a severe respiratory and eye irritant that can cause nausea, diarrhea and dehydration.”

    Research by the PP Blog shows that Daniel Smith apparently has supporters who’ve issued an appeal to “Please take a stand to help save MMS and Daniel Smith from the FDA.” A headline for video on the site describes the FDA as a “Cult of Tryanny.” A narrator describes the FDA as a “rogue agency” and superimposes the images of FDA Commissioner Margaret A. Hamburg and others against the backdrop of a height chart. It appears to be a ham-handed way to suggest that Hamburg and the other purported “rogues” should be booked at a police station.

    From the Justice Department statement (italics added):

    As part of the scheme to manufacture MMS, the indictment alleges that Smith, Delong, and others smuggled sodium chlorite into the United States from Canada using fraudulent invoices to hide the true end use of the product.   In these invoices, according to the indictment, they falsely claimed that the ingredients they were purchasing for MMS were to be used in wastewater treatment facilities.

    According to the charging documents, Smith and Delong were the managing members of PGL Smith co-founded the company, and Delong frequently handled financial transactions for the company and recruited friends and family to participate in the business. The indictment alleges that Smith and Delong paid Tammy Olson to handle all customer inquiries regarding the product.   It is alleged that Tammy Olson continued selling MMS on her own website after federal agents shut down the Project GreenLife website and production facilities.  

     The indictment also alleges that Smith and Delong paid Chris Olson to clandestinely manufacture MMS in a building on his property after regulators from the Food and Drug Administration (FDA) inspected PGL’s original manufacture and shipping locations.

  • URGENT >> BULLETIN >> MOVING: FDA Chemist Cheng Yi Liang Pleads Guilty In Insider Trading Case; ‘Shocking Abuse Of Trust,’ Feds Say Of Schemer’s Plot To Use Database To Harvest Illegal Profits

    >> BULLETIN >> MOVING: Cheng Yi Liang, the FDA chemist accused in March of mining the agency’s database for drug approvals or denials and using the information to make insider trades, has pleaded guilty to securities fraud and failing to disclose illicit profits.

    Liang, 57, of Gaithersburg, Md., faces a maximum term of 25 years in federal prison. Sentencing is scheduled for Jan. 9. The case was one that embarrassed the FDA and its employees, but one that exposed the corruption of a federal worker who used the tools of government to line his own pockets.

    The SEC simultaneously charged Liang civilly in March, opening up a second litigation front.

    As part of a plea agreement in the Feds’ criminal case, Liang will forfeit $3.7 million, a home and condominium in Maryland and funds  in 10 bank or investment accounts, federal prosecutors said.

    The FDA is a branch of the U.S. Department of Health and Human Services (HHS).

    “Profiting based on sensitive, insider information is not only illegal, but taints the image of thousands of hard-working government employees,” said Elton Malone,  special agent in charge of the HHS-Office of Inspector General Special Investigations Branch.  “We will continue to insist that federal government employee conduct be held to the highest of standards.”

    “Mr. Liang used inside information about pharmaceutical companies — information he had access to solely because of his position at the FDA — to pocket millions in illicit profits,” said Assistant Attorney General Lanny Breuer. “In a shocking abuse of trust, Mr. Liang exploited his position as a chemist in the FDA’s Office of New Drug Quality Assessment to cash in, using the accounts of relatives and acquaintances to hide his illegal trading.  Now, like many others on Wall Street and elsewhere, he is facing the significant consequences of trading stocks on inside information.”

    Breuer is head of the Justice Department’s Criminal Division.

    While employed at FDA, Liang “was required to file a Confidential Financial Disclosure form disclosing, among other things, investment assets with a value greater than $1,000 and sources of income greater than $200.,” investigators said. “During the time period of his insider trading scheme, Liang annually filed these forms and failed to disclose using the controlled accounts or his income from the illicit securities trading.”

    The FBI participated in the criminal probe.

    “Those who use privileged and valuable information for personal gain, break the trust placed in them as a government employee and the integrity of the research they conduct on behalf of the U.S. government,” said James W. McJunkin, assistant director in charge of the agency’s Washington Field Office.

  • TV, Web Pitchman Donald Lapre Arraigned In ‘Medical Facility’ After Arrest By Federal Agents; Accused Huckster Recovering From ‘Self-Inflicted’ Wounds To Legs After Missing Court Date

    Donald Lapre. From vitamin promo.

    He called it “The Greatest Vitamin in the World.” Federal prosecutors in Arizona, however, called it conspiracy, mail fraud, wire fraud, promotional money-laundering and transactional money-laundering, accusing Donald Lapre of selling “essentially worthless” Internet businesses to more than 226,000 victims.

    And now Lapre, 47, is under arrest. Prosecutors said he skipped a June 22 court date, a decision that caused an arrest warrant to be issued, a “Wanted” poster to be created and a brief manhunt to ensue.

    Lapre was arrested on June 23. Prosecutors, who earlier advised the public that Lapre may be suicidal, said he was found with “self-inflicted” wounds to his legs and taken to a hospital. He was arraigned inside a “medical facility” by a federal magistrate judge yesterday.

    Tens and tens of thousands of Lapre’s customers were defrauded out of nearly $52 million after responding to his TV and web pitches, prosecutors said.

    Customers lured by the prospect of receiving “$1,000 checks” were dubbed “independent advertisers,” but Lapre provided them “false vitamin sales records” and sold them “bulk,” untargeted web traffic while claiming the traffic was targeted, prosecutors said.

    “The ‘business’ primarily consisted of selling the Greatest Vitamin in the World . . . over the Internet and the opportunity to sell the opportunity to do the same thing to others,” prosecutors said.

    Sales reps “regularly” signed up “independent advertisers” even if they did not own a computer, prosecutors said.

    “Mr. Lapre used incessant nationally televised infomercials to hawk his vitamins and worthless websites as a way to get rich quick without working hard,” said U.S. Attorney Dennis K. Burke of the District of Arizona. “His scams swindled a sea of victims, but thanks to the efforts of the [U.S.] Postal Inspection Service and the IRS, he will face justice.”

    Lapre was charged in a 41-count indictment issued by a federal grand jury earlier this month. He potentially faces decades in prison, if convicted on all counts.

    Fox 10 News in Phoenix reported that Lapre hid from authorities in a 24-hour gym.

    Read a 2005 enforcement letter from the FDA to Lapre.

    Marshals: Wanted Man Camped Out Inside Gym: MyFoxPHOENIX.com

  • FEDS: Man Ran Theft Scheme From FTC Headquarters, Stealing More Than $218,000 From Consumer Watchdog Agency; Harold Hughes Faces Up To 10 Years In Prison After Guilty Plea

    Two weeks after an employee of the U.S. Food and Drug Administration was accused of stealing confidential information from a government database to profit from illicit stock trades, another government employee accused in a separate case of taking advantage of his position to commit a crime has pleaded guilty.

    Harold Hughes, 58, of Arlington, Va., was a supply clerk for the Federal Trade Commission. In April 2009, just two months after he began his stint as an FTC clerk, Hughes “began using FTC money to make unauthorized purchases,” federal prosecutors said.

    By the time the scheme was discovered, Hughes had used FTC money to acquire computers, TVs and DVD players illicitly, eventually draining $218,636 from the agency’s coffers, prosecutors said.

    Part of his gambit, prosecutors said, was to order the items and then sell them for cash at a discount.

    Some of the items were delivered to FTC headquarters, and Hughes “used his proximity to the mailroom and his familiarity with its employees to avoid detection,” prosecutors said.

    In some cases, he removed the illicitly purchased items from the FTC building and shipped “other items via Federal Express using FTC funds,” prosecutors said.

    “As the scheme continued, Hughes arranged for items to be shipped directly to his residence in Virginia and to the residences of people to whom he had arranged to sell the items,” prosecutors said.

    Prosecutors did not say who his customers were.

    The FTC discovered the thefts in December 2010, about 22 months after Hughes became an agency shipping clerk, prosecutors said. Hughes was “removed” from his job, and an investigation was launched.

    “Before the FTC discovered the theft and removed Hughes from his position as supply
    clerk in December 2010, Hughes made unauthorized purchases from vendors totaling $217,372.11, and he accrued $1,264.10 in unauthorized shipping charges, causing a total loss to the FTC of $218,636.21,” prosecutors said.

    Hughes faces a maximum prison term of 10 years. He has agreed to make restitution and to an order of forfeiture, prosecutors said. He is scheduled to be sentenced July 13.

    On March 29, federal agents arrested Cheng Yi Liang, 56, of Gaithersburg, Md. Liang worked at the FDA as a chemist, and prosecutors said he mined information from the agency to make illicit stock trades and rack up $3.6 million in illegal profits and avoided losses.

    Liang, 56, also was sued by the SEC.

    Officials have cautioned the public against painting with too wide a brush when a government employee gets in trouble.

    Multiple agencies became part of the probes into both the conduct of Liang and Hughes, according to records.

  • FTC Warns That Scammers Are Trading On Radiation Fears To Hawk Potassium Iodide Treatment In Aftermath Of Events In Japan; Be Cautious And Selective, Agency Advises

    Fraudsters are following the headlines about radiation fears in Japan and designing sales pitches to scare U.S. consumers into buying potassium-iodide treatments, the FTC warned today.

    Last week, the agency warned against charity scams that may emerge to mine illicit profits from the devastating earthquake and tsunami.

    “Potassium iodide, or KI, can help prevent thyroid cancer, which is one of the biggest risks from contamination with radioactive iodine,” the FTC said.  “However, public health experts agree that U.S. residents should not buy or take potassium iodide unless specifically notified or instructed by public health officials.”

    And, the FTC added, “If you decide to buy potassium iodide, buy it only from a reputable source. Iosat, ThyroSafe, and ThyroShield are the only potassium iodide products that are FDA-approved and can be legally marketed and sold in the United States.”

    Read the FTC’s warning on potassium-iodide treatment scams.

    Read the FTC’s warning on charity scams trading on events in Japan.

    Get more information on U.S. health policy from the Food and Drug Administration (FDA).

  • MPB Affiliate Says Members Are ‘Partners’ With Walmart And That Program ‘Guaranteed’ Not To Be Scam; Separate Promo Depicts Michelle Obama As Experiencing Oval Office Gas Attack After Sampling ‘Beans’ At Sam’s Club

    This promo for MPB Today claims affiliates become "partners" with Walmart and that business owners are "Granted FREE Groceries" for referring business to the MLM program. The promo appeared last night on a site that is heavily advertising the program — even after Walmart's name had gone missing from the landing page on MPB Today's website.

    UPDATED 10:42 A.M. EDT (U.S.A.) Using the soundtrack from the legendary rock band Heart’s 1985 hit single “What about love,” an affiliate of MPB Today is claiming on YouTube that the company’s members become “partners” with Walmart and that MPB’s multilevel-marketing (MLM) program is “Guaranteed” not to be a scam.

    Heart could not be contacted immediately to determine if the MPB affiliate was authorized to use the song, which features the voice of Ann Wilson, in a sales promotion for an MLM program tied to a Florida-based grocery company known as Southeastern Delivery.

    Walmart has not responded to a request last week from the PP Blog that asked the company to comment on legal and regulatory issues surrounding the use of its name in promotions for MPB Today. The Blog specifically asked Walmart if it knew that MPB Today was using the company name in sales pitches and that at least one affiliate had claimed that Walmart gift cards distributed by MPB to its purported customers could be converted to Walmart prepaid Visa cards, which can be used the same as cash.

    The Blog also asked Walmart if it was affiliated with MPB Today and whether it approved of the use of its brand in the MPB Today MLM program.

    On Tuesday, the MPB Today website removed images of a Walmart store and business titans Donald Trump and Warren Buffet. It was unclear if Walmart, Trump and Buffet had forced the removal.

    Even after MPB Today removed the images, an affiliate promo appeared online last night that claimed MPB Today members were “partners” with Walmart. Ads for MPB Today have targeted Food Stamp recipients, senior citizens, Ponzi scheme victims, foreclosure subjects, people of faith and members of the public who are unhappy with the administration of President Barack Obama.

    One animated ad for MPB Today depicted First Lady Michelle Obama as having experienced a gas attack after sampling “beans” at Sam’s Club. Sam’s Club operates under the Walmart flag.

    This animated pitch for MPB Today depicts First Lady Michelle Obama as having an embarrassing gas attack in the Oval Office after sampling "beans" at a Sam's Club. In the promo, Michelle Obama later gets knocked out by a drunken Hillary Clinton, who is portrayed as a Nazi. President Obama gives Clinton a left-handed Nazi salute in the promo.

    The ad, which portrayed President Obama and Secretary of State Hillary Clinton as Nazis, potentially could alienate customers regardless of their political views. Why an affiliate would imply in an ad that MPB Today prefers Obama opponents as customers is unclear. Such a caustic ad potentially could injure multiple brands because MPB affiliates have claimed Walmart is affiliated with the firm and the name of Sam’s Club appears in the anti-Obama promo.

    MPB Today operator Gary Calhoun has a poor record with the Better Business Bureau for his operation of a previous company, United Pro Media. The company’s predecessor firm, Trim International, was ordered by the U.S. Food and Drug Administration to stop violating federal law in its marketing of a product positioned as a treatment for Lou Gehrig’s Disease, cancer and other severe medical conditions.

    The U.S. Department of Agriculture said last week that it was conducting a review into claims made about MPB Today. The agency said yesterday that its review was ongoing.

    MPB Today is being marketed on social-media sites. It also is being marketed on at least three forums that are infamous for promoting Ponzi schemes.

  • MPB Today Operator Was Subject Of Inquiry By U.S. Food And Drug Administration For ‘Cell Rejuvenator’ Product That Claimed To Treat Lou Gehrig’s Disease, Alzheimer’s, Down Syndrome

    This MPB Today pitch claims a $200, "ONE-TIME" grocery purchase from Southeastern Delivery can "TOTALLY ELIMINATE" future grocery bills.

    Gary Calhoun, the operator of a multilevel-marketing (MLM) program that is targeting Food Stamp recipients, Ponzi scheme victims, foreclosure subjects and people of faith, received a warning letter in 2006 from the U.S. Food and Drug Administration for his marketing of a product that claimed to treat multiple diseases, according to federal records.

    Calhoun, who now operates an MLM program known as MPB Today and a grocery business tied to the program, was ordered by the FDA to stop violating provisions of the Federal Food, Drug, and Cosmetic Act. The grocery business is known as Southeastern Delivery LLC.

    On Friday, the U.S. Department of Agriculture (USDA) said it was opening a “review” of claims made in the MPB Today program and the associated grocery business.

    The FDA’s letter pertained to a Calhoun-operated business known as Trim International and a now-defunct website known as MyTrim.com. Calhoun also operated a business known as United Pro Media LLC, which became a subject of complaints to the Better Business Bureau and was given an “F” rating, the BBB’s lowest rating on a 14-step scale.

    In 2006, according to the FDA, Calhoun was marketing a product known as “TCR Cell Rejuvenator.” The agency said the product was positioned as a treatment for “Neurodegenerative diseases: Alzheimer’s, Parkinson’s, amyotrophic lateral sclerosis, axonal and other neuropathies, Down’s and other syndromes.”

    Amyotrophic lateral sclerosis (ALS) commonly is referred to as Lou Gehrig’s Disease, in recognition of the famed New York Yankees’ first baseman, the subject of the tear-jerking 1942 movie “The Pride of the Yankees,” which starred Gary Cooper. Gehrig died in 1941.

    TCR Cell Rejuvenator also was positioned as a treatment for “recurrent Herpes, common cold and flu,” amid MyTrim claims it could be used “to treat patients with Alzheimer’s, Parkinson’s, cancer and other infectious diseases and neurological disorders,” according to the FDA.

    Meta tags on the site also referenced “prostate cancer,” the FDA said.

    Calhoun was ordered by the FDA to notify it “in writing within 15 working days of receipt of this letter about the steps that you have taken to correct” violations. The company eventually went out of business.

    “[T] he introduction or delivery of a new drug into interstate commerce without an FDA-approved application is a prohibited act,” the FDA advised Calhoun. “No such applications exist for this product.

    “Furthermore, many of the diseases or conditions for which this product is offered are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners,” the FDA said. “Therefore, adequate directions for use for these conditions cannot be written so that a layman can use this drug safely for its intended purposes.”

    The agency said Calhoun had misbranded the product because the “product’s labeling fails to bear adequate directions for its intended uses for those diseases or conditions which are not amenable to self-diagnosis and treatment.”

    MPB affiliates claim a single grocery purchase of $200 through Southeastern Delivery can result in free groceries for life.

    Read the FDA’s warning letter to Calhoun.

  • BULLETIN: DO NOT INGEST: ‘Miracle Mineral Solution,’ Also Known As ‘Miracle Mineral Supplement’ Or ‘MMS,’ Produces ‘Industrial Bleach’ And Causes ‘Serious Harm,’ FDA Says

    “Serious harm,” including “life-threatening low blood pressure,” may come to consumers who drink “Miracle Mineral Solution” (MMS), an “an oral liquid also known as “Miracle Mineral Supplement,” the U.S. Food and Drug Administration warned.

    The FDA warned consumers to “stop using it immediately and throw it away.” The product is being marketed online.

    When used as directed, the product “produces an industrial bleach that can cause serious harm to health,” the agency said.

    “Multiple independent distributors” are selling the product online, the agency said, noting that the packaging may vary.

    “The FDA has received several reports of health injuries from consumers using this product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration,” the agency said.

    Consumers are instructed “to mix the 28 percent sodium chlorite solution with an acid such as citrus juice,” the agency said. “This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.”

    “MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer, and other conditions,” the agency said. “The FDA is not aware of any research that MMS is effective in treating any of these conditions. MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.”

    The FDA said it is continuing “to investigate and may pursue civil or criminal enforcement actions as appropriate to protect the public from this potentially dangerous product.”

    Read the FDA warning on MMS.