AG LYNCH MAKES VIDEO REGARDING UNSAFE DIETARY SUPPLEMENTS

FROM:  U.S. JUSTICE DEPARTMENT 

Tuesday, March 8, 2016

Attorney General Lynch Discusses Department's Efforts to Protect Consumers From Unsafe Dietary Supplements

As part of National Consumer Protection Week, Attorney General Loretta E. Lynch recorded a video to talk about the department’s work protecting the health and safety of consumers from unsafe dietary supplements.

“At the Department of Justice, we are committed to working with our partners across the federal government to protect the health and safety of all Americans,” said Attorney General Lynch.  “Recently, we announced a nationwide operation targeting unlawful dietary supplements.  We are bringing civil and criminal cases against more than 100 makers and marketers of supplements who were violating federal law by misrepresenting ingredients; by making unsupported health claims; or even by lacing products with undeclared substances.”

The complete text of the Attorney General’s video message is below:

“Hello.  As part of National Consumer Protection Week, I want to take a moment to talk to you about dietary supplements, which are used by millions of Americans every day.  What many Americans don’t know is that dietary supplements are not subject to testing by the Food and Drug Administration before they reach store shelves – meaning that every day, millions of Americans are ingesting substances whose safety and efficacy are not guaranteed.

“Some of these supplements are simply a waste of money, promising results they can’t deliver or advertising ingredients that they don’t contain.  And too often, these supplements don’t just abuse consumer trust – they also endanger public health.  Some contain harmful ingredients, causing consumers to fall ill.  Others falsely claim to cure illness and disease, leading patients to use them as a substitute for the proven therapies they need.  But whether these supplements are deceptive or dangerous, the fact remains that too many companies are making a profit by misleading – and in some cases harming – American consumers.

“At the Department of Justice, we are committed to working with our partners across the federal government to protect the health and safety of all Americans.  Recently, we announced a nationwide operation targeting unlawful dietary supplements.  We are bringing civil and criminal cases against more than 100 makers and marketers of supplements who were violating federal law by misrepresenting ingredients; by making unsupported health claims; or even by lacing products with undeclared substances.

“In one case, for example, the Justice Department brought criminal charges against high-ranking executives at USPlabs, a company that sold workout and weight loss supplements.  As we alleged, they claimed that their products were made from natural plant extracts, when in fact, they were made from untested synthetic chemicals from China.  In several cases, consumers suffered severe liver damage.  And although the company was allegedly aware of the risks their product posed, they continued to sell it to consumers, compromising the health and well-being of thousands of Americans.

“The Justice Department is determined to hold bad actors in the dietary supplement industry accountable for their actions.  But consumers need to do their part to protect themselves.  I urge consumers to be cautious when choosing to take dietary supplements.  Visit the FDA and the Federal Trade Commission websites, where you can find useful information about dietary supplements.  Use tools developed by the Department of Defense and the U.S. Anti-Doping Agency, including a smartphone app, to help you make informed choices.  And above all, if you are considering taking a dietary supplement, talk to a doctor first.  Should you and your health care provider decide that dietary supplements are right for you, know that the Department of Justice is working tirelessly to ensure that the products you choose are safely manufactured, accurately labeled, and honestly marketed – because the American people deserve nothing less.”

DIETARY SUPPLEMENT COMPANY OWNER SENT TO PRISON FOR ADDING FILLERS TO DIETARY SUPPLEMENTS

FROM:  U.S. JUSTICE DEPARTMENT 

Wednesday, September 9, 2015

Owner of Dietary Supplement Company Sentenced to Prison for Multimillion-Dollar Scheme to Adulterate Dietary Supplements

Company’s Executive Vice President Pleads Guilty to Obstruction of an Agency Investigation

The owner and president of a dietary supplement manufacturing company in Flanders, New Jersey, was sentenced to prison today for the sale of diluted and adulterated dietary ingredients and supplements, the Department of Justice announced.

Barry Steinlight, 70, of Hackettstown, New Jersey, was sentenced by U.S. District Court Judge Esther Salas of the District of New Jersey to serve 40 months in prison and one year of supervised release.  Steinlight was also ordered to forfeit $1 million in profits from his fraudulent scheme.  Steinlight previously pleaded guilty to a one-count information charging him with conspiring to commit wire fraud.

“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.”

Steinlight was the president and owner of Raw Deal Inc., a dietary supplement manufacturer.  In pleading guilty, Steinlight admitted that from at least 2009 through November 2013, he instructed Raw Deal employees to add “fillers,” including maltodextrin, viobin cocoa replacer and rice flours, to the dietary ingredients and supplements sold to customers.  These “fillers” were added without customer consent or knowledge.  Steinlight also directed Raw Deal employees not to list the “fillers” as ingredients on certificates of analysis issued to its customers as proof of the identity of the ingredients contained in the products.  During his plea hearing, Steinlight admitted that Raw Deal Inc.’s gross profits during the scheme were between $7 million and $20 million.

Yesterday, Raw Deal’s executive vice president, Catherine Palmer, 38, of Budd Lake, New Jersey, pleaded guilty to a one-count information charging her with obstructing an agency investigation.  The obstruction charge carries a statutory maximum 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.

According to court documents, Palmer lied to U.S. Food and Drug Administration (FDA) investigators and ordered a subordinate to falsify a dietary supplement product’s ingredient list 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.  This practice hid from the FDA the fact that Steinlight and Raw Deal diluted the products before sale to unsuspecting customers.

Court documents also revealed that Steinlight directed Raw Deal employees to create certificates of authenticity that falsely claimed that certain Raw Deal products were kosher or organic.

“Consumers expect labels that accurately describe the products they ingest,” said U.S. Attorney Paul J. Fishman of the District of New Jersey.  “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.”

“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,” said Acting Special Agent in Charge Jeffrey J. Ebersole of the 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.”

Principal Deputy Assistant Attorney General Mizer and U.S. Attorney Fishman commended the investigative efforts of the FDA’s Office of Criminal Investigations.  The government is represented by Assistant U.S. Attorney Joseph Mack of the District of New Jersey, Deputy Chief of the office’s Health Care and Government Fraud Unit; Special Assistant U.S. Attorney Shannon M. Singleton of the FDA’s Office of Chief Counsel; and Trial Attorneys Patrick Runkle and David Sullivan of the Civil Division’s Consumer Protection Branch.  Paralegal Jeffrey Skonieczny of the District of New Jersey also assisted in the criminal investigation.

U.S. DEPARTMENT OF JUSTICE WARNS ABOUT DIETARY SUPPLEMENTS

FROM:  U.S. DEPARTMENT OF JUSTICE
Keeping Tabs On Supplements
June 20th, 2012 Posted by Tracy Russo
The following post appears courtesy of the Consumer Protection Branch of the Civil Division
The dietary supplement industry has grown exponentially in recent decades, expanding from a niche health market into a major industry offering purported solutions for all types of ailments.

In 1994, Congress struck a balance between the dietary supplement industry and the public interest by enacting a law that generally treated dietary supplements as food rather than medicine. That means, for example, dietary supplements are generally not required to go through pre-market approval like pharmaceuticals.  

In 2007, the Food and Drug Administration (FDA) recognized that stronger regulations for the manufacturing of dietary supplements were needed.  Important new requirements have been introduced, in an effort to ensure that dietary supplements contain what they claim to contain.

In the last few years, the Consumer Protection Branch of the Civil Division, the FDA, and the Federal Trade Commission have collaborated in a number of actions designed to protect consumers.   When its inspections reveal serious deficiencies in a dietary supplement firm’s labeling, manufacturing, or advertising, the FDA typically sends the firm a warning letter giving the firm a certain amount of time to rectify the violations, and may work with the firm to recall products with potential risks.  You can find out about these actions and protect yourself by signing up for FDA recall alerts and by checking the FDA and FTC websites for warning letters issued to firms whose dietary supplements you may have purchased.

If the firm does not remedy the violations, the matter may be referred to the Justice Department for civil or criminal prosecution.  In one recent case, the Consumer Protection Branch filed a civil suit against a Paterson, NJ-based supplement maker that had a serious rodent infestation, manufacturing problems that resulted in allergen cross-contamination, and various labeling errors.  One of the firm’s products—which had been labeled to be dairy-free but in fact contained milk—even caused a life-threatening anaphylactic reaction in a consumer with a severe milk allergy.

Flouting a court-ordered shut down, the manufacturers simply opened up shop in a new location.  Ultimately, the Justice Department secured a criminal conviction and the firm was ordered to pay $1 million in fines.  Perhaps more significantly, the three principals of the firm were given lengthy prison terms: 40 months for the president and 34 months for the production and quality assurance managers.

Violations in the dietary supplement industry will not be tolerated.  Consumers turn to these products for their health and sense of well-being.  Consumers rely on the labels of dietary supplements to tell them about the effectiveness of the supplements and the allergens in the product.  Consumers should be able to trust that the companies that produce dietary supplements make sure their products are free from harmful impurities and manufactured under sanitary conditions.