12.03.15
As part of a coordinated, nationwide sweep, the Department of Justice and its federal partners have pursued civil and criminal cases against more than 100 makers and marketers of illegal products sold as dietary supplements.
The actions resulted from a yearlong effort that began in November 2014 to focus enforcement resources in an area of the dietary supplement market that is causing increasing concern among health officials nationwide. In each case, the department or one of its federal partners alleged the sale of supplements that contain ingredients other than those listed on the product label or the sale of products that make health or disease treatment claims that are unsupported by adequate scientific evidence.
During the period of the sweep, 117 individuals and entities were pursued through criminal and civil enforcement actions. Of these, 89 were the subject of cases filed since November 2014.
Criminal Matters
The sweep included a criminal case charging USPlabs LLC and several of its corporate officers. An 11-count indictment was unsealed on Nov. 17 against USPlabs—which is not affiliated with and shouldn’t be confused with the standards setting organization U.S. Pharmacopeia (USP). The Dallas, TX-based company was known for its widely popular workout and weight loss supplements sold under names such as Jack3d and OxyElite Pro.
The sweep included federal court cases in 18 states and was a coordinated effort between government agencies. On Nov. 17 the effort was announced by the Department of Justice, FDA, FTC, the U.S. Postal Inspection Service (USPIS), the Department of Defense (DoD) and the U.S. Anti-Doping Agency (USADA).
The DoD and USADA also participated in the sweep to unveil new tools to increase awareness of the risks unlawful products pose to consumers and, in particular, to assist service members targeted by illegitimate athletic performance products sold as supplements.
“The Justice Department and its federal partners have joined forces to bring to justice companies and individuals who profit from products that threaten consumer health,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “The USPlabs case and others brought as part of this sweep illustrate alarming practices the department found—practices that must be brought to the public’s attention so consumers know the serious health risks of untested products.”
The indictment alleged that USPlabs engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients after it put them in its products. According to the indictment, USPlabs told some of its retailers and wholesalers that it used natural plant extracts in its Jack3d and OxyElite Pro products when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory.
The indictment also alleged the defendants sold some of their products without determining whether they would be safe to use. In fact, as the indictment noted, the defendants knew of studies that linked the products to liver toxicity.
The indictment also alleged that in October 2013 USPlabs and its principals told FDA that it would stop distribution of OxyElite Pro after the product had been implicated in an outbreak of liver injuries. The indictment alleged that, despite this promise, USPlabs engaged in a surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible. It was sold at dietary supplement stores across the nation.
Charges are among 14 criminal cases prosecuted by the Civil Division’s Consumer Protection Branch and U.S. Attorney’s Offices across the country from November 2014 to November 2015. Of the 14 criminal cases prosecuted during this timeframe, 11 cases against 29 individuals and entities have been filed since November 2014.
Civil Cases
The Department of Justice also filed five civil cases seeking injunctive relief against a number of businesses and individuals that allegedly distributed products that did not conform to dietary supplement Good Manufacturing Practices (GMPs) and made claims that rendered them unapproved and misbranded drugs.
For example, the civil complaints filed alleged that companies sold supplements as disease cures. These matters, investigated by USPIS and the FDA, included cases against companies that unlawfully sold products as treatments for various diseases including Alzheimer’s disease, cancer, herpes and arthritis.
A civil complaint also targeted a company that sold an appetite control product that contained 1, 3 dimethylamylamine (DMAA), an unsafe food additive under the federal Food, Drug and Cosmetic Act, that wasn’t declared as an ingredient.
Another complaint targeted a company selling a “proprietary blend” of herbs and other compounds allegedly marketed to alleviate opiate withdrawal symptoms.
Trade Groups Welcome Federal Action
Industry trade representatives, who had been calling for such federal intervention to target rogue companies and products, applauded news of the enforcement actions.
Loren Israelsen, president of the United Natural Products Alliance, Salt Lake City, UT, said the sweep was welcome and overdue. “We were gratified to see the breadth of agencies represented. UNPA and responsible industry have long urged regulators to take decisive action against non-compliant products.”
The clear message for industry, Congress, the media and consumers, he added, is that various agencies maintain broad authority to regulate dietary supplements. “We encourage regulators to continue to assure consumers of wide access to safe, beneficial and well-researched dietary supplements. For our part, we will continue to work closely with all regulators on the types of cases they described to support and encourage a supplement industry that operates within the law and continues to be deserving of widespread consumer trust.”
UNPA and other groups have invested significant time and energy on education and self policing, “but we need the force of law,” Mr. Israelsen said, “to remove products and companies that have no interest in selling legitimate dietary supplements.” The news was “a good demonstration of regulators taking action. We say, ‘carry on.’”
American Herbal Products Association (AHPA) President Michael McGuffin said the efforts were “appropriately focused on companies alleged to have acted in contravention to the established laws that are in place to ensure informed consumer access to safe dietary supplements. AHPA fully supports appropriate enforcement of all the laws that regulate the dietary supplement industry.”
In addition, Mr. McGuffin said the Justice Department’s Mr. Mizer “accurately identified enforcement and education as the most effective steps that can be taken to mitigate the risk of criminals looking to defraud dietary supplement consumers by selling unlawful products.”
Steve Mister, president and CEO, Council for Responsible Nutrition (CRN), Washington, D.C., said the trade group was grateful the agencies took such an important step in protecting consumers and responsible companies.
“These actions should serve as a strong warning to any company selling products in the dietary supplement space that if you’re going to engage in illegal activity, you’re going to pay the price.”
CRN reached out to the Department of Justice in May this year, noting concerns that “companies engaging in blatant criminal activity were presenting a serious public health risk and hijacking the credibility of the reputable industry. We urged the Department of Justice to use all available tools to hold transgressors fully accountable for their actions ... Our request—on behalf of the responsible industry—was addressed.”
These federal actions serve to both “help consumers navigate the market to avoid products that may do them harm, and also level the playing field for responsible companies who do things right. We pledge our support to help the government on this important initiative,” Mr. Mister said.
The Natural Products Association, Washington, D.C., issued a statement applauding the enforcement actions against “rogue elements that are giving the overwhelming majority of legitimate dietary supplement manufacturers and retailers a bad image.”
“The fact is that America’s dietary supplement supply is the safest in the world because of the strong rules and good manufacturing practices that are prevalent among our members,” NPA noted.
“We have long called on the government to prosecute illegal activity to the full extent of the law,” and these actions demonstrate “the government’s vast power to regulate this industry. We welcome the coordination and collaboration of the other agencies involved, and offer to work with them and others to continue educating the public about the benefits of proper dietary supplement usage. This is good news both for millions of Americans who use dietary supplements and the hardworking people in our business who are meeting the growing demand for natural products.”
The actions resulted from a yearlong effort that began in November 2014 to focus enforcement resources in an area of the dietary supplement market that is causing increasing concern among health officials nationwide. In each case, the department or one of its federal partners alleged the sale of supplements that contain ingredients other than those listed on the product label or the sale of products that make health or disease treatment claims that are unsupported by adequate scientific evidence.
During the period of the sweep, 117 individuals and entities were pursued through criminal and civil enforcement actions. Of these, 89 were the subject of cases filed since November 2014.
Criminal Matters
The sweep included a criminal case charging USPlabs LLC and several of its corporate officers. An 11-count indictment was unsealed on Nov. 17 against USPlabs—which is not affiliated with and shouldn’t be confused with the standards setting organization U.S. Pharmacopeia (USP). The Dallas, TX-based company was known for its widely popular workout and weight loss supplements sold under names such as Jack3d and OxyElite Pro.
The sweep included federal court cases in 18 states and was a coordinated effort between government agencies. On Nov. 17 the effort was announced by the Department of Justice, FDA, FTC, the U.S. Postal Inspection Service (USPIS), the Department of Defense (DoD) and the U.S. Anti-Doping Agency (USADA).
The DoD and USADA also participated in the sweep to unveil new tools to increase awareness of the risks unlawful products pose to consumers and, in particular, to assist service members targeted by illegitimate athletic performance products sold as supplements.
“The Justice Department and its federal partners have joined forces to bring to justice companies and individuals who profit from products that threaten consumer health,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “The USPlabs case and others brought as part of this sweep illustrate alarming practices the department found—practices that must be brought to the public’s attention so consumers know the serious health risks of untested products.”
The indictment alleged that USPlabs engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients after it put them in its products. According to the indictment, USPlabs told some of its retailers and wholesalers that it used natural plant extracts in its Jack3d and OxyElite Pro products when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory.
The indictment also alleged the defendants sold some of their products without determining whether they would be safe to use. In fact, as the indictment noted, the defendants knew of studies that linked the products to liver toxicity.
The indictment also alleged that in October 2013 USPlabs and its principals told FDA that it would stop distribution of OxyElite Pro after the product had been implicated in an outbreak of liver injuries. The indictment alleged that, despite this promise, USPlabs engaged in a surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible. It was sold at dietary supplement stores across the nation.
Charges are among 14 criminal cases prosecuted by the Civil Division’s Consumer Protection Branch and U.S. Attorney’s Offices across the country from November 2014 to November 2015. Of the 14 criminal cases prosecuted during this timeframe, 11 cases against 29 individuals and entities have been filed since November 2014.
Civil Cases
The Department of Justice also filed five civil cases seeking injunctive relief against a number of businesses and individuals that allegedly distributed products that did not conform to dietary supplement Good Manufacturing Practices (GMPs) and made claims that rendered them unapproved and misbranded drugs.
For example, the civil complaints filed alleged that companies sold supplements as disease cures. These matters, investigated by USPIS and the FDA, included cases against companies that unlawfully sold products as treatments for various diseases including Alzheimer’s disease, cancer, herpes and arthritis.
A civil complaint also targeted a company that sold an appetite control product that contained 1, 3 dimethylamylamine (DMAA), an unsafe food additive under the federal Food, Drug and Cosmetic Act, that wasn’t declared as an ingredient.
Another complaint targeted a company selling a “proprietary blend” of herbs and other compounds allegedly marketed to alleviate opiate withdrawal symptoms.
Trade Groups Welcome Federal Action
Industry trade representatives, who had been calling for such federal intervention to target rogue companies and products, applauded news of the enforcement actions.
Loren Israelsen, president of the United Natural Products Alliance, Salt Lake City, UT, said the sweep was welcome and overdue. “We were gratified to see the breadth of agencies represented. UNPA and responsible industry have long urged regulators to take decisive action against non-compliant products.”
The clear message for industry, Congress, the media and consumers, he added, is that various agencies maintain broad authority to regulate dietary supplements. “We encourage regulators to continue to assure consumers of wide access to safe, beneficial and well-researched dietary supplements. For our part, we will continue to work closely with all regulators on the types of cases they described to support and encourage a supplement industry that operates within the law and continues to be deserving of widespread consumer trust.”
UNPA and other groups have invested significant time and energy on education and self policing, “but we need the force of law,” Mr. Israelsen said, “to remove products and companies that have no interest in selling legitimate dietary supplements.” The news was “a good demonstration of regulators taking action. We say, ‘carry on.’”
American Herbal Products Association (AHPA) President Michael McGuffin said the efforts were “appropriately focused on companies alleged to have acted in contravention to the established laws that are in place to ensure informed consumer access to safe dietary supplements. AHPA fully supports appropriate enforcement of all the laws that regulate the dietary supplement industry.”
In addition, Mr. McGuffin said the Justice Department’s Mr. Mizer “accurately identified enforcement and education as the most effective steps that can be taken to mitigate the risk of criminals looking to defraud dietary supplement consumers by selling unlawful products.”
Steve Mister, president and CEO, Council for Responsible Nutrition (CRN), Washington, D.C., said the trade group was grateful the agencies took such an important step in protecting consumers and responsible companies.
“These actions should serve as a strong warning to any company selling products in the dietary supplement space that if you’re going to engage in illegal activity, you’re going to pay the price.”
CRN reached out to the Department of Justice in May this year, noting concerns that “companies engaging in blatant criminal activity were presenting a serious public health risk and hijacking the credibility of the reputable industry. We urged the Department of Justice to use all available tools to hold transgressors fully accountable for their actions ... Our request—on behalf of the responsible industry—was addressed.”
These federal actions serve to both “help consumers navigate the market to avoid products that may do them harm, and also level the playing field for responsible companies who do things right. We pledge our support to help the government on this important initiative,” Mr. Mister said.
The Natural Products Association, Washington, D.C., issued a statement applauding the enforcement actions against “rogue elements that are giving the overwhelming majority of legitimate dietary supplement manufacturers and retailers a bad image.”
“The fact is that America’s dietary supplement supply is the safest in the world because of the strong rules and good manufacturing practices that are prevalent among our members,” NPA noted.
“We have long called on the government to prosecute illegal activity to the full extent of the law,” and these actions demonstrate “the government’s vast power to regulate this industry. We welcome the coordination and collaboration of the other agencies involved, and offer to work with them and others to continue educating the public about the benefits of proper dietary supplement usage. This is good news both for millions of Americans who use dietary supplements and the hardworking people in our business who are meeting the growing demand for natural products.”
