The United States Department of Justice Nov. 17 announced it had taken criminal action against more than 100 makers and marketers of dietary supplements.

The cases came as part of a nationwide sweep that dated back to November 2014, the DOJ said in a statement. It focused on enforcement resources in an area of the dietary supplement market that has been causing increased concern among health officials, it added.

In each case filed, the Justice Department or one of its federal partners alleged the sale of supplements contained ingredients other than what was listed on the product label. It added that, if not for the mislabeled product, the sale of products that make health or disease treatment claims that are not supported by adequate scientific evidence led to the cases filed.

Among the cases announced was a criminal case charging USPlabs LLC, known for its workout and weight loss supplements, and a number of its corporate officers, the Justice Department said.

Following the sweep on USPlabs and its products such as Jack3d and OxyElite Pro, federal court cases were opened up in 18 states.

Many agencies, including the Food and Drug Administration, the Federal Trade Commission, the U.S. Postal Inspection Service and the Internal Revenue Service’s criminal investigation unit took part in the effort. Additionally, the Department of Defense and the U.S. Anti-Doping Agency are participating in the sweep to unveil new tools to increase awareness of the risks in taking unlawful dietary supplements.

Jeevan Zutshi, an author and Indian American owner of a real estate brokerage firm in Fremont, Calif., lost his son in 2008 after a short-term, four-day illness.

Zutshi and his family believe the March 19, 2008, death of his son Amit was the result of overusing over-the-counter health supplements. Amit Zutshi was 30.

“I paid a very heavy price, and life changed because of these evil manufacturers and dealers of OTC (drugs),” Zutshi told India-West.

As a result, the family started the Amit Zutshi Foundation to honor his life as well as to bring awareness about the “issues faced by youth in this fast paced agitated life of present times.”

In addition to the foundation, Jeevan Zutshi wrote a book entitled, “The Last Smile.” The book “shares a real life story of a consumer in the loosely regulated U.S. health supplements market and sheds light on the dire consequences from being uninformed.”

“The Last Smile” book inspired a film of the same name. It is being directed by San Francisco-based filmmaker Shankey Srinivasan, who has won awards at various film festivals for his works. The film is currently in pre-production.

“The last scene of our movie appears to reflect exactly what just happened with these manufacturers,” Zutshi said, adding the movie should be released sometime in December.

Zutshi added that he “lobbied against the manufacturers and lack of FDA oversight,” meeting with Sen. Sherrod Brown, Congressmen Frank Pallone, Ed Royce and Pete Stark; and Congresswoman Jackie Speier, among many others in the years since his son’s death. “Congressman Mike Honda and Congresswoman Jackie Speier have been very responsive and effective in handling this issue,” he added.

In the Justice Department statement, principal deputy assistant attorney general Benjamin Mizer said, “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. 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.”

Zutshi compounded on Mizer’s statement, adding, “It seems pretty clear at this point that the FDA needs broadened authority and appropriate levels of funding and staff to be sure that supplement sellers are held responsible for what’s in their products.”

“People like to talk about health freedom, but in addition to choice, that also means the freedom to walk into a store and feel confident that you are not buying a fraudulent and dangerous product,” he told India-West.

A graduate of San Jose State University in San Jose, Calif., Zutshi is also the founder of the Indo-American Community Federation, which was created in 1993 to encourage Indian Americans to participate in mainstream civic life.

The joint-agency sweep pursued 117 individuals and entities through criminal and civil enforcement action, with 89 subject to cases filed since November 2014.

Dallas-based USPlabs was charged with an 11-count indictment, including S.K. Laboratories Inc. for the sale of their products. Several officers, including S.K. Laboratories vice president Sitesh Patel, received various counts associated with the unlawful sale of the supplements.

The indictment alleges that USPlabs engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling. The company then told some of its retailers and wholesalers that it used natural plant extracts in products called Jack3d and OxyElite Pro, when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory, according to the indictment.

USPlabs had told the FDA in October 2013 that it would stop distribution of OxyElite Pro after the product had been implicated in an outbreak of liver injuries. However, the company attempted to sell as much of the product as quickly as possible, the indictment alleged.

“The criminal charges against USPlabs should serve as notice to industry that if products are a threat to public health, the FDA will exercise its full authority under the law to bring justice,” FDA deputy commissioner for global regulatory operations and policy Howard Sklamberg said in a statement.

(1) comment


I feel for the family. However, just like other drugs, not reading the warning label or misusing has dire consequences. Tylenol is one of the most deadly OTC drug on the market with hundreds of fatal overdoses per year, yet the FDA continues to allow it on the shelf.

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