Sainah Theodore says she took the recommended dose of a fat-burning pill for a few days, then had trouble sleeping before falling victim to "complete insomnia".

Josh Long, Associate editorial director, Natural Products Insider

January 9, 2014

2 Min Read
New Yorker Says Supplement Made Her Insomniac, Erratic

NEW YORKSainah Theodore claims a fat-burning dietary supplement induced her manic behavior.

Now, she's suing the health store where she purchased Natural Lipo X.

On Dec. 7, 2012, Theodore purchased a bottle of the supplement from Natural Health Food Center in Brooklyn.

She took the recommended dose for a few days, then had trouble sleeping before falling victim to "complete insomnia," according to the 62-page lawsuit that was filed in the New York Supreme Court in Kings County.

The lawsuit described her subsequent behavior as "erratic, bizarre and aggressive".

Later, Theodore allegedly began hearing voices, received a traffic ticket for "Obstructing an Intersection" and caused interior and exterior damage to her homeall due to "her sleeplessness and insomnia".  

On Dec. 21, 2012, she was involuntarily admitted to the psychiatric ward of the Queens Medical Center and released three days later, according to the complaint.

The 26-year-old Army Reservist told the New York Daily News that her upcoming deployment to Afghanistan had to be put on hold, possibly forever.

The Queens, New Yorker blames Natural Lipo X.

According to the complaint, the fat-burning supplement is tainted with dangerous pharmaceuticals including sibutramine and phenolphthalein.

FDA warned consumers that sibutramine is a class-four controlled substance that can result in increased blood pressure, palpitations and seizure. Phenolphthalein used to be an ingredient in over-the-counter (OTC) laxative products. FDA concluded 15 years ago that the drug was not GRAS (generally recognized as safe) after studies concluded it posed a possible carcinogenic risk. FDA said the substance also has been known to cause mutations to DNA.

Neither sibutramine nor phenolphthalein is identified on the label of the supplement, the lawsuit alleged.

Kennedy Angeliz, who identified himself as the manager's son at Natural Heath Food Center, said an insurance company was handling the lawsuit.

"We try to do the best we can to help people stay as healthy as possible with no bad intentions," he told Natural Products INSIDER.

Theodore is represented by New York attorneys Brian Pascale and Marc Ullman.

The lawsuit named as defendants Natural Health Food Center and its president Adalgisa Garcia.

Ullman said he has not been able to identity the manufacturer of Natural Lipo X. Theodore's lawyers plan to figure that out during the litigation.

Supplements marketed for weight loss and erectile dysfunction (ED) have been targeted by FDA for including hidden, often dangerous ingredients. From 2008 through 2013, FDA flagged 340 supplements that are "tainted" with concealed drugs and other dangerous chemicals.

"There is no shortage of products out there that are tainted," Dan Fabricant, Ph.D., director of FDA's division of dietary supplement programs, told INSIDER last year. "I think that's the problem we have seen."

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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