The five lawsuits are part of a yearlong sweep that produced civil injunctions and criminal actions against 117 distributors or manufacturers of spiked products that are falsely marketed as dietary supplements.

Josh Long, Associate editorial director, Natural Products Insider

November 18, 2015

3 Min Read
DOJ Sues Dietary Supplement Marketers for Disease Claims, GMP Violations

FDA in recent days has moved to shut down five companies as part of a broad sweep against unlawful activity in the dietary supplement industry.

The U.S. Department of Justice (DOJ) filed complaints in California, Florida, Massachusetts and New Jersey to crack down on businesses that have sold illegal ingredients, marketed natural products as cures for diseases and failed to produce supplements in accordance with FDA’s eight-year-old cGMPs (current good manufacturing practices).

The five lawsuits are part of a yearlong sweep that produced civil injunctions and criminal actions against 117 distributors or manufacturers of dietary supplements and spiked products that are falsely marketed as dietary supplements. Since November 2014 alone, 89 entities and individuals were the subject of cases filed by the DOJ.

The court docket has been filling up with dietary supplement cases in recent days.

New York-based Bethel Nutritional Consulting, one of the companies named in a recent lawsuit, has shut its doors. Bethel and the individual defendants have agreed to be bound by an agreement that prohibits them from selling dietary supplements until they meet the law’s requirements, according to a DOJ press release.

Bethel closed its doors on Oct. 31, according to its website. The company did not immediately respond to requests for comment.

“Bethel Nutritional Consulting Inc. was ordered by a federal court to stop selling its products and recall all of our inventory," the company revealed on its website. “We cannot reopen until Bethel Nutritional comes into compliance with the U.S. Food and Drug Administration’s dietary supplement manufacturing regulations and requirements."

According to DOJ, Bethel Nutritional Consulting and the individual defendants were producing supplements out of compliance with cGMPs and making claims about products that rendered them unapproved and misbranded new drugs. FDA testing further revealed some of the company’s products contained undeclared active pharmaceutical ingredients, including a substance that was withdrawn from the market in 2010 due to safety concerns, according to the government.

Another company that was sued by DOJ was found to be selling a product that contained DMAA, which FDA considers an unsafe food additive, and has been linked to deaths and private lawsuits.

VivaCeuticals Inc., doing business as Regeneca Worldwide, failed to list DMAA as an ingredient in its product RegeneSlim Appetite Control, according to the lawsuit. In support of DOJ’s position that the product is intended to treat diabetes, high cholesterol and high blood pressure, the complaint referenced such claims as “lowers serum cholesterol," “lowers blood pressure," and “promotes proper insulin function … [and] increases insulin".

Regeneca Worldwide did not immediately respond to a request for comment.

DOJ also recently sued Clifford Woods LLC (dba Vibrant Life), James R. Hill (dba Viruxo) and Lehan Enterprises Inc. (dba Optimum Health), as well as a number of individual defendants tied to the companies.  Viruxo’s online store is closed, and nobody answered a call to the listed phone number. Vibrant Life did not immediately respond to a request for comment.

Lesa Sverid, an individual defendant named in the Optimum Health lawsuit, told the Cape Cod Times on Tuesday she was not prepared to comment. The company’s website has been suspended.

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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