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some of the company’s products contained undeclared active pharmaceutical ingredients, including a substance that was withdrawn from the market in 2010 due to safety concerns, according to the government.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.