USPlabs, which sold the best-selling workout supplement Jack3d, and six of its executives face criminal charges for the unlawful sale of nutritional supplements, the U.S. Justice Department said Tuesday in announcing a larger probe by federal agencies aimed at stemming the sale of unproven products.
The indictment says that USPlabs LLC used a synthetic stimulant made in China to make Jack3d and OxyElite Pro but told retailers that the supplements were manufactured from plant extracts. The supplements had $400 million in sales between 2008 and 2013, according to the indictment.
“From California to Maine, consumers ingest pills, powders and liquids every day, not knowing whether they are wasting money or whether they may end up harming, rather than helping, themselves. Unfortunately, many of these products are not what they purport to be or cannot do what the distributors claim they can do,” said Benjamin C. Mizer, Principal Deputy Assistant Attorney General.
Six executives with USPlabs and S.K. Laboratories, which actually manufactured the supplements for USPlabs, face criminal charges. Four were arrested on Tuesday and two were expected to surrender, the Justice Department said.
A sweeping multi-agency federal investigation has resulted in a slew of criminal and civil charges being brought against more than 100 companies that either make or market supposed dietary supplements for selling products that allegedly contain ingredients other than those listed on the label, or products that make unsubstantiated health or disease-treatment claims.
The investigation, resulting in court cases being filed in 18 states, involved the Justice Department, the Food and Drug Administration, the Federal Trade Commission, the U.S. Postal Inspection Service, and the IRS.
The headliner criminal indictment [PDF] was filed in a California federal court against Dallas-based USP Labs, and several of its executives and senior level employees. Four of those employees were arrested Tuesday morning, with the other two slated to surrender themselves. The defendants’ assets — including investment accounts, real estate, and luxury cars — have been seized.
Prosecutors allege that USP, perhaps best known for supplements like Jack3d and OxyElite Pro, conspired to import ingredients from China using false certificates of analysis and false labeling, then lied about the source and nature of those ingredients after it put them in its products. The labels for these products claimed they contained natural plant extracts, but the indictment alleges that USP used a synthetic stimulant manufactured in a Chinese chemical factory.
The indictment also alleges that the defendants knew of studies that linked their products to liver toxicity, but chose to ignore that evidence.
In Oct. 2013, after OxyElite Pro had been implicated in an outbreak of liver injuries, USP told the FDA it would stop distribution of the supplement. But according to the indictment, USP endeavored to unload as much of the product as it could in a short period of time.
The DOJ and FDA teamed up for a number of civil cases filed in the last week.
The suit against Clifford Woods LLC (d/b/a “Vibrant Life”) alleges that the company unlawfully misled consumers by marketing Taheebo Life Tea, Life Glow Plus, Germanium and Organic Sulfur (identified as methyl sulfonyl methane) as treatments for medical conditions like Alzheimer’s and cancer without any proof or approval.
The company behind the supplement Viruxo misleadingly marketed the dietary supplement as a treatment for herpes, according to prosecutors.
Optimum Health — the company that made products like DMSO Cream, DMSO Cream with Aloe, and DMSO Roll On — is accused of illegally marketing these items as treatments arthritis and cancer.
Bethel Nutritional Consulting and its principals allegedly distributed dietary supplements in a manner that does not conform to current good manufacturing practice for dietary supplements. The company is also accused of making claims about the uses for many of the products that render them unapproved and misbranded drugs. FDA testing of Bethel products turned up evidence of active pharmaceutical ingredients not listed on the products’ labels, including one ingredient that was withdrawn from the market in 2010 because of safety concerns.
VivaCeuticals, Inc. (d/b/a Regeneca Worldwide) allegedly sold adulterated supplements like RegeneSlim Appetite Control, which was found to contain the ingredient 1, 3 dimethylamylamine (DMAA), an unsafe food additive under the federal Food, Drug and Cosmetic Act.
Still hungry for more lawsuits? Good, because we’ve got them. The FTC and DOJ partnered up for some civil actions of their own against companies with allegedly deceptive marketing.
Florida-based Sunrise Nutraceuticals is accused of falsely claiming that dietary supplement Elimidrol alleviates opiate withdrawal symptoms and increases a user’s likelihood of overcoming opiate addiction.
Six individuals and five companies have been sued by the government for allegedly making false and misleading health and efficacy claims online and in direct mail ads for products like W8-B-Gone (get it? Weight-be-gone… ugh), CITRI-SLIM 4, and Quick & Easy diet pills. These ads featured bogus weight-loss experts, used fictional scientific studies, and lied about having clinical proof that users would experience a “RAPID FAT meltdown diet program.”
Then there’s NPB Advertising, Inc., another company to try to ride the “Dr. Oz effect” from that one show where the good doctor (who is not at all an ethically questionable shill for the lose-weight-quick industry) touted green coffee bean extract as a “miracle” weight loss product. NPB is accused of using false weight-loss claims and fake news websites to market “Pure Green Coffee.”