WASHINGTON — The big news in the supplement industry is the Department of Justice’s Tuesday indictment of supplement companies that skirted regulations and either sold products with unlisted ingredients or sold products falsely claiming health benefits or treatment.
The Department of Justice also filed in the past week five civil cases seeking injunctive relief against a number of businesses and individuals that allegedly sold supplements as disease cures or that were otherwise in violation of the law.
These matters, investigated by USPIS and the FDA, include the following:
United States v. Clifford Woods, doing business as Vibrant Life, and Clifford Woods: With this complaint, the DOJ alleges that Woods and Vibrant Life unlawfully sold Taheebo Life Tea, Life Glow Plus, Germanium and Organic Sulfur (identified as methyl sulfonyl methane) as treatments for various diseases including Alzheimer’s disease and cancer. The complaint alleges that the defendants’ conduct defrauded consumers through the sale of unapproved new and misbranded drugs;
United States v. James R. Hill, doing business as Viruxo: The DOJ says that Hill unlawfully sold a dietary supplement called Viruxo as a treatment for herpes and that his and Viruxo’s conduct defrauded consumers through the sale of unapproved new and misbranded drugs;
United States v. Lehan Enterprises, doing business as Optimum Health, and Lesa Sverid. According tot the DOJ’s complaint, the defendants unlawfully sold products called DMSO Cream, DMSO Cream with Aloe and DMSO Roll On as treatments for conditions and diseases including arthritis and cancer. The complaint alleges that defendants sold unapproved new and misbranded drugs;
United States v. Bethel Nutritional Consulting, Felix Ramirez and Kariny Ramirez: According to the DOJ complaint, the defendants distribute dietary supplements in a manner that does not conform to current good manufacturing practice for dietary supplements and are making claims about the uses for many of the products that render them unapproved and misbranded drugs. According to FDA testing, the products sold by the defendents have unlisted active pharmaceutival ingredients, among them an ingredient that was pulled from the market in 2010 due to safety concerns. The defendents have agreed to abide by an injunction preventing the sale of their dietary supplements until they become compliant;
United States v. VivaCeuticals, doing business as Regeneca Worldwide, and Matthew Nicosia: This complaint that dietary supplements sold by the defendants are adulterated because they are not manufactured in accordance with the FDA’s current good manufacturing practice regulations. One of the dietary supplements, a product called RegeneSlim Appetite Control (RegeneSlim), contains an unsafe food additive that is not declared as an ingredient. In addition, the defendants allegedly market RegeneSlim as a disease cure.
Civil actions brought by the FTC as part of the sweep to combat unsubstantiated supplement claims include the following:
Sunrise Nutraceuticals: According to the FTC’s complaint, Sunrisedeceptively claims that its dietary supplement Elimidrol, a “proprietary blend” of herbs and other compounds, alleviates opiate withdrawal symptoms and increases a user’s likelihood of overcoming opiate addiction. The FTC alleges that Sunrise’s ads for Elimidrol are deceptive because the claims they make are false or unsubstantiated;
Health Nutrition Products: The FTC’s complaint charged Crystal Ewing, five other individuals and five companies with making false and misleading health and efficacy claims in direct mail ads and on a website owned by Ewing. In ads for W8-B-Gone, CITRI-SLIM 4 and Quick & Easy diet pills, the defendants featured bogus weight-loss experts. Citing fake scientific studies, the defendants also deceptively claimed to have clinical proof that consumers would experience a “RAPID FAT meltdown diet program” that lets them shed five pounds in four days with one pill, or up to 20 pounds in 16 days with four pills. The proposed court orders announced today will settle the FTC’s charges against three defendants involved in the scheme. The order against repeat offender Ewing and her company Classic Productions requires them to admit liability in the case, bans them from selling weight-loss programs, products and services, and imposes a non-suspended judgment of $2.7 million;
NPB Advertising: According to the FTC’s complaint, NPB and others capitalized on the green coffee bean diet fad by using false weight loss claims and fake news websites to market a dietary supplement called Pure Green Coffee. The proposed court order announced today settles the FTC’s charges, bars the defendants from the deceptive acts and practices described in the complaint and imposes a $30 million judgment that will be suspended upon the sale of certain assets, payment of $160,800, and the collection and turnover of an additional $155,760 that was lent to a third party.