The Wall Street Journal (11/18, Burton, Subscription Publication) reports that dietary supplement maker USPlabs LLC and its executives were charged with fraud by a Federal grand jury in Texas on Tuesday. Officials from the Justice Department, the Food and Drug Administration, the Federal Trade Commission, the US Postal Inspection Service, and other agencies say the indictment was part of a nationwide effort targeting illegal marketing of dietary supplements.
The New York Times (11/17, B2, O’Connor) reports in its “Well” blog that the USPlabs indictment is “at the center” of a “yearlong federal investigation into the dietary supplement industry,” resulting in a “widespread crackdown on more than 100 companies accused of selling tainted or misleading products.” USPlabs sold a supplement, OxyElite Pro, linked to a 2013 outbreak of liver disease that killed one person and sickened 97 people.
Bloomberg News (11/17, Mittelman, Townsend) reports that SK Laboratories Inc., “which makes supplements for USPlabs, was also charged in the case.”
The AP (11/18, Tucker) reports that USPlabs was directed by the FDA to recall its OxyElite Pro product in 2013, and while it told the agency it would stop distributing it, it instead began a “surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible,” according to the criminal complaint.
The Washington Post (11/17, Merle, Dennis) reports that USPlabs allegedly told retailers that some of its products had natural plant extracts that were actually a synthetic stimulant made in a chemical factory in China, the DOJ complaint alleges.
USA Today (11/17, Golshan) reports that the FDA “has long been scrutinized for a lack of urgency toward the illegal activity in the supplement industry.” While FDA deputy commissioner for global regulatory operations and policy Howard Sklamberg characterized the agency’s enforcement as “vigorous,” some experts criticize the agency for merely issuing warning letters without further action.
The Hill (11/18, Wheeler) reports that the DOJ also filed civil cases against Vibrant Life, Viruxo, Optimum Health, Bethel Nutritional Consulting and Regeneca Worldwide. The Federal Trade Commission “has also taken civil actions against Sunrise Nutraceuticals LLC, Health Nutrition Products and NPB Advertising Inc.” for allegedly “making false, misleading or unsubstantiated health and efficacy claims