As part of the federal government's ongoing efforts to address unlawful dietary supplements, the Department of Justice announced today criminal cases against three individuals for violations of the federal Food, Drug and Cosmetic Act (FDCA) related to purported disease cures. Each of the three individuals was also the subject of a civil case brought by the department, which they have now agreed to settle by entry of consent decrees of permanent injunction.
Each of the individuals and companies is alleged to have marketed and sold products as treatments for serious diseases including herpes, cancer, Alzheimer's and AIDS, without obtaining approval from the U.S. Food and Drug Administration (FDA) to distribute such products as drugs.
“These enforcement actions highlight the department's continued focus on unlawful dietary supplements, including unsupported cures for serious diseases such as cancer, Alzheimer's, and herpes,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department's Civil Division. “Consumers desperate for help, including Americans facing serious illnesses, sometimes turn to untested substances and forgo proven therapies. The Department of Justice is committed to seeking out those firms that risk public health in favor of profit.”
Guy Lyman and Flor Nutraceuticals LLC
Today, the United States filed acriminal informationin the U.S. District Court for the Eastern District of Louisiana, charging Guy Lyman of New Orleans, Louisiana, with one misdemeanor count of introduction of an unapproved new drug into interstate commerce in violation of the FDCA. The information alleges that Lyman distributed the product Herpaflor as a herpes treatment, without receiving approval from FDA to distribute Herpaflor.
The United States simultaneously filed acivil complaintagainst Lyman and his company, Flor Nutraceuticals LLC, in the Eastern District of Louisiana. The civil complaint alleges that the defendants sold liquid and tablet drug and dietary supplement products named Herpaflor, which they intended as herpes treatments, but that the products were not approved by FDA. Lyman and Flor Nutraceuticals agreed to a consent decree of permanent injunction to prohibit the sale of Herpaflor as a treatment for herpes. The consent decree, which is subject to court approval, was also filed today.
Today, the United States also filed acriminal informationin the U.S. District Court for the Middle District of Florida, charging James Hill of Ocala, Florida, with one misdemeanor count of distributing an unapproved new drug in violation of the FDCA. The information alleges that Hill distributed the unapproved new drug Viruxo Immune Support (Viruxo) as a treatment for herpes.
The Justice Department previouslyannouncedthe entry of aconsent decree of permanent injunctionagainst Hill on Feb. 26, to resolve a civil complaint filed against him in the Middle District of Florida. The injunction prohibits Hill from selling Viruxo as a herpes treatment.
Clifford Woods and Clifford Woods LLC
The Justice Department also announced today that Clifford Woods, of Los Angeles, California,pleaded guilty to a criminal chargefor distribution of an unapproved new drug and agreed to entry of a consent decree. On May 9, Woods pleaded guilty in U.S. District Court for the Central District of California to aone-count informationalleging that he promoted and distributed the product Taheebo Life Tea as a treatment for cancer, despite the fact that the product had not been approved as a drug by the FDA.
Woods, along with his company, Clifford Woods LLC, also agreed to aconsent decree of permanent injunctionto prohibit them from selling products as cures for a variety of diseases. The consent decree, which was entered by the Court on June 27, resolves a civil complaint that the department filed against Woods and Clifford Woods LLC in the Central District of California. The civil complaint alleged that the defendants, doing business as Vibrant Life, sold products that they promoted as treatments for cancer, type 2 diabetes, Alzheimer's disease, HIV infection and AIDS. For instance, the complaint alleged that the defendants promoted certain products “as a treatment for cancer,” as having “shown results in tumor reduction,” and as being able to “change a cancer cell into a non-malignant cell.” The complaint further alleged that the defendants defrauded consumers by promoting certain products to cure, mitigate, treat, or prevent a disease despite the absence of well-controlled clinical studies or other credible scientific substantiation to support those claims.
Principal Deputy Assistant Attorney General Mizer thanked the Postal Inspection Service for its thorough investigation of these cases. The government is represented in the three criminal cases by Trial Attorney Ann Entwistle and in the three civil cases by Trial Attorney Daniel Zytnick, both of the Civil Division's Consumer Protection Branch. The government is also represented in the civil case against Hill by Assistant U.S. Attorney Lacy R. Harwell Jr. of the U.S. Attorney's Office for the Middle District of Florida. Deputy Chief Counsel Perham Gorji and Senior Counsel Claudia J. Zuckerman of the Department of Health and Human Services' Office of General Counsel – Food and Drug Division provided assistance in these cases. Further assistance was provided by the U.S. Attorney's Offices for the Eastern District of Louisiana, Middle District of Florida, and Central District of California.
For more information about the Consumer Protection Branch, visit its website athttp://www.justice.gov/civil/consumer-protection-branch.
Central District of California DOJ / 16-803 / July12, 2016