| U.S. Food and Drug Administration |
FDA Statement, Jul 22, 2004
U.S. Department of Justice
Carol C. Lam
United States Attorney
Southern District of California
News Release Summary
United States Attorney Carol C. Lam announced that a Grand Jury sitting in
the Southern District of California returned an eight-count indictment against
San Diego-based corporation Metabolife International, Inc., and its founder,
Michael J. Ellis. The indictment charges both defendants with six counts of
making false, fictitious and fraudulent representations to the Food and Drug
Administration (FDA), and two counts of corruptly endeavoring to influence,
obstruct and impede proceedings concerning the regulation of dietary supplements
containing ephedra being conducted by the FDA, an agency of the Department of
Health and Human Services. Until FDA banned the sale of ephedra in the United
States in 2003, Metabolife was one of the largest retailers of dietary
supplements in the United States, based largely on sales of its ephedra-based
product, Metabolife 356.
According to Assistant United States Attorneys Phillip L.B. Halpern and Kyle
W. Hoffman, who are prosecuting the case, Metabolife and Ellis are charged with
falsely representing a number of different material facts to the FDA in letters
dated April 17, 1998 and February 9, 1999. These representations included false
statements by the Defendants that “Metabolife ha[d] never received one notice
from a consumer that any serious adverse health event has occurred because of
the ingestion of Metabolife 356” and that the company had a “claims-free
history.”
United States Attorney Lam said, "It is never acceptable for corporations to
lie to regulatory agencies, but it is particularly egregious when those lies
threaten the public health."
"One of FDA's highest priorities involves our responsibility to ensure that
information about products we regulate is truthful and not misleading, because
people depend on that information to make informed choices," said Acting FDA
Commissioner Dr. Lester M. Crawford. "We will pursue to the full extent of the
law those who would seek to mislead consumers by providing false information or
impeding investigations of risky products."
This case is being investigated by the FDA Office of Criminal Investigations
and the IRS Criminal Investigation Division. United States Attorney Lam stated
that the investigation is continuing.
The defendants are scheduled to be arraigned before Magistrate Judge Louisa
Porter in San Diego on Tuesday, July 27, 2004 at 10:30 a.m.
DEFENDANTS Case Number: 03 CR 1088-J
Metabolife International, Inc. San Diego, CA
Michael J. Ellis
SUMMARY OF CHARGES AND MAXIMUM PENALTIES
Making False Statements to the Food and Drug Administration in violation of
Title 18, United States Code, Section 1001 (Counts 1, 2, 3, 5, 6 and 7)
Maximum penalty is five years in prison and a fine not to exceed
$250,000.
Obstruction of Agency Proceedings in violation of Title 18, United States
Code, Section 1505 (counts 4 and 8)
Maximum penalty is five years in prison and a fine not to exceed $250,000
PARTICIPATING AGENCIES
Food and Drug Administration, Office of Criminal Investigation Internal
Revenue Service, Criminal Investigation Division
An indictment itself is not evidence that the defendants
committed the crimes charged. The defendants are presumed innocent until the
Government meets its burden in court of proving guilt beyond a reasonable doubt.
This advisory was prepared by the FDA Office of Public Affairs.