Office of the Attorney General News Release Archive


Wednesday, September 15, 1999

CORNYN SHUTS DOWN SALE OF UNAPPROVED DRUG

Dallas based Quantum Leap Inc. ordered to destroy product and refund customers

AUSTIN - Texas Attorney General John Cornyn today announced a settlement that requires Dallas based Quantum Leap, Inc. to destroy nearly 15,000 bottles of products containing human growth hormone ("HGH"). The settlement, known as an Assurance of Voluntary Compliance, also requires the company to stop distributing the products without the approval of the Federal Food and Drug Administration. In addition, Quantum Leap has agreed to refund consumers their purchase price and pay a total of $45,000 to the State in civil penalties, investigative costs and attorneys fees.

Quantum Leap, Inc. has distributed Regenesis and Lifespan, both of which were advertised to contain HGH, as dietary supplements through multi-level marketing. The State alleges that Regenesis and Lifespan are unapproved new drugs under both federal and state drug laws because they contain HGH and have not been approved by the FDA.

HGH is produced by the pituitary gland and genetically synthesized versions are available legally only for use in humans with FDA approval or if a physician has prescribed its use for a patient. In addition, the possession with intent to distribute and the distribution of HGH for unapproved uses or without a physician's prescription are felony criminal offenses under federal law.

Quantum Leap Inc. must refund any consumer who requests a refund in writing or returns a container from any of these products within 180 days of the filing of this AVC. Requests for refunds should be sent to Quantum Leap, Inc., 3230 Commander Rd., Carrollton, Texas 75006.

The Assurance of Voluntary Compliance was filed in Dallas County District Court. This case was handled by Assistant Attorney General Joyce Wein Illya in the Dallas office of the Attorney General's Consumer Protection Division.

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Contact Ted Delisi, Heather Browne, or Tom Kelley at (512) 463-2050