FDA Cases for Mislabelling of GHB
DEFENDANT: Gary (Last Name removed to allow privacy), at Dallas, Texas (N.D.Texas); Criminal No. 3:94-CR-102-R.
CHARGED 3-24-94:
Count 1: The defendant knowingly made a false statement during an inspection where he told FDA agents that he had not received any products containing gamma hydroxybutyric acid (GHB) from any other supplier when, in fact, he had received GHB products from at least one other source--18 U.S.C. section 1001.
Count 2: The defendant, with the intent to defraud and mislead, caused 50 misbranded bottles of GHB to be introduced in interstate commerce. The bottles were misbranded in that they were in package form and did not bear labels containing the name and place of business of the manufacturer, packer and distributor or an accurate statement of the quantity of the contents in terms of weight measure and numerical count--502(b). The bottles were also misbranded in that the labels failed to bear the established name of the drug and adequate directions for use--301(a), 303(a)(2), and 18 U.S.C. section 2.
DISPOSITION: Guilty plea; sentenced to 33 months in prison and three years of supervised release. (F.D.C. No. 66859; S.J. No. 11)
DEFENDANT: Jeffrey (Last Name removed to allow privacy), d/b/a Champion Distributors, at Horsham, Pa. (E.D.Pa.); Criminal No. 92-0009-01.
CHARGED 6-6-91:
Count 1: The defendant caused to be introduced into interstate commerce a bulk quantity of GHB which was misbranded in that the labels failed to bear adequate directions for use--301(a), 303(a)(1), and 18 U.S.C. section 2.
Count 2: The defendant caused the introduction of an unapproved new drug into interstate commerce--301(d) and 303(a)(1).
DISPOSITION: Guilty plea; sentenced to 18 months' probation and fined $500. (F.D.C. No. 66107; S.J. No. 12)
CHARGED 3-24-94:
Count 1: The defendant knowingly made a false statement during an inspection where he told FDA agents that he had not received any products containing gamma hydroxybutyric acid (GHB) from any other supplier when, in fact, he had received GHB products from at least one other source--18 U.S.C. section 1001.
Count 2: The defendant, with the intent to defraud and mislead, caused 50 misbranded bottles of GHB to be introduced in interstate commerce. The bottles were misbranded in that they were in package form and did not bear labels containing the name and place of business of the manufacturer, packer and distributor or an accurate statement of the quantity of the contents in terms of weight measure and numerical count--502(b). The bottles were also misbranded in that the labels failed to bear the established name of the drug and adequate directions for use--301(a), 303(a)(2), and 18 U.S.C. section 2.
DISPOSITION: Guilty plea; sentenced to 33 months in prison and three years of supervised release. (F.D.C. No. 66859; S.J. No. 11)
DEFENDANT: Jeffrey (Last Name removed to allow privacy), d/b/a Champion Distributors, at Horsham, Pa. (E.D.Pa.); Criminal No. 92-0009-01.
CHARGED 6-6-91:
Count 1: The defendant caused to be introduced into interstate commerce a bulk quantity of GHB which was misbranded in that the labels failed to bear adequate directions for use--301(a), 303(a)(1), and 18 U.S.C. section 2.
Count 2: The defendant caused the introduction of an unapproved new drug into interstate commerce--301(d) and 303(a)(1).
DISPOSITION: Guilty plea; sentenced to 18 months' probation and fined $500. (F.D.C. No. 66107; S.J. No. 12)