=~FILED
Case 8:15-cr-00283-GJH Document 1 Filed 05/20/15
Page 1 of__
7

OOERED

=-_LOGGED

MA
'"

ATGREE "

gn~d~
.

IN THE UNITED STATES DISTRICT cQuR~Fs'~"RYC~
FOR THE DISTRICT OF MARYLAND'

*

UNITED STATES OF AMERICA

*
v.

*

CRIMINAL

NO.

G->JI-I

\ S c..v-d'1S3

*
GA VIN BURNS SMITH,

*
*

*

Defendant

*
*
*
*
*
*******

(Introduction of Misbranded Dru~s
Into Interstate Commerce \Vith Intent
to Defraud or Mislead, 21 U.S.c.
~~ 331 (a), 333(a)(2); Aiding and
Abetting, 18 U.S.c. ~ 2; Forfeiture, 28
U.S.c. ~ 2461(a), 21 U.S.c. ~~ 334,
853(p»

INDICTMENT
COUNTS ONE THROUGH SEVEN
(Introduction of Misbranded Drugs Into Interstate
Commerce With Intent to Defraud or Mislead)
The Grand Jury for the District of Maryland charges that:
Introduction
At all times relevant to this Indictment:
I.

The Food and Drug Administration ("FDA") was an agency of the United States

Government charged with the responsibility of protecting the health and safety of the public by
enforcing the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C.

99

301-397, to ensure

that, among other things. drugs sold for use by or upon humans were safe and effective, and bore
labeling containing accurate information and adequate directions for use. The FDA's
responsibilities under the FDCA included regulating the manufacture, labeling, and distribution
of all drugs. drug components, and biological products introduced into interstate commerce.

 Case 8:15-cr-00283-GJH Document 1 Filed 05/20/15 Page 2 of 7

2.

The FDCA defined a "drug" as, among other things. "articles intended for use in

the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals," and
"articles (other than food) intended to affect the structure or any function of the body of man or
other animals." 21 U.S.c.

S 321 (g)(l).

A "new drug" was defined as any drug the composition

of which is not generally recognizcd by experts as safe and effective for the use under the
conditions prescribed, recommended, or suggested in the labeling. 21 U.S.C.
3.

S 321(p).

The FDCA provided that, before a new drug can be shipped in interstate

commerce, its manufacturer first must obtain FDA approval of a New Drug Application
("'NDA") for that drug. 21 U.S.c.

SS

355(a) and 331(d). The manufacturer ofa new drug must

have submitted information in the NDA showing to the FDA's satisfaction that the new drug was
safe and effective for its intended use. 21 U.S.C.
4.

S 355(b)(I);

21 C.F.R.

S 314.50.

The FDA enforced drug safety and efficacy standards by guarding against the

misbranding of drugs. Under the FDCA, a drug was misbranded if its labeling was false or
misleading in any particular. 21 U.S.C.

S 352(a).

Labeling included "all labels and other

written, printed, or graphic matter upon any a11icleor any of its containers or wrappers, or
accompanying such article." 21 U.S.c.

S 321(m).

A drug was deemed misbranded unless its

labeling bore. among other things: (1) truthful and non-misleading infonnation; (2) adequate
directions for use; and (3) adequate warnings against use in those with pathological conditions or
by children where its use may be dangerous to health, or against unsafe dosage or methods of
direction of administration application, in such manner or form as are necessary for the
protection of users. 21 U.S.c.
5.

SS

352(a) and (t).

The FDCA prohibited the introduction or delivery for introduction into interstate

commerce (or the causing thereof) of any drug that was misbranded, 21 U.S.C.
2

S 331(a),

and any

 Case 8:15-cr-00283-GJH Document 1 Filed 05/20/15 Page 3 of 7

new drug unless an application for that drug had been tiled with the FDA, 21 U.S.c.

SS

331 (d)

and 355.
The Defendant
6.

Defendant Gavin Burns SM ITH was a resident of Florida, and owned and

operated Precision Peptides ("Precision") and DNA Peptides ("'DNA Peptides'").
7.

SMITH owned and operated Precision from at least in or about December 20 I0

through in or about April 2012. Precision operated out of 1642 Land 0' Lakes Boulevard, Lutz,
Florida, and advertised on the Internet through the website www.precisionpeptides.com

("the

Precision website").
8.

SMITH owned and operated DNA Peptides between in or about April 20 I2

through in or about May 2015.

From between in or about April 2012 through at least in or about

August 22, 2012, DNA Peptides operated out of 8022 Old Country Road 54, New Port Richey,
Florida, and advertised on the Internet from the website www.dnapeptides.com.

9.

-

On or about August 22.. 2012, law enforcement executed search warrants issued

by the United States District Court for the Middle District of Florida at Precision (1642 Land 0'
Lakes Boulevard, Lutz, Florida) and DNA Peptides (8022 Old Country Road 54, New Port
Richey, Florida).
10.

At some time after August 22, 2012, but prior to in or about March 2015, SMITH

began operating DNA Peptides out of his residence at 8306 Night Owl Court, New Port Richey,
Florida, and advertised on the Internet from the website www.dnapeptides.net
www.dnapeptides.com.
11.

(collectively, with

"the DNA Peptides websites").

Through Precision and DNA l'eptides, SMITH sold body-enhancing injectable

drugs to individual consumers seeking to enhance their physiques. The drugs that SMITH sold
3

 Case 8:15-cr-00283-GJH Document 1 Filed 05/20/15 Page 4 of 7

through Precision and DNA peptides included, but were not limited to, Growth Hormone
Releasing Peptide-2 ("GHRP-2"), Growth HomlOne Releasing Peptide-6 ("GHRP-6''),
Melanotan II, Growth HomlOne Releasing Hormone ("CJC-1295"), Ipamorelin, I-Iuman Growth
Honnone Fragment ("HGH Fragment"), Mechano Growth Factor, and Dehydroepiandrosterone
("DHEA"). These drugs were not approved by the FDA for usc in humans.
12.

SMITH caused the DNA Peptides and Precision websites to display numerous

disclaimcrs stating that the products sold on the websites were "For Rcsearch/Laboratory

Use

Only." In addition. prior to purchasing any products from the DNA Peptides or Precision
websites, each customcr was asked to certify that the customcr had read the following
disclaimer: "The chemicals/materials

for sale here are intended for laboratory and research use

only, unless otherwise explicitly stated. They are not intended for human ingestion or for use in
products that may be ingested." SMITH sold the products in vials that were labeled, "For
Research/Laboratory Use Only" and "Not intended for human use."
The Charge
13.

On or about each date listed below, in the District of Maryland and elsewhere, the

defendant.
GA VIN BURNS SMITH,
with the intent to defraud and mislead, did cause the introduction into interstate commerce drugs
that were misbranded under Title 21, United States Code, Section 352. in that their labels bore
false and misleading labeling, to wit, the labels stated that the products were for research use

4

 Case 8:15-cr-00283-GJH Document 1 Filed 05/20/15 Page 5 of 7

only, when in fact SMITH knew and fully intended that the products be used to affect the
structure and function of the body.

COUNT

DATE

MAILING

I

November 21, 2011

2

February 9. 2012

3

May 2, 2012

4

November 1,2012

5

April 17,2013

6

August 5, 2013

7

March 12,2015

Package containing four vials labeled "Sildenafil Citrate;" four
vials labeled "GHRp.2;" one vial labeled "Melatonan II;" two
vials labeled "CJC.1295;" and, one vial labeled "Myostatin
Propeptide, " mai led from 1642 Land 0' Lakes Boulevard,
Lutz, Florida to 14625 Baltimore Ave, Laurel, Maryland.
Package containing four vials labeled "CJC-1295 NO DAC:"
sixteen vials labeled "GHRP-2;" four vials labeled
"Ipamorelin;" and, four vials labeled "HGH Fragment," mailed
from 1642 Land 0' Lakes Boulevard, Lutz, Florida to 14625
Baltimore Ave, Laurel, Marvland.
Package containing four vials labeled "GHRp.2;" lour vials
labeled "CJC.1295 NO DAC;" two vials labeled "HGH
Fragment;" and, four vials labeled "Ipamorelin," mailed from
8022 Old Country Road 54, New Port Richey, Florida to
14625 Baltimore Ave, Laurel, Maryland.
Package containing sixteen vials labeled "GHRp.2;" four vials
labeled "CJC.1295 DAC;" four vials labeled "HGH
Fragment;" and, four vials labeled "Ipamorelin," mailed from
8022 Old Country Road 54, New Port Richey, Florida to 5430
Lynx Lane, Columbia, Marvland.
Package containing one vial labeled "ACE.031;" one vial
labeled "Follistatin;" four vials labeled "GHRP.2;" and, one
vial labeled "PT -141:' mailed from 8022 Old Country Road
54, New Port Richey, Florida to 5430 Lynx Lane. Columbia,
Maryland.
Package containing two vials labeled "GHRP-6;" two vials
labeled "CJC.1293;" one vial labeled "Follistatin;" and, one
vial labeled "Ipamorelin," mailed from 8022 Old Country
Road 54, New Port Richey. Florida to I0451 Twin Rivers
Road, 288, Columbia, Marvland.
Package containing one vial labeled "Melanotan 1I;" four vials
labeled "GHRP.6;" four vials labeled "CJC 1295 NO DAC;"
two vials labeled "Sermorelin;" two vials labeled "TB.500;"
and. two vials labeled "Triptore/in," mailed from 6306 Night
Owl Court, New Port Richey, Florida to 10901 Rhode Island
Avenue, Beltsville, Marvland.

21 V.S.c.
18 V.S.c.

SS 331(a)
S2

and 333(a)(2)
5

 Case 8:15-cr-00283-GJH Document 1 Filed 05/20/15 Page 6 of 7

FOFEITURE ALLEGATION
The Grand Jury for the District of Maryland further tinds that:
J.

Pursuant to Federal Rule of Criminal Procedure 32.2, notice is hereby given to the

defendant that the United States will seek forfeiture as part of any sentence in accordance with
Title 28, United States Code, Section 2461 (a), and Title 21, United States Code, Sections 334
and 853(p), in the event of the defendant's conviction on any of Counts One through Seven of
this Indictment.
2.

As a result of the offenses set forth in Counts One through Seven of this

Indictment, the defendant,
GA VIN BURNS SMITH,
shall forfeit to the United States of America, all property, real and personal, (a) which was used
or intended to be used to commit the offense, or (b) which constitutes and is derived from
proceeds traceable to the offense.
3.

The property to be forfeited includes, but is not limited to, the following: a money

judgment equal to the value of the proceeds of the charged offense, which amounts to at least
$2,102.684.06 in United States currency.
4.

Ifany of the property described above as being subject to forfeiture, as a result of

any act or omission of any defendant:
a.

cannot be located upon the exercise of due diligence;

b.

has been transferred or sold to, or deposited with, a third person;

c.

has been placed beyond the jurisdiction of the Court;

d.

has been substantially diminished in value; or,

6

 Case 8:15-cr-00283-GJH Document 1 Filed 05/20/15 Page 7 of 7

e.

has been commingled with other property which cannot be divided
without difficulty;

it is the intent of the United States, pursuant to Title 21, United States Code, Section 853(P), to
seek forfeiture of any other property of said defendant up to the value of the forfeitable property,
that is, at least $2, I02,684.06.

28 U.S.C.
21 U.S.C.

S 2461 (a)

SS 334 and

853(p)

Red J.

. f.uH
fOSR/hPfLA~

Rod J. Rosenstein
United States Attorney
A TRUE BILL:

sim/;)o IS

SIGNATURE REDACTED

Forepersofr'...)

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Date

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