[Federal Register Volume 81, Number 220 (Tuesday, November 15, 2016)]
[Notices]
[Pages 80077-80078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27417]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1162]


Louis Daniel Smith: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The U.S. Food and Drug Administration (FDA or Agency) is 
issuing an order under the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) permanently debarring Louis Daniel Smith from providing 
services in any capacity to a person that has an approved or pending 
drug product application. FDA bases this order on a finding that Mr. 
Smith was convicted of felonies under Federal law for conduct relating 
to the development or approval, including the process for development 
or approval, of a drug product, or otherwise relating to the regulation 
of a drug product under the FD&C Act. Mr. Smith was given notice of the 
proposed permanent debarment and an opportunity to request a hearing 
within the timeframe prescribed by regulation. Mr. Smith failed to 
respond. Mr. Smith's failure to respond constitutes a waiver of his 
right to a hearing concerning this action.

DATES: This order is effective November 15, 2016.

ADDRESSES: Submit applications for special termination of debarment to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Enforcement, 
Office of Enforcement and Import Operations, Office of Regulatory 
Affairs (ELEM-4144), Food and Drug Administration, 12420 Parklawn Dr., 
Rockville, MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A)) 
requires debarment of an individual if FDA finds that the individual 
has been convicted of a felony under Federal law for conduct relating 
to the development or approval, including the process for development 
or approval, of any drug product. Section 306(a)(2)(B) of the FD&C Act 
requires debarment of an individual if FDA finds that the individual 
has been convicted of a felony under Federal law for conduct otherwise 
relating to the regulation of any drug product under the FD&C Act.
    On October 27, 2015, the U.S. District Court for the Eastern 
District of Washington entered judgment against Mr. Smith for one count 
of conspiracy, in violation of 18 U.S.C. 371, three counts of 
introducing misbranded drugs into interstate commerce with intent to 
defraud or mislead, in violation of section 301(a) of the FD&C Act (21 
U.S.C. 331(a)), which according to section 303(a)(2) of the FD&C Act 
(21 U.S.C. 333(a)(2)) constitutes a felony, and one count of smuggling 
in violation of 18 U.S.C. 545.
    The factual basis for this conviction is as follows: Mr. Smith was 
a managing member of PGL International, LLC (PGL), and served as the 
director of PGL's operations. PGL is a Nevada corporation, which 
marketed and sold various health-related products, including Miracle 
Mineral Solution (MMS), a mixture of sodium chlorite and water. Sodium 
chlorite is an industrial chemical used as a pesticide and for 
hydraulic fracking and wastewater treatment. Sodium chlorite cannot be 
sold for human consumption and suppliers of the chemical include a 
warning sheet stating that it can cause potentially fatal side effects 
if swallowed. Mr. Smith obtained chemicals needed to manufacture the 
misbranded drug MMS without revealing to regulators and suppliers the 
true purpose of the chemicals; used those chemicals to manufacture the 
misbranded drug MMS in a facility that was not disclosed to regulators; 
offered the misbranded drug MMS for sale on Web sites Mr. Smith had 
established; and sold that drug in interstate commerce.
    From on or about September 11, 2004, to at least on or about July 
16, 2012, in the Eastern District of Washington and elsewhere, Mr. 
Smith introduced, delivered for introduction into interstate commerce, 
and caused the introduction and delivery for introduction into 
interstate commerce, with the intent to defraud or mislead, misbranded 
drugs. In addition, he knowingly defrauded the United States and also 
impeded the lawful government functions of FDA, specifically, FDA's 
duty to protect the health and safety of the public by, among other 
things, ensuring that drugs marketed in the United States are safe and 
effective for their intended uses and are manufactured in 
establishments that are registered with FDA, and that the labeling of 
such drugs bears true and accurate information.
    As a result of this conviction, FDA sent Mr. Smith by certified 
mail on August 5, 2016, a notice proposing to permanently debar him 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal was based on 
a finding, under section 306(a)(2) of the FD&C Act, that Mr. Smith was 
convicted of felonies under Federal law for conduct relating to the 
development or approval, including the process for development or 
approval, of a drug product, or conduct otherwise relating to the 
regulation of a drug product under the FD&C Act. The proposal also 
offered Mr. Smith an opportunity to request a hearing, providing him 30 
days from the date of receipt of the letter in which to file the 
request, and advised him that failure to request a hearing constituted 
a waiver of the opportunity for a hearing and of any contentions 
concerning this action. Mr. Smith received the proposal on August 8, 
2016. Mr. Smith did not request a hearing and has, therefore, waived 
his opportunity for a hearing and any contentions concerning his 
debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import 
Operations, Office of Regulatory Affairs, under section 306(a)(2) of 
the FD&C Act, under authority delegated to him (Staff Manual Guide 
1410.35), finds that Louis Daniel Smith has been convicted of felonies 
under Federal law for conduct relating to the development or approval, 
including the process for development or approval, of a drug product, 
or conduct otherwise relating to the regulation of a drug product under 
the FD&C Act.
    As a result of the foregoing finding, Louis Daniel Smith is 
permanently debarred from providing services in any capacity to a 
person with an approved or pending drug product application under 
sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 
382), or under section 351 of the Public Health Service Act (42 U.S.C. 
262), effective (see DATES) (see section 201(dd) (21 U.S.C. 321(dd)), 
306(c)(1)(B), and 306(c)(2)(A)(ii) of the FD&C Act). Any person with an 
approved or pending drug product application who knowingly employs or 
retains as a consultant or contractor, or otherwise uses the services 
of Louis Daniel Smith, in any capacity during his debarment, will be 
subject to civil money penalties (section 307(a)(6) of the

[[Page 80078]]

FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Smith provides services in any 
capacity to a person with an approved or pending drug product 
application during his period of debarment he will be subject to civil 
money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA 
will not accept or review any abbreviated new drug applications from 
Mr. Smith during his period of debarment (section 306(c)(1)(B) of the 
FD&C Act).
    Any application by Mr. Smith for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2016-N-1162 and sent to the Division of Dockets 
Management (see ADDRESSES). All such submissions are to be filed in 
four copies. The public availability of information in these 
submissions is governed by 21 CFR 10.20.
    Publicly available submissions will be placed in the docket, and 
will be viewable at http://www.regulations.gov or at the Division of 
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: November 9, 2016.
Armando Zamora,
Deputy Director, Office of Enforcement and Import Operations, Office of 
Regulatory Affairs.
[FR Doc. 2016-27417 Filed 11-14-16; 8:45 am]
 BILLING CODE 4164-01-P