Contains Nonbinding Recommendations  
Compliance Policy Guide 
Section 101.100 FDA Considerations for Recommending Charges 
Under 21 U.S.C. 331(a) or (d) for Causing the Introduction of 
Violative Products into Interstate Commerce 
Guidance for FDA Staff 
 
Submit one set of either electronic or written comments on this guidance at any time. Submit 
electronic comments to http://www.regulations.gov. Submit written comments to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket number of this 
Compliance Policy Guide: FDA-2016-D-3329. 
 
For questions regarding this document contact Anthony Taube with the Office of Regulatory 
Affairs (ORA) at 240-402-4565.  
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Regulatory Affairs 
 
October 2016   
 
  Contains Nonbinding Recommendations  
Table of Contents  
 
I.  Introduction 
 
II.  Background 
 
III.  Policy 
 
A. Factors FDA Staff will Consider 
 
B. Collaboration with Federal Law Enforcement Agencies  
 
IV.  Regulatory Action Guidance 
   
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  Contains Nonbinding Recommendations  
Compliance Policy Guide 
Section 101.100 FDA Considerations for Recommending Charges 
Under 21 U.S.C. 331(a) or (d) for Causing the Introduction of 
Violative Products into Interstate Commerce 
Guidance for FDA Staff 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this 
topic.  It does not create or confer any rights for or on any person and does not operate to bind 
FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance.  If you cannot 
identify the appropriate FDA staff, call the telephone number listed on the title page of this 
guidance.  
 
I.  Introduction:  
 
The purpose of this Compliance Policy Guide is to provide guidance to FDA staff when 
considering recommending charges under 21 U.S.C. 331(a) or (d), the Food Drug & Cosmetic 
Act 301(a) or (d). 
 
FDAs guidance documents, including this guidance document, do not establish legally 
enforceable responsibilities.  Instead, guidances describe the agencys current thinking on a topic 
and should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidances means that something 
is suggested or recommended, but not required. 
 
II.  Background 
 
Sections 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
 331(a) and (d)) prohibit introducing, delivering for introduction, or causing the introduction 
or delivery for introduction into interstate commerce of certain products that violate the FD&C 
Act, such as adulterated or misbranded food, drugs, devices, tobacco products and cosmetics, as 
well as unapproved new drugs.  
 
Over the past few decades, an increasingly global and national marketplace has expanded the 
number of complex multi-party transactions involving FDA-regulated products.  Modern 
technologies such as the Internet have made direct sales from global and national manufacturers 
and distributors to a wider range of middlemen both more feasible and more common. Given the 
changes in technology and the greater variety of transactions, FDA is clarifying its enforcement 
policy with respect to certain types of conduct under section 301(a) or (d) of the FD&C Act, 
under a causing theory. 
 
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  Contains Nonbinding Recommendations  
As the Supreme Court has held, the overriding purpose of the FD&C Act is to protect the public 
from unsafe and ineffective products by regulating those products throughout the distribution 
chain. To ensure the integrity of that distribution chain, in considering judicial actions involving 
potential charges under section 301(a) or (d) of the FD&C Act for causing the introduction of 
violative products into interstate commerce through purchasing or ordering such products 
(purchasing conduct), FDA staff recommending enforcement actions to the United States 
Department of Justice (DOJ) will focus on only purchasing conduct by those firms or individuals 
who perform a direct or facilitating role in distributing FDA-regulated products, rather than on 
ultimate consumers, as discussed below.  
 
III.  Policy 
 
FDA staff must carefully consider any decision to recommend a civil injunction or criminal 
prosecution involving purchasing conduct that violates section 301(a) or (d) of the FD&C Act 
based on a causing theory. 
 
A. Factors FDA Staff will Consider 
 
FDA staff will apply the following criteria in evaluating such potential charges: 
 
1.  FDA staff will not recommend to DOJ a criminal prosecution charging an 
ultimate consumer with a violation of section 301(a) or (d) for purchasing 
conduct.   In determining whether an individual is an ultimate consumer, 
agency staff may look behind any representation by the individual that the 
products at issue are for personal use.  In doing so, staff will take into account 
factors such as the volume of product ordered and shipped to the individual, the 
frequency of such orders and shipments, and any other indicia of distribution 
beyond personal use. 
2.  Generally, FDA staff also will not recommend to DOJ a civil injunction against 
an ultimate consumer (as defined above) premised on a violation of section 301(a) 
or (d) for purchasing conduct.  However, an exception to this general policy may 
be made where both FDAs Deputy Commissioner for Global Regulatory 
Operations and Policy and Chief Counsel: (1) specifically find that a compelling 
public health need or other compelling circumstances warrant bringing such an 
action, AND (2) authorize the agency to recommend such an action to DOJ.  
Those officials will not delegate such authority.  
3.  When there is sufficient evidence supporting either (A) a charge under section 
301(c) for receiving violative products in interstate commerce and proffering their 
further delivery or (B) a subsequent violation of section 301(a) or (d) after receipt 
of the violative products, FDA staff will not recommend to DOJ a civil injunction 
or a criminal prosecution against a middleman based on purchasing conduct.   
4.  When there is not sufficient evidence under paragraph 3(A) or 3(B), above, FDA 
staff will not recommend to DOJ a civil injunction or criminal prosecution against 
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  Contains Nonbinding Recommendations  
a middleman based on purchasing conduct in violation of section 301(a) or (d) 
except under the following circumstances: 
A.  The purchasing conduct involves facilitating distribution between third parties 
and either other middlemen or ultimate consumers; OR   
B.  Both FDAs Deputy Commissioner for Global Regulatory Operations and 
Policy and Chief Counsel: (1) specifically find that a compelling public health 
need or other compelling circumstances warrant bringing such a charge AND 
(2) authorize the agency to recommend such a charge to DOJ.  Those officials 
will not delegate such authority. 
5.  If, after following the process described in paragraphs 2 and 4(B) above, FDAs 
Deputy Commissioner for Global Regulatory Operations and Policy and Chief 
Counsel authorize the agency to recommend charges to DOJ, FDA staff will 
advise DOJs Consumer Protection Branch of the recommendation. 
 
These criteria are intended solely for use by FDA personnel, do not create or confer any rights or 
benefits for or on any person, and do not operate to bind FDA. 
 
B. Collaboration with Federal Law Enforcement Agencies 
 
The importation or distribution of misbranded or adulterated articles remains unlawful under the 
FD&C Act.  See 21 U.S.C.  331, 355, 381.  FDA staff should, as appropriate, confer with other 
federal law enforcement agencies, including DOJ and the U.S. Department of Homeland 
Security/Customs and Border Protection, to prevent or deter the unlawful importation or 
distribution of misbranded or adulterated articles.  See, e.g., 18 U.S.C.  541, 542, 545; 19 
U.S.C.  1592, 1595a; 21 U.S.C.  331-334, 381. 
 
IV.  Regulatory Action Guidance 
 
Refer to the FDA Regulatory Procedures Manual section Chapter 6 for information on Judicial 
Actions. 
 
Issued:  10/18/2016 
 
 
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