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OPDP 2014 Enforcement
Lessons
Enforcement Activity Declining
139
156
108
7564
28 25 23 2922 19 21
4152
31 28 249
0
40
80
120
160
200
1997 2000 2003 2006 2009 2012
OPDP Enforcement Letters
Social Media Enforcement
22%of OPDP letters were
social media/space-limited
3
4
The Violations
• Omission of risk information
• Omission of material facts
5
6
7
The Violations
• Omission of risk information
• Inadequate presentation of
established name
• Lack of adequate directions for use
• Failure to submit 2253
8
The 2009 Violations
• Omission of risk information
• Failure to use established name
• Inadequate communication of indication
• Overstatement of efficacy
9
Lessons from 2014 Activity
• Promulgate your policies
• Regularly monitor prominent platforms
• Control your “agents”
10
