Promotion of FDA-Regulated Medical Products 11
for review and request that the agency take appropriate
enforcement action.
By its own estimate, NAD processes 150 adver-
tising cases annually, and its decisions constitute the
largest compilation of advertising decisions in the US.
Because NAD legal experts apply federal advertising law
standards to the challenges they review, NAD (and its
appellate body, the National Advertising Review Board,
or NARB) decision database is instructive and educa-
tional for all businesses who advertise their products or
services in the US.
References
1. What We Do. FDA website. https://www.fda.gov/AboutFDA/
WhatWeDo/. Accessed 2 September 2018.
2. 21 U.S.C. 321(g)(1) (2016). Cornell Law website. https://www.
law.cornell.edu/uscode/text/21/321https://www.law.cornell.
edu/uscode/text/21/321. Accessed 2 September 2018.
3. 21 U.S.C. 321(h). Cornell Law website. https://www.law.
cornell.edu/uscode/text/21/321. Accessed 2 September 2018.
4. 21 CFR Subchapters C &D (2016). Cornell Law website.
https://www.law.cornell.edu/cfr/text/21/chapter-I. Accessed 2
September 2018.
5. 21 CFR Subchapter H. GPO website. https://www.gpo.gov/
fdsys/granule/CFR-2011-title21-vol8/CFR-2011-title21-vol8-
chapI-subchapH. Accessed 2 September 2018.
6. The Office of Prescription Drug Promotion. FDA website.
https://www.fda.gov/aboutfda/centersoffices/officeofmedi-
calproductsandtobacco/cder/ucm090142.htm. Accessed 2
September 2018.
7. 21 CFR 314.81(b)(3)(i). FDA website. https://www.fda.gov/
aboutfda/centersoffices/officeofmedicalproductsandtobacco/
cder/ucm090142.htm. Accessed 2 September 2018.
8. 21 CFR 202.1(j)(4). FDA website. https://www.accessdata.
fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=202.1.
Accessed 2 September 2018.
9. Providing Regulatory Submissions in Electronic and Non-Electronic
Format—Promotional Labeling and Advertising Materials for
Human Prescription Drugs: Draft Guidance for Industry (April
2015). FDA website. https://www.fda.gov/downloads/Drugs/
Guidances/UCM443702.pdf. Accessed 2 September 2018.
10. Ibid at 18.
11. Ibid at 8.
12. Ibid at 8–9.
13. Number of core initial promotional campaign material reviews
completed in the month. FDA website. https://www.accessdata.
fda.gov/scripts/fdatrack/view/track.cfm?program=cder&id=C-
DER-RRDS-Number-of-campaign-material-reviews-completed.
Accessed 2 September 2018.
14. FDA-TRACK CDER Dashboard. FDA website. https://www.
fda.gov/AboutFDA/Transparency/track/ucm206444.htm.
Accessed 2 September 2018.
15. Op cit 13.
16. Op cit 9 at 5–11.
17. Ibid at 22.
18. Draft Guidance for Industry: Direct-to-Consumer Television
Advertisements—FDAAA DTC Television Ad Pre-Dissemination
Review Program (March 2012). FDA website. www.fda.gov/
downloads/Drugs/Guidances/UCM295554.pdf. Accessed 2
September 2018.
19. 21 CFR 202.1(j)(1). FDA website. https://www.accessdata.
fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=202.1.
Accessed 2 September 2018.
20. 21 U.S.C. 356(b). GPO website. https://www.gpo.gov/
fdsys/search/pagedetails.action?collectionCode=US-
CODE&browsePath=Title+21%2FChapter+9%2FSub-
chapter+V%2FPart+A%2FSec.+356b&granuleId=US-
CODE-2011-title21-chap9-subchapV-partA-sec356b&package-
Id=USCODE-2011-title21&collapse=true&fromBrowse=true.
Accessed 2 September 2018.
21. 21 CFR 314.550. FDA website. https://www.accessdata.fda.
gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.550.
Accessed 2 September 2018.
22. 21 CFR 314.560. FDA website. https://www.accessdata.fda.
gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.560.
Accessed 2 September 2018.
23. Op cit 9 at 6–7.
24. “Office of Prescription Drug Promotion Submission Process
and eSubmissions Updates” presentation by Lisa Hubbard,
Group Leader, DPDP, OPDP at the DIA Conference:
Marketing Pharmaceuticals 2012: Workshop for Regulatory/
Legal/Communications Professionals and Promotional Review
Teams, 16–17 February 2012, Washington, DC.
25. Drug Information for Consumers: Prescription Drug
Advertising. FDA website. https://www.fda.gov/Drugs/
ResourcesForYou/Consumers/PrescriptionDrugAdvertising/
default.htm. Accessed 2 September 2018.
26. Truthful Prescription Drug Advertising and Promotion.
FDA website. https://www.fda.gov/drugs/guid-
ancecomplianceregulatoryinformation/surveillance/
drugmarketingadvertisingandcommunications/ucm209384.
htm#ExamplesofViolations. Accessed 2 September 2018.
27. OPDP Research. FDA Website. https://www.fda.gov/aboutfda/
centersoffices/officeofmedicalproductsandtobacco/cder/
ucm090276.htm. Accessed 2 September 2018.
28. FDA Warning Letter, 23andMe 11/2013. FDA web-
site. https://www.fda.gov/ICECI/EnforcementActions/
WarningLetters/2013/ucm376296.htm. Accessed 2 September
2018.
29. 15 U.S.C. 52(a) (2016). GPO website. https://www.gpo.gov/
fdsys/granule/USCODE-2011-title15/USCODE-2011-title15-
chap2-subchapI-sec52. Accessed 2 September 2018.
Part
I
Part
II
Part
III
Chapter
1
Chapter
4
Chapter
7
Chapter
2
Chapter
5
Chapter
3
Chapter
6
for review and request that the agency take appropriate
enforcement action.
By its own estimate, NAD processes 150 adver-
tising cases annually, and its decisions constitute the
largest compilation of advertising decisions in the US.
Because NAD legal experts apply federal advertising law
standards to the challenges they review, NAD (and its
appellate body, the National Advertising Review Board,
or NARB) decision database is instructive and educa-
tional for all businesses who advertise their products or
services in the US.
References
1. What We Do. FDA website. https://www.fda.gov/AboutFDA/
WhatWeDo/. Accessed 2 September 2018.
2. 21 U.S.C. 321(g)(1) (2016). Cornell Law website. https://www.
law.cornell.edu/uscode/text/21/321https://www.law.cornell.
edu/uscode/text/21/321. Accessed 2 September 2018.
3. 21 U.S.C. 321(h). Cornell Law website. https://www.law.
cornell.edu/uscode/text/21/321. Accessed 2 September 2018.
4. 21 CFR Subchapters C &D (2016). Cornell Law website.
https://www.law.cornell.edu/cfr/text/21/chapter-I. Accessed 2
September 2018.
5. 21 CFR Subchapter H. GPO website. https://www.gpo.gov/
fdsys/granule/CFR-2011-title21-vol8/CFR-2011-title21-vol8-
chapI-subchapH. Accessed 2 September 2018.
6. The Office of Prescription Drug Promotion. FDA website.
https://www.fda.gov/aboutfda/centersoffices/officeofmedi-
calproductsandtobacco/cder/ucm090142.htm. Accessed 2
September 2018.
7. 21 CFR 314.81(b)(3)(i). FDA website. https://www.fda.gov/
aboutfda/centersoffices/officeofmedicalproductsandtobacco/
cder/ucm090142.htm. Accessed 2 September 2018.
8. 21 CFR 202.1(j)(4). FDA website. https://www.accessdata.
fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=202.1.
Accessed 2 September 2018.
9. Providing Regulatory Submissions in Electronic and Non-Electronic
Format—Promotional Labeling and Advertising Materials for
Human Prescription Drugs: Draft Guidance for Industry (April
2015). FDA website. https://www.fda.gov/downloads/Drugs/
Guidances/UCM443702.pdf. Accessed 2 September 2018.
10. Ibid at 18.
11. Ibid at 8.
12. Ibid at 8–9.
13. Number of core initial promotional campaign material reviews
completed in the month. FDA website. https://www.accessdata.
fda.gov/scripts/fdatrack/view/track.cfm?program=cder&id=C-
DER-RRDS-Number-of-campaign-material-reviews-completed.
Accessed 2 September 2018.
14. FDA-TRACK CDER Dashboard. FDA website. https://www.
fda.gov/AboutFDA/Transparency/track/ucm206444.htm.
Accessed 2 September 2018.
15. Op cit 13.
16. Op cit 9 at 5–11.
17. Ibid at 22.
18. Draft Guidance for Industry: Direct-to-Consumer Television
Advertisements—FDAAA DTC Television Ad Pre-Dissemination
Review Program (March 2012). FDA website. www.fda.gov/
downloads/Drugs/Guidances/UCM295554.pdf. Accessed 2
September 2018.
19. 21 CFR 202.1(j)(1). FDA website. https://www.accessdata.
fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=202.1.
Accessed 2 September 2018.
20. 21 U.S.C. 356(b). GPO website. https://www.gpo.gov/
fdsys/search/pagedetails.action?collectionCode=US-
CODE&browsePath=Title+21%2FChapter+9%2FSub-
chapter+V%2FPart+A%2FSec.+356b&granuleId=US-
CODE-2011-title21-chap9-subchapV-partA-sec356b&package-
Id=USCODE-2011-title21&collapse=true&fromBrowse=true.
Accessed 2 September 2018.
21. 21 CFR 314.550. FDA website. https://www.accessdata.fda.
gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.550.
Accessed 2 September 2018.
22. 21 CFR 314.560. FDA website. https://www.accessdata.fda.
gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.560.
Accessed 2 September 2018.
23. Op cit 9 at 6–7.
24. “Office of Prescription Drug Promotion Submission Process
and eSubmissions Updates” presentation by Lisa Hubbard,
Group Leader, DPDP, OPDP at the DIA Conference:
Marketing Pharmaceuticals 2012: Workshop for Regulatory/
Legal/Communications Professionals and Promotional Review
Teams, 16–17 February 2012, Washington, DC.
25. Drug Information for Consumers: Prescription Drug
Advertising. FDA website. https://www.fda.gov/Drugs/
ResourcesForYou/Consumers/PrescriptionDrugAdvertising/
default.htm. Accessed 2 September 2018.
26. Truthful Prescription Drug Advertising and Promotion.
FDA website. https://www.fda.gov/drugs/guid-
ancecomplianceregulatoryinformation/surveillance/
drugmarketingadvertisingandcommunications/ucm209384.
htm#ExamplesofViolations. Accessed 2 September 2018.
27. OPDP Research. FDA Website. https://www.fda.gov/aboutfda/
centersoffices/officeofmedicalproductsandtobacco/cder/
ucm090276.htm. Accessed 2 September 2018.
28. FDA Warning Letter, 23andMe 11/2013. FDA web-
site. https://www.fda.gov/ICECI/EnforcementActions/
WarningLetters/2013/ucm376296.htm. Accessed 2 September
2018.
29. 15 U.S.C. 52(a) (2016). GPO website. https://www.gpo.gov/
fdsys/granule/USCODE-2011-title15/USCODE-2011-title15-
chap2-subchapI-sec52. Accessed 2 September 2018.
Part
I
Part
II
Part
III
Chapter
1
Chapter
4
Chapter
7
Chapter
2
Chapter
5
Chapter
3
Chapter
6