Guidance for Industry 
Internet/Social Media Platforms with 
Character Space Limitations 
Presenting Risk and Benefit Information 
for Prescription Drugs and Medical 
Devices 
 
 
DRAFT GUIDANCE 
 
This guidance document is being distributed for comment purposes only. 
 
Comments and suggestions regarding this draft document should be submitted within 90 days of 
publication in the Federal Register of the notice announcing the availability of the draft guidance.  
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 listed in the notice 
of availability that publishes in the Federal Register. 
 
For questions regarding this draft document, contact (CDER) Jean-Ah Kang at 301-796-1200; (CBER) 
Office of Communication, Outreach and Development at 800-835-4709 or 240-402-7800; (CVM) 
Dorothy McAdams at 240-453-6802; or (CDRH) Deborah Wolf at 301-796-5732. 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
Center for Veterinary Medicine (CVM) 
Center for Devices and Radiological Health (CDRH) 
 
June 2014 
Advertising  
 
Guidance for Industry
 
Internet/Social Media Platforms with 
Character Space Limitations
Presenting Risk and Benefit Information 
for Prescription Drugs and Medical 
Devices 
 
Additional copies are available from: 
 
Office of Communications, Division of Drug Information  Communications Staff (CVM) 
Center for Drug Evaluation and Research  Center for Veterinary Medicine 
Food and Drug Administration  Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 51, rm. 2201  7519 Standish Place, HFV-12 
Silver Spring, MD 20993-0002  Rockville, MD 20855 
Tel: 301-796-3400; Fax: 301-847-8714;  Tel: 240-276-9300; 
E-mail: druginfo@fda.hhs.gov  E-mail: AskCVM@fda.hhs.gov 
http://www.fda.gov/Drugs/GuidanceComplianceRegulator http://www.fda.gov/AnimalVeterinary/GuidanceComplianceE
yInformation/Guidances/default.htm  nforcement/GuidanceforIndustry/default.htm 
 
Office of Communication, Outreach and Development   Office of the Center Director 
Center for Biologics Evaluation and Research  Guidance and Policy Development 
Food and Drug Administration  Center for Devices and Radiological Health 
10903 New Hampshire Ave., WO71, Room 3128  Food and Drug Administration 
Silver Spring, MD 20993  10903 New Hampshire Ave., Bldg. 66, rm. 5431 
Tel: 800-835-4709 or 240-402-7800;   Silver Spring, MD 20993-0002 
E-mail: ocod@fda.hhs.gov  Tel: 301-796-5900; 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceCo E-mail: CDRH-Guidance@fda.hhs.gov 
mplianceRegulatoryInformation/default.htm  http://www.fda.gov/MedicalDevices/DeviceRegulationandGu
idance/GuidanceDocuments/default.htm 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
Center for Veterinary Medicine (CVM) 
Center for Devices and Radiological Health (CDRH) 
 
June 2014 
Advertising Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
TABLE OF CONTENTS 
 
I.  INTRODUCTION.........................................................................................1 
 
II.  BACKGROUND...........................................................................................2 
 
III.  OVERVIEW OF FDAS POLICY ON PRESENTING RISK AND BENEFIT 
INFORMATION ON INTERNET/SOCIAL MEDIA PLATFORMS WITH 
CHARACTER SPACE LIMITATIONS..............................................................5 
 
IV.  GENERAL FACTORS CONSIDERED IN THE COMMUNICATION OF BENEFIT 
INFORMATION ON INTERNET/SOCIAL MEDIA PLATFORMS WITH 
CHARACTER SPACE LIMITATIONS..............................................................6 
 
V.  FACTORS CONSIDERED IN THE DISCLOSURE OF RISK INFORMATION ON 
INTERNET/SOCIAL MEDIA PLATFORMS WITH CHARACTER SPACE 
LIMITATIONS.............................................................................................8 
 
VI.  RECOMMENDATIONS FOR THE INCLUSION OF OTHER PRODUCT 
INFORMATION ON INTERNET/SOCIAL MEDIA PLATFORMS WITH 
CHARACTER SPACE LIMITATIONS............................................................13  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1
1  Guidance for Industry  
2   
3  Internet/Social Media Platforms with Character Space Limitations 
4  Presenting Risk and Benefit Information for Prescription Drugs and Medical 
5  Devices 
6    
7   
8  This draft guidance, when finalized, will represent the Food and Drug Administrations (FDAs or 
9  Agencys) current thinking on this topic.  It does not create or confer any rights for or on any 
10  person and does not operate to bind FDA or the public.  You may use an alternative approach if the 
11  approach satisfies the requirements of the applicable statutes and regulations.  If you want to 
12  discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.  
13  If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title 
14  pages of this guidance. 
15   
16   
17  I.  INTRODUCTION 
18   
19  This draft guidance is intended to describe FDAs current thinking about how manufacturers, 
20  packers, and distributors (firms) of prescription human and animal drugs (drugs) and medical 
21  devices for human use (devices)2 that choose to present benefit information should present both 
22  benefit and risk information within advertising and promotional labeling (sometimes collectively 
23  referred to in this guidance document as promotion) of their FDA-regulated medical products on 
24  electronic/digital platforms that are associated with character space limitationsspecifically on the 
25  Internet and through social media or other technological venues (Internet/social media).   Examples 
26  of Internet/social media platforms with character space limitations include online microblog 
27  messaging (e.g., messages on Twitter or tweets, which are currently limited to 140 character 
28  spaces per tweet) and online paid search (e.g., sponsored links on search engines such as Google 
29  and Yahoo, which have limited character spaces as well as other platform-imposed 
                                                 
1 This draft guidance has been prepared by the Office of Prescription Drug Promotion (OPDP) in the Center for Drug 
Evaluation and Research (CDER) in consultation with the Center for Biologics Evaluation and Research (CBER), the 
Center for Veterinary Medicine (CVM), and the Center for Devices and Radiological Health (CDRH). 
2 The recommendations in this draft guidance also apply to biological products that are approved for marketing under 
section 351 of the Public Health Service Act (PHS Act).  Because each biological product also meets the definition of 
drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), it is also subject to regulation under 
provisions of the FD&C Act applicable to drugs or devices, as well as the regulations implementing these provisions, 
except that a biological product licensed under section 351 of the PHS Act is not required to have an approved new 
drug application under section 505 of the FD&C Act (21 U.S.C. 355).  See PHS Act section 351(j) (42 U.S.C. 262(j)).  
References to drugs and devices in this guidance therefore also include biological products that fall within each of 
those definitions.  The recommendations in this draft guidance do not apply to veterinary biological products regulated 
under the Virus-Serum-Toxin Act (21 U.S.C. 151, et seq.) by the U.S. Department of Agriculture.  This draft guidance 
does not address devices solely intended for use in animals. 
1  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
 
 
30  considerations).3  This draft guidance presents considerations to illustrate FDAs thinking on 
31  factors that are relevant to the communication of benefit and risk information on Internet/social 
32  media platforms with character space limitations.4 
33   
34  Please note that this draft guidance does not address promotion via product websites, webpages on 
35  social media networking platforms (e.g., individual product pages on websites such as Facebook, 
36  Twitter, YouTube), and online web banners, as the Agency believes that these specific types of 
37  Internet/social media platforms do not impose the same character space constraints as online 
38  microblog messaging and online paid search.  This draft guidance also does not address responsive 
39  web design or other technology-specific layout features that may result in product promotion 
40  presentations that differ depending on the technology used to view them (e.g., desktop computer 
41  monitors, mobile devices, tablets). 
42   
43  FDAs guidance documents, including this draft guidance, do not establish legally enforceable 
44  rights or responsibilities.  Instead, guidances describe the Agencys current thinking on a topic and 
45  should be viewed only as recommendations, unless specific regulatory or statutory requirements 
46  are cited.  The use of the word should in Agency guidances means that something is suggested or 
47  recommended, but not required. 
48   
49  II.  BACKGROUND 
50   
51  Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Agency has responsibility for 
52  regulating the manufacture, sale, and distribution of drugs and medical devices in the United 
53  States.  This authority includes oversight of the labeling of drugs and medical devices (21 U.S.C. 
54  352(a)) and the advertising of prescription drugs and restricted medical devices (21 U.S.C. 352(n), 
55  (q), and (r)).5 
56   
57  Section 201(m) of the FD&C Act defines labeling as all labels and other written, printed, or 
58  graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such 
59  article (21 U.S.C. 321(m)).6  The U.S. Supreme Court has explained that the language 
60  accompanying such article in the labeling definition is interpreted broadly, to include materials 
61  that supplement or explain an article.  No physical attachment between the materials and the article 
62  is necessary; rather, it is the textual relationship between the items that is significant (Kordel v. 
                                                 
3 While online microblog messaging and online paid search examples are specifically illustrated within this draft 
guidance, FDAs recommendations may also apply to advertising and promotional labeling on other types of 
Internet/social media platforms with character space limitations. 
4 This guidance document focuses on use of character-space-limited platforms by firms to make claims about their 
legally marketed drugs and devices that are consistent with their approved or required labeling.  Representations by a 
firm in character-space-limited platforms may also provide evidence of the intended use of the product, but that issue 
is not the focus of this draft guidance. 
5 Devices may become restricted by regulation issued under section 520(e) of the FD&C Act (21 U.S.C. 360j(e)), by 
performance standard issued pursuant to section 514(a)(2)(B)(v) (21 U.S.C. 360d(a)(2)(B)(v)), or by order approving 
an application for premarket approval (i.e., a PMA) pursuant to section 515(d)(1)(B)(ii) (21 U.S.C. 360e(d)(1)(B)(ii)). 
6 See also 21 CFR 1.3(a). 
2  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
 
 
63  United States, 335 U.S. 345, 350 (1948)).  FDA generally recognizes two types of labeling:  (1) 
64  FDA-required labeling7 and (2) promotional labeling.  Promotional labeling is generally any 
65  labeling, other than the FDA-required labeling, that is devised for promotion of the product.  
66  Examples of materials that may be considered promotional labeling pieces for prescription drugs 
67  are described in 21 CFR 202.1(l)(2).  The scope of labeling for prescription medical devices is 
68  described in 21 CFR 801.109. 
69   
70  The FD&C Act does not define what constitutes an advertisement, but FDA regulations provide 
71  several examples, including advertisements in published journals, magazines, other periodicals, 
72  and newspapers, and advertisements broadcast through media such as radio, television, and 
73  telephone communication systems (21 CFR 202.1(l)(1)). 
74   
75  Under the FD&C Act and FDA's implementing regulations, promotional labeling for drugs and 
76  devices and advertisements for prescription drugs and restricted devices misbrand the product if 
77  they make representations about the use of a firms product without disclosing certain information 
78  about the products risk (FD&C Act sections 502(a)(n)(q)(r), 201(n); 21 CFR 1.21(a); 21 CFR 
79  201.1).  When using Internet/social media platforms with character space limitations for product 
80  promotion, firms should consider the following provisions8: 
81   
82    Any promotional labeling for a drug or device must be truthful and non-misleading (FD&C 
83  Act sections 502(a), 201(n)). 
84   
85    Any promotional labeling that makes claims about a firms prescription drug or prescription 
86  device must include certain information, such as the indicated use of the product and the risks 
87  associated with use of the product (21 CFR 201.100(d), 201.105(d) and 801.109(d)). 
88   
89    Pursuant to section 502(c) for drugs and devices, information required to appear on the label or 
90  labeling must be placed prominently thereon with such conspicuousness and in such terms as 
91  to render it likely to be read and understood by the ordinary individual under customary 
92  conditions of purchase and use. 
93   
                                                 
7 Much FDA-required labeling is subject to FDA review and approval.  For example, after drafting by the 
manufacturer, labeling is reviewed and approved by FDA as part of the new drug application (NDA), new animal drug 
application (NADA), biologics license application (BLA) or premarket approval application (PMA) review (see 21 
CFR 314.50(c)(2), 514.1(b)(3), 601.2(a), 814.20(b)(10) and 814.44(d)).  For devices that are subject to premarket 
notification (510(k)) requirements, the 510(k) must contain the proposed labeling sufficient to describe the device, its 
intended use, and the directions for its use (21 CFR 807.87(e)).  All devices, including those exempt from premarket 
review, are subject to the requirements of applicable labeling regulations, including requirements for adequate 
directions for use (see 21 CFR Part 801).  For a prescription drug or prescription device to be exempted from the 
FD&C Acts requirement of adequate directions for use (21 U.S.C. 352(f)(1)), its FDA-required labeling must contain, 
among other information, information addressing product hazards and other risk information, as specified in FDA 
regulations (21 CFR 201.100(d)(1), (3), 201.105(c)(1), and 801.109). 
8 This is not an exhaustive list. 
3  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
 
 
94    Any advertising that makes representations about the use of a firms prescription drug must 
95  include certain risk information (FD&C Act section 502(n); 21 CFR 202.1).9  Similarly, 
96  section 502(r) of the FD&C Act requires a brief statement of intended uses and relevant risk 
97  information in restricted-device advertising.  Section 502(q) of the FD&C Act provides that 
98  restricted-device advertising that is false or misleading in any particular misbrands the 
99  device.  Note that reminder promotion, which calls attention to the name of a product but 
100  does not make any representations or suggestions about the product, is exempt from many of 
101  these labeling and advertising disclosure requirements (21 CFR 200.200, 201.100(f), 
102  201.105(d)(2), 202.1(e)(2)(i), 801.109(d)).10 
103   
104    Prescription drug advertisements must present a fair balance between information relating to 
105  risk and information relating to benefit (21 CFR 202.1(e)(5)(ii)).  In addition, risk information 
106  must be presented with a prominence and readability reasonably comparable to claims about 
107  drug benefits (21 CFR 202.1(e)(7)(viii)). 
108   
109    Furthermore, for prescription drug advertisements to be truthful and non-misleading, they must 
110  contain risk information in each part, as necessary, to qualify any representations and/or 
111  suggestions made in that part about the drug.  The risk information may be concise if 
112  supplemented by a prominent reference to the presence and location elsewhere in the 
113  advertisement of a more complete discussion (21 CFR 202.1(e)(3)(i)). 
114   
115    In addition, section 201(n) of the FD&C Act provides that in determining whether a drug or 
116  device is misbranded because its labeling or advertising is misleading, it must be considered 
117  whether the labeling or advertising fails to reveal facts that are material with respect to possible 
118  consequences of the use of the product as represented in the labeling or advertising or under 
119  conditions of use that are customary or usual. 
120   
121  Risk information should be comparable in content and prominence to benefit claims within the 
122  product promotion (i.e., a balanced presentation).  Achieving a balanced presentation requires 
123  firms to carefully consider the desired benefit claims and risk profiles for their products when 
124  choosing a promotional platform.  FDA acknowledges that Internet/social media platforms 
125  associated with character space limitations may pose challenges for firms in providing a balanced 
126  presentation of both risks and benefits of medical products, as discussed above. 
127   
                                                 
9 As set forth above, with regard to devices, the Agencys authority over promotional labeling extends to all devices, 
whereas its authority over advertising extends to restricted devices.  Regardless of the type of device, FDA encourages 
firms to use the practices outlined in this guidance to benefit the public health. 
10 This draft guidance does not apply to those reminder promotions (labeling or advertising that calls attention to the 
name of a drug or device but does not include indications, dosage recommendations, or other information) that are 
exempted by regulation from the requirements under the FD&C Act for the disclosure of risk information.  See 21 
CFR 200.200, 201.100(f), 201.105(d)(2), 202.1(e)(2)(i), 801.109(d).  But see 21 U.S.C. 352(r) (requiring certain risk 
information in all restricted-device advertisements). 
4  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
 
 
128  FDA is issuing this draft guidance to aid firms in effectively communicating benefit and risk 
129  information in product promotion using character-space-limited platforms such as online 
130  microblog messaging and online paid search.11  However, regardless of the platform, truthful, 
131  accurate, non-misleading, and balanced product promotion best serves the public health.  For some 
132  products, particularly those with complex indications or extensive serious risks, character space 
133  limitations imposed by platform providers may not enable meaningful presentations of both benefit 
134  and risk (although they may be sufficient for reminder promotionssee footnote 10).  If an 
135  accurate and balanced presentation of both risks and benefits of a specific product is not possible 
136  within the constraints of the platform, then the firm should reconsider using that platform for the 
137  intended promotional message (other than for permitted reminder promotion). 
138   
139  III.  OVERVIEW OF FDAS POLICY ON PRESENTING RISK AND BENEFIT 
140  INFORMATION ON INTERNET/SOCIAL MEDIA PLATFORMS WITH 
141  CHARACTER SPACE LIMITATIONS 
142   
143  Regardless of character space constraints that may be present on certain Internet/social media 
144  platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk 
145  information within the same character-space-limited communication.  The firm should also 
146  provide a mechanism to allow direct access to a more complete discussion of the risks associated 
147  with its product. 
148   
149  Section IV discusses general factors that firms should consider in the communication of benefit 
150  information on Internet/social media platforms with character space limitations, which directly 
151  impacts the communication of risk information.  Section V explains in detail the factors that FDA 
152  considers in the disclosure of risk information on Internet/social media platforms with character 
153  space limitations.  Section VI provides firms with additional recommendations for the inclusion of 
154  other product information (including certain required product information other than risk/benefit 
155  information, as applicable) on Internet/social media platforms with character space limitations. 
156   
157  Please note that sections IV, V, and VI provide hypothetical examples12 that, when taken in 
158  totality, illustrate FDAs recommendations for how firms may disseminate product promotion on 
159  Internet/social media platforms with character space limitations.  The examples build on the 
160  considerations set forth from the previous section and are numbered accordingly to identify related 
161  examples (e.g., examples 1A, 1B, and 1C are related to the same hypothetical productexample 
162  1A incorporates benefit information, example 1B adds risk information to example 1A, and 
163  example 1C provides additional recommendations for examples 1A and 1B to illustrate, in totality, 
                                                 
11 CDERs OPDP, formerly known as the Division of Drug Marketing, Advertising, and Communications (DDMAC), 
issued 14 enforcement letters involving sponsored link promotion on Apr 2, 2009 (see FDAs enforcement website 
available at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLetters
andNoticeofViolationLetterstoPharmaceuticalCompanies/ucm055773.htm). 
12 The hypothetical examples involve fictitious products and are not an endorsement of the fictitious product names.  
5  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
 
 
164  a final example of promotion on an Internet/social media platform with character space limitations 
165  to which the Agency would not intend to object). 
166   
167  FDA recommends that firms first carefully consider the complexity of the indication and risk 
168  profiles for each of their products to determine whether a character-space-limited platform is a 
169  viable promotional tool for a particular product, and then take the factors, recommendations, and 
170  hypothetical examples outlined in this guidance document into account when developing benefit 
171  and risk presentations.  The public health is best served when risk and effectiveness information 
172  about drug and device products is clearly and accurately communicated. 
173   
174  IV.  GENERAL FACTORS CONSIDERED IN THE COMMUNICATION OF BENEFIT 
175  INFORMATION ON INTERNET/SOCIAL MEDIA PLATFORMS WITH 
176  CHARACTER SPACE LIMITATIONS 
177   
178  When the Agency evaluates advertising and promotional labeling for compliance with the FD&C 
179  Act and FDAs implementing regulations, it determines whether claims about both the benefits and 
180  risks of the product are accurate and non-misleading.  The Agency also looks at whether benefits 
181  and risks are presented in a comparably prominent manner (as outlined above in section II).  Thus, 
182  considerations involving the content and format of benefit information are an inherent part of 
183  FDAs evaluation of risk presentations on Internet/social media platforms. 
184   
185  In communicating benefit information on Internet/social media platforms with character space 
186  limitations, firms should consider the following points: 
187   
188  1.  Benefit information should be accurate and non-misleading and reveal material facts within 
189  each individual character-space-limited communication (e.g., each individual message or 
190  tweet). 
191   
192  When communicating benefit information about its product, a firm should ensure that benefit 
193  information is accurate and non-misleading.  In doing so, the firm should also reveal material facts 
194  about the use of its product, such as limitations to an indication or the relevant patient population. 
195  For example, a firm should refer to the Indications and Usage portion of the Highlights of 
196  Prescribing Information that is available for many human prescription drugs to help determine 
197  what information to convey, although the firm is generally not required to use the precise wording 
198  found there.  Labeling for an approved premarket approval application (PMA) for class III medical 
199  devices or use information consistent with a cleared intended use for 510(k) medical devices 
200  provides the basis for the benefit information related to devices.  Such information would include 
201  material facts that the firm should present within the individual character-space-limited 
202  communication because, without doing so, the benefit information in totality may be misleading. 
203   
204  2.  Benefit information should be accompanied by risk information within each individual 
205  character-space-limited communication. 
206   
6  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
 
 
207  A firm should also consider whether, once benefit information is conveyed in an accurate and non-
208  misleading manner, enough capacity will remain in the character-space-limited communication to 
209  adequately convey required risk information.  Please refer to section V for factors firms should 
210  consider in the disclosure of risk information.  In addition, a firm should consider whether enough 
211  capacity will remain in the character-space-limited communication to adequately convey certain 
212  other required information, as applicable.  Please refer to section VI for additional 
213  recommendations firms should consider for the inclusion of other product information. 
214   
215  3.  If a firm concludes that adequate benefit and risk information, as well as other required 
216  information, cannot all be communicated within the same character-space-limited 
217  communication, then the firm should reconsider using that platform for the intended 
218  promotional message. 
219   
220  Example 1A:  A firm is considering promotion of its prescription drug NoFocus on Twitter, which 
221  is limited to 140 character spaces per message or tweet.  NoFocus is indicated for mild to moderate 
222  memory loss.  Any benefit information that the firm communicates about NoFocus should be 
223  accurate and non-misleading and include material facts about the use of NoFocus, i.e., that it is 
224  indicated for mild to moderate memory loss. 
225   
226  The firm considers including the following benefit information within the tweet [the information in 
227  brackets denotes character spaces used/140 available character spaces in a tweet]: 
228   
229  NoFocus for mild to moderate memory loss [40/140] 
230   
231  The benefit information for NoFocus that is communicated within the first 40 character spaces of 
232  this tweet is accurate and non-misleading and includes material facts about the indication and 
233  limitations to the use of NoFocus.  The firm should consider whether the remaining 100 character 
234  spaces are enough to include risk information and certain other required information, as applicable, 
235  about NoFocus.  See examples 1B and 1C in sections V and VI in this draft guidance, respectively, 
236  for further considerations on the disclosure of risk and other information for NoFocus within this 
237  tweet.  If the firm concludes that adequate benefit and risk information, as well as other required 
238  information, cannot all be communicated within the same tweet, then the firm should reconsider 
239  using Twitter for the intended promotional message for NoFocus. 
240   
241  Example 2A:  A firm is considering promotion of its prescription drug Headhurtz using Googles 
242  Sitelink extensions (sponsored link promotion that contains character space limitations and specific 
243  formatting requirements, sometimes referred to in this guidance document as Sitelinks).13  
244  Headhurtz is indicated for severe headache associated with traumatic brain injury.  Any benefit 
245  information that the firm communicates about Headhurtz should be accurate and non-misleading 
                                                 
13 The example featured in this guidance relies on one specific Google formatting option (current as of Jan 22, 2014); 
however, it may be possible to follow the concepts outlined in this draft guidance for other types of sponsored link 
promotion or Internet/social media platforms with character space limitations. 
7  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
 
 
246  and include material facts about the use of Headhurtz, i.e., that it is indicated for severe headache 
247  associated with traumatic brain injury. 
248   
249  The firm considers including the following benefit information within the sponsored link 
250  promotion [the information in brackets denotes character spaces used/available character spaces 
251  per line of the sponsored link promotion]:   
252   
253  Headhurtz [9/25] 
254    www.headhurtz.com [17/35] 
255  For severe headache from traumatic brain injury [47/70] 
256   
257  The benefit information for Headhurtz that is communicated within the character spaces for this 
258  specific sponsored link format is accurate and non-misleading and includes material facts about the 
259  indication and limitations to the use of, and the specific patient population for, Headhurtz.  The 
260  firm should consider whether risk information and certain other required information, as 
261  applicable, about Headhurtz can also be included within the remaining character spaces for this 
262  specific sponsored link format.  See examples 2B and 2C in sections V and VI in this draft 
263  guidance, respectively, for further considerations on the disclosure of risk and other information 
264  for Headhurtz within this sponsored link format.  If the firm concludes that adequate benefit and 
265  risk information, as well as other required information, cannot all be communicated within this 
266  same sponsored link format, then the firm should reconsider using Googles Sitelinks for the 
267  intended promotional message for Headhurtz. 
268   
269  V.  FACTORS CONSIDERED IN THE DISCLOSURE OF RISK INFORMATION ON 
270  INTERNET/SOCIAL MEDIA PLATFORMS WITH CHARACTER SPACE 
271  LIMITATIONS 
272   
273  This section of the draft guidance outlines factors considered in the disclosure of risk information 
274  on Internet/social media platforms with character space limitations.  As previously stated, 
275  regardless of character space constraints that may be present on certain Internet/social media 
276  platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk 
277  information within the same character-space-limited communication.  The firm should also 
278  provide a mechanism to allow direct access to a more complete discussion of the risks associated 
279  with its product. 
280   
281  In general, the Agency considers two primary factors to determine whether risk information is 
282  comparable in scope to benefit information within promotional materials: (1) whether the risk 
283  information qualifies any representations made about the product (i.e., content of the risk 
284  information compared to content of the benefit information) and (2) whether the risk information is 
285  presented with a prominence and readability comparable to the benefit claims about the product.14 
                                                 
14 FDA has developed separate draft guidance that, when final, will represent the Agencys current thinking on how 
firms should, in general, present risk information in other types of promotional materials. See the draft guidance for 
8  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
 
 
286   
287  However, the Agency is aware of the challenges in balancing benefit and risk information within 
288  the character space constraints of certain Internet/social media platformsparticularly in terms of 
289  contentbecause of the sheer volume of information.  The Agency believes that a concise 
290  disclosure of specific risk information may be presented together with benefit information within 
291  the confines of character-space-limited Internet/social media platforms if supplemented by a 
292  prominent reference to the presence and location elsewhere of a more complete discussion of the 
293  risks associated with the product (or for restricted-device advertising, a brief statement of 
294  intended use and relevant risk information) and that this is consistent with requirements of the 
295  FD&C Act and FDAs implementing regulations (see section II).  These concepts are further 
296  elucidated below in this section of the guidance document. 
297   
298  In communicating risk information on Internet/social media platforms with character space 
299  limitations, firms should consider the following points: 
300   
301  1.  Risk information should be presented together with benefit information within each individual 
302  character-space-limited communication (e.g., each individual message or tweet). 
303   
304  2.  The content of risk information presented within each individual character-space-limited 
305  communication should, at a minimum, include the most serious risks associated with the 
306  product. 
307   
308  At a minimum, a firm should communicate the most serious risks associated with the product 
309  together with the benefit information within the individual character-space-limited communication.  
310  For a prescription human drug, the most serious risks would generally include all risk concepts 
311  from a boxed warning, all risks that are known to be fatal or life-threatening, and all 
312  contraindications15 from the approved product labeling (the PI).  If a prescription human drug does 
313  not have a boxed warning, fatal or life-threatening risks, or any contraindications, the most 
314  significant warnings or precautions about the product should be communicated.  For animal drugs, 
315  the most serious risks would include potential injury to human handlers/animal patients and risk of 
316  drug residues entering the human food chain.  For devices, if a particular risk is associated with a 
317  particular identifiable use or population, then each of those should be included.  The Agency 
318  believes that communication of the most serious risks as outlined above would provide a concise 
319  statement of risk information about the product for promotion on Internet/social media platforms 
320  with character space limitations. 
321   
                                                                                                                                                                
industry entitled Presenting Risk Information in Prescription Drug and Medical Device Promotion available at 
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf. 
15 For prescription human drugs, if the only contraindication listed in the PI is hypersensitivity, the Agency would not 
expect that contraindication to be included as part of the risk disclosure within the character-space-limited 
communication unless there were documented cases of hypersensitivity occurring in patients who took the product. 
9  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
 
 
322  3.  A mechanism, such as a hyperlink, should also be provided within each individual character-
323  space-limited communication to allow direct access to a more complete discussion of risk 
324  information about the product. 
325   
326  In addition to presenting the most serious risks within the individual character-space limited 
327  communication, FDA recommends that a firm also include in that communication a direct 
328  hyperlink to a destination (e.g., landing page) that is devoted exclusively to the communication of 
329  risk information about the product.  Examples of such landing pages providing direct and exclusive 
330  access to risk information could include a website devoted to providing comprehensive risk 
331  information about the product, a particular webpage within a website that is devoted to providing 
332  comprehensive risk information about the product, or a portable document format (PDF) file that is 
333  devoted to providing comprehensive risk information about the product.  An example that the 
334  Agency would not consider to provide direct and exclusive access to risk information would 
335  include a hyperlink only to a products home page that also includes benefit information and other 
336  claims or graphics.  Firms may include supplemental hyperlinks (e.g., to a product home page, to a 
337  PI, or to a brief summary) either within the character-space-limited communication itself or on the 
338  landing page of risk information, but the Agency recommends that a direct hyperlink to a landing 
339  page that is devoted exclusively to comprehensive risk information about the product be initially 
340  included within the original character-space-limited communication.16 
341   
342  Many Internet/social media platforms allow the use of uniform resource locator (URL) shortening 
343  services, which are likely to result in a URL or web address with fewer character spaces.  The 
344  Agency does not intend to object to the use of such URL shortening services; however, when 
345  possible, the Agency recommends that the URL or web address itself denote to the user that the 
346  landing page consists of risk information (e.g., www.product.com/risk).  Please note that if the 
347  URL or web address itself is promotional in content or tone, FDA may take into consideration 
348  whether any resulting claims are false or misleading or provide evidence in support of other 
349  violations under the FD&C Act and FDAs implementing regulations (e.g., a URL such as 
350  www.bestcancercuredrug.com may be misleading). 
351   
352  4.  The prominence of risk information should be comparable to the benefit information within 
353  each individual character-space-limited communication, taking into consideration any 
354  formatting capabilities available on the specific Internet/social media platform.  
355   
356  If a firm uses techniques to emphasize benefit information within the character-space-limited 
357  communication, the firm should consider similar techniques to achieve comparable emphasis of 
                                                 
16 A firm should consider how to fulfill other regulatory requirements for advertising or promotional labeling as 
applicable, such as providing an accompanying brief summary or PI with promotion for a drug (see 202.1(e)(1) and 
201.100(d)).  Where such requirements apply, the Agency expects that a firm would provide access to a brief summary 
or PI to accompany the communication in the character-space-limited Internet/social media platform, for example, by 
providing a direct hyperlink to those materials either within the character-space-limited communication itself or on the 
landing page of risk information.  However, note that a link to a brief summary or PI should not be used in place of 
disclosing risk information within the original character-space-limited communication. 
10  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
 
 
358  risk information for its product.17  Additionally, FDA recommends that, where the platform 
359  enables the use of different formatting, a firm utilize those formatting capabilities to highlight 
360  significant risk information, such as a boxed warning (e.g., a firm should present the boxed 
361  warning in bolded text to convey the seriousness of that particular risk for its product).   
362   
363  Example 1B (continued from example 1A):  A firm is considering promotion of its prescription 
364  drug NoFocus on Twitter, which is limited to 140 character spaces per message or tweet.  NoFocus 
365  is indicated for mild to moderate memory loss.  There are no boxed or other warnings and no 
366  known fatal or life-threatening risks included in the PI for NoFocus.  The most serious precaution 
367  associated with NoFocus is that it may cause seizures in patients with a seizure disorder.  Since 
368  benefit information was provided within the tweet (example 1A), the firm should communicate, at 
369  a minimum, the most serious risks associated with NoFocus within the same tweet.  The firm 
370  should also include within the same tweet a direct hyperlink to a more complete discussion of risk 
371  information about NoFocus.  Additionally, the prominence of risk information should be 
372  comparable to the benefit information contained within the tweet, taking into consideration any 
373  formatting capabilities that may be available. 
374   
375  The firm considers including the following benefit and risk information within the tweet: 
376   
377  NoFocus for mild to moderate memory loss; may cause seizures in patients with a seizure 
378  disorder www.nofocus.com/risk [117/140] 
379   
380  In the above example, benefit information for NoFocus is accurate and non-misleading, and the 
381  most serious risks associated with NoFocus are communicated together with the benefit 
382  information within the tweet.  The firm includes a direct hyperlink to the Important Safety 
383  Information webpage (within the product website) that is devoted to providing comprehensive 
384  risk information about NoFocus.  In addition, the URL www.nofocus.com/risk (emphasis added) 
385  denotes that the landing page is comprised of risk information, and the URL is not promotional in 
386  tone.  The firm conveys risk information within the tweet in a comparable manner to the benefit 
387  information.  See example 1C in section VI in this draft guidance for further considerations on the 
388  inclusion of other product information for NoFocus within this tweet. 
389   
390  Example 2B (continued from example 2A):  A firm is considering promotion of its prescription 
391  drug Headhurtz using Googles Sitelinks.18  Headhurtz is indicated for severe headache associated 
                                                 
17 FDA acknowledges that providers of character-space-limited platforms frequently dictate aspects controlling the 
presentation of text that affect prominence and readability (e.g., font size and style).  Where the platform provider only 
permits one type of text, issues affecting comparability are less likely to arise. 
18 Googles Sitelink extensions format allows up to six additional links (Sitelinks) to be shown in addition to the 
display URL (www.headhurtz.com in this example).  Under parameters set by Google, the link text for each of the 
Sitelinks must be 25 characters or fewer.  The link text must directly relate to the content on the landing page for that 
link and point to different content, i.e., no Sitelinks may lead to the same landing page or to the same content.  In 
addition, Sitelinks may not direct to the same landing page as the destination URL (the landing page for 
www.headhurtz.com in this example).  Furthermore, up to two optional description lines (35 characters or fewer per 
line) may be created for display underneath each of the Sitelinks.  This information is current as of Jan 22, 2014; 
11  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
 
 
392  with traumatic brain injury.  The PI for Headhurtz includes a boxed warning about the potential for 
393  brain swelling and warnings about a potentially fatal drug reaction and a drop in heart rate that 
394  may be life-threatening.  Since benefit information was provided within the sponsored link format 
395  (example 2A), the firm should communicate, at a minimum, the most serious risks associated with 
396  Headhurtz within the same sponsored link format.  The firm should also include within the same 
397  sponsored link format a direct hyperlink to a more complete discussion of risk information about 
398  Headhurtz.  Additionally, the prominence of the risk information should be comparable to the 
399  benefit information contained within the sponsored link format, taking into consideration any 
400  formatting capabilities that may be available. 
401   
402  The firm considers including the following benefit and risk information within the sponsored link 
403  promotion: 
404   
405  Headhurtz [9/25] 
406    www.headhurtz.com [17/ 35] 
407  For severe headache from traumatic brain injury [47/ 70] 
408  Boxed warning [13/25]       Warning [7/25] 
409  Potential for brain swelling [28/35]    Potentially fatal drug reaction [31/35] 
410  Warning [7/25]         Risk information [16/25] 
411  Life-threatening drop in heart rate [35/35]  Important safety information [28/35] 
412   
413  In the above example, benefit information for Headhurtz is accurate and non-misleading.  
414  Consistent with the Google-imposed formatting requirements outlined in footnote 18, the firm 
415  chooses to utilize three of the six Sitelinks to convey the most serious risks associated with 
416  Headhurtz, including the boxed warning and additional warnings about fatal and life-threatening 
417  risks.  Therefore, the most serious risks associated with Headhurtz are communicated together with 
418  the benefit information within the sponsored link format.  The firm also includes a fourth Sitelink 
419  that provides direct access to a more complete discussion of risk information about Headhurtz.  
420  Furthermore, consistent with the Google-imposed link requirements outlined in footnote 18, the 
421  firm creates four different landing pages, each with different content.  The first Sitelink is a direct 
422  hyperlink to a webpage that is devoted to providing detailed information about the boxed warning 
423  on the potential for brain swelling.  The second and third Sitelinks are direct hyperlinks to 
424  webpages that are each devoted to a discussion of the specific warning conveyed within the 
425  descriptions under these Sitelinks (i.e., a potentially fatal drug reaction and a life-threatening drop 
426  in heart rate).  The fourth Sitelink is a direct hyperlink to the Important Safety Information 
427  webpage (within the product website) that is devoted to providing comprehensive risk information 
428  about Headhurtz.  The firm conveys risk information within the sponsored link format in a 
429  comparable manner to the benefit information.  See example 2C in section VI in this draft 
430  guidance for further considerations on the inclusion of other product information for Headhurtz 
431  within this sponsored link format. 
                                                                                                                                                                
please refer to Googles website for more specific information on its advertising policies.  See Sitelink extensions 
available at https://support.google.com/adwordspolicy/answer/1054210 and Show additional links below your ad text 
available at https://support.google.com/adwords/answer/2375416. 
12  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
 
 
432   
433  VI.  RECOMMENDATIONS FOR THE INCLUSION OF OTHER PRODUCT 
434  INFORMATION ON INTERNET/SOCIAL MEDIA PLATFORMS WITH 
435  CHARACTER SPACE LIMITATIONS 
436   
437  This section of the draft guidance provides additional recommendations regarding the inclusion of 
438  other product information (including certain required product information other than risk/benefit 
439  information, as applicable) on Internet/social media platforms with character space limitations.  In 
440  addition to including both benefit and risk information within a character-space-limited 
441  communication, there may be other applicable legal requirements to consider. 
442   
443  In communicating product information on Internet/social media platforms associated with 
444  character space limitations, firms should consider the following: 
445   
446    Sections 502(e), (n), and (r) of the FD&C Act (21 USC 352(e), (n), and (r)) require that the 
447  established name accompany the trade or brand name in labeling and in prescription drug and 
448  restricted-device advertising.  Drug regulations specifically require that the established name 
449  be in direct conjunction with the proprietary name or designation (21 CFR 201.10(g)(1) and 
450  202.1(b)(1)).19 
451   
452    The drug regulations also stipulate that advertisements shall prominently display the name of at 
453  least one specific dosage form and have the quantitative ingredient information required by 
454  section 502(n) of the FD&C Act in direct conjunction with such display.  If other dosage forms 
455  are listed in the advertisement, the quantitative ingredient information for such dosage forms 
456  shall appear in direct conjunction and in equal prominence with the most prominent listing of 
457  the names of such dosage forms (21 CFR 202.1(d)(2)). 
458   
459  With regard to the above regulatory provisions when using Internet/social media platforms with 
460  character space limitations, the Agency does not intend to object where the following approaches 
461  are used: 
462   
463    Firms should communicate both the proprietary (trade or brand) name and established name 
464  (for drugs, often referred to as the generic name) within the character-space-limited 
465  communication.  The generic name of the product should be listed directly to the right of, or 
466  directly below, the brand name. 
467   
468    On the landing page associated with each hyperlink provided in the character-space-limited 
469  communication, firms should again communicate both the brand and established names as 
470  recommended in the preceding bullet.  In addition, for prescription drugs, firms should 
                                                 
19 FDA has developed separate guidance that addresses product name placement and size in promotion.  See the draft 
guidance Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling available at 
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070076.pdf. 
13  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
 
 
471  prominently display at least one dosage form and quantitative ingredient information in direct 
472  conjunction with the brand and established names. 
473   
474  In addition, the Agency believes that common abbreviations (including scientific and medical 
475  abbreviations), punctuations marks, and other symbols may, in many cases, reasonably be used to 
476  help address character space constraints.  The following examples illustrate instances where the 
477  Agency does not intend to object to such usage: 
478   
479    Commonly recognized linguistic symbols may be substituted for words.  For example, the 
480  ampersand symbol (&) may be used in place of the word and. 
481   
482    Punctuation marks may be used to help with the presentation of information.  For example, 
483  dashes may be used to help separate benefit and risk information. 
484   
485    A scientific abbreviation may be used to denote a chemical ingredient name (e.g., HCl for 
486  hydrochloride; HBr for hydrobromide). 
487   
488  Example 1C (continued from example 1B):  A firm is considering promotion of its prescription 
489  drug NoFocus on Twitter, which is limited to 140 character spaces per message or tweet.  NoFocus 
490  is indicated for mild to moderate memory loss.  There are no boxed or other warnings and no 
491  known fatal or life-threatening risks included in the PI for NoFocus.  The most serious precaution 
492  associated with NoFocus is that it may cause seizures in patients with a seizure disorder.  The 
493  FDA-approved name is NoFocus (rememberine hydrochloride) Capsules, and NoFocus is 
494  available as 200mg capsules.  In addition to taking into consideration factors for communicating 
495  benefit and risk information within the character-space-limited communication as described in 
496  sections IV and V, the firm should also communicate the brand and established names within the 
497  tweet. 
498   
499  The firm considers including the following product information, together with benefit and risk 
500  information about NoFocus, within the tweet: 
501   
502  NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in 
503  patients with a seizure disorder www.nofocus.com/risk [134/140] 
504   
505  In the above example, the brand and established names are communicated together within the 
506  tweet.  Note that the firm uses the abbreviation HCl in place of hydrochloride within the 
507  established name presentation.  The firm uses a dash with no additional spaces to separate the 
508  benefit and risk information.  As specified in example 1B, the firm includes a direct hyperlink to 
509  the Important Safety Information webpage (within the product website) that is devoted to 
510  providing comprehensive risk information about NoFocus.  At the top of the landing page, the firm 
511  again communicates the brand and established names together with the dosage form and 
512  quantitative information in direct conjunction as follows: NoFocus (rememberine hydrochloride) 
14  Contains Nonbinding Recommendations 
Draft  Not for Implementation  
 
 
513  200mg Capsules.  FDA would not intend to object to this tweet for NoFocus, as described in 
514  totality in examples 1A, 1B, and 1C. 
515   
516  Example 2C (continued from example 2B):  A firm is considering promotion of its prescription 
517  drug Headhurtz using Googles Sitelinks.  Headhurtz is indicated for severe headache associated 
518  with traumatic brain injury.  The PI for Headhurtz includes a boxed warning about the potential for 
519  brain swelling and warnings about a potentially fatal drug reaction and a drop in heart rate that 
520  may be life-threatening.  The FDA-approved name is Headhurtz (ouchafol) Tablets, and 
521  Headhurtz is available as 200mg tablets.  In addition to taking into consideration factors for 
522  communicating benefit and risk information within the character-space-limited communication as 
523  described in sections IV and V, the firm should also communicate the brand and established names 
524  within the sponsored link format. 
525   
526  The firm considers including the following product information, together with benefit and risk 
527  information about Headhurtz, within the sponsored link format: 
528   
529  Headhurtz (ouchafol) [20/25] 
530    www.headhurtz.com [17/ 35] 
531  For severe headache from traumatic brain injury [47/ 70] 
532  Boxed warning [13/25]       Warning [7/25] 
533  Potential for brain swelling [28/35]    Potentially fatal drug reaction [31/35] 
534  Warning [7/25]         Risk information [16/25] 
535  Life-threatening drop in heart rate [35/35]  Important safety information [28/35] 
536   
537  In the above example, the brand and established names are communicated together within the 
538  sponsored link format.  As specified in example 2B, consistent with the Google-imposed link 
539  requirements outlined in footnote 18, the firm creates four different landing pages, each with 
540  different content, to convey risk information for Headhurtz.  At the top of each of these landing 
541  pages, the firm again communicates the brand and established names together with the dosage 
542  form and quantitative information in direct conjunction as follows: Headhurtz (ouchafol) 200mg 
543  Tablets.  FDA would not intend to object to this sponsored link format for Headhurtz, as described 
544  in totality in examples 2A, 2B, and 2C. 
15