Description
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.” This draft guidance responds to, among other things, stakeholder requests for specific guidance and describes FDA's current thinking on how manufacturers, packers, and distributors (firms) of prescription human and animal drugs (drugs) and medical devices for human use (devices), including biological products, that choose to present benefit information should present both benefit and risk information within advertising and promotional labeling of their FDA-regulated medical products on electronic/digital platforms that are associated with character space limitations, specifically on the Internet and through social media or other technological venues (Internet/social media). The draft guidance represents FDA's current thinking on specific aspects of FDA's evolving consideration of social media platforms and other Internet-related matters. FDA continues actively to review, analyze, and develop approaches to a variety of topics related to the labeling and advertising of medical products, including the development of this and other guidance addressing the use of social media platforms and the Internet.
Scope & Applicability
Product Classes
9Scope of promotional labeling recommendations
For animal drugs, the term serious adverse drug experience is defined in 21 CFR 514.3.
Advertising requirements for restricted devices on social media; Advertising requirements for devices with character space limitations
Human prescription drugs including biological products
Medical devices intended for human use; Approved or cleared medical devices
development program for drug and biological products
Early-phase randomized, double-blind, parallel assignment clinical study
Devices with specific advertising requirements under 502(r)
Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.
Stakeholders
4manufacturers are responsible for ensuring that their labels conform to all applicable FDA labeling laws
Entities developing animal food ingredients and participating in AFIC.
Firms responsible for drug and device promotion
entities involved in the distribution of devices
Regulatory Context
Attributes
8Requirement for prescription drug ads to balance risk and benefit information.
Required information in direct conjunction with dosage form
Field B.2.2.2 describing the physical form of the VMP
Commercial name granted by an authority for marketing
Naming format required for other products in the combination regimen.
Content recommendation for patient labeling
visual presentation of the product name; Established name must have prominence commensurate with the proprietary name.
Requirement for information to be likely read and understood by an ordinary individual.
Identified Hazards
Hazards
4Risk information that must be addressed in labeling for exemptions.
Warning for Headhurtz
Boxed warning risk for Headhurtz
Serious precaution associated with NoFocus
Related CFR Sections (8)
- 21CFR202.1§ 202.1 Prescription-drug advertisements.
Prescription drug as used in this section means any drug defined in section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act or § 201.105 of this chapter , applicable to drugs intended for use by humans and to veterinary drugs, respectively.Read full regulation →
- 21CFR201.10§ 201.10 Drugs; statement of ingredients.
(a) The ingredient information required by section 502(e) of the Federal Food, Drug, and Cosmetic Act shall appear together, without any intervening written, printed, or graphic matter, except the proprietary names of ingredients, which may be included with the listing of established names, and suchRead full regulation →
- 21CFR1.3§ 1.3 Definitions.
(a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce.Read full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR1.21§ 1.21 Failure to reveal material facts.
(a) Labeling of a food, drug, device, cosmetic, or tobacco product shall be deemed to be misleading if it fails to reveal facts that are:Read full regulation →
- 21CFR201.1§ 201.1 Drugs; name and place of business of manufacturer, packer, or distributor.
(a) A drug or drug product (as defined in § 320.1 of this chapter ) in finished package form is misbranded under section 502 (a) and (b)(1) of the act if its label does not bear conspicuously the name and place of business of the manufacturer, packer, or distributor. This paragraph does not apply toRead full regulation →
- 21CFR201.100§ 201.100 Prescription drugs for human use.
A drug subject to the requirements of section 503(b)(1) of the act shall be exempt from section 502(f)(1) if all the following conditions are met:Read full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
Related Warning Letters (10)
- 2025-09-16
Advertising & Promotional Labeling/Drugs/Biological Products
CSL Behring
- 2025-09-16
False & Misleading Claims/Misbranded
Aytu Biopharma
- 2025-09-16
False & Misleading Claims/Misbranded
Novo Nordisk Inc.
- 2025-09-16
False & Misleading Claims/Misbranded
Eli Lilly and Company
- 2025-09-16
False & Misleading Claims/Misbranded
Alora Pharmaceuticals
- 2025-06-10
False & Misleading Claims/Misbranded
Sprout Pharmaceuticals, Inc.
- 2025-05-20
False & Misleading Claims/Misbranded
Sarfez Pharmaceuticals, Inc.
- 2025-03-11
False & Misleading Claims/Misbranded
Aurora Pharmaceutical
- 2025-03-11
False & Misleading Claims/Misbranded
Elanco Animal Health
- 2024-03-12
False & Misleading Claims/Misbranded
Boehringer Ingelheim Animal Health USA
See Also (8)
- Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Status: Draft)
- Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling-Final (Status: Final)
- Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA (Status: Final)
- Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs (Status: Draft)
- Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (Status: Final)
- Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs (Status: Final)
- Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry (Status: Final)
- Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers : Guidance for Industry (Status: Final)