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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and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 This draft guidance responds to, among other things, stakeholder requests for specific guidance and describes FDA's current thinking on how manufacturers, packers, and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 The draft guidance represents FDA's current thinking on specific aspects of FDA's evolving consideration of social media platforms and other Internet-related matters.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
9Human prescription drugs including biological products
Advertising requirements for restricted devices on social media; Advertising requirements for devices with character space limitations
For animal drugs, the term serious adverse drug experience is defined in 21 CFR 514.3.
Scope of promotional labeling recommendations
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
7Prescribing Information for Drug X includes a boxed warning
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.
High-priority risk information for disclosure
Required risk information for character-limited communications
Identified Hazards
Hazards
2Disclosure of risks associated with medical products
potential concern for milk-based products; Chemical hazards in milk, honey, and game meat; Potential hazard identified for dairy and egg products.; Potential chemical hazard in game meat
Related CFR Sections (14)
- 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 →
- 21CFR201.105§ 201.105 Veterinary drugs.
A drug subject to the requirements of section 503(f)(1) of the act shall be exempt from section 502(f)(1) of the act if it is a designated medical gas (as defined in § 201.161(c)(1) ) or a medically appropriate combination of designated medical gases and is in compliance with § 201.161 , or if all tRead 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 →
- 21CFR514.1§ 514.1 Applications.
(a) Applications to be filed under section 512(b) of the act shall be submitted in the form and contain the information described in paragraph (b) of this section, as appropriate to support the particular submission. If any part of the application is in a foreign language, an accurate and complete ERead full regulation →
- 21CFR601.2§ 601.2 Applications for biologics licenses; procedures for filing.
(a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing aRead full regulation →
- 21CFR814.20§ 814.20 Application.
(a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR200.200§ 200.200 Prescription drugs; reminder advertisements and reminder labeling to provide price information to consumers.
(a) Prescription drug reminder advertisements and reminder labeling intended to provide price information to consumers are exempt from the requirements of §§ 201 .100 and 202.1 of this chapter if all of the following conditions are met:Read 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)
- Consumer-Directed Broadcast Advertisements: Guidance for Industry (Status: Final)
- Presenting Risk Information in Prescription Drug and Medical Device Promotion (Status: Draft)
- Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs (Status: Draft)
- Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule Questions and Answers (Status: Final)
- Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA (Status: Final)
- Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (Status: Final)