Description
This guidance provides recommendations for presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements for prescription human drug and biological products and prescription animal drugs and in DTC promotional labeling for nonprescription animal drugs (collectively, promotional communications). For the purposes of this guidance, quantitative efficacy and risk information refers to information that numerically addresses the likelihood or magnitude of a drug’s efficacy or risks.
Scope & Applicability
Product Classes
4Scope of promotional labeling recommendations
development program for drug and biological products
Scope of promotional labeling recommendations
Scope of promotional labeling recommendations
Stakeholders
6Entity responsible for submitting NDINs
Entity whose name appears on the label
Entity responsible for submitting NDINs
MAHs are expected to follow-up all pregnancy reports from consumers
drug and device manufacturers communicating with payors
Entities developing animal food ingredients and participating in AFIC.
Regulatory Context
Attributes
8Numerical information about drug effectiveness; Numerical data describing how well a drug works.
Numerical information about drug risks; Numerical data describing the probability or severity of adverse effects.
Numerical data regarding the effectiveness of a drug.
Numerical data regarding the safety risks of a drug.
A recommended format for presenting probabilities (e.g., 57 out of 100).
A recommended format for presenting probabilities (e.g., 57%).
A format for presenting probabilities (e.g., 33% reduction) that consumers find harder to understand.
The difference in risk between treatment and control groups.
Identified Hazards
Hazards
1A serious risk associated with Drug X that must be accurately characterized.
Related CFR Sections (2)
- 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 →
- 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 →
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 (7)
- 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)
- Regulatory Considerations for Prescription Drug Use-Related Software (Status: Draft)
- Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Status: Draft)
- Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers : Guidance for Industry (Status: Final)
- Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers (Status: Draft)
- Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs (Status: Final)