• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Laws & Regulations about Advertising & Promotional Labeling

Select Laws and Regulations for:

Prescription Drugs and Biologics
Biologic Devices
Tissues

 

Prescription Drugs and Biologics

Definitions: 

- Biologic products  42 USC 262(i)

- Drugs  21 USC 321(g)

- Advertisement  21 CFR 202.1(l)(1)

- Promotional labeling  21 CFR 202.1(l)(2) and 21 USC 321(m)

Required submission of advertising and promotional labeling

- Biologics 21 CFR 601.12(f)(4)

- Drugs 21 CFR 314.81(b)(3)(i)

- Accelerated approval biologics  21 CFR 601.45 

- Accelerated approval drugs  21 CFR 314.550

- Changes to an approved application biologics:  21 CFR 601.12(a)(4)

- Changes to an approved application drugs:  21 CFR 314.70(a)(4)

Content of Advertisements and Promotional Labeling

- Information to be included in advertisements:  21 CFR 202.1(e)(1) through (5)

- Advertisements that are false, lacking in fair balance, or otherwise misleading:  21 CFR 202.1(e)(6), 21 USC 321(n), and 21 USC 352

- Advertisements that may be false, lacking in fair balance, or otherwise misleading:  21 CFR 202.1(e)(7)

- Promotion of an investigational new drug/biologic:  21 CFR 312.6(b) and 21 CFR 312.7(a)

- Ingredients and proprietary names in advertisements:  21 CFR 202.1(a) through (d)

- “Intended uses”: 21 CFR 201.128, and 201.100(c)(1) and 21 USC 502 (f)(1)

- Reminder advertisements:  21 CFR 202.1(e)(2)(i) and 21 CFR 200.200

- Reminder labeling:  21 CFR 201.100(f) and 21 CFR 200.200

- Misleading statements:  21 CFR 201.6

- Proprietary names: 

     - Size and location 21 CFR 202.1(b)

     - Fanciful:  21 CFR 201.10(c)(3), and 202.1(a)(3) and 21 USC 321(n)

     - Similarity in spelling or pronunciation:  21 CFR 201.10(c)(5) and 202.1(a)(3)

Prohibited Acts, Injunction Proceedings, and Penalties:  21 USC 331, 332, and 333

Established names: 21 CFR 299.4, FFDCA Sec. 502(e)

 

Devices:

Definitions:

- Device:  21 USC 321(h)

- Restricted device:  21 USC 360j(e)(1)

- “Intended uses”  21 CFR 801.4

Misleading statements:  21 CFR 801.6, 21 USC 321(n), and 21 USC 352

Misbranding by reference to premarket notification:  21 CFR 807.97

Promotion of an investigational device:  21 CFR 812.7(a)

Reminder labeling:  21 CFR 801.109(d)

Prohibited Acts and Penalties:  21 USC 331, 332, 333, and 334

  • Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Definition:  21 CFR 1270.3(j)

Regulation of HCT/Ps:  21 CFR 1271.10

 

 

-

Key Resources

-
 

Contact FDA

301-827-3028
301-827-3528 Fax
Advertising and Promotional Labeling Branch (APLB)

Office of Compliance and Biologics Quality

Center for Biologics Evaluation and Research

Food and Drug Administration

1401 Rockville Pike, HFM-602

Rockville, MD 20852-1448