Safeguarding American Agriculture

Federal Relay Service

APHIS is an agency of USDA’s Marketing and Regulatory Programs (Voice/TTY/ASCII/Spanish)

 An Equal Opportunity Provider and Employer 1-800-877-8339

 

 

United States 

Department of 

Agriculture

Animal and Plant 

Health Inspection 

Service 

Veterinary Services 

Washington, DC 

20250 

VETERINARY SERVICES MEMORANDUM NO. 800.98 

TO: VS Management Team (VSMT) 

 Biologics Licensees, Permittees, and Applicants 

 Directors, Center for Veterinary Biologics 

FROM: John R. Clifford /s/ Andrea M. Morgan 7-25-08 

 Deputy Administrator 

 Veterinary Services 

SUBJECT: Advertising and Promotional Materials 

I. PURPOSE 

This memorandum provides guidance concerning advertising and claims which are made 

about licensed veterinary biological products which are regulated under the Virus-SerumToxin Act (21 USC 151, et seq.). 

II. CANCELLATION 

This memorandum cancels Veterinary Services Memorandum No. 800.98 dated June 25, 

2008. 

III. BACKGROUND 

The regulations in 9 CFR 102.4(b)(3) specify that before the Animal and Plant Health 

Inspection Service (APHIS) may issue a U.S. Veterinary Biologics Establishment 

License, applicants must file written assurance with APHIS that the biological products 

which are licensed to be prepared in the establishment will not be advertised so as to 

mislead or deceive the purchasers, and that the packages or containers in which the 

biologics are to be marketed will not bear any statement, design, or device which is false 

or misleading in any particular. Similarly, an application for a permit to import 

veterinary biological products must contain information regarding all claims to be made 

on labels and advertising matter used in connection with or related to the biological 

product to be imported. Mounted copies of final container labels, carton labels, and 

enclosures to be used with the imported product must be submitted as provided in part 

112 of the regulations. 

 The Center for Veterinary Biologics (CVB) does not routinely monitor advertising 

 materials that appear in various trade and scientific journals to determine if they contain 
VETERINARY SERVICES MEMORANDUM NO. 800.98 

Page 2 

statements concerning the product that are false and misleading. However, all reports of alleged 

false or misleading advertising or claims submitted to CVB are reviewed. Advertising or claims 

that are found to be false or misleading in any particular will be brought to the attention of the 

licensee or permittee by written notification as outlined in Section IV of this document. More 

drastic action may be taken in cases where inappropriate advertising or claims may render a 

product dangerous or harmful to such an extent that immediate action is necessary. 

IV. GUIDELINES 

 A. Advertising and Claims Based on APHIS Approved Labeling 

An advertisement or claim that restates information on APHIS approved labeling and 

which does not include artwork, pictures, or designs which by implication expand or 

modify such information as to make it false or misleading is acceptable. An 

advertisement or claim which misleads by misquoting APHIS requirements or 

encourages the user to disregard label directions and otherwise use or handle the product 

in a manner that is inconsistent with approved labeling is considered false and 

misleading. 

 B. Advertising Claims Based on APHIS Approved Data 

Data which validates protection claims such as prevention of infection, prevention of 

disease(s), and aid in the prevention of disease(s) are the basis for issuing veterinary 

biological product licenses and permits. Product advertisements should accurately 

present the claims reviewed and approved by APHIS. 

 C. Advertising Claims for Enhanced Performance 

Although performance parameters such as increased rate of gain, increased feed 

efficiency, and increased milk production may be monitored and submitted with data 

from a host animal protection study, only protection data are considered in the evaluation 

of a veterinary biological product for licensing purposes. Therefore, advertising 

veterinary biologics in a manner which, by inferences such as “data on file with USDA,” 

implies that performance claims have been reviewed and approved by APHIS is 

considered false and misleading. 

 D. Advertising Claims Based on Data Taken from Published Literature 

APHIS does not review data published in the literature concerning claims for veterinary 

biologics. For the purposes of licensing product and/or validating claims, only 

manufacturer submitted data are reviewed. Therefore, product advertisements which 

feature claims that are based on studies presented in published literature may be 

considered false and misleading. To preclude the appearance of such, only APHIS 

approved claims should be used in association with the advertising of veterinary 

biologics. 
VETERINARY SERVICES MEMORANDUM NO. 800.98 

Page 3 

 E. Advertising Involving Comparison Studies of Competitive Products 

APHIS does not consider data resulting from a comparison study with a licensed product 

in its decision to issue a veterinary biological product license. In addition, APHIS does 

not review the results of comparative studies of such products published in scientific or 

trade journals. Therefore, advertising disputes between veterinary biologics 

manufacturers originating from comparison studies presented in published articles should 

not be submitted to APHIS for arbitration. 

V. COMPLIANCE PROCEDURES 

The regulations in 9 CFR 105.1 specify, in part, that APHIS may suspend or revoke an 

establishment license, product license, or permit that is being used to facilitate the labeling or 

advertising of a product so as to mislead the purchaser in any particular. APHIS may take such 

action if other initiatives designed to gain compliance fail. Other compliance initiatives may 

consist of the following: 

 A. Letters of Advice 

 The Center for Veterinary Biologics-Inspection Compliance (CVB-IC) may send a 

 letter of advice specifying the claim, design, or device that is considered to be false or 

 misleading. Licensees or permittees may be asked to respond to APHIS’ findings by 

 supplying information to support continued use of a claim, design, or device or by 

 agreeing to take specific corrective action in regard to claim, design, or device within a 

 specified time frame. 

 B. Infraction Notice 

 The CVB-IC may send an infraction notice when the licensee or permittee does not 

 respond to the letter of advice. The infraction notice could cite failure to take the 

 specified corrective action as evidence of willful violation. Such violation could subject 

 the license to suspension or revocation in accordance with 9 CFR 105.1(b). 

 C. Pre-review of Advertising 

 APHIS does not normally review each piece of proposed new advertising. Occasionally, 

 however, APHIS may agree to review advertising copy prior to its publication if the 

 licensee is uncertain of the acceptability of a specific claim, design, or device.