Center for Veterinary Medicine (CVM) RECALLS

1. Center for Veterinary Medicine (CVM) RECALLS

2. GUIDANCE • 21 CFR 7.40 provides guidance on the policy, procedures, and industry responsibilities for recalls. • Chapter 7 of the Regulatory Procedures Manual outlines the guidance for the procedures necessary for the FDA to classify a recall.

3. DEFINITION • Recall means a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, i.e., seizure. • Recalls are generally more efficient than formal administrative or civil actions, especially when the product has been widely distributed.

4. VIOLATIONS • Recalls are initiated for violations of the Food, Drug, and Cosmetic Act (FD&C Act) for which we would take legal action. • In instances where there is no violation, the firm will do a Market Withdrawal of the product.

5. REGULATORY AUTHORITY • Prior to 2011 CVM recalls were Voluntary • Prior to 2011 Voluntary Exception: • FDA requested Recall - All FDA requests for firms to recall must be approved by the Associate Commissioner for Regulatory Affairs (ACRA). • January 2011 the Food Safety Modernization Act (FSMA)was passed which would give the FDA new powers to increase inspections of food processing facilities and force companies to recall tainted food. FDA was given the Mandatory Recall Authority for food that can cause serious adverse health consequences or death to humans or animals (SACODHA)

6. CLASSES OF RECALLS • There are 3 classes of recalls: • Class I • Class II • Class III

7. CLASS I • A Class I recall is a situation in which there is a strong likelihood that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

8. CLASS I • Class I Recalls usually require that a press release be issued by the recalling firm. • The sign-off package needs to include a HHE, as well as the investigational and analytical documents from the monitoring district office. • All Class I Recalls must be approved by the Associate Commissioner for Regulatory Affairs (ACRA).

9. CLASS II • A Class II recall is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

10. CLASS III • A Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

11. ALL CVM Recalls • All CVM recalls require a new or previous Health Hazard Evaluation (HHE) be done. • They are classified by CVM Recall Coordinator with final approval. • Press is usually required for Class I recalls.

12. Health Hazard Evaluation (HHE) • HHE is performed by a specialist(s) in the recalling area; • Existing conditions could contribute to a clinical situation that could expose humans or animals to a health hazard; • Disease, injury or death have already occurred; • Assessment of how the hazard will affect the animals or human population;

13. Health Hazard Evaluation (HHE) (cont) • Assessment of degree of seriousness of health hazard to population at risk; • Assessment of likelihood of occurrence of hazard; and • Assessment of immediate or long-term occurrence of the hazard.

14. DISTRICT FIELD OFFICE • Within 24 hours, notify Recall Operations Staff & responsible center that a recall is being planned or underway. • Within 5 days of submitting alert through Recall Enterprise System (RES), submit Recall Recommendation. • Provide assistance to firm, i.e., in preparing recall letters, press releases, etc. • Manage FDA’s audit program

15. CENTER’S RESPONSIBILITY • Class I recalls require a new HHE. • For Class II and Class III recalls, if an up-to-date HHE does not exist covering the situation, the center recall coordinator requests one from the HHE committee. • Center Recall Coordinator classifies the recall. • Concurs in or changes the firm’s strategy for recall and effectiveness checks.

16. CENTER’S RESPONSIBILITY (cont) • Determines depth of recall. • Determines level of FDA audit program. • Monitor and track trends in recalls. • Address enforcement strategies where recalls might be a component.

17. DEPTH OF RECALL • Wholesale Level • Retail Level • Consumer Level

18. CVM RECALLS FY 2006 - 2011 • FY 06 – 136 Recalls • FY 07 – 1131 Recalls (Melamine Recall) • FY 08 – 247 Recalls • FY 09 - 284 Recalls • FY 10 - 196Recalls • FY 11 - 410Recalls

19. CVM Contacts • Kathy Hemming Thompson @ Kathy.Hemming@fda.hhs.gov • Dillard Woody @ Dillard.Woody@fda.hhs.gov