NGFA submitted a statement to the U.S. Food and Drug Administration (FDA) on Aug. 9 concerning the agency’s proposed rule for labeling requirements for approved or conditionally approved new animal drugs.
While the proposed rule would create new requirements for labeling animal drug products, it also would significantly expand the required content for final printed labels of Type B and Type C medicated feeds.
Among other things, NGFA within the statement recommended that FDA:
- Not establish requirements for guaranteed analysis and ingredient listings on medicated customer-formula feed labels that would be inconsistent with state feed laws.
- Expressly state that proposed general formatting requirements for animal drug labels do not apply to final printed medicated feed labels.
- Eliminate the proposed requirement that FDA contact information be provided on every medicated feed label.
- Clarify that required lot numbers may be applied to the label, package, invoice or shipping document, as allowed by FDA’s current good manufacturing regulations for medicated feed.
- Not require final printed medicated feed labels to include the revision date of the associated representative labeling created by the drug sponsor.
- If the agency wishes to proceed with rulemaking that would significantly impact the content and format of final printed medicated feed labeling, further engage with medicated feed manufacturers and other stakeholders to ensure that any new requirements produce benefits that are commensurate to the cost.
In addition, NGFA’s statement included an economic impact analysis that highlighted the significant cost that commercial feed manufacturers would incur to comply with the proposed requirements.
Please contact NGFA Senior Vice President of Feed David Fairfield with any questions.