NGFA comments on FDA recall modernization

NGFA submitted comments to the U.S. Food and Drug Administration (FDA) regarding its proposal to modernize recalls of FDA-regulated commodities.

“NGFA believes there are opportunities to modernize FDA’s policies and practices to improve the effectiveness and efficiency of recalls by enhancing the consistency, transparency, and communications associated with its recall processes,” NGFA noted.

Among its comments, NGFA outlined the following priorities for recalls:

• Recalls should be appropriately and consistently delineated from market withdrawals.
“As an example, we believe FDA should not characterize a minor, out-of-tolerance result from an animal food nutrient assay as a recall situation when the assay result would not be subject to legal action by FDA and does not pose a risk to animal or public health,” the comments stated. 

• Consistency, timeliness and accuracy of recall classifications should be ensured. “NGFA believes industry would benefit from FDA providing clearer direction on their classification process for Class I, II, and III recalls, and establishing more definitive timelines for determining classifications,” the comments stated. “Further, we believe FDA’s health hazard evaluations should be shared with affected firms to promote consistency, awareness, and transparency within FDA’s processes.”

• Training on FDA directives and policies related to recalls should be provided. “In addition, we believe all entities involved in recalls would benefit from FDA issuing a concise recall handbook…that articulates a clearer and standardized interpretation of FDA requirements and expectations,” NGFA stated. 

• Expectations among FDA Recall Coordinators should be more consistent. “We believe FDA should take steps to ensure that all recall coordinators have consistent interpretations and expectations associated with recall requirements,” NGFA noted. “In addition, NGFA members have experienced situations in which multiple recall coordinators are involved with one recall event, which has created confusion and duplication of efforts.”

• Communication between all entities involved in the recall – federal, state and industry – should be coordinated and harmonized. “Our members indicate that during a recall event they often receive multiple requests for the same information from both state regulatory agencies and FDA,” which causes undue stress on industry personnel, NGFA noted.

Read the full comments here.