FDA Director Discusses Number of Deficiency FCNs at Keller and Heckman Seminar

The increased number of Food Contact Notifications (FCNs) being withdrawn led the U.S. Food and Drug Administration (FDA) to conduct a study on the reasons behind the withdrawals, said Dr. Denis Keefe, Director, Office of Food Additive Safety, FDA. Speaking at Keller and Heckman’s Food Packaging Law Seminar on October 9, 2017, Dr. Keefe explained that in 2014, 118 FCNs were received by the Agency, 88 became effective, and 30 were withdrawn. Just two years, later, in 2016, of the 118 FCNs that FDA received, 60 became effective and 48 were withdrawn, a fall of 25%. The Agency is seeing a similar pattern this year.

Concerning the increased number of FCNs withdrawn over the last couple of years, Dr. Keefe stated, “This is disturbing to us. We don’t want to enter into a review process that ends in a withdrawal; it uses up our resources and is costly to industry.” The study conducted by FDA analyzing of the FCN process found that the largest increase in deficiencies was due to administrative or regulatory issues (9 in 2014 compared to 32 in 2016).

However, a significant increase of deficiencies in the environmental assessment sections of the FCNs were found (64 in 2014 compared to 83 in 2016). Furthermore, of the FCNs withdrawn in 2014, five could be attributed solely to environmental deficiencies compared to 10 in 2016. (For more information on environmental deficiencies in FCNs, see the PackagingLaw.com article, What’s Behind FDA’s Increased FCN Deficiency Letters Related to EAs and How to Respond.)

Another observation from the analysis, was that antimicrobial FCN submissions increased 30% between 2014 and 2016. Overall, in 2014, FDA issued letters pointing to deficiencies in 95 notifications and 32 of these second letter was issued and in 2016, FDA found 107 FCNs to be deficient with 43 receiving a second letter. Dr. Keefe encouraged attendees at the Keller and Heckman seminar to work with FDA to reduce the number of deficiency and withdrawal letters.

Overall, FDA has received 1,797 FCNs since the inception of the program. Of those, 1,287 are effective, 443 were withdrawn, 11 were not accepted, FDA objected to 26, and 30 are still under review, Dr. Keefe explained.

Dr. Keefe also discussed other trends that the Agency is seeing. These include:

• Citizen Petitions to initiate FDA rulemaking to amend existing food additive or color additive regulations to restrict or prohibit the use of certain food additives (e.g., BPA, BHA, certified color additives) and to prohibit the use of a food ingredient (e.g., partially hydrogenated oils (PHOs))
• Litigation to compel FDA to: respond to Citizen Petitions (e.g., BPA, PHOs, salt & sodium); finalize proposed rules (e.g., FSMA, GRAS Notification Program) or finalize food additive petitions (perchlorate)
• Food Additive or Color Additive Petitions to repeal food additive regulations based on abandonment (e.g., BPA, 2 perfluoroalkyl compounds, perchlorate, styrene)
• Food Additive or Color Additive Petitions to repeal food additive regulations based on safety (e.g., perfluoroalkyl ethyl compounds, perchlorate, 7 synthetic flavoring agents, 30 ortho-phthalates, lead acetate)
• “Active” packaging
• Novel protein sources (e.g., insect, microbial, GE-microbial, plant-based)

In response to a question about environmental assessments, Dr. Keefe encouraged industry to submit Citizen Petitions to expand the categorical exclusions for food-contact materials. These should include a roadmap and the data needed to support the request. (For more information on categorical exclusions in environmental assessments, see the PackagingLaw.com article, What’s Behind FDA’s Increased FCN Deficiency Letter Related to EAs and How to Respond.)