It is no secret that since the Trump Administration took over in late January, the Food and Drug Administration (FDA or agency) has been quieter than usual with regard to guidance documents and Federal Register Notices most likely due to President Trump’s 2-for-1 Executive Order and the lack of a Commissioner. However, the ties seem to be slowly turning and we are starting to see a bit more activity from FDA. Of course, we expect that things will pick up as soon as the agency gets a new Commissioner and FDA refocuses its priorities for the next few years. In the meantime, below is a roundup of a couple of the latest publications recently issued by the Agency.
DUNS Number Recognized as Acceptable for Importer Identification
On March 31st, 2017, FDA issued a guidance document entitled “Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs Regulation,” finding the “DUNS [Data Universal Numbering System] number appropriate to meet Agency needs to accurately identify [Foreign Supplier Verification Programs] (FSVP importers so that [the agency] can effectively implement, monitor compliance with, and enforce the FSVP requirements.[i]”
As you may recall, under the FSVP Final Rule, importers of food for humans and animals are required to verify that “the food they import into the United States is produced in compliance with the hazard analysis and risk-based preventive controls and standards for produce safety provisions in the Federal Food, Drug, And Cosmetic Act [], is not adulterated, and is not misbranded with respect to food allergen labeling.[ii]” The FSVP Final Rule also requires that an importer provider provide “its legal business name, electronic mailing address, and UFI recognized as acceptable by the FDA for each line entry of food product offered for importation into the United States.[iii]” FDA has now officially recognized the “DUNS number, “assigned and management by [Dun & Bradstreet], as an acceptable UFI for the purpose of compliance with the FSVP regulation.[iv]”
The DUNS number is available free of charge to all importers. You may obtain a DUNS number by contacting D&B by phone at 866-705-5711, email at govt@dnb.com or by visiting the D&B website at http://www.dnb.com/duns-number.html or through the FDA portal at https://fdadunslookup.com/. In the guidance document, FDA warns that while a DUNS number can typically be obtained within a few days, it could take up to 45 days or more in some circumstances.[v]
The first compliance date for importers subject to the FSVP Final rule is right around the corner – May 30, 2017.
FDA Announces Public Meeting in Preparation for the Upcoming International Cooperation on Cosmetic Regulation (ICCR-11) Meeting
On April 6, 2017, FDA announced that it will be holding a public meeting to “receive input on topics pertaining to the regulation of cosmetics to help the agency prepare for the International Cooperation on Cosmetics Regulation-11 meeting[vi]”to be held in Brasilia, Brazil, July 12-14, 2017. The ICCR is a voluntary international group of cosmetics regulatory authorities from Brazil, Canada, The European Union, Japan and the United States. ICCR members work together to “make decisions through consensus that will be compatible with the laws, policies, rules, regulations and directives of the respective administrations and governments.[vii]”
The public meeting will be held on May 25, 2017 from 2:00 p.m. to 4:00 p.m. at the Harvey W. Wiley Federal Building, 5001 Campus Drive, Auditorium (first floor), College Park, MD 20740.
FDA will make an agenda available on its website at http://www.fda.gov/Cosmetics/InternationalActivities/ICCR/default.htm on or before May 18, 2017 depending on the number of requests for oral presentations.
Any requests for oral presentations should be submitted to FDA by May 11, 2017. Full registration information is available in the Federal Register Notice.
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[i] Guidance at 4.
[ii] 80 Fed. Reg. 74225 (November 27, 2015).
[iii] FDA’s Constituent Update, “FDA Recognizes DUNS Number as Acceptable for Importer Identification,” available at https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm549668.htm.
[iv] Guidance at 4.
[v] Id.
[vi] See FDA’s Constituent Update dated April 6, 2017 – “FDA to Hold Public Meeting in Preparation for International Cooperation on Cosmetics Regulation (ICCR-11) Meeting.”
[vii] Id.
