U.S. FOOD & DRUG 

May 14, 2018 

Tammy L. Whitcomb 

Acting Inspector General 

United States Postal Service 

1735 North Lynn Street 

Arlington, VA 22209 

Dear Ms. Whitcomb, 

We are writing to provide an update on: issues you raised in your recent report "Prohibited Inbound 

International Mailings," and affirm our commitment to increasing our presence and activity at United States 

international mail facilities (IMFs) aimed at the interdiction ofdrugs illegally brought into the United 

States, including narcotics. We are very pleased that the United States Food and Drug Administration 

(FDA) was recently granted additional funding as part ofthe Omnibus, which will significantly aid in these 

efforts, as would the new and enhanced authorities that Congress is considering. 

As you are aware, Americans are exposed to an overwhelming number of dangerous products, including 

drugs that may be counterfeit, contaminated, expired, or otherwise unsafe, that enter the United States 

through international mail packages. We are dealing with sophisticated bad actors who are deliberately 

exploiting potential gaps and weaknesses in our authorities. 

As you noted in your report, addressing the large volumes ofitems received through the international mail 

presents significant challenges, including the fact that shippers often purposely avoid labeling in an attempt 

to defeat FDA jurisdiction. Currently, under the Federal Food, Drug, and Cosmetic Act, FDA is required, 

for every parcel, to determine its intended use as a drug and that it is, or appears to be, unapproved, 

adulterated, or misbranded. When there is no labeling, determining intended use can take a great deal of 

labor and resources and sometimes is not possible as a practical matter. 

You specifically called attention to a particularly large volume ofpackages currently stored by the United 

States Postal Service (USPS) at the IMF in Miami pending identification ofa permanent resolution. This 

matter has posed a significant logistical challenge for FDA and our federal partners given both the volume 

involved and the limitations in the existing law that hinder our ability to handle such packages in an 

expeditious and efficient way. However, I can now report that after careful consideration ofall possible 

options that comply with current law, we have a plan as to the disposition ofthese packages. FDA plans to 

take possession ofthe 6,000 packages and process them for refusal and destruction. 

U.S. Food & Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20903 

www.fda.gov 
U.S. FOOD & DRUG 

As you noted in the report, at FDA's request, the USPS has possession ofapproximately 25 bulk mail 

containers, containing approximately 6,000 parcels from a single shipper- Global Drug Supply (GDS) 

which are declared as "prescription medications for personal use" and addressed to individual United States 

consumers. These packages were received at the IMF in Miami on or about July 2016. 

Additionally, on or about June 2016, Customs and Border Protection (CBP) notified FDA they had 

received approximately 3 ,962 packages, via international mail, from GDS which also are declared as 

"prescription medications for personal use" and addressed to individual United States consumers. In July 

of2016, FDA took custody ofthese GDS parcels, moved them to FDA's local resident post and 

subsequently processed them for admissibility. All but one ofthese 3,962 parcels were ultimately refused 

admission by FDA because they appeared to be unapproved and misbranded drugs. 

Operation Safeguard was a foreign parcel interdiction operation led by CBP at IMFs and Express Courier 

Hubs during which a series of"blitz" operations were executed where up to 100 parcels were examined 

each day for three days. Under Operation Safeguard in 2016, 82 ofthe parcels that CBP randomly selected 

for examination were shipped by GDS. These articles were referred to FDA stafffor physical examination 

and admissibility review. 

Based on reviews ofshipping labels, prescription order forms, product labeling and the content ofthe 

packages, FDA determined all 82 packages contained misbranded and unapproved new drugs from foreign 

or unknown sources. The outside of each ofthese 82 packages contained information that was identical to 

that ofthe approximately 10,000 GDS packages being held by FDA and USPS. All 10,000 packages have 

identical shipping labels on the outside ofthe package (customs declaration) stating: (I) the contents ofthe 

parcel are "Prescription Medications for Personal Use"; (2) a specific value under $2,500; (3) a 7-digit 

reference number in the same format; namely Ref: XXXXXXX; ( 4) the parcel was shipped by GDS from 

Barbados; and (5) ifundeliverable, the parcel should be returned to a certain address. 

Given the significant resources required to process these I 0,000 packages due to factors such as the number 

ofpackages, the inherent challenges in determining intended drug use, the fact that the packages were 

being shipped to different parties, and the fact that many different products were involved, FDA spent 

considerable time determining how best to proceed. As stated above, FDA plans to take possession ofthe 

6,000 packages USPS has been holding at our request, and work with the USPS to either process the 

packages at the USPS location or move them to another location for processing. We plan to send 

notifications of destruction to the individual addressees for the 3,962 packages FDA is holding, and dual 

notifications ofrefusal and destruction to the individual addressees for the 6,000 packages USPS is holding. 

Our intent is to seek destruction ofall I 0,000 parcels. 

While we have reached a solution for handling the 10,000 GDS packages, ensuring this process is more 

efficient and effective going forward is of critical concern to the agency, and we are pursuing several 

actions to enhance our ability to proactively manage the risks posed to American consumers from drugs 

brought into the United States through the IMFs. 

U.S. Food & Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20903 

www.fda.gov 
U.S. FOOD &DRUG 

First, we are increasing FDA's presence and activity at the IMFs. Last year, FDA increased the number of 

import investigators in the IMFs from eight to twenty-two full-time employees which is staffing to our full 

capacity based on available space. This will allow us to nearly triple the number of suspicious packages 

that we can open and inspect, going to approximately 40,000 packages per year. With the additional 

funding granted to us, we will make another substantial increase in our import staffworking in the IMFs. 

This will allow us to further increase the number ofpackages that we can open and inspect, to 

approximately 100,000 packages per year. To do so, we will be working closely with CBP and USPS to 

address the logistical challenges related to this expansion of our staff. We are confident that we can work 

together to inspect a far greater volume ofsuspicious packages that arrive at the IMFs and thereby reduce 

the risks these dangerous packages pose to American consumers. 

We are increasing our intelligence gathering by our own experts and working with CBP to increase 

information sharing as well. We are also working to expand the use of enhanced technology and hand-held 

tools in the IMFs, and are making commensurate investments in our laboratories to ensure we have the 

regulatory science to support the actions. Lastly, we are increasing our already substantial collaborative 

efforts with CBP and USPS to find additional areas where we might better leverage our collective resources 

and expertise. 

These are just some ofthe tools we are pursuing to enhance our mission and help ensure that we do not 

need to store large volumes ofillegal drugs, including narcotics at the IMFs in the future. 

I appreciate your interest in this effort and look forward to .keeping you updated on our progress. 

Melinda K. Plaisier 

Associate Commissioner for Regulatory Affairs 

U.S. Food &Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20903 

www.fda.gov