The premise that the Food and Drug Administration (FDA) has "failed" to keep all illegal drugs out of the US via mail is misleading, as the issue involves complex, multifaceted challenges that are largely outside the FDA's sole control. The FDA's role is to provide a "front line defense" at international mail facilities (IMFs), but it works in collaboration with other agencies like U.S. Customs and Border Protection (CBP) and the Postal Inspection Service.
The persistence of illegal mail-order drugs is not a failure of a single agency, but a reflection of several systemic obstacles.
Interagency coordination
problems
- Divided responsibilities: The FDA
regulates drugs, while the CBP and Postal Service are responsible for
package screening and enforcement. The Government Accountability Office
(GAO) and other oversight groups have noted that this division of
responsibilities can lead to poor coordination.
- Inconsistent enforcement: Historically, the FDA has sometimes directed Customs to release small packages of prescription drugs that had been detained. This undermined Customs' efforts and illustrated a lack of cohesive policy.
Evasion of screening and
detection
- High volume of mail: International mail
facilities process an overwhelming number of packages daily. This sheer
volume makes it impossible to conduct a detailed, hands-on inspection of
every single item.
- Advanced electronic data (AED) loopholes:
The Stop All Dangerous Opioids (STOP) Act of 2018 required international
mail to include AED with information on the sender, recipient, and
contents. However, an October 2023 report from the Department of Homeland
Security's Office of Inspector General found that CBP had failed to fully
implement the act, including improperly granting waivers and failing to
impose penalties for incomplete data.
- Chemical obfuscation: Traffickers have
been very effective at using complex and innovative methods to disguise
illicit substances, making detection difficult.
- Technological limitations: While agencies are deploying advanced technologies like non-intrusive inspection and AI, these tools are not foolproof. Bad actors constantly adapt their methods to stay ahead of enforcement techniques.
Global and jurisdictional
challenges
- International sourcing: Many counterfeit
and illegal drugs are manufactured abroad and shipped to the US. Since the
sellers are not within US borders, American law enforcement's ability to
take direct action against them is limited.
- Dark web anonymity: The use of the dark
web and cryptocurrencies allows drug vendors and buyers to operate with a
high degree of anonymity, making it difficult for law enforcement to
identify and prosecute them.
- International cooperation: The ability to act against foreign sellers depends on cooperation from their home countries, which can be inconsistent.
Enforcement resource
limitations
- Manpower and budget: Federal law
enforcement agencies like the FDA and CBP have limited resources and
competing priorities, which restricts their ability to dedicate staff to
mail inspection. For example, a single FDA investigator can spend 20
minutes on one suspicious package, a time-intensive process that doesn't
scale well.
- Staff expertise: Investigating dark web activity and other sophisticated trafficking schemes requires specialized skills and equipment, which can be in short supply.
Congressional and
administrative oversight
- Congressional hearings: A House Oversight
Committee hearing in April 2025 addressed the FDA's regulatory
"bottlenecks" and noted that illicit products were flooding the
market.
- Internal audits: A September 2023 report from the DHS Inspector General showed that CBP allowed inadmissible mail into the country due to poor internal communication and failures to enforce the STOP Act.
Multiple factors prevent the Food and Drug Administration (FDA) from stopping mail-order illegal drugs, including the sheer volume of international packages, resource limitations, the covert methods used by traffickers, and the complex legal jurisdiction over foreign sellers. While the FDA and its partner agencies, like U.S. Customs and Border Protection (CBP), have enforcement strategies, they are insufficient to inspect and intercept every piece of illicit mail.
Volume of international mail
The scale of the problem makes
it impossible to check every package for illegal drugs:
- Millions of international packages arrive
in the U.S. annually, far exceeding the inspection capacity of the FDA and
CBP.
- Much of this mail, coming from more than
180 countries, lacks the detailed advance electronic data (AED) needed to
identify suspicious shipments.
- Illicit synthetic drugs, like fentanyl, are extremely potent and can be hidden in very small quantities, making them harder to detect than traditional drug shipments.
Challenges with foreign
sellers
International boundaries
create significant legal and enforcement hurdles:
- The FDA's authority is limited when
sellers operate outside U.S. borders.
- Enforcement efforts are largely restricted
to asking foreign governments to take action or requesting that CBP
intercept packages at ports of entry.
- Online pharmacies and sellers often operate anonymously or in jurisdictions where U.S. laws are unenforceable, making prosecution difficult.
Regulatory and enforcement
limitations
Agencies face persistent
regulatory challenges and resource constraints:
- The FDA relies on cooperation with other
agencies, including the CBP, Drug Enforcement Administration (DEA), and
U.S. Postal Service (USPS), to enforce regulations and intercept
shipments.
- Despite legislation like the STOP Act of
2018, government watchdogs have found that federal agencies, including the
CBP and USPS, have not consistently met all requirements to screen
international mail for illegal substances.
- In one 2023 report, the DHS Office of the Inspector General noted that the CBP did not consistently target mail for inspection or evaluate the effectiveness of its screening operations.
Tactical evasion by
traffickers
Drug traffickers continuously
adapt their methods to avoid detection:
- They often use fake or fraudulent sender
information on packages to obscure their true identities.
- Traffickers exploit loopholes, like using
countries with less rigorous screening protocols to ship packages.
- The practice of "port shopping," where illicit products are repeatedly sent to different U.S. ports of entry to find a weak point, has been a known tactic.
Balancing risk and resources
Government agencies must
balance multiple priorities when inspecting international mail. The sheer
volume of traffic means that not every potential threat can be fully
investigated.
- Focusing on high-threat
items: Federal agencies often prioritize the interception of weapons
and more potent drugs, like fentanyl, which may result in less attention
being paid to other illegal drugs.
- Inspecting a small percentage: The number of international packages inspected is only a tiny fraction of the total volume. In 2022, KFF Health News reported that the FDA examined a small number of drug shipments at international mail facilities, which does not reflect the total volume of illicit products entering the country.
Comments
US consumers should not be able to buy drugs that are ordered on the internet or TV and delivered by mail. They should buy all drugs at their Pharmacies who order from US manufacturers. Better control by Federal Agencies is needed and should require Congress to pass a Law that limits sales of over-the-counter drugs to licensed Pharmacies.
Norb Leahy, Dunwoody GA Tea Party Leader
No comments:
Post a Comment