Shifts in FDA and Customs Regulations Under Changing Administrations

Shifts in FDA and Customs Regulations Under Changing Administrations

As we see new leadership in Washington, there’s no shortage of questions surrounding customs and FDA regulations for imported goods. The back-and-forth between administrations can often bring about significant policy changes. Under the Biden administration, we saw executive orders reversing many of the policies enacted during Trump’s first term. But now, with Trump back in office in 2025, many of those policies are being reinstated.

For instance, the regulatory environment has seen a notable shift. During Trump’s administration, one of the key initiatives was the reduction of regulations—agencies had to eliminate two existing regulations for every new one introduced. This led to a significant reduction in the regulatory burden on industries such as FDA, USDA, and customs. However, now under the 2025 shift, businesses are seeing an increase in regulatory activity. The FDA has issued several notices proposing or finalizing regulations across various sectors, from medical devices to pet food, antibiotics, and even infant formula. These changes can create more complexity for businesses navigating imports.

New Challenges in Customs Enforcement and the $800 Limit

In addition to changes at the FDA, customs regulations are also evolving. One notable area of concern has been the $800 limit on goods entering the U.S. for personal use, especially items sold directly to consumers via online platforms like Amazon. Customs has ramped up enforcement efforts around this so-called “loophole,” which could have significant implications for companies importing goods at this threshold.

Businesses must stay on top of these evolving regulations as they could affect both compliance efforts and business operations in a rapidly changing landscape.

The Current State of FDA and Customs Responses: Delays and Uncertainty

Working with the FDA and customs has become more challenging in recent months. There’s been a slowdown in response times, with many attorneys, customs brokers, and importers encountering delays. The FDA, in particular, has been slower to respond to inquiries, and there appears to be some hesitation in decision-making. This could be due to several factors, including staff shortages, shifting priorities, and growing pains as agencies adjust to the new political climate.

While we expect things to stabilize in the coming months, businesses should prepare for potential delays and logistical hurdles when it comes to navigating cross-border compliance.

Tariffs and Their Impact on FDA-Regulated Imports

Tariffs are another major topic of discussion. Under the Trump administration, tariffs were imposed on Chinese goods to address concerns over trade practices like undervalued labor and currency manipulation. Now, with Trump back in office, discussions are resurfacing about raising tariffs, particularly on goods from China, Canada, and Mexico. These increased tariffs could significantly impact industries relying on imports from these regions, including fresh produce—a critical component of U.S.-Canada and U.S.-Mexico trade.

For FDA-regulated products, this could mean higher costs for imported food items, which could trickle down to consumers. Businesses must stay vigilant, as changes in tariff policies could affect pricing structures, trade flows, and regulatory compliance for FDA products.

Conclusion: Staying Informed in a Shifting Regulatory Landscape

The regulatory landscape is in constant flux, and businesses need to remain agile as they navigate these changes. From shifting FDA regulations to the impact of customs enforcement and tariffs, it’s more important than ever for companies to stay informed and prepared to adjust their strategies. We’ll continue to monitor these developments and keep you updated on the latest trends and compliance challenges.