Benjamin England has a unique and extensive background at the intersection of FDA regulations and customs law. With over 20 years of experience, he has worked across various sectors, providing both legal counsel and consulting services to businesses engaged in FDA-regulated industries.
Career Background:
Benjamin began his career as a microbiologist with the FDA, where he worked in both import and domestic compliance, as well as investigations. His journey later took him to Miami, where he worked in enforcement with both the FDA and Customs. After attending law school, he returned to Washington, D.C. and continued to expand his expertise in the complex relationship between FDA regulations and customs law. This experience eventually led him to establish a law and consulting practice that serves businesses operating at the intersection of these two regulatory frameworks.
Understanding the Intersection of FDA Regulations and Customs Laws:
The relationship between FDA regulations and customs laws is critical for businesses engaged in the import and export of FDA-regulated products. As Benjamin points out, most FDA-regulated products eventually cross international borders, whether being imported or exported. This intersection can be confusing for businesses that are comfortable with FDA compliance but unfamiliar with customs requirements — or vice versa.
For example, while a company may have a strong understanding of FDA regulations for food, pharmaceuticals, or medical devices, the customs process introduces additional requirements and risks that companies may not anticipate. When importing, businesses must navigate the interplay between customs regulations and FDA requirements, which can lead to complications if not managed correctly.
Common Mistakes in FDA Import Compliance:
One of the most common mistakes businesses make when importing FDA-regulated products is failing to understand the information required for FDA admissibility when crossing the border. FDA compliance is evaluated through electronic submissions, customs brokers, and screening systems that occasionally trigger further examination or inquiries. Many importers are caught off guard by the specific documentation or product information the FDA requires, which can lead to unnecessary delays or inspections.
Industry-Specific Challenges:
Certain industries and types of goods face more significant challenges when navigating FDA and customs regulations. For example, products considered to be high-risk — such as prescription drugs and medical devices — are subject to the strictest FDA regulations due to the potential health risks associated with failure or contamination. On the other hand, lower-risk products like food and cosmetics still require attention to labeling and safety but face less stringent regulatory scrutiny. Regardless of the product category, all goods must comply with FDA standards and, when imported, customs laws.
Labeling Issues: A Common Compliance Pitfall
One of the most frequent and easily overlooked issues is labeling compliance. A product can be deemed misbranded if the required information is missing, misleading, or incorrect. This includes mandatory details such as product identity, ingredient statements, and net quantity declarations. Importantly, claims that suggest a product has medical benefits (e.g., a cosmetic claiming to treat a medical condition) can lead to misbranding issues. At the border, customs officers and FDA agents can quickly spot these violations, resulting in delays or confiscation of goods.
Trends in FDA and Customs Enforcement:
In recent years, both FDA and customs enforcement activity has become more stringent. However, there has been a shift toward delays in decision-making, with issues taking months to resolve, compared to a quicker turnaround in the past. As the regulatory landscape continues to evolve, the potential for increased tariffs on imported goods, particularly those from China and Mexico, may create additional challenges for businesses navigating FDA and customs requirements.
Looking ahead, the potential changes in administration and political shifts could influence FDA policies, especially regarding the regulation of food, cosmetics, and pharmaceuticals. However, at the operational level, businesses should expect a continued focus on compliance with existing FDA regulations and customs requirements.
Advice for Small Businesses and Startups:
For smaller businesses or startups, navigating the complex regulatory environment can be especially challenging. Benjamin offers several key pieces of advice:
- Understand Your Product: Whether it’s a dietary supplement, cosmetic, drug, or food product, it’s crucial to understand what category your product falls into and the specific FDA regulations that apply.
- Read the Regulations: Avoid relying solely on guidance documents or third-party articles. Instead, familiarize yourself with the actual FDA regulations to understand the language and requirements.
- Seek Expert Guidance: Even if you don’t have a dedicated compliance team, it’s beneficial to have a trusted advisor you can consult for quick, actionable advice. Benjamin often provides 20–30-minute consultations that can save companies weeks of potential headaches.
- Stay Proactive About Compliance: Small businesses must remain vigilant about meeting both FDA and customs requirements to avoid disruptions at the border.
Stay Informed with FDA Imports:
Benjamin England has created a platform, FDA Imports, to help companies stay informed and navigate the complexities of FDA regulations and customs compliance. Through his consulting services and podcast, he shares valuable insights and updates on regulatory trends, offering businesses the guidance they need to succeed in a heavily regulated environment.
Get in Touch:
If you need assistance with FDA import regulations or want to stay up to date with the latest trends in FDA enforcement and customs compliance, FDAImports is here to help. Contact Benjamin and his team via email at contact@fdaimports.com or visit FDAImports.com for more information.
