|FDA, USDA & US Customs Compliance|
The Way Through to the US Market for FDA- and USDA-Regulated Goods
| What Do We Do?|
We advise many of the world’s leading pharmaceutical, medical device, food, cosmetic and other FDA-regulated life sciences companies and guide them through the entire product life cycle. FDA regulates a wide variety of products that are used in the aesthetic, medical spa and laser industries, including cosmetics, drugs, dermabrasion rollers, laser hair removal and other medical devices. Our team helps clients make sound business decisions and assess regulatory risks.
We also counsel more than 1000 clients in over 120 countries regarding other related government agencies, including U.S. Customs and Border Protections ("CBP”), the Federal Trade Commission (FTC), Consumer Product Safety Commission (CSPC), the U.S. Department of Agriculture (USDA), and the U.S. Patent and Trademark Office (USPTO).
We partner with our clients every step of the way, providing assistance and counsel whenever needed to get products to the desired market.
Who Are We?
We are former FDA officials, consultants, and attorneys specializing in regulatory, business, import, advertising and marketing, and intellectual property law. We know the cosmetics, drug and medical device industries. We know the regulations. And, we understand the interdisciplinary nature of important business decisions companies must make involving manufacturing, marketing, branding, intellectual property, import/export and complex regulatory compliance.
FDA, USDA, and U.S. Customs Compliance
We create solutions to the unique challenges and problems facing companies seeking to successfully market their products in the United States. This includes regulatory compliance with FDA, USDA and U.S. Customs.
|FDA Industries |
- Dietary Supplements
- Food & Beverages
- Medical Devices
- Electronic & Radiological Devices
- FDA Detentions/Refusals
- Import Alert Assistance
- Label Review & Design
- Registration & Product Listing
- Internet Marketing and Claims Analysis
- New Product Evaluation/Development
|US Customs & Intellectual Property|
- Trademark Infringement
- Trademark Filing
- Lanham Act
- Lever Rule
- International Trade Law
- FDA Inspections
- Warning Letters & 483’s
- Criminal Investigations
- Administrative Detention
- In Rem Seizures
- USDA Permits
- Third Party/Foreign Government Certification
- Letter of No Jurisdiction
- Export Certificates
810 Landmark Drive, Suite 126
Glen Burnie, MD 21061
Phone: (410) 220-2800
Fax: (443) 583-1464
|Benjamin L. England, Esq.|
Founder and CEO, Benjamin L. England & Associates, LLC, & FDAImports.com, LLC
Mr. England routinely represents domestic and foreign companies of all sizes, assisting them in identifying FDA, USDA, FTC, EPA, and state requirements. His representation enables his clients to better understand and fully comply with federal and state requirements, and thereby reduce the risk of regulatory interference with products being imported, exported, or distributed in interstate commerce.
A 17-year veteran of FDA, Mr. England served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. Before this, he served in scientific, inspectional, compliance and criminal and civil enforcement capacities as an FDA Consumer Safety Officer, Compliance Officer, a Senior Special Agent with FDA’s Office of Criminal Investigations (OCI) and an
analytical regulatory microbiologist. Read more.
|William G. Nychis|
Senior Regulatory Advisor, FDAImports.com
Mr. Nychis provides comprehensive FDA regulatory assistance to companies marketing or distributing FDA regulated goods in the United States. With 40 years of experience at FDA, Mr. Nychis has served in a wide range of capacities, with special emphasis on compliance issues related to human drug, cosmetic, and dietary supplement industries. His extensive FDA background includes compliance and enforcement work in drug import/export issues, jurisdictional questions pertaining to combination products relevant to drug/device, drug/dietary supplement, and drug/cosmetic determinations.
He has been successful at obtaining releases for refused finished drug products and API and prepared guidance for contract manufacturers. His work to improve Standard Operating Procedures (SOP) and supply chain efficiencies for clients helps them to minimize governmental intervention for import transactions. Read more.
About Benjamin L. England & Associates, LLC
Benjamin L. England & Associates, LLC is an interdisciplinary federal and state regulatory practice focusing on industry sectors regulated by FDA, DEA, Customs, and state health and safety agencies. Together with our sister company, FDAImports.com, Benjamin L. England & Associates LLC actively meets the international regulatory, consulting, and legal needs of hundreds of clients in more than one hundred countries. Our clients range from innovative, entrepreneurial start-ups to Fortune 100 publicly-traded international companies.
We are FDA veterans and business attorneys and consultants, with over 100 years of former FDA experience on staff. Members of our team worked in high-level compliance and enforcement positions in drugs, medical devices, cosmetics and dietary supplements areas.