FDA Attorneys & Consultants

Our Lawyers and Consultants Have Extensive Experience in All Areas of FDA Compliance and Defense

**Attorney Nick Oberheiden**
FDA Team Lead

**Attorney Lynette Byrd**
FDA Team Lead
Former DOJ Attorney

Attorney John Sellers — **John W. Sellers**
FDA Team Lead
Former Senior DOJ Trial Attorney

The U.S. Food and Drug Administration (FDA) plays an active role in ensuring that dangerous foods, drugs, medical devices, and cosmetics do not compromise the American public’s health and safety. Its primary source of authority is the Food, Drug, and Cosmetic Act (FD&C Act); and, under the FD&C Act, it has implemented extensive rules and regulations that govern everything from manufacturing practices to marketing practices, and from when companies can bring their products to market to when their products need to be recalled.

Due to the extraordinary number of companies that fall within the FDA’s enforcement jurisdiction, it relies heavily on companies to self-regulate, and it expects all companies to implement policies, procedures, production and process controls, and safeguards that are sufficient to avoid putting dangerous products on retailers’ and healthcare providers’ shelves. As a result, when the FDA takes action and uncovers apparent violations of FDA regulations, it often moves swiftly to impose substantial penalties. This makes proactive compliance critical, and companies in all industries must be prepared to affirmatively demonstrate compliance when facing scrutiny from the FDA.

FDA Counsel with Experience in All Areas of Compliance

We assist companies in all industries with all aspects of FDA compliance. Our FDA compliance team includes both former federal prosecutors and former FDA personnel who bring extensive experience and critical insights to helping companies understand and meet their obligations. Our lawyers and consultants provide advice in areas including:

FDA Food Compliance

The FDA regulates the manufacture, importing, marketing, and sale of several types of food products, including food additives, dietary supplements, bottled water, and infant formulas, among others. Companies in all segments of the chain of distribution must ensure strict compliance with the FD&C Act and the pertinent FDA rules and regulations.

FDA Drug Compliance

Drug compliance has been among the FDA’s top enforcement priorities in recent years. We assist drug companies with all aspects of FDA compliance—in addition to assisting with Drug Enforcement Administration (DEA) compliance and federal compliance in other areas. From pre-market submissions through bringing new drugs to market and responding to recall notices and warning letters, we provide end-to-end FDA compliance services for drug companies throughout the U.S. and worldwide.

FDA Biologics Compliance

The FDA regulates biologics including allergenics, blood, blood components, gene therapies, recombinant therapeutic proteins, somatic cells, tissues, and vaccines, among others. Similar to chemically synthesized drugs, biologics are subject to numerous pre-market and post-market requirements, and biologics manufacturers must carefully navigate the FDA’s approval processes before offering their products to healthcare providers, pharmacies, and consumers. We have extensive experience in this area and can help guide your company through the process of developing a favorable relationship with the FDA.

FDA Medical Device Compliance

Medical device compliance has also been a recent priority enforcement area for the FDA. This is largely due to widespread recalls involving implantable medical devices that failed to meet the FDA’s approval standards. From Current Good Manufacturing Practice (CGMP) and International Organization for Standardization (ISO) compliance to managing pre-market submissions and post-market surveillance, we assist medical device manufacturers with all aspects of FDA compliance as well.

FDA Electronic Device Compliance

One of the least well-known areas of the FDA’s oversight is its regulation of electronic devices that emit radiation. Along with medical devices, this includes non-medical devices such as microwaves, sunlamps, and laser products. All products sold in the U.S. that emit radiation must meet the FDA’s radiation safety requirements, and manufacturers must be prepared to provide the FDA with testing records and reliable data when necessary.

FDA Cosmetics Compliance

The FDA regulates cosmetics sold in the United States that are manufactured both domestically and abroad. Among numerous other requirements, cosmetics importers, manufacturers, and retailers must ensure that their products are labeled accurately, and they must avoid making any false or misleading representations regarding their products’ effects or capabilities. We assist cosmetics companies with establishing, maintaining, and documenting compliance so that they do not face unnecessary risks during FDA inspections and investigations.

FDA Veterinary Product Compliance

The FDA’s Center for Veterinary Medicine is one of several federal agencies that regulate domestic and agricultural animal products sold in the United States. This includes not only animal drugs, but also feed and pet foods, animal devices, and animal vaccines. We help companies that import, manufacture, sell, and use these products effectively manage compliance with all pertinent legal and regulatory requirements.

FDA Tobacco Product Compliance

The FDA continues to actively regulate the manufacturing, marketing, and distribution of cigarettes and other tobacco products. It has been active in enforcing cigarette, e-cigarette, and other companies’ compliance obligations in recent years. Our FDA lawyers and consultants provide end-to-end compliance services for tobacco companies focused on avoiding FDA scrutiny whenever possible and withstanding FDA scrutiny when necessary.

Dr. Nick Oberheiden

Founder

Attorney-at-Law

Lynette S. Byrd

Former DOJ Trial Attorney

Partner

Brian J. Kuester

Former U.S. Attorney

Hon. Kevin McCarthy

55th Speaker, U.S. House of Representatives (ret.)

Government Consultant

Mike Pompeo

Of Counsel

Former U.S. Secretary of State

John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara

Federal Appeals Attorney

Nicholas B. Johnson

Former Prosecutor

Roger Bach

Former Special Agent (DOJ)

Chris J. Quick

Former Special Agent (FBI & IRS-CI)

Michael S. Koslow

Former Supervisory Special Agent (DOD-OIG)

Ray Yuen

Former Supervisory Special Agent (FBI)

Defense Counsel for FDA Inspections, Investigations, and Enforcement Proceedings

Along with our FDA compliance services, we also serve as defense counsel for companies facing FDA inspections, investigations, and enforcement proceedings. We handle inquiries at all stages of the commercialization process, including (but not limited to):

Pre-market inspections
Voluntary and involuntary recall notices
FDA Warning Letters
Office of Regulatory (ORA) inspections
Inquiries conducted by other FDA offices and subdivisions (i.e., the Center for Veterinary Medicine and Center for Tobacco Products)
FDA enforcement proceedings

Depending on the circumstances involved, these and other enforcement efforts can lead to substantial penalties. This includes not only fines and other civil monetary penalties (CMP), but also denial (or revocation) of FDA approval, other administrative penalties, and even criminal prosecution. As a result, an informed and strategic defense is critical, and companies that are facing FDA scrutiny must work quickly to determine the most appropriate course of action in light of the circumstances at hand.

With former federal prosecutors, a former FDA Special Agent, and a former FDA Compliance Director on our team, we are capable of providing immediate insight and recommendations to companies that are facing FDA scrutiny. We are also capable of quickly developing and executing targeted defense strategies focused on securing a specific desired outcome. If your company has received a Warning Letter or is facing any other form of scrutiny from the FDA or one of its offices or subdivisions, we encourage you to contact us promptly for more information.

FAQs: Avoiding (and Surviving) Scrutiny from the FDA

What Does it Take to Manage an Effective FDA Compliance Program?

Managing an effective FDA compliance program is not an easy task. Statutory and regulatory requirements vary (often widely) between industries, and companies must ensure that they are taking all of the necessary steps based on the nature of their operations and the specific products that they import, manufacture, distribute, market, or sell. At Oberheiden P.C., we rely on extensive experience to help companies fully understand and address their FDA compliance obligations.

How Can I Determine if My Company is FDA Compliant?

Determining if your company is FDA compliant involves conducting an internal risk assessment. Our attorneys regularly conduct FDA risk assessments for clients, examining their compliance policies and procedures, their operations, and any areas where compliance failures have the potential to lead to civil or criminal enforcement. If you have concerns about your company’s FDA compliance program, making informed decisions about what additional measures are necessary is a key first step toward effective risk management.

What Types of Issues Can Lead to Scrutiny from the FDA?

Numerous issues can lead to scrutiny from the FDA. This includes everything from failing to strictly follow the applicable procedures for obtaining clearance under Section 501(k) to improperly labeling and marketing drugs, devices, and other products. If your company is facing an FDA inspection or investigation, understanding why will be critical to developing and executing an informed defense strategy.

How Can (and Should) Companies Prepare for FDA Inspections?

Preparing for an FDA inspection starts with ensuring that your company will be fully prepared to demonstrate compliance with all applicable statutory and regulatory requirements. When facing an FDA inspection, you do not want to encounter any surprises. A proactive approach is critical, as encountering unanticipated issues during an FDA inspection can lead to costly delays and the potential for further FDA scrutiny.

What Are the Risks of Facing an FDA Investigation?

FDA inspections can present substantial risks for companies and their owners. While FDA inspections are generally administrative or civil in nature, administrative penalties and civil fines can prove incredibly costly. The FDA pursues criminal enforcement when warranted as well, and company executives and other personnel targeted in criminal investigations can face both fines and prison time.

Contact the FDA Lawyers at Oberheiden P.C.

If you have questions about FDA compliance or need strategic defense counsel for an FDA inspection, investigation, or enforcement proceeding, we can help. We have the experience you need, and we can get to work immediately if necessary. To schedule a complimentary initial consultation with an FDA lawyer at Oberheiden P.C., please call 888-680-1745 or tell us how we can help online today.