FDA Food Compliance
FDA Food Compliance Team Lead
FDA Food Compliance Team Lead
Former DOJ Attorney
FDA Food Compliance Team Lead
Former Senior DOJ Trial Attorney
The U.S. Food and Drug Administration (FDA) has substantial authority to regulate food products sold in the United States in order to protect public health. Its regulatory jurisdiction extends not only to companies that manufacture food products domestically, but also to companies that export food products to the U.S.—and all companies involved in the subsequent chain of distribution of the food supply for the country. For all companies subject to the FDA’s oversight, a proactive and detail-oriented approach to compliance is critical, as non-compliance with the FDA’s food requirements, as with all federal agencies, can lead to substantial administrative, civil, or even criminal penalties.
At Oberheiden P.C., we provide comprehensive FDA compliance services for food product manufacturers and other companies in the U.S. and abroad. This includes both compliance services and defense services for FDA inspections, investigations, and enforcement proceedings. With a team that includes former federal prosecutors and former FDA employees and enforcement personnel, we are intimately familiar with companies’ FDA regulated products compliance obligations as well as the FDA’s expectations and enforcement priorities, and we rely on our insights to help our clients manage comprehensive and cost-effective FDA compliance programs.
Key FDA Compliance Considerations for Food Companies
Managing FDA food compliance is not an easy task. In addition to complying with the Food, Drug, and Cosmetic Act (FD&C Act) and all of the FDA regulations that apply to food manufacturers, importers, and distributors generally, many food companies must also comply with regulations that are specific to the types of foods they sell. For example, the FDA has implemented Compliance Programs that are specific to foods including (but not limited to):
- Aquaculture Seafoods Containing Chemotherapeutics
- Dietary Supplements
- Foods that Contain Mycotoxins
- Infant Formulas
- Medical Foods
- Milk and Eggs
- Molluscan Shellfish
The FDA has also adopted Compliance Programs that are specific to various aspects of the food manufacturing, marketing, and distribution processes. For example, the FDA’s NLEA, Nutrient Sample Analysis, and General Food Labeling Requirements Program establishes detailed requirements for things like allergen declarations, allergen source labeling, and nutrition labeling to oversee the labeled health benefits of food. The FDA’s Retail Food Protection Compliance Program establishes similarly detailed requirements for addressing foodborne illness risk factors such as unsafe food sources, cooking and holding temperatures, and cross-contamination.The FDA also has an office of Minority Health and Health Equity to ensure equity for FDA approved products.
And this just scratches the surface of FDA food compliance.
To help our clients meet their FDA food compliance obligations—and to help our clients demonstrate compliance to the FDA when necessary—we help them take a proactive approach to addressing all pertinent legal and regulatory requirements. Along with addressing general compliance under the FD&C Act and addressing all pertinent FDA Compliance Programs, this includes addressing compliance concerns such as:
FDA Food Compliance Program Development and Implementation
All companies that are subject to the FDA’s oversight must develop and implement custom-tailored FDA compliance programs. For food companies, this begins with identifying all relevant statutes, regulations and FDA Compliance programs. Our lawyers and consultants work closely with our clients to determine their specific compliance obligations, and then we use our experience and insights to craft policies and procedures that are specifically designed to help our clients efficiently manage FDA compliance on an ongoing basis.
FDA Food Compliance Training
Training is a key aspect of compliance program implementation. Along with developing compliance policies and procedures for our clients, we also develop training programs that are suited to personnel at various levels of their organizations. For companies in the food industry, all personnel play a role in compliance management, and this means that all personnel need to have a clear understanding of their specific expectations and responsibilities.
Sampling Compliance
Under the Food Safety Modernization Act, food companies are required to conduct sampling in order to ensure that their products are safe for consumption in many circumstances. We help our clients execute and document compliant food sampling programs to help ensure public safety and withstand FDA scrutiny when necessary.
Preparing for FDA Inspections
For food companies targeting the U.S. market, dealing with FDA inspections is a part of doing business. To ensure that these inspections go smoothly, companies should prepare thoroughly in advance. This requires a clear understanding of what the FDA’s inspectors will be looking for, and it requires an equally clear understanding of what is (and isn’t) required when it comes to FDA food compliance. We have extensive experience on both sides of FDA inspections, and we can use this experience to guide your company through the FDA inspection process successfully.
Economically Motivated Food Adulteration (Food Fraud)
Food fraud, or what the FDA calls “economically motivated food adulteration,” has been a priority enforcement area for the Administration in recent years. Recent enforcement actions have targeted adulteration and misrepresentation of the ingredients in food products including honey, maple syrup, olive oil, juice, spices, infant formula, and seafood, among others. We help our clients avoid inadvertently engaging in food fraud, and we ensure that our clients have the on-hand documentation needed to demonstrate their good-faith compliance efforts to the FDA.
Reportable Food Registry Compliance
Food companies are required to report potential adverse health consequences associated with their products through the FDA’s Reportable Food Registry. Of course, disclosing health and safety concerns can expose food companies to FDA scrutiny as well. We help our clients determine when disclosure is required, and we help them execute disclosure strategies focused on mitigating any potential risks for administrative, civil, or criminal penalties.
Recalls, Seizures, and Voluntary Destruction
We also assist our clients with recalls, seizures, and voluntary destruction of adulterated and other violative food products. These, too, can be high-risk matters requiring a careful and strategic approach. If your company needs to issue a recall (or needs to decide whether to issue a recall), or if you are facing the prospect of an FDA seizure or the need to voluntarily destroy potentially dangerous food products, our lawyers and consultants can guide you forward.
FDA Defense Counsel for Food Companies in the U.S. and Abroad
Along with providing FDA compliance guidance to food companies, we also serve as FDA defense counsel for companies that are facing federal scrutiny. Whether you have received an informal inquiry from the FDA, an Untitled Letter or Warning Letter, a search warrant or subpoena, or any other unexpected communication from the FDA or its federal law enforcement partners, the steps you take next could have significant long-term ramifications.
In these scenarios, we work closely with our clients to help them take all necessary steps internally (i.e., instituting a legal hold) while simultaneously communicating with the FDA on their behalf. A prompt and coordinated response is critical, and food companies facing FDA scrutiny must be extremely careful to avoid mistakes that could lead to further scrutiny or other unnecessary consequences. With our lawyers’ and consultants’ experience on both sides of FDA enforcement matters, we have the insights and capabilities needed to help our clients deal with the FDA with confidence.
Put our highly experienced team on your side
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)
FAQs: FDA Compliance for Food Manufacturers, Importers, and Distributors
What Types of Foods Does the FDA Regulate?
The FDA regulates most types of foods that are not regulated by the U.S. Department of Agriculture (USDA). This includes manufactured food products as well as natural foods other than meat and poultry (though there are exceptions). As a result, nearly all food companies need to address FDA compliance—whether they manufacture or grow food products domestically or import food products from abroad.
What Are the FDA’s Food Compliance Programs?
The FDA’s Food Compliance Programs are sets of regulations that are specific to certain types of foods as well as food handling, packaging, and marketing practices. While not all of the FDA’s Food Compliance Programs apply to all food companies, most companies will need to comply with at least one (and likely several) of these regulatory requirements.
How Does the FDA Enforce Food Compliance?
The FDA enforces food compliance through various means. This includes inspecting companies’ facilities, issuing Untitled Letters and Warning Letters, issuing recall notices and requests for voluntary destruction, seizing adulterated foods, and working with other federal law enforcement agencies to pursue civil and criminal charges.
What Are the Risks of FDA Noncompliance for Food Manufacturers, Importers, and Distributors?
The risks of FDA noncompliance for food manufacturers, importers, and distributors can be substantial. Along with mandatory recalls, destruction, and seizures, FDA enforcement actions can also lead to civil monetary penalties (CMP) or criminal fines and imprisonment. As a result, food companies that are facing scrutiny from the FDA must engage experienced counsel to develop an effective defense strategy immediately.
How Can Food Companies Avoid Issues with the FDA?
Food companies can avoid issues with the FDA by taking a proactive approach to compliance. Companies that prioritize compliance—and that take the additional step of documenting their compliance efforts on an ongoing basis—will put themselves in the best position to avoid triggering FDA inquiries and to survive routine FDA inspections unscathed.
Speak with an FDA Food Compliance Lawyer or Consultant at Oberheiden P.C.
If you would like to know more about our FDA food compliance practice, we invite you to get in touch. Please call 888-680-1745 or contact us online to schedule a complimentary consultation at Oberheiden P.C.
