The Ultimate Guide to Food, Drug, and Cosmetic Act (FDCA) Compliance

Learn What Manufacturers and Other Companies Need to Know About the FDCA from Our FDA Compliance Lawyers and Consultants

The federal Food, Drug, and Cosmetic Act (FDCA) is a key piece of legislation for manufacturers of food, drugs, medical devices, cosmetics, and other regulated products. The U.S. Food and Drug Administration (FDA) vigorously enforces all provisions of the FDCA, pursuing administrative, civil, and criminal penalties as warranted. Along with manufacturers, the FDCA applies to importers, exporters, shippers, relabelers, and a variety of other companies as well—and these companies must also maintain strict compliance to avoid unwanted FDA scrutiny.

So, what does it take to comply with the FDCA?

The short answer is, “It depends.” Different companies have different obligations under the FDCA, and much of the statute is divided into chapters that address specific regulated industries. As a result, “FDCA compliance” means different things in different circumstances, and managing an effective FDCA compliance program starts with understanding which provisions of the statute apply.

The Food, Drug, and Cosmetic Act (FDCA): An Overview

Before the Food, Drug, and Cosmetic Act, food and drug regulation was covered on the federal level by the 1906 Pure Food and Drug Act, which laid the foundation for the FDA and consumer protections.

In 1938, the FDCA was passed. The FDCA consists of 10 chapters, each of which contains numerous sections. These sections are further broken down into subsections that establish specific rules, requirements, and prohibitions.

For example, one of the most important sections of the FDA is Section 301 (21 U.S.C. Section 331), which appears in Chapter 3 and is titled “Prohibited Acts.” It contains 59 subsections, each of which prohibits certain acts and omissions. Some examples include:

• “The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.” (21 U.S.C. Section 331(a))
• “The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.” (21 U.S.C. Section 331(b)).
• “The refusal to permit entry or inspection as authorized by section 374 of this title [pertaining to FDA inspections].” (21 U.S.C. Section 331(f)).
• “The failure to comply with any requirements of the provisions of, or any regulations or orders of the Secretary [of the FDA] . . . .” (21 U.S.C. Section 331(u)).
• “The making of a knowingly false statement in any statement, certificate of analysis, record, or report required or requested under section 381(d)(3) of this title [pertaining to importing and exporting].” (21 U.S.C. Section 331(w)).

As noted above, the FDCA includes several industry-specific chapters that include additional requirements and prohibitions for companies in regulated industries. These chapters include:

• Chapter IV – Food 
• Chapter V – Drugs and Medical Devices
• Chapter VI – Cosmetics 
• Chapter VIII – Imports and Exports
• Chapter IX – Tobacco Products 

These chapters vary greatly from one to the next. For example, while Chapter V (Drugs and Medical Devices) covers everything from adulteration and misbranding to pediatric studies and adverse event reporting, Chapter VI (Cosmetics) is comparatively straightforward—focusing solely on adulteration and misbranding while authorizing the FDA to create appropriate exemptions via its regulatory authority.

This raises another important point about the FDCA: While the FDCA is itself an expansive statute that requires a detail-oriented approach to compliance, the FDA’s regulations promulgated under the statute are far more complex, far-reaching, and nuanced. As a result, when addressing FDCA compliance, manufacturers and other companies cannot look exclusively to the statutory language itself. Rather, they must address the FDA’s regulations and guidance documents as well, and they must ensure that they are dutifully addressing all pertinent statutory and regulatory requirements so that they will be prepared to withstand scrutiny from the FDA when necessary.

7 Steps for Implementing an Effective FDCA Compliance Program

In light of the FDCA’s scope and depth (and the FDA’s regulatory authority under the statute), implementing an effective FDCA compliance program is far from a straightforward process. To avoid inadvertent violations that could lead to administrative or civil penalties, manufacturers and other companies must take steps including (but not limited to):

• Determine Which Provisions of the FDCA Apply – As noted above, a key first step toward effectively managing FDCA compliance is determining which statutory provisions apply. This will be different not only for companies in different industries, but also for companies within the same industry in many cases. 
• Identify All Applicable FDA Regulations – Along with identifying all applicable sections of the FDCA, manufacturers and other companies must also identify all applicable FDA regulations. The FDA has adopted voluminous regulations that expand upon companies’ statutory requirements under the FDCA. 
• Develop Custom-Tailored FDCA Compliance Policies and Procedures – Due to the differing nature of companies’ compliance obligations, all companies need to develop custom-tailored FDCA compliance policies and procedures. This is critical; and, while often a time-intensive part of the process, it cannot be ignored or overlooked. 
• Conduct Internal FDCA Compliance Training Programs – Once a company has developed custom-tailored FDCA compliance policies and procedures, one of the next steps is to conduct appropriate internal training programs. Companies will typically need to develop and present multiple training programs that are specific to different departments and roles. 
• Proactively Manage the FDCA’s Pre-Market Approval and Notification Requirements – For drug manufacturers, medical device manufacturers, and other companies, proactively managing the FDCA’s pre-market approval and notification requirements is a core aspect of compliance. The FDCA and the FDA’s regulations establish clear, specific, and extensive requirements for different types of regulated products. 
• Engage FDCA-Compliant Vendors and Business Partners – When working with vendors and business partners, companies that are subject to the FDCA must also ensure that these third parties comply with the FDCA as necessary. The FDA has clearly stated its position that regulated companies cannot avoid liability for statutory or regulatory violations by outsourcing labeling, packaging, or other critical operations.  
• Monitor, Audit, and Document Compliance On an Ongoing Basis – Establishing FDCA compliance is not a one-time event. Rather, it is an ongoing process that requires companies to take proactive steps to ensure that their operations, personnel, vendors, and business partners are all doing what is necessary for them to meet their statutory and regulatory obligations. Companies should monitor their FDCA compliance efforts regularly, conduct regularly scheduled and ad hoc audits as warranted, and continue to document their compliance efforts so that they will be prepared to affirmatively demonstrate compliance to the FDA. 

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Former U.S. Attorney

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

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Mike Pompeo

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Former U.S. Secretary of State

John W. Sellers

Former Senior DOJ Trial Attorney

Linda Julin McNamara

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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: Complying with the Food, Drug, and Cosmetic Act

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If you have questions (or concerns) about your company’s obligations under the Food, Drug, and Cosmetic Act, we invite you to get in touch. To arrange a complimentary initial consultation at Oberheiden P.C., please call 888-680-1745 or tell us how we can reach you online today.