10.2: Enforcement Terminologies

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Jack O'Grady
Austin Community College

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Legal Terminology

Before we continue on the discussion of FDA enforcement, it is important to understand some key terms in this area. The FD&C Act frequently refers to interstate commerce, adulteration, and misbranding.

Interstate Commerce applies to all steps in the manufacture, packaging, and distribution of a product. It is common that some of the ingredients or packaging most likely originate from out of state or even out of the country and even will leave the state.

What Makes a Product Adulterated?

From the FDA (FDA, 2016). Note that regarding adulteration, the law addresses the composition of the product, the conditions under which the product is manufactured, shipped, and stored, the product's container.

A product shall be deemed to be adulterated if:

If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling
If it consists of any filthy, putrid, or decomposed substance
If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health
If its container is composed of any poisonous or deleterious substance which may render the contents injurious to health
If it contains an unapproved color (or other) ingredient

What makes a product Misbranded?

Section 602 of the FD&C Act [21 U.S.C. 362] describes what causes a product to be considered misbranded. It includes not only what the label says but also what it fails to say! Note that under the FD&C Act, the term "misbranding" applies to false, misleading, or missing information or packaging.

A product shall be deemed to be misbranded:

. If its’ labeling is false or misleading
If the label is missing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count
If any word, statement, or other information required is not prominently placed
If its container is filled as to be misleading

Monitoring

Bioresearch Monitoring (BIMO)

The overarching goals of the FDA's bioresearch monitoring (BIMO) program are to defend the rights, safety, and welfare of subjects involved in FDA-regulated clinical trials (fda.gov).

Additionally, the BIMO serves to determine the accuracy and reliability of clinical trial data submitted to the FDA and to assess compliance with the FDA's regulations governing the conduct of clinical trials. The BIMO program performs on-site inspections of both clinical and nonclinical studies carried out to support research and marketing applications/submissions to the agency.

To learn more about the research monitoring program: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/fda-bioresearch-monitoring-information

The FDA Tests Products

How do quality issues come to the attention of the FDA? The FDA can purchase and test products on its own. The FDA can also inspect production facilities. If a product is found to be defective (or an inspection facility to be out of compliance), there are several options the FDA may pursue: 1. warn the public, 2. seize products from the market, and 3. bring a seizure or injunction case in court, to name a few.