What does the term "biotechnology product" encompass?

The term "biotechnology product" specifically refers to products that are derived from biological sources and often includes the use of living organisms and biological processes. This encompasses a wide range of products, including those made from genetically modified organisms (GMOs), as these organisms can be engineered to produce proteins, enzymes, or other substances that are useful in various applications such as medicine, agriculture, and environmental management.

Biotechnology products can include not only therapeutic proteins, monoclonal antibodies, and vaccines but also diagnostics, gene therapies, and cells used in cell therapy. The characteristic that ties these products together is their reliance on biological systems and their manipulation to achieve desired outcomes.

In contrast, products simply manufactured using synthetic chemicals do not fall under the definition of biotechnology products, as they lack the biological component. Vaccines developed from natural substances alone does not capture the breadth of biotechnology, which includes many engineered products as well. Additionally, the notion of products that do not require FDA oversight contradicts the rigorous regulatory framework that applies to biotechnology products to ensure safety and efficacy.