FDA Process

The United States Food and Drug Administration (commonly known and written as “FDA”) is a federal agency whose acronym gets thrown around a lot. But do you actually know what the FDA does or regulates? The FDA regulates food, drugs, medical devices, radiation-emitting products, vaccines, animal/veterinary products, cosmetics and tobacco products for use in the United States.

Although the FDA regulates these categories, not all products are required to go through pre-market approval before they are sold. Some products are regulated only after they are for sale and some are only investigated if an issue with the product occurs. However, prescription drugs and vaccines are always subject to FDA regulation prior to their release. In current events, you may be hearing about drug companies seeking emergency authorization for their COVID-19 vaccines. The FDA is currently reviewing a number of pharmaceutical companies’ vaccines for safety and will release a statement on December 10, 2020 for at least one of the vaccine submissions.

To approval a product (such as a vaccine), the FDA experts review the results of all clinical testing that has been performed by the companies. The FDA does not do any kind of developing or testing of the products themselves. The product must be proven safe and effective for approval. The agency uses an analysis that determines if the benefits outweigh the known risks of the product.

However, this analysis does not apply to tobacco products because a safe tobacco product does not exist. The FDA refers to the process of allowing a tobacco product to be distributed as a “marketing order.” It does not mean the product has been approved, but rather that the company has complied with the federal requirements.

Other products that are subject to FDA regulations only after the products are on the market include cosmetics, meal replacements, pet food, infant formula, and vitamin supplements. These companies may have to comply with other federal regulations and standards for their products, but are not subject to FDA approval.

Source: www.fda.gov