“FDA-approved” is a designation you may have seen or heard about in the news. Seeing that a product is FDA-approved can give you a sense of assurance that the product is safe and that the claims made are true. That’s because the Food and Drug Administration (FDA) follows a strict and thorough approval process for any product that it has jurisdiction over. Today, we’ll be explaining what the approval process is and what products the FDA approves.
Before we begin to look at how the FDA authorizes products, we need to explain what types of products the FDA does and does not approve. The reasoning for this is critical. If a product that the FDA should be approving doesn’t have the FDA-approval designation, you may want to avoid it. Alternatively, if a product that shouldn’t have the designation is promoting it, something is wrong and possibly even illegal.
The products that the FDA approves are generally medicines or food related. The two we would be most familiar with are medications (both name-brand and over-the-counter) and what are called biological products (or biologics), a category of products that includes vaccines, gene therapies, and products made with plasma. The FDA also approves food additives to ensure that the ingredients and chemicals that go into our food and food for animals are safe. This category includes individual ingredients and additives like artificial coloring.
There are some items where a “yes” or “no” for approval isn’t so simple. In some cases, they may be regulated by the FDA but not require approval to be sold. Some types of items are split into categories where certain items require approval and others don’t.
The first of these are medical devices, which the FDA separates into risk-based classes. The more risk a device can place the user in, the higher the class with Class I being the lowest and Class III being the highest. Generally, Class I devices don’t require anything, Class II requires clearance that they are safe, and Class III requires full FDA premarket approval to be sold legally.
If you’ve ever received a blood transfusion or a heart valve transplant, you’ve dealt with this next category. Human cells, tissues, and cellular and tissue-based products (HCT/Ps) are regulated and partially approved by the FDA to prevent the spread of disease from contaminated HCT/Ps. While all HCT/Ps are regulated by the FDA, only some require approval.
The FDA is allowed to regulate any product that emits radiation, like your microwave, to ensure that it is safe to use. Before a radiation-emitting product can be sold, it must receive certification from the FDA that it follows FDA standards and doesn’t emit harmful or unnecessary radiation. This is not a full approval as the tests are run by the company itself and not the FDA.
These are only a few examples of products that fall under the FDA’s authority but don’t receive a full approval. Others can include manufacturing facilities (which are sometimes inspected as part of the approval process), tobacco products (which have their own FDA guidelines they must follow), or cosmetics. One notable type of product that doesn’t receive approval or even regulation from the FDA is dietary supplements. Compound drugs, or drugs made from ingredients combined by a pharmacist or doctor to tailor medication to a specific person’s needs, also are not approved by the FDA.
Once a product that needs FDA approval has been developed, it needs to undergo several different phases of testing. Before a new drug, for example, can apply for FDA approval, it must be tested on animals, by the drug company, to prove its safety and effectiveness. Once these tests are complete, the company may submit an Investigational New Drug (IND) application. The FDA reviews this application to ensure the product is safe for human clinical trials.
If the FDA determines this is the case, the drug company can begin Phases 1 through 3 of clinical trials, starting with smaller groups and getting larger as they move through the phases. Phase 1 focuses on product safety, while Phase 2 focuses on effectiveness. Phase 3 tests both prior to approval. Once Phase 3 is complete, the FDA and company will meet before the company submits the New Drug Application (NDA). This NDA will be reviewed, along with the drug’s labeling and the facility where the drug will be manufactured. If these are all satisfactory, the drug may be approved. A similar process is followed for other approved products like food and color additives.
The FDA approval process can take a long time, and this is by design. It should take a long time to approve a new drug, for example, so that any possible negative side effects can be caught. This also allows the FDA to know that the drug’s benefits outweigh the negatives.
There are situations where the process can be sped up, especially in cases of great need. We saw this with the COVID-19 vaccines. This is an accelerated approval process that is often used with treatments for life-threatening illnesses, like cancer or HIV/AIDs. Furthermore, there is the Fast Track process, which a company can request if they have a medication that fits specific criteria. The Breakthrough Therapy process may be requested for a drug that shows more promising results than what is currently on the market among other qualifications. It may be used alongside the Fast Track process. Finally, a Priority Review may be used if the FDA plans to act on the NDA within six months, instead of the standard 10 months. When this process is set by the FDA, more attention and resources are directed to assist with a quick but thorough approval process.
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The FDA approval process is critical to protecting the public by ensuring the products they approve are safe and effective. While this isn’t always a smooth or fast process, without it, we could quickly return to the era of snake oil salesmen hocking miracle cures that do nothing or even cause their own issues. Whether it’s making sure drugs do what they’re supposed to or the ingredients in our food are safe to eat, FDA approval processes are important for the trust and effectiveness of food and medication.