You hear phrases like “FDA-approved” or “according to the FDA” all the time, but what does that exactly mean? The FDA—the Food & Drug Administration—sounds like it has a lot of say in what hits the market. But what falls under the umbrella of its authority? And what exactly is this agency looking for when it regulates so many products?
If the FDA approves something, does that definitely mean it’s safe? More importantly, if the FDA doesn’t approve something, does that mean it’s dangerous?
First, it’s important to understand the purpose of the FDA. This agency operates under the United States Department of Health and Human Services and exists to protect public health by regulating (as its name suggests) food and drugs, as well as other products like cosmetics and tobacco. It’s the agency that ensures drugs are safe and effective, and that you have all the information you need as a consumer to make responsible choices.
The FDA was established in 1906 via the Pure Food and Drugs Act with the intention of preventing abuse or negligence on the part of manufacturers. Since then, the agency has grown to be the reigning body in charge of:
- Approval of drugs before they hit the U.S. market
- Inspection of production facilities that make food, medicine, and tobacco
- Regulation of the marketing and distribution of tobacco products
- Recalls on products with safety concerns
How does the FDA go about approving medicine?
Drug manufacturers have to put any new medicine through a series of clinical trials involving human test subjects. If the drug passes three phases of testing, the manufacturer then submits a new drug application to the FDA, which will then review the trial data to ensure the drug is effective (it does what it claims it will do) and safe (its benefits outweigh any risks or side effects). The FDA will also review labels that will be put on the drug’s packaging and the facilities where it is being made. All these factors go into the FDA’s decision as to whether it will approve or deny the application of a new medicine on the market.
Is this approval process just for drugs and medicine?
The FDA also looks at medical devices—everything from stethoscopes to heart catheters—and vaccines, plus food ingredients like preservatives, artificial colors, and texturizers, and food additives like wrappers or adhesives that could come in contact with the food.
If something isn’t FDA approved, does that mean it’s dangerous?
Not necessarily. For one thing, the FDA doesn’t approve products like supplements—these don’t technically fall under the category of medicine. This could include vitamins and minerals, or it could include pills and powders like those intended to help you lose weight or build muscle. It might also be put on herbal products, such as chamomile or dandelion root.
In all of these cases, the FDA has not evaluated whether these products are safe or effective. A powder can claim it will help your body burn fat, but there’s no regulation behind such a claim. That’s why you’ll see a disclaimer on the label that says the product isn’t FDA-approved and isn’t intended for the cure or prevention of any disease.
Why do some people distrust products with FDA approval?
Some people are still wary even when the FDA gives something the thumbs up. Case in point: aspartame, the non-nutritive sweetener used in Equal and many diet sodas. The FDA approved this ingredient back in the 1980s after it was tested in more than 100 studies on both humans and lab animals.
Despite the FDA’s approval, some people still don’t trust aspartame—and they’re not without reason. Subsequent studies have suggested that lab rats consuming high doses of aspartame develop cancer. But this research has been inconclusive, and the FDA maintains its stance that there isn’t enough scientific information to support a change in its conclusions about the safety of aspartame. Even the National Cancer Institute conducted its own research in 2006 and did not find aspartame consumption had any relationships with cancer risk.
In short, individual consumers might opt to avoid certain products because of select scientific studies, but the FDA bases its decision on the evidence it deems most convincing. That sense of public trust still holds influence in other ways. For example, in 2015, Pepsi dropped aspartame from the recipe for Diet Pepsi and started using sucralose, the non-nutritive sweetener used to make Splenda.
How did the COVID-19 vaccines get FDA approval so quickly?
Vaccines are different from drugs in that they are created to prevent a condition, not cure it. However, they must also go through a rigorous testing process to ensure they are effective and safe. In the case of the COVID-19 vaccines, these were approved under what’s known as an Emergency Use Authorization (EUA), usually applied during a public health crisis when there’s an urgent need for approval. Per the FDA’s website, the agency uses EUA to expedite the “development and availability of vaccines that have met the agency’s rigorous and science-based standards for quality, safety, and effectiveness.”
I’ve heard the FDA takes money from pharmaceutical companies? Isn’t that a problem?
Critics of the FDA, including the Public Citizens Health Research Group and the National Center for Health Research, have expressed concern that there’s too much money from pharmaceutical companies involved in the FDA.
This started with the Prescription Drug User Fee Act, a piece of 1992 legislation that made it the law for pharmaceutical companies to pay the FDA to review their applications for approval. The idea is that this ensures the FDA has the resources to review all the products coming before it—the problem is that much of the money the FDA gets is now coming straight from pharmaceutical companies rather than from the government. While the FDA states it has systems in place to avoid conflicts of interest, public trust in the agency continues to waver.
The Prescription Drug User Fee Act expires every five years and was last renewed in 2017—it will be up for renewal again in September 2022.
