What Does “FDA Approved” Mean, and Who Can Use This Phrase? 

The phrase “FDA Approved” is used on the labels of many products, in many cases falsely to mislead the consumers’ perception of the quality of a given product. FDA released a consumer advisory last week to list, in plain language, the regulatory processes for all the products in regulates which should be widely used to educate consumers. The advisory lists basic concepts such as the fact that FDA does not “approve” physician offices, laboratories, or manufacturing facilities, even those manufacturing pharmaceutical products. Also, that while FDA reviews drugs, biologics, and some medical devices prior to their approval to market, it does not develop any of its own products. Similarly, FDA does not approve tobacco products, medical foods, cosmetics, infant formula, dietary supplements, food labels, but does approve food additives and color additives. The consumer advisory is a great resource to simplify explaining the applicable FDA processes to the lay person. Many of these basics are not obvious to even many physicians and pseudo-experts who tout the “FDA approved” labels loosely. So, next time someone tells you their product is “FDA approved” refer them to this page to close the conversation. It is ironic that in the year 2022, there are still a lot of misperceptions about what FDA regulates and how. It is very important for an average consumer to be aware of these simple facts and the only reliable unbiased agency to that is the FDA.