Why is FDA approval so important?
The FDA’s role is to make sure that products on the market are shown to be safe and effective when used as directed, but there are different levels of FDA scrutiny that apply to different kinds of products. And because weight loss dietary supplements don’t have the same level of requirements that drugs do, you can’t be sure that what you buy for weight loss will do what it claims to do.
Dietary supplements do not need approval from the FDA before they are marketed. So the weight loss dietary supplements you see and hear about are not usually required to prove that they work or that they’re safe – unlike prescription or over-the-counter drugs, which are supported by evidence from clinical trials.
The FDA regulates drug products and dietary supplements differently.
There are significant differences in the FDA regulation of drug products and dietary supplements. A few of these variations are provided in the chart below.
| Drug Products |
Dietary Supplements |
| Evidence of safety is required before marketed. |
Unless new ingredients are used, evidence of safety is not required before marketed. |
| Labeling must be approved. |
Labeling is not reviewed. |
| Warnings on labels are required. |
Warnings on labels are usually not required; however, disclaimer language is required. |
Know the facts.
The FDA goes to great lengths to ensure your safety. However, as mentioned above, they do not review weight loss dietary supplements. So it’s important to know all the facts so that you can protect yourself. While many supplements are safe and effective, it’s a good idea to be cautious and talk with your doctor or pharmacist to determine what may be best for you.