Do Dietary Supplements for Weight Loss Require FDA Approval or Clinical Trials Before Being Sold?

Posted on 15 May 2015 20:58

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It is a common misconception that the FDA requires dietary supplements for weight loss to be approved for use before they can be marketed.

Many people also think that a "clinical trial" must be ran on the product before it can be legally sold. This is not only untrue, but quite naive.

Given all the herbal weight loss supplements on the market the idea that actual clinical trials have been conducted for each and every one of them is just silly.

Equally silly is the idea that the FDA would automatically hold a clinical trial as evidence of effectiveness.

Dietary herbal supplements, including those for weight loss, are not regulated as drugs by the FDA, but instead are regulated under the Dietary Supplement Health and Education Act of 1994.

Whereas drugs are basically considered unsafe until proven safe, dietary supplements are considered safe until proven unsafe.

As long as a dietary supplement ingredient is not a brand-new ingredient, there is absolutely no requirement for clinical trials or any sort of premarket review to be conducted before they are brought to market. Nor is any approval by the FDA required.

A dietary supplement company does not need to contact the FDA at all before selling their product.


The weight loss supplement maker is, like any other dietary supplement marketer, required to to determine that the product is safe and that their label claims are safe and not misleading. It is this fact that causes confusion. See, there is a big difference between holding a company responsible for ensuring the safety of their product and the truthfulness of their claims, and requiring them to provide that evidence to the FDA beforehand.

In other words, a company can market a weight loss supplement regardless of whether it is safe or effective. That shouldn't be a problem, right, because the FDA is watching! They will quickly check up on the product and see determine whether it is safe, and whether the claims made about it are truthful and not misleading. Wrong! The FDA cannot possibly determine the safety and efficacy of every weight loss supplement brought on the market. If a product is brought to the attention of the FDA or the FTC, both agencies, separately or jointly, may take action against manufacturers if their products contain unsafe ingredients of if they make unsubstantiated claims about the products. Another cause for action is if the product contains an ingredient(s) that is classified as a pharmaceutical (which happens very often).

What this means is that in reality an unsafe and ineffective product can be marketed and sold for years. Millions of units can be sold, and millions of people can be either ripped off or endangered. When you see a product making outrageous weight loss claims, or any other ridiculous claims, do not think that "it must be true or the FDA would have pulled it from the market."

Are Clinical Trials Done of Weight Loss Supplements?

Clinical trials of any kind are hardly ever done for weight loss supplements. When they are, they are of shoddy quality and performed by the company itself, or funded by the company. Even if a high-quality trial was run, it still doesn't mean, beyond the shadow of a doubt, that the product is safe and effective.

However, most of the "evidence" for the efficacy of the ingredients in weight loss supplements are based on very limited limited theoretical data or testing in animal and laboratory studies. For the most part, supplement companies wanting to put together "weight loss formulas" simply look for any ingredient that has been mentioned along with weight loss in any kind of literature they can find. Then they just throw them all together with not thought whatsoever. Even if one of the ingredients "work" assuming that mixing a bunch of ingredient together will work better is unjustified, to say the least. The ingredients may interact in unknown ways, producing no effect whatsoever or harmful effects.

The most common weight loss ingredients in dietary supplements have very little real evidence to support their use, or no good evidence at all. They have either a minimal effect on weight loss, or no effect at all.

For more information see the NIH's Office Of Dietary Supplements' factsheet on Dietary Supplements for Weight Loss.

This page created 15 May 2015 20:58
Last updated 04 Mar 2016 19:45

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