Do Dietary Supplements Require FDA Approval Before Being Sold?

It is a common assumption that “they wouldn’t sell it if it weren’t safe.” Is this a safe assumption? Do dietary supplements have to be approved by the FDA before they are sold? Do they need to have clinical trials to prove they work and are safe?

Just as it is a common assumption that the dietary supplement lining store shelves must be safe, it is also a common misconception that the FDA requires dietary supplements to be approved for use before they can be marketed. Many people also think that a “clinical trial” must be run on the product before it can be legally sold. This is not only untrue but creates some dangerous opportunities for marketing lies.

One of the biggest markets for dietary supplements, especially herbals, is weight loss. Many weight loss supplement marketers rely on the idea that clinical trials must be conducted for every one of them. They even imply that the FDA automatically holds a clinical trial on new products! This is outright silly, but many people believe it!

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.

The “Safe Until Proven Unsafe” Standard

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 its product.

The Difference Between Responsibility and Oversight

The weight loss supplement maker is, like any other dietary supplement marketer, required to determine that the product is safe and that its label claims are safe and not misleading. It is this fact that confuses. 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 determine whether it is safe and whether the claims made about it are truthful and not misleading. Wrong!

Why the FDA Can’t Watch Every Shelf

The FDA cannot possibly determine the safety and efficacy of every weight loss supplement brought to 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 or 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).

The Danger of Unsubstantiated Marketing Claims

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 a 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 is based on very 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 no thought whatsoever. Even if one of the ingredients works, assuming that mixing a bunch of ingredients 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.