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?
Dietary supplements are not the core subject area of Culinary Lore. That is true. However, the subject of this post, I think, is just the kind of thing that my readers would expect me to know. And they would be right. I have a very good background in dietary supplements and apply myself to researching and learning about them just as I do food-related subjects. And, of course, I’ve mentioned the FDA once or twice on this site.
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 ran 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 each and 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.
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 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 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 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).
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 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 work, 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.
For more information see the NIH’s Office Of Dietary Supplements’ factsheet on Dietary Supplements for Weight Loss.