The Food and Drug Administration (FDA) does not approve all fat burners, and in fact can only take action against them under specific circumstances. The prevailing belief is that the FDA is responsible for all foods and supplements that Americans take. However, the FDA doesn’t regulate supplements the way it does drugs. Does FDA approve fat burners can be answered!
What is the FDA Policy about Fat Burners?
The policy of the FDA with regards to fat burning and dietary supplements is that it is the manufacturer who must ensure that the product is safe. The only time when the FDA can step in is when a consumer files a complaint about a product, in this case a fat burner.
Under the Dietary Supplement Health and Education Act of 1994, fat burners and other dietary supplements are classified as foods instead of drugs. Because of this, fat supplements are categorized as a type of food under the statute with the warning that they may be treated as drugs if circumstances warrant it.
Similar to other food substances, the FDA doesn’t impose efficacy and safety testing requirements for fat burners, and just like food they do not need prior FDA approval. Even so, these supplements are subject to FDA regulations concerning misbranding and adulteration. In addition, the FDA can take action against fat burners if it is proven they are unsafe.
Misbranding is applied if a fat burner or another diet supplement is marketed as a drug without the necessary clinical and medical trials that regular drugs undergo. However, manufacturers of fat burners are allowed to issue claims of health benefits like losing weight. However, the FDA does not allow them to make claims that the product can prevent, cure or diagnose a disease, and a disclaimer must be stated on the label.
According to the regulations, if a fat burner manufacturer includes a claim in connection with the product, the FDA must be notified within 30 days after the product has been introduced to the market.
What Will the FDA do if Fat Burners are Found Guilty of Violations?
If a manufacturer violates any of the rules stated above the FDA can and will take action against the manufacturer. They can of course, remove the product from the market, but usually other steps are taken first.
The first thing that the FDA usually does is send the violator an untitled letter concerning the issue, stating that a response is necessary. A warning letter may be sent along with the untitled letter or it may be issued if there is no response to the first letter. The warning letter explains what the violation is as well as a demand for a response. Next, the FDA will issue a press release or hold a press conference to notify the public that the supplement have violated the law.
Under the law the FDA is not required to give prior notice to these companies when a press release or conference is done, and the FDA can also order the fat burner manufacturer to recall the product. The FDA has no real power to order a recall but manufacturers invariably follow the agency to avoid more severe sanctions.
The FDA can order violators to disgorge their offending products from product sales to other parties and offer restitution. If necessary, the agency can also ask courts for an injunction and seize the products in violation of the law. If the FDA finds probable cause that the food product is dangerous and can cause injury, it can seize the food without a prior court order.
For the first offense, a fine not exceeding $1,000 and imprisonment of one year may be imposed, and there are stiffer penalties for repeat offenses. In addition, the president of an offending company may be held criminally liable even if he doesn’t have any prior knowledge of the offense.
As an example in 2014 there was this warning from the FDA.” Public Health Warning Against Unregistered Fat Burner HCA 500mg Capsule Containing Both Amphetamine and Sibutramine”
How Can We Be Sure Fat Burners are Safe?
While the FDA cannot act on its own without prior complaints, they have taken steps to protect the public via their tainted supplement page. Here you’ll be able to go through a list of supplements the FDA has deemed tainted. You will be able to read the company name, the hidden ingredients, what the product is for (i.e., weight loss, muscle building etc.). The list on the website is updated often so it’s a good idea to go there.
With regards to over the counter fat burners, you should read the list of ingredients and avoid those that might interact with any medication you’re taking. You should also go to the company website and check what the side effects are. Needless to say don’t take any supplements that are on the FDA tainted list.
Which Fat Burners are Effective?
The best way to determine if a fat burner is effective is to check the ingredients. Obviously the more you know about fat burners and how they work, the less likely you’ll end up with an ill effective product.
Second, you should take careful note of the fat burner’s claims. If the product says you will lose weight without going on a diet or exercise, be wary because weight loss supplements are not effective if there is no effort on the part of the individual.
Third, you need to ask what kind of fat burning supplement you’re looking for. If you want to lose weight without losing energy, look for fat burners with yerba mate, tyrosine or theobromine. If you want to boost your metabolism, green tea extract and raspberry ketones will be important.
There are also fat burners that can enhance brain function so your mental faculties remain sharp even as you lose weight. If this is what you’re looking for you’ll need a fat burner with vinpocetine, beta-phenylethylamine and huperzine. There are also fat burners that can help you fight carbohydrate overconsumption, such as those with kidney bean extract, alpha lipoic acid and chromium.
Now as to does FDA approve fat burners .. not exactly, but they do certainly investigate when concerns are raised. You can read more here.