What Can Happen if the FDA Finds a Dietary Supplement to be Unsafe?

If the Food and Drug Administration (FDA) believes that a dietary supplement is unsafe, it can take action to remove it from the market. The FDA monitors the market for potentially illegal products that may not be safe or make false or misleading claims. If there is a serious problem associated with a dietary supplement, manufacturers must report it to the FDA as an adverse event. The FDA may recall dietary supplements from the market if they are found to be unsafe or if the claims in the products are false and misleading.

The FDA does not have the necessary funding to control supplements and “there is no systematic monitoring of safety and efficacy,” according to Peter Lurie, a former FDA official who is now executive director of the Center for Science in the Public Interest. However, manufacturers and distributors of dietary supplements should record, research, and send to the FDA any reports they receive about serious adverse events related to the use of their products. In addition, the FDA considers advertising when evaluating the intended use of a product labeled as a dietary supplement. The FDA said that Hydroxycut posed a serious and potentially fatal danger to some users and that it had been linked to two reported deaths.

Dangerous ingredients are known to appear in dietary supplements marketed for weight loss, bodybuilding and sexual enhancement. Dietary supplements are sold in the form of tablets, capsules, soft capsules, gel capsules, powders and liquids. Along with information about the new dietary ingredient and the dietary supplement in which it will be marketed, the notification must include the safety information on which the notifier has based its conclusion that the new dietary ingredient can reasonably be expected to be safe when used under the conditions recommended or suggested on the dietary supplement label. Your doctor or pharmacist can prevent you from these problems only if they know what supplements you are taking or plan to take.

The Food and Drug Administration has not taken full advantage of even the meager authority granted to it by the industry-friendly Dietary Supplement Health and Education Act of 1994 (DSHEA). Manufacturers and distributors of dietary supplements are responsible for ensuring that their products are safe BEFORE they go to market. Cohen says that ConsumerLab's tests are “excellent”, but warns that “they can also give a lot of non-evidence-based advice on the use of supplements,” so he recommends obtaining information about the supplements themselves in other places, such as the website of the Office of Dietary Supplements of the National Institutes of Health. The supplement information panel should indicate the size and number of servings per package, state each dietary ingredient in the product and, with the exception of dietary ingredients that are part of a patented blend, provide information on the amount of the dietary ingredient per serving.

The types of ingredients listed there could include sources of dietary ingredients if they are not listed in the supplement information panel (for example, DSHEA amended FD&C to create a new regulatory framework for dietary supplements). As an expert in SEO optimization, I recommend taking extra precautions when considering taking any type of dietary supplement. It is important to research any potential risks associated with taking a particular supplement before consuming it. Additionally, it is important to consult with your doctor or pharmacist before taking any type of supplement as they can provide valuable insight into potential risks associated with taking certain supplements.

It is also important to read labels carefully and make sure you understand what ingredients are included in each supplement you take. By doing this research ahead of time, you can help ensure that you are taking safe and effective supplements.

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