Do You Need Approval From the FDA for Dietary Supplements?

lumonol brain supplementDietary supplements are very popular. People take dietary supplements in addition to their regular meals for various reasons. Generally, the supplements are available at supermarkets, health food stores, and other local retailers. They are also available online at various health related sites. The dietary supplements might contain important minerals, vitamins, or herbal ingredients that are designed to be beneficial. The supplements are available in gel form, tablet form, liquids, and powdered form. Today, there is a lot of confusion concerning FDA approval for dietary supplements. Let’s take a closer look at this issue.

The main reason for this post is related to a retailer we worked with selling brain supplements. After reading a best nootropics Lumonol review, a few questions were asked in respect of FDA approval. So let’s take a look at whether FDA approval for brain supplements actually matters.

FDA Regulations

The FDA does have some say over the type of ingredients that are included in dietary supplements along with labeling. True, the manufacturer of the supplement must meet those regulations. Certainly, the FDA expects all dietary supplement manufacturers to test their products and make sure that they are safe for the consumer before distributing. However, the FDA is a guardian over the rules governing false advertising of the supplement. For example, a company that makes exaggerated or false claims about the product that they’ve submitted to the consumer market. For example, claiming a product will help the consumer lose 20 pounds of fat in a week. This is clearly an exaggeration. They also have rules about labeling. The key ingredients in the product should be clearly outlined on the label.

FDA Approval

Certainly, there is a lot of confusion around whether a product actually has FDA Approval. A number of consumers assume that a diet supplement must have the FDA Approval in order to be sold in stores. Dietary supplements are meant to supplement an individual’s food and lifestyle habits. They are not considered drugs. Therefore, the dietary supplements do not require prior FDA approval before they are placed on the consumer market. However, it is important to note that all dietary supplements must be safe, must not contain false claims, and must meet FDA regulations.

How The FDA Approves New Drugs

The Food And Drug Administration is one of the most strict regulators in the world. It covers all kinds of products, but it’s main focus is arguably drugs. For example, in order to be considered for approval, the company would be responsible for testing the product themselves. So they bear all the risk and costs. But in case you’re wondering about the possible bias from being in charge of testing the product yourself. Well, there is very little room for bias and cheating in these tests. Since the company testing the product must follow strict guidelines with the relevant supervision.

Centre for drug evaluation and research will inform the company what kind of tests are necessary and how many are required for FDA approval to be given to a product.

As you can see, the process is not simple, and it certainly isn’t easy. It’s an expensive, very long and difficult process. But this process does ensure the consumer is kept safe.

Recently there have been reports of drugs being sold without FDA approval, but that have been approved in different jurisdictions. This could potentially leave consumers more exposed to more dangerous drugs, since the tests may not have passed the strict
guidelines imposed by the FDA.

To give you an idea of just how difficult it is to get a drug certified,

The below video explains the FDA approval process for new drugs in more detail and also explains how this agency is ensuring we are protected from foreign imported drugs.

Do You Understand Your Consumer Rights?

undestand your consumer rightsA consumer spots a commercial on television. A car dealer is selling a specific model car for a very low price. The consumer rushes to the dealer to purchase that model car. However, upon arriving the consumer is told that the car is not available, but that another higher priced model is available. He tries to force the buyer to purchase the higher priced automobile. He purchases the vehicle and it is a lemon. In another scenario, a collection agency is calling an individual at various times during the day and night. They even contact the individual’s employer. The consumer is totally frustrated and does not know what to do. Both consumers should be aware that they have  specific consumer rights to fight back against misleading advertising and abusive behavior by a business.

Consumer Rights

There is a consumer law in place that protects individuals from being abused by certain business practices that are deemed illegal. For example, misleading advertising, bad products, or abusive business practices. These laws are designed to punish a business that takes advantage of a consumer in order to profit. The government enforces these laws. Victims are allowed to file a lawsuit against the company, as individuals or join a class action suit with others against the same business. It certainly pays for an individual to understand that they do have legal rights and that a company does not have the right to take advantage of an individual in order to profit.

Filing Consumer Rights Claims

Anyone that feels that a company or business has violated their rights should act immediately. The first course of action is to seek legal advice Find out if there are others in the same situation. It might be appropriate to join a class action suit against the company. In other circumstances, it might be more appropriate to file an individual claim against the business.