FDA Regulations On Dietary Supplements

If you have a company that manufactures and sells dietary supplements, you need to take FDA regulations on dietary supplements seriously. In answer to what is presumably your first question, yes, both dietary supplement products and dietary supplement ingredients are regulated within the United States. Both of these aspects of dietary supplements are regulated by the FDA, which is responsible for regulatory measures and information related to such areas as food, pharmaceuticals and more.

Moving forward from that thought, there are a few things you are going to want to keep in mind.

FDA Regulations and Dietary Supplements

First of all, when it comes to FDA regulations on dietary supplements, you need to ask yourself the following: Have you ever heard of the Dietary Supplement Health and Education Act of 1994? If not, you are definitely going to want to familiarize yourself with this significant piece of dietary supplement legislation.

Simply put, the DSHEA classifies all dietary supplement products as food products, rather than drugs. This measure ensures that companies like yours maintain access to high-quality, natural food supplements. Natural products cannot be protected through patents. This fact would doom supplements to extinction, if they had to endure the costly, time-consuming process of approval that is required for drugs. The act defines these supplements as products that are designed to supplement a diet, featuring items such as vitamins, minerals, herbs, other botanicals, amino acids and others.

Furthermore, the act also establishes acceptable labeling claims, making it clear that it is the responsibility of the FDA to establish whether or not a dietary supplement is safe. Safety requirements pertaining to emerging dietary ingredients are also outlined through the DSHEA.

It is a common misconception with the public that dietary supplements are not regulated. This is simply not true. FDA regulations on dietary supplements cover two important aspects. In the first place, the FDA handles regulations in relation to the labeling of the product. Any claims made must be submitted within thirty days of its first use. In addition to this, the FDA also holds manufacturers responsible for maintaining good manufacturing practices.

In the end, it is the responsibility of every dietary supplement manufacturer to understand how the FDA and the DSHEA apply to them. For the sake of the health and growth of your company, it is definitely in your best interests to take the DSHEA seriously. Doing so can also help to establish a measure of trust with your potential customers.