According to Dietary Supplement Health and Education Act of 1994, the manufacturers who produce supplements have to be responsible ensuring the safety of the products before being marketed.
These manufacturers are not responsible with providing information to the Food and Drug Administration Board before they release a product out on the market. There is also no need for the board’s approval on the supplements ingredients before they start selling the products.
When it comes to the use of health supplements, FDA regulation varies in comparison to the ones used on food and drug products as there is a responsibility on a post-marketing activity through monitoring safety as well as product information.
- Monitoring safety – FDA regulation regarding the supplements implies monitoring the safety of such product that is released on market. In case FDA needs to take action in that it forbids the use of a specific supplement, then the Board has to prove that there were.
- The FDA regulation for the supplements can be issued under reviews, scientific literature, studies, reports as well as public comments.
- This took place in 1997 when they suggested that the amount of ephedrine alkaloids should be limited because a lot of side effects were reported.
- Product information – regulation on nutritional supplements include the monitoring of the label claims truthfulness. Basically, they must disclose what is in the product on the external label.
- Next there are the instructions of use, other ingredients in descending order, the Supplements Facts panel, the name of the producer and the contact address in case someone needs more information upon the product.
- Best practices – FDA regulation on health supplements will approach as well the establishing of the good manufacturing practices or the shorter form – GMPs for producers of nutritional supplements. In order to make sure that the ingredients that are mentioned to be packed inside the nutritional supplement product that is marketed are the right one and in the corresponding amount, then you can select the manufacturer that complies with GMPs.