Does the FDA regulate dietary supplements enough? In short, my answer is no. Although dietary supplements are not new, recently, dietary supplements are reaching new popularity. Companies are now marketing their products through social media to reach a new younger audience. They have influencers endorse their pretty pills in bright and ostentatious packaging. Why the FDA cannot regulate all of this has a lot more to do with politics than one might think.
Since FDA is a government organization, it can only do what Congress allows them to do. Even if they were to become independent, the same laws will still be in place. The FDA is not required to look at products before they are put on the market. However, companies still have to follow good manufacturing practices and support their product’s claims with evidence and put a disclaimer that their product is not examined by the FDA; but, this evidence does not need to be submitted to the FDA. Therefore, producers can make any claims about their product that they want so long it is not a specific medical claim.
Only after the product is put on the market can the FDA inspect it and recall it if adverse effects are being reported. Since there are so many products available, Congress passed the Dietary Supplement Health and Education Act (DSHEA) to help the FDA regulate the products. However, this act backfired. It allowed products to go directly to the market with unfounded claims because only producers had to guarantee the quality and legitimacy of their products. Manufacturers could identify their products as “generally recognized as safe” (GRAS) in order to not have to report new ingredients to the FDA.
For more information, visit my “Notes” page and look at the pdf titled “FDA Regulation Notes”.
Comments