Tag: Post market enforcement

In 1994, the Dietary Supplement Health and Education Act (DSHEA) fundamentally changed how the FDA regulates nutritional products, which is precisely why the FDA does not approve dietary supplements in the same way it does prescription medications. This legislative distinction places the responsibility for product safety squarely on the manufacturers, not the government.

According to a 2018 CBS News report, an analysis of an FDA database found nearly 800 warnings for dietary supplements containing unapproved, dangerous ingredients over a ten-year period. This statistic highlights the critical issue many consumers don't understand: **why doesn't the FDA approve supplements?** The answer lies in a fundamental difference in regulatory classification, with significant implications for nutrition and safety.