Why is the regulation of dietary supplements considered less stringent compared to drugs?

The regulation of dietary supplements is indeed considered less stringent compared to drugs primarily because they are generally assumed to be safe until proven harmful. This framework reflects the philosophy of the Dietary Supplement Health and Education Act (DSHEA) of 1994, which places the burden of proof of safety on the FDA only if a supplement poses a risk to public health. In contrast, pharmaceuticals undergo rigorous pre-market testing for safety and efficacy, which must be demonstrated before they can be approved for use.

This difference in regulatory approach is significant because it allows dietary supplements to enter the market with less oversight in terms of safety testing. As a result, consumers may encounter supplements that have not undergone the same level of scientific scrutiny as prescription or over-the-counter medications.

Other factors such as affordability, testing requirements, and shelf life may play roles in the production and distribution of dietary supplements, but they do not fundamentally shape the regulatory environment in the same way that the presumption of safety does. The essence of the regulation centers on the assumption of safety for dietary supplements, allowing for a less stringent regulatory framework compared to that of drugs.