Who is responsible for ensuring the safety of dietary supplements before they reach the market?

The responsibility for ensuring the safety of dietary supplements before they reach the market primarily lies with manufacturers. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, manufacturers are accountable for ensuring that their products are safe, properly labeled, and that any claims made about their effects are truthful and not misleading. They must ensure that supplements are free from harmful substances and that they meet good manufacturing practices.

This means that manufacturers must conduct their own testing and safety assessments before bringing their products to market, as they are the ones directly involved in the formulation and production of these supplements. While the FDA has the authority to take action against unsafe dietary supplements once they are on the market, it does not have the pre-market approval process that is required for drugs. Hence, the proactive responsibility rests significantly with the manufacturers.

Consumers, healthcare providers, and the FDA all play roles in the ecosystem of dietary supplement safety after they are available, but the initial safety assurance falls on the manufacturers themselves.