If a dietary supplement poses a safety concern, who is responsible for proving that it is unsafe?

The correct answer is that the FDA is responsible for proving that a dietary supplement is unsafe. In the context of dietary supplements, the law places the burden of proof regarding safety on the FDA rather than the producers or consumers.

Under the current regulatory framework established by the Dietary Supplement Health and Education Act (DSHEA), dietary supplements are generally considered safe until proven otherwise. The FDA does not need to approve dietary supplements before they are marketed, but it has the authority to take action against any supplement that it determines to be unsafe after it has been on the market. This means that if a dietary supplement raises safety concerns, it is up to the FDA to investigate and demonstrate that the product poses a risk to public health.

Producers and distributors are required to ensure that their products are safe and accurately labeled, but they do not carry the burden of proving safety in the same way that the FDA must when assessing safety concerns. Meanwhile, consumers are encouraged to report adverse reactions but are not responsible for proving the safety or unsafety of a product. Thus, it is the FDA's role to oversee the safety of dietary supplements and act if there are substantiated safety concerns.