Final answer:
The responsibility for ensuring that a dietary supplement is safe falls on the manufacturer, as per the Dietary Supplement Health and Education Act of 1994. The FDA regulates supplements more like food than pharmaceuticals, requiring Good Manufacturing Practices but not pre-market approval.
Step-by-step explanation:
Who has the responsibility for ensuring that a dietary supplement is safe? The direct answer is 1) the manufacturer.
In the United States, the safety and efficacy of dietary supplements are primarily the responsibility of the manufacturer. This is due to the Dietary Supplement Health and Education Act (DSHEA) of 1994, which shifted the responsibility for determining the safety of these supplements from the government to the manufacturers themselves. The FDA does have regulatory authority and establishes good manufacturing practices, but it does not require dietary supplements to meet the strict safety and efficacy standards that pharmaceutical drugs must adhere to before hitting the market. Instead, it is only after a supplement is demonstrated to be hazardous that the FDA can take action to remove it from the market.
Consequently, manufacturers are expected to ensure their products are safe before they are sold, and consumers trust that the products meet the claims made by the company. However, the level of oversight is significantly less than what is required for prescription medications, leading to an environment where consumers must also practice due diligence.