Final answer:
The Dietary Supplement Health and Education Act of 1994 shifted the responsibility for dietary supplement safety from the FDA to manufacturers, allowing supplements to be marketed without FDA approval unless a new ingredient was introduced. Under the Act, fitness supplements, such as protein, became prevalent, and while they can support fitness goals, they should not replace a balanced diet.
Step-by-step explanation:
The Dietary Supplement Health and Education Act of 1994
The Dietary Supplement Health and Education Act (DSHEA) of 1994 changed how dietary supplements are regulated in the United States. Prior to DSHEA, the U.S. Food and Drug Administration (FDA) was responsible for ensuring the safety of dietary supplements. However, the enactment of DSHEA transferred this responsibility to manufacturers. Post-DSHEA, supplements no longer required FDA approval before being marketed. Only when a new dietary ingredient is added must a manufacturer provide the FDA with evidence to substantiate the safety or effectiveness of that ingredient.
The DSHEA was a significant milestone that reinforced the position of the fitness supplements industry and led to an increase in product sales. Moreover, the FDA still regulates supplements under DSHEA, but it does so more like it regulates food than drugs. Manufacturers must adhere to Good Manufacturing Standards, but supplements do not have to meet the rigorous standards set for pharmaceuticals. Claims about risk reduction of disease or targeting specific body systems can be made by manufacturers, but they must include disclaimers stating that the products are not intended "to diagnose, treat, cure, or prevent any disease." The FDA only removes supplements from the market after they have been proven hazardous.
Despite the popularity of supplements in supporting fitness goals, like bodybuilders supplementing with protein, it is important to note that supplements are intended to be just that—supplementary. Supplements should not replace a healthy and well-balanced diet. A diet is the primary source of nutrients, and supplements should be considered as an additional source, not a substitute.