Which of the following is a TRUE statement regarding the regulation of dietary supplements?
a. The FDA must approve new dietary supplements before they can be sold.
b. It is not uncommon for supplements to be contaminated with banned substances.
c. The FDA verifies that supplements contain the ingredients listed on the product label.
d. A number of nutrient and botanical ingredients have maximum allowable potencies.
The correct answer and explanation is:
The correct answer is b. It is not uncommon for supplements to be contaminated with banned substances.
Explanation:
The regulation of dietary supplements in the United States is not as stringent as that for prescription medications or food. The FDA does not approve dietary supplements before they are marketed, as indicated by option a, so manufacturers are responsible for ensuring that their products are safe and comply with the law before they are sold. The FDA only steps in to regulate supplements once a problem arises, such as when there are reports of harm or contamination.
Regarding option b, it is true that dietary supplements can sometimes be contaminated with substances that are banned or prohibited, especially if they are produced in facilities that are not adequately monitored. This contamination can occur during production or as a result of adulteration with undeclared ingredients, including substances that are illegal in sports, such as performance-enhancing drugs. The lack of pre-market FDA approval means that products may be marketed without sufficient testing, leading to potential contamination issues.
Option c is false because the FDA does not routinely verify that the ingredients listed on a supplement’s label are accurate. Instead, manufacturers are responsible for ensuring the accuracy of the information. The FDA only intervenes if a product is found to be misbranded or if consumer complaints highlight discrepancies.
Finally, option d is also false because there are no specific maximum allowable potencies for most nutrients and botanicals in dietary supplements, except for a few exceptions like vitamins or minerals with upper tolerable intake levels (ULs) established by the Institute of Medicine. However, the FDA does not regulate the potency limits of most botanical ingredients in supplements.
Thus, the most accurate statement is that contamination of supplements with banned substances is a real concern.