Question

"Which of the following is true about the Dietary Supplements?

a. The supplement does not have to prove effectiveness before going to market.
b. The supplement is not tested by the FDA for safety prior to going to market.
c. The FDA requires the label be accurate about what the product contains.
d. Companies are not required to report serious adverse effects to the FDA.
e. The FDA may pull a dietary supplement from the market if good manufacturing processes were not followed or the supplement is found to pose a threat to patient safety."

Answer 1

The statement that dietary supplements do not have to prove effectiveness before going to market is true, as is the fact that they are not tested by the FDA for safety prior to sale. Labels must be accurate regarding contents, and serious adverse effects must be reported to the FDA. The FDA can remove a product from the market for safety concerns or manufacturing violations.

Step-by-step explanation:

When considering the content loaded question "Which of the following is true about the Dietary Supplements" it is important to recognize that the Dietary Supplements Health and Education Act (DSHEA) has significantly influenced the responsibilities of manufacturers and the regulatory role of the FDA.

Here is the breakdown of each statement:

• The supplement does not have to prove effectiveness before going to market. This is true. Manufacturers are not required to prove the effectiveness of a dietary supplement before it is marketed to the public.
• The supplement is not tested by the FDA for safety prior to going to market. This is also true. Under DSHEA, the responsibility for safety shifted from the government to the manufacturer.
• The FDA requires the label be accurate about what the product contains. That is correct. The FDA requires dietary supplements to have truthful and non-misleading labeling, including an accurate list of ingredients.
• Companies are not required to report serious adverse effects to the FDA. This statement is incorrect. Dietary supplement firms are required to report serious adverse events to the FDA.
• The FDA may pull a dietary supplement from the market if good manufacturing processes were not followed or the supplement is found to pose a threat to patient safety. Yes, the FDA can take action against any dietary supplement on the market that is deemed to be misbranded or adulterated.

Overall, while the FDA does not evaluate dietary supplements for efficacy or safety before they go to market it does enforce certain regulations ensuring accurate labeling and can intervene if products are found to be hazardous or improperly manufactured.