Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

Under what condition can the FDA remove a dietary supplement from the market?

1. If it is promoted with false advertising

2. If it is discovered to contain allergens

3. If it is adulterated or presents a significant risk of illness

4. If the manufacturer changes ownership

The correct answer is: If it is adulterated or presents a significant risk of illness

The FDA has the authority to remove a dietary supplement from the market primarily if it is deemed adulterated or if it presents a significant risk of illness. Adulteration refers to a product being harmful or not meeting the safety standards set by the FDA. This can include contamination with harmful substances, presence of harmful levels of natural toxins, or non-compliance with good manufacturing practices. When a dietary supplement poses a significant risk of illness, whether through its ingredients, improper manufacturing processes, or formulation, the FDA can take action to protect public health by removing the product from market access. The emphasis here is on safeguarding consumers from any potential health threats that could arise from using the supplement in question. While false advertising and the presence of allergens are serious issues related to dietary supplements, they do not, in themselves, directly authorize the FDA to remove a product from the market unless they contribute to a condition of adulteration or significant health risk. Additionally, a change in ownership of a manufacturer does not, automatically or inherently, create grounds for market removal unless it results in a change that affects product safety or compliance.