Superfoods Regulatory Frameworks & Compliance 3

Question 1

What is the primary purpose of the New Dietary Ingredient (NDI) notification process?

Accepted Answer

To notify the FDA of safety evidence for ingredients introduced after 1994

Answer

The NDI notification requires manufacturers to submit safety evidence to the FDA for dietary ingredients not marketed in the US before October 15, 1994.

Question 2

A superfood company sells spirulina tablets and wants to claim they 'reduce the risk of cancer.' What type of claim is this, and what is required?

Accepted Answer

Disease claim requiring FDA drug approval

Answer

Claims that a product reduces the risk of a disease are drug claims under FDA regulations, requiring the product to undergo the drug approval process.

Question 3

Which USDA program certifies that a superfood is produced without synthetic pesticides, GMOs, or irradiation?

Accepted Answer

USDA Organic

Answer

The USDA Organic certification program prohibits synthetic pesticides, GMOs, and irradiation, among other practices.

Question 4

Under the Food Safety Modernization Act (FSMA), what is the key shift in philosophy for food and supplement safety?

Accepted Answer

From reactive to preventive controls

Answer

FSMA fundamentally shifted US food safety from a reactive (responding to outbreaks) to a preventive (preventing contamination before it occurs) framework.

Question 5

A US importer brings in moringa powder from India. Under FSMA, which rule primarily governs the safety of this imported superfood?

Accepted Answer

Foreign Supplier Verification Programs (FSVP)

Answer

The FSMA Foreign Supplier Verification Programs (FSVP) rule requires US importers to verify that their foreign suppliers meet US food safety standards.

Superfoods Practice Test

Superfoods Practice Test

Superfoods Regulatory Frameworks & Compliance 3