Superfoods Regulatory Frameworks & Compliance 5

Question 1

Which labeling requirement applies to a superfood bar that contains peanuts as a minor ingredient in a coating?

Accepted Answer

Peanuts must be declared as a major food allergen on the label

Answer

Under the Food Allergen Labeling and Consumer Protection Act (FALCPA), peanuts must be declared as a major food allergen regardless of the amount present.

Question 2

A superfood supplement company fails to register its manufacturing facility with the FDA. What is the legal consequence?

Accepted Answer

The products are legally considered adulterated and can be refused entry or seized

Answer

Failure to register a dietary supplement manufacturing facility makes the products legally adulterated under the FD&C Act, allowing the FDA to refuse entry or initiate seizure.

Question 3

Under the FTC's 'competent and reliable scientific evidence' standard, what is required to support a superfood health claim in advertising?

Accepted Answer

Tests, analyses, or studies that are competent and reliable for evaluating the specific claim

Answer

The FTC requires that health claims be supported by competent and reliable scientific evidence, which must be relevant to the specific product and population targeted.

Question 4

Which scenario would trigger an FDA import alert for a superfood ingredient?

Accepted Answer

A product from a facility with a history of contamination or CGMP violations

Answer

FDA import alerts are typically triggered by a pattern of violations, such as contamination or CGMP failures at a specific foreign facility, allowing FDA to detain products without physical examination.

Question 5

What is the role of a Certificate of Analysis (COA) in superfood regulatory compliance?

Accepted Answer

It documents that a batch has been tested and meets defined specifications

Answer

A Certificate of Analysis (COA) is a quality document that confirms a specific batch has been tested and meets identity, purity, strength, and composition specifications.

Superfoods Practice Test

Superfoods Practice Test

Superfoods Regulatory Frameworks & Compliance 5