Superfoods Regulatory Frameworks & Compliance 4

Question 1

Which federal agency would investigate a superfood company making false weight-loss claims in TV commercials?

Accepted Answer

FTC Bureau of Consumer Protection

Answer

The FTC Bureau of Consumer Protection investigates deceptive advertising claims, including false weight-loss claims in commercials and online ads.

Question 2

A superfood supplement tests positive for an undisclosed pharmaceutical drug. Under FDA authority, what can the agency mandate?

Accepted Answer

A mandatory recall of the adulterated product

Answer

The FDA has authority to mandate recalls of adulterated or misbranded dietary supplements, including those containing undisclosed pharmaceutical compounds.

Question 3

What is the significance of the Generally Recognized as Safe (GRAS) designation for superfood ingredients?

Accepted Answer

It means the ingredient is safe for use in conventional food without pre-market approval

Answer

GRAS status allows ingredients to be used in conventional foods without pre-market FDA approval, based on a history of safe use or scientific consensus.

Question 4

Which type of adverse event report is MANDATORY for dietary supplement manufacturers under 21 CFR Part 111?

Accepted Answer

Serious adverse events only

Answer

Manufacturers must report serious adverse events (those resulting in death, hospitalization, disability, or requiring medical intervention) to the FDA within 15 business days.

Question 5

Under EU regulations, how are superfoods like chia seeds treated differently than in the US?

Accepted Answer

Novel foods in the EU require pre-market authorization, unlike in the US

Answer

The EU Novel Food Regulation requires pre-market authorization for foods not widely consumed in the EU before May 15, 1997, such as chia seeds when first introduced.

Superfoods Practice Test

Superfoods Practice Test

Superfoods Regulatory Frameworks & Compliance 4