Keto Diet Standards and Regulations 5

Question 1

How does the FDA's Generally Recognized as Safe (GRAS) designation apply to ingredients in keto food products?

Accepted Answer

Ingredients with GRAS status can be used in food without pre-market FDA approval

Answer

Ingredients with GRAS status may be used in food formulations without requiring FDA pre-market approval, though the manufacturer bears responsibility for the safety determination.

Question 2

When a US physician places a patient on a medically supervised ketogenic diet for weight loss, which professional guideline most directly governs the physician's practice?

Accepted Answer

State medical board standards and professional medical society guidelines

Answer

Physicians are governed by their state medical board's standards of care and relevant professional medical society guidelines when prescribing medically supervised diets.

Question 3

The Keto Certified program requires products to contain no more than how many grams of net carbs per serving to qualify for certification?

Accepted Answer

5g

Answer

The Keto Certified standard by the Paleo Foundation requires that certified products contain no more than 5 grams of net carbs per serving.

Question 4

Under the FTC Act, which action would be considered deceptive when marketing a ketogenic diet program?

Accepted Answer

Claiming a keto program 'guarantees' 30 pounds of weight loss in 30 days without substantiation

Answer

Unsubstantiated weight-loss guarantee claims violate the FTC Act's prohibition on deceptive advertising, particularly given the FTC's specific guidance on weight-loss advertising.

Question 5

Which regulatory pathway would a company use to market a ketogenic diet drug (not a supplement) for obesity treatment in the US?

Accepted Answer

FDA New Drug Application (NDA) or Abbreviated NDA process

Answer

A product intended to treat obesity through a drug mechanism must go through FDA's NDA or ANDA approval process, which requires clinical trials demonstrating safety and efficacy.

Keto Diet Practice Test

Keto Diet Practice Test

Keto Diet Standards and Regulations 5