Regulatory Compliance & Legal Framework Flashcards

When a dietary supplement manufacturer submits a New Dietary Ingredient (NDI) notification to the FDA, what is the minimum number of days before marketing the ingredient that the notification must be filed?

Answer: 75 days

DSHEA requires manufacturers to notify the FDA at least 75 days before marketing a dietary supplement containing a new dietary ingredient.

A nutritionist creates a social media post featuring a client testimonial claiming a supplement 'eliminated my chronic fatigue in two weeks.' To comply with FTC guidelines, the post must:

Answer: Disclose any material connection and include a disclaimer that results are not typical

FTC guidelines require disclosure of material connections and that atypical results are clearly communicated so consumers are not misled.

Which of the following is a legitimate 'qualified health claim' that may appear on a food label with FDA authorization?

Answer: 'Omega-3 fatty acids may reduce the risk of coronary heart disease'

The FDA has authorized a qualified health claim for omega-3 fatty acids and reduced risk of coronary heart disease, with appropriate qualifying language.

An ISSA nutritionist working with athletes discovers a client is using a supplement containing a banned substance. According to professional ethical standards, the nutritionist should FIRST:

Answer: Inform the client of the banned status and potential consequences, then document the discussion

The nutritionist's first ethical obligation is to inform the client of the risk and consequences, document the conversation, and recommend discontinuation.

Which statement about the Food Safety Modernization Act (FSMA) of 2011 is accurate in the context of dietary supplements?

Answer: FSMA gave the FDA mandatory recall authority for foods and supplements that pose safety risks

FSMA granted the FDA mandatory recall authority for food and dietary supplements, shifting from the previous voluntary recall system.

A client signs an informed consent form before beginning nutrition counseling. The PRIMARY legal purpose of this document is to:

Answer: Ensure the client understands the services, their limitations, and voluntarily agrees to participate

Informed consent ensures clients understand the scope, limitations, and risks of services before voluntarily agreeing to participate, forming a foundational ethical and legal protection.

Under DSHEA, which of the following ingredients would be classified as a dietary ingredient permitted in supplements?

Answer: Vitamins, minerals, herbs, botanicals, and amino acids

DSHEA defines dietary ingredients as vitamins, minerals, herbs or other botanicals, amino acids, and substances such as metabolites and concentrates.