Regulatory Compliance & Legal Framework Flashcards

Which of the following best describes the legal difference between a 'health claim' and a 'structure/function claim' on a food or supplement label?

Answer: Health claims require FDA authorization; structure/function claims do not require pre-approval but need a disclaimer

Health claims must be authorized by the FDA, while structure/function claims require only a 30-day manufacturer notification and a mandated disclaimer.

An ISSA-certified nutritionist operating in a state with a licensed dietitian practice act should primarily be aware of:

Answer: State-specific scope of practice laws that may restrict nutrition counseling activities

State dietitian practice acts vary widely and may restrict who can provide medical nutrition therapy or use protected titles, directly affecting a nutritionist's scope.

Under the Nutrition Labeling and Education Act (NLEA), which food products are exempt from standard Nutrition Facts labeling requirements?

Answer: Fresh produce and most raw meats sold individually

Fresh fruits, vegetables, and most raw single-ingredient meats are generally exempt from mandatory Nutrition Facts labeling under NLEA.

A supplement label states 'This product has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.' This is known as a:

Answer: DSHEA disclaimer for structure/function claims

This mandatory disclaimer is required by DSHEA whenever a dietary supplement makes a structure/function claim on its label.

Which action by a nutritionist would most likely constitute negligence in a legal context?

Answer: Advising a client to discontinue prescribed medication based on dietary assessment

Advising a client to stop prescribed medication exceeds a nutritionist's scope of practice and could constitute negligence or unauthorized medical practice.

The term 'organic' on USDA-certified food products means the product must contain at least what percentage of organically produced ingredients?

Answer: 95%

To display the USDA Organic seal, products must contain at least 95% organically produced ingredients by weight (excluding water and salt).

Which federal law established the framework for nutrition and health claims on food labels and expanded the FDA's authority over food labeling?

Answer: Nutrition Labeling and Education Act (NLEA) of 1990

The NLEA of 1990 standardized nutrition labeling requirements and defined the framework for health claims on food products.