Food laws and regulations

List the three major U.S. federal agencies responsible for food regulation and their primary responsibilities.

FDA: Oversees most foods, labeling, and additives USDA: Regulates meat, poultry, and egg products EPA: Oversees pesticide residues and water safety

What are the four categories of food additives established by the FDA?

Food Additives (require pre-market approval). GRAS Substances (Generally Recognized As Safe). Prior-Sanctioned Substances (approved by FDA or USDA before 1958). Color Additives (regulated under the 1960 Amendment).

What does FALCPA stand for and what does it require of the food industry?

Food Allergen Labeling and Consumer Protection Act. Food industry must list major food allergens on food labels, either in the ingredient statement or as contains _________; FDA must report back to congress on progress within 18 months; increase inspection with regard to allergen prevention; Develop a final rule within 4 years allowing the use of "gluten free" on food labels; Increase inspection with regard to allergen prevention

Name three types of foods that are exempt from nutrition labeling.

Food sold by small businesses, food sold in restaurants for immediate consumption, ready-to-eat foods, foods that contain insignificant amounts of nutrients, dietary supplements (except in food form), infant formula, medical foods, custom-processed fish and game, foods shipped in bulk but not sold to consumers in that form, donated foods, meat and poultry products. in small packages (less than .5 oz.), meat and poultry products produced or packaged at retail.

Name 12 foods exempt from the NLEA.

Food sold by small businesses, sold in restaurants, ready to eat foods prepared on site for immediate consumption, foods with insignificant amounts of nutrients, dietary supplements, infant formula, medical foods, custom processed fish and game, foods sold in bulk not sold to consumers in that form, donated foods, meat/poultry products weighing <.5oz, meat/poultry products at retail

Three food groups exempt from mandatory nutrition labelling.

Fresh Produce, fruits, veggies, medical food, alcohol, bottled water, bulk fruits, airplane service foods, free samples, coffee, tea and spices

Name the three natural colorants approved by FDA on 9th May, 2025 in its efforts to phase out petroleum based dyes.

Galdieria extract blue, Butterfly pea flower extract, Calcium phosphate

Define the terms GRAS and ADI as they relate to food additives, and provide the full name of the U.S. government agency that generally oversees these regulations.

GRAS stands for Generally Recognized As Safe, a status that exempts substances from formal FDA premarket approval. ADI stands for Acceptable Daily Intake, the amount of a substance that can be consumed daily over a lifetime without appreciable health risk. The overseeing agency is the Food and Drug Administration (FDA).

Explain the regulatory distinction between GRAS determination and food additive approval in the U.S., including who bears the burden of proof.

GRAS substances are generally recognized as safe based on scientific consensus; manufacturers may self-affirm GRAS status with supporting evidence. Food additives require premarket FDA approval via a food additive petition, with FDA bearing final authority. GRAS relies on publicly available data and expert consensus; additives require formal review.

What does HACCP stand for and give its 7 principles.

HACCP: Hazard Analysis Critical Control Points; 1. conduct hazard analysis, 2. identify critical control points, 3. establish critical limits, 4. establish monitoring procedures, 5. establish corrective actions, 6. establish verification procedures, 7. establish record-keeping procedures

What does FSMA's HARPC stand for?

Hazard Analysis and Risk-Based Preventive Controls

What are the Standards of Identity for high, medium, and low fat contents in chocolate/cocoa?

High fat (breakfast cocoa) – not less than 22% cocoa fat, Medium fat - less than 22% cocoa fat and not less than 10%, Low fat - less than 10% cocoa fat

Explain the difference between identity standards, quality standards, and fill-of-container standards under U.S. food law, and give one example of each.

Identity standards define required ingredients/composition (e.g., mayonnaise). Quality standards specify acceptable characteristics (e.g., canned peas). Fill-of-container standards regulate container fill (e.g., canned fruits).

Name the years in which following acts were enacted: Massachusetts Unwholesome Food Act, Pure Food and Drug Act, Federal Meat Inspection Act, FD&C act, Fair Packaging and Labeling act, Wholesome Meat Act, Nutrition Labeling and Education Act, Dietary Supplement Health and Education Act, Bioterrorism Act, Food Allergen Labeling and Consumer Protection Act, Food Safety Modernization Act, FASTER Act

Massachusetts Unwholesome Food Act 1785, Pure Food and Drug Act 1906, Federal Meat Inspection Act 1906, FD&C act 1938, Fair Packaging and Labeling act 1967, Wholesome Meat Act 1967, Nutrition Labeling and Education Act 1990, Dietary Supplement Health and Education Act 1994, Bioterrorism Act 2002, Food Allergen Labeling and Consumer Protection Act 2004, Food Safety Modernization Act 2011, FASTER Act 2021

What 2 parabens are permitted for use in food products in US?

Methylparaben, propylparaben

List the major food allergens that must be declared on U.S. food labels under FALCPA.

Milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame (added in 2023).

Name the six items that must be present on the label of meat products?

Name, Net Weight, Ingredient Statement, Company, Storage Instructions, & Inspection Legend.

Describe the Delaney Clause.

Part of the 1958 Food Additives Amendment; prohibits the approval of any food additive shown to cause cancer in humans or animals.

Based on FDA definition, four substances exempt from the definition of food additive.

Pesticide residues, color additives, new animal drugs, dietary supplements

Name the year following major laws were published: Pure food and drug act, food drug and cosmetic act, Nutrition labeling and education act, US organic food production act, food safety modernization act

PFDA: 1906 FDCA: 1938 NLEA: 1990 USOFPA: 1990 FSMA: 2011