Food and Drug Law

Lawsuits from Misbranding (claims)

-"All natural", "nutritious", "healthful" that are permitted or not regulated by FDA, but are nonetheless misleading -"Nutrient content" claims (General Mills with heart healthy) -Food fraud occurring in the market ~"Grape seed oil" product is falsely labeled because it contains less than 25% grape seed oil ~Olive oil false labeled "100% Pure Olive Oil" because it contains "olive-pomace oil" or "olive-residue oil" or "pomace"

Health Claims

-(1) A substance (whether a food, food component, or dietary ingredient) and -(2) A disease or health-related condition -Ex: "diets high in calcium may reduce the risk of osteoporosis" -Nutrient content claims (approval by FDA) ~Label claims that characterize the level of a nutrient in a food (low fat, high fiber, low calorie, etc) -Issues with industry manipulating labels -Have to make link between substance-disease

Food Regulations

-1906 Pure Food & Drug Act (Roosevelt) -1938 Food, Drug, & Cosmetic Act (Roosevelt) -1958 FD&C Act Amendment (congress) -1960 Color Additive Amendment (congress) -1990 Nutritional & Educational Act -1996 Food Quality Protection Act -1997 Amendment (Affirmation of GRAS Status) -2011 Food Safety and Modernization Act (FSMA)

Hazards causing safety issues

-48 Million Foodborne illnesses annually in US -Most from microbiological hazards -Food additives not as likely to cause harm except sometimes chronic (aspartame) -Consumers fear additives more than they are a safety problem

Food Allergen Labeling and Consumer Protection Act 2006

-Affect about 4 million individuals in the US from mild to life-threatening allergic reactions -Mandates that food containing 8 major allergens must declare the food in plain language on the ingredient list ~"Contains" or bolded, or parenthesis after derivative like albumin (egg) -90% of food-allergic reactions from these allergens -Must be listed even if present in colors, flavors, or spice blends

Dietary Supplement Health and Education Act 1994

-Amendment for dietary supplements as food -FDA regulated them to make sure they were safe and wholesome, and that their labeling was truthful and not misleading -Under the amendment, dietary ingredients used in dietary supplements are no longer subject to premarket evaluations -Takes too long to keep up with industry growth -Caused some big problems: federa for bulking up caused heart issues for some athletes -No standards for dietary supplements

Food Quality Protection Act 1996

-Amendment passed unanimously by Congress with broad support from industry, agricultural groups, environmental, and health organizations -Established a new, uniform standard for setting pesticide residue tolerances in both raw and processed food (reasonable certainty that no harm will result from aggregate exposure) -Repeals Delany Clause -Applies ONLY to pesticides

Delaney Clause

-An exception to hazard -Any material containing any substance shown to cause cancer in man or animals may not be added to foods -No consideration given to "hazard" vs. "levels" -These are never approved

Serving size

-Basis for reporting food's nutrient content -Determined by FDA (otherwise can manipulate) using consumption surveys -Amount of food customarily eaten at one time -Info must be expressed in common household (cup, oz, Tbs, Tsp, Piece, Slice) and metric (grams, mL) measures

Selected Authorized Health Claims

-Calcium and osteoporosis -Dietary fat and cancer -Dietary saturated fat and cholesterol and heart disease -Fiber containing grain products, fruits, and vegetables (certain foods) and cancer -Fruits, vegetables and grain products (soluble fiber) and heart disease -Non-carcinogenic sweeteners and dental caries -Soy protein and heart disease -Plant stanols/ sterols and heart disease

GRAS Self-Affirmation

-Company can declare a substance is GRAS -Panel of experts look at safety, notify FDA that the compound is safe -Needs public info -Way to avoid premarket approval for an additive

1906 Pure Food and Drugs Act

-Creation of FDA -Revolutionized food supply ~Encouraged better sanitization in food processing ~Discouraged use of chemical preservatives -"Adulteration" and "Misbranding" -Prohibited interstate transport of unlawful products (defined federal trading vs. state) -New labels (mostly for drugs: misinformation) -Presence of federal food and drug inspector encouraged compliance -Ability to prosecute industry: got industry's attention to look more at additives and safety

Delany Clause Dilemma (1958)

-EPA had negligible risk approach to pesticide residues in raw food (cancer risk of one-in-one-million) -Zero tolerance required for potential cancer-causing chemicals in processed food -Current technology allows for detection of extremely small residue levels, versus not being able to them before -Different standards for raw and processed food created regulatory problem for EPA -A food additive since intentionally added

Food additive

-Either in the food or in contact with the food (wrapper still considered) -Any substance intentionally added to food -NOT pesticides, dietary ingredients of dietary supplements, color additive, new animal drug, or substance approved before 9/6/1958 -Can be direct or indirect, but is intentionally added -Patented to FDA

Federal Food, Drug, and Cosmetic Act

-Enacted in 1938 -FDA interprets the law, ensures foods are safe -Basis for sanitary and safe food supply -Administered by FDA of USDA (now FDA separate from USDA) -Controls all food in interstate commerce except meat and poultry (USDA: Food Safety Inspection Services (FSIS)) -Assures food is safe, wholesome, fair value (quality that protects the consumer)

Dietary Fiber

-FDA definition includes naturally occurring and those added to foods that show a physiological health benefit

Added Sugars

-FDA is requiring grams and % Daily Value for added sugars ~Difficult to meet nutrient needs and calorie limits if consuming more than 10% of calories from added sugars -Dietary patterns lower in sugar-sweetened foods and beverages are associated with a reduced risk of cardiovascular disease -Design clarifies that added sugars are a subset of total sugars

GRAS Self Affirmation 1997

-FDA issued a rule setting out a notification process to replace GRAS affirmation ~FDA provides for a voluntary notification process if a company wishes advise FDA of its GRAS/SA findings -Two core principles: ~Assessment of ingredient's safety and basis is "generally recognized" by experts in the field ~Two ways to demonstrate this: ~Current scientific assessment done by an expert review panel (easier) ~Showing the food ingredient was sold in commerce in foods prior to 1/1/1958. Seldom used for most dietary ingredients presently sold -Can avoid premarket approval

Pre-Market Approval

-FDA review data and evaluate petitioner's safety argument -FDA communicates with petitioner to resolve any questions and/or additional data needs -FDA review the documentation -FDA reaches a scientific conclusion and makes a recommendation -Objections and Public Hearings -Judicial Review -Amendment or Repeal of Regulations

Reasonable certainty of no harm

-FFDCA -Concept of safety: whether a substance is hazardous to the health of man or animal -Safety requires this based on the proposed use of an additive -It does not--and cannot--require proof beyond any possible doubt that no harm will result under any conceivable circumstance -Based on HAZARD not toxicity

Color Additives Amendment 1960

-First amendment since 1958 -To FD&C Act requires dyes used in foods, drugs, cosmetics, and certain medical devices to be approved by FDA prior to their marketing

Structure/function claims

-Statements that address a role of specific substance in maintaining normal healthy structures or functions of the body -"fiber maintains bowel regularity" or "antioxidants maintain cell integrity" or "calcium builds strong bones" -Manufacturer is responsible for ensuring the accuracy and truthfulness of these claims -FDA has not evaluated the claim

GRAS

-Generally recognized as safe -Under section 201(s) and 409 of the FFDCA, any food additive subject to premarket review unless it is generally recognized among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive. -Common knowledge exists about the safety of the substance (generally available data and info about the use of the substance are known and accepted widely by qualified experts): Consensus among qualified experts that those data and information establish that the substance is safe under the conditions of its intended use. -Cannot be patented

Preventative Controls

-Identify and implement preventative controls to minimize or prevent identified hazards -Must monitor and verify and take corrective action when needed ~Include environmental and produce testing programs ~Must keep records of these activities for 2 years -Risk-based ~Consistent with current scientific understanding of safe food manufacturing/ handling -Traceability (very important) ~By Jan 2013, FDA must require additional record keeping for "high risk" foods

The "Natural" Controversy

-Majority of food labeling lawsuits, at least 100 since 2011, have alleged the misleading use of the "natural" claim -Confusion from FDA reluctance to establish an enforceable standard ~Difficult to define because the food has probably been processed and is no longer a product of the earth ~FDA has not developed a definition for use of the term or its derivatives ~The agency has no objected to the use of the term if the food does not contain added color, artificial flavors, or synthetic substances ~Often look for double functionality in lawsuits

Color additive

-Material that is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived from a vegetable, animal, mineral, or other source, and that is capable of imparting color when added or applied to a food -Except any material used solely for a purpose other than coloring -Paprika, for color (1960) versus flavor (1958)

Food Hazards

-Microbiology (top concern gvt) -Nutritional -Environmental -Natural Toxicants -Pesticide Residues -Food Additives (top concern for consumers)

Food Additive Petition Review

-NOT intended to ensure, nor is it possible to ensure, safety without absolute certainty -"Reasonable certainty of no harm" rather than "Certainty of No Theoretical Possibility of Harm" -Consensus (public) decision made under uncertainty that provides a fair evaluation of all the data of record ~Must protect public health ~Will withstand scientific, procedural, and legal challenge from all sides -Very long process (5 years) -Premarket approval

Limitations of 1906 Act

-No provision for food quality or standardized labeling -Only focused on safety -Consumers had no way of knowing that the products were of low quality -Jams were a big problem: toxic red dyes to color -Sold rotten eggs -Preservatives used that were harmful

If an ingredient is GRAS for one use, is it GRAS for all uses?

-Not necessarily, the use of a substance, not the substance itself, is the part for GRAS exemption -A determination of the safety of the use of an ingredient includes info about the characteristics of the substance, the estimated dietary intake under the intended conditions of use, and the population will consume the substance -Dietary intake depends on food categories in which it will be used and the level of use in each -Some uses are intended for a narrow population such as infants with formula, so there may be special considerations associated with that population but not the general use of the food substance -Formal petition needed if use is not listed as a GRAS ingredient (approved for the application, not the ingredient)

2 events prompting federal law by 1883

-Poison Squad: team of USDA chemists to look at additives (led by Dr. Wiley)--book in 1906 -The Jungle by Upton Sinclair: focused on meat processing in Chicago

Misbranding or Fraud

-Presence or absence of specific attributes on label which is false, deceptive, or misleading -Every aspect of label is considered in determining if false or misleading -Many lawsuits from this -Companies more concerned with this than government due to reputation (can get sued)

Hazard

-Probability that injury will result -Level of consumption taken into account -Exception: Delaney Clause -Determined by FDA using risk assessment

GRAS Affirmation

-Process that FDA developed in the 1970s -President Nixon directed FDA to re-examine the safety of substances considered to be GRAS (concerns for cyclamate salts and saccharin) -FDA announced that the agency would evaluate, by contemporary standards of the time, the available safety information regarding substances considered to be GRAS ~If revaluation of current data confirmed that use was GRAS, given new GRAS regulation ~FDA also established procedures whereby an individual could petition FDA to review GRAS status of substances that have no been considered as part of the agency's GRAS review -FDA can't check everything

Dietary supplement

-Product (other than tobacco) that is intended to supplement the diet -Intended for ingestion in pill, capsule, tablet, or liquid form -Not represented for use as a conventional food or as the sole item of a meal or diet -Must be labeled -Includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a supplement or food before approval, certification, or license -Most common is fish oil -Stevia was before it became an additive

Nutrition Labeling and Education Act 1990

-Provides FDA with specific authority to require nutrition labeling of most foods regulated by the Agency; and to require that all nutrient content claims and health claims be consistent with agency regulations -Exemptions and special labeling provisions: small business, restaurants for immediate consumption, prepared and sold in retail establishment -State regulations (NY--requires labeling)

Why update the nutrition facts label?

-Reflects updated scientific information: ~Link between diet, chronic diseases, and public health -Updated serving sizes are needed to reflect changes in amounts of foods consumed (to what people actually eat, not what they should eat) -Draws attention to calories and serving sizes, two important elements for consumers to make healthier food choices

Partially hydrogenated oils (PHO's)

-Removed GRAS status over time -Due to researching indicating trans fats increase cardiovascular disease.

Ingredient Statement

-Required on foods having more than one ingredient -Usually below nutrition facts and above manufacturer and distributor information -Ingredients must be listed with high content ingredient to least weight ingredient -An ingredient containing two more more ingredients can be listed under common name with ingredients in parenthesis -Ingredients of less than 2% by weight should be at end and can have statement "contains 2% or less of ____."

1958 Amendment

-Requires FDA approval for use of an additive prior to inclusion in food unless determined safe by FDA or USDA prior to 1958 amendment (prior-sanctioned substances) OR GRAS substance -Requires pre-market approval of new uses of food additives (petition additive to FDA for approval) -Presented by company (can take ~5 years, very expensive) -Requires manufacturer to prove an additive's safety for the ways it will be used: establishes standard of review, standard of safety, and formal rule making procedures

Food and Drug Law

-Sec 409 Unsafe Food Additives: the use of a food additive is unsafe, unless that use conforms to a regulation, notification, or exemption issues by FDA under sec 409 -Sec 402 Adulterated Food: a food is adulterated...if it is, or if it contains any food additive that is unsafe -Sec 301 Prohibited Acts: the intro or delivery into interstate commerce of any food that is adulterated or misbranded

New nutrition facts label

-Serving size changed, bolded for easy read -Calories larger and bolder -No more calories from fat, focus on type of fat -Added sugars -Took away vitamins A and C, now have D and potassium (KCl mixed with NaCl to decrease salt)

Food Safety Modernization Act 2011 (FSMA)

-Signed into law by Obama -Improve safety and focus on imported foods into US -Reaction to three major events: 2006 E. coli outbreak in spinach, 2007 melamine contamination of pet food, 2008-09 salmonella outbreak in peanut butter -Focus on prevention, not inspection/testing -Risk-based approach -Supply chain traceability/ transparency ~Know your supplier, particularly for imports -Enable food safety crises rapid response, containment -Enhance FDA's inspection/ enforcement authority -Hazard analysis (effective July 2012): identify/evaluate known or reasonably foreseeable hazards AND must be reanalyzed every 3 years or whenever a significant change is made affecting risk

Before FDA

-State level regulations -Some states too relaxed or too strict (Wisconsin-dairy)

Dietary guidance

-Statements that address a role of dietary patterns or of general categories of foods in health -"Diets rich in fruits and vegetables may reduce the risk of some types of cancer" or "carrots are good for your health" or "calcium is good for you" -Must be truthful and non-misleading -Do not have to be approved by FDA

Trans fats

-Targeted by FDA after too much evidence of increased health risks -Given until June 2018 to remove partially hydrogenated oils (PHOs) from their produces -Removed GRAS, now must be an additive -However, need premarket approval with evidence, but evidence says it's not safe

Toxicity

-The capacity of a substance to produce an injury (anything could be at a high enough level) -Levels are not considered

Fats

-Trans fat remains on label; FDA's final determination on partially hydrogenated oils does not impact naturally occurring trans fats -"Calories from fat" is no longer permitted; type of fat is more important than amount (limit saturated fat)

Foreign Supplier Verification Program

-US importers must have a program by Jan 2013 to verify that imported food is produce in accordance with US requirements -Monitoring records for shipments -Lot-by-lot certification of compliance -Annual on-site inspections -Checking the hazard analysis and preventative controls of foreign suppliers and -Periodically testing and sampling of shipments

Vitamins and Minerals

Actual amount and % DV for: -Vitamin D, Calcium, Iron, Potassium -Nutrients of public health significance -Vitamins A and C no longer required -Can voluntarily declare other vitamins and minerals (vitamin C in juice)