QUIZ 2
Ingredients Statement
-Required when a product is fabricated from two or more ingredients -Listed in descending order of predominance unless labeled to follow the "2% or less rule" or for spices, colors and flavors (this changed when the new allergen labeling requirements went into effect in January 2006 -Sub-listing is required for all multi- ingredient components (eg. Multiple sweetners, must be listed separately)
Nutrition Label Changes
-What are the things added: added sugars, vitamin D, and potassium, and percent daily value of vitamin d, ca, fe, and K -what are the things removed: calories from fat -type size increases for cal, servings per container, and serving size -footnote changes percent DV says much a nutrient in a a serving of food contributes to 2000 calorie diet
Information panel
1. It could be at a particular location on the package other than the principal display panel 2. Information panel must contain certain mandatory features. These are: - Ingredients statement - Signature line - Nutrition facts 3. Mandatory features must be placed in sequence with each other
Allowable label claims
1. Nutrient content claims 2. Structure/function claims 3. Health claims 4. Disease/drug claims 5. Dietary guidance
GRAS substance
A substance that is "generally recognized among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to Jan. 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use"
What organization's regulations implement key provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002?
FDA regulations
Inspection legend and establishment number
It may be any size but must be legible
If you use any additive not identified in the specific standard, what would it be necessary to do?
It would be necessary to petition FDA or FSIS for approval.
Signature Line
Name and place of business of the manufacturer, packer or distributor Example: Distributed by Ohio State University Dairy Store 2015 Fyffe Rd. Columbus, OH 43210
If a food is treated with or by radiation, what must it have on the packaging?
The Radura Logo
Net Weight Statement
The statement of net quantity of contents must be on all containers in retail trade Dual net weight between 1 & <4 pounds NET WT. 16 OZ. (1 LB.) Must be located at the lower 30% of the PDP Size and spacing requirements should be adhered to
Why this regulation of homeland security?
The notification will allow the FDA, working with U.S. Customs and Border Protection (CBP), to more effectively target inspections and ensure the safety of imported foods. Also, to allow FDA to locate sources of potential bioterrorism or outbreaks of food-borne illnesses.
Nutrient content claims
a. Also called a "descriptor" characterizes the amount of a given nutrient in a food
Health Claims
a. Is intended to restore confidence and consistency in food labeling i. Intended to offer marketing incentives b. In 1997 the FDAMA required "Authoritative statements" relating to health claims c. Ex. of health claims added under FDAMA d. Example: i. Ca reduces the risk of osteoporosis
Equivalent Claims
a. Made if both the reference food and labeled food are a good source of the nutrient on a per serving basis b. Ex. contains as much vitamin c as a glass of orange juice
Percent and Amount Claims
a. Options 3 - the statement does not implicitly characterize the level of the nutrient and is not false or misleading. With this option, no disclosure statement is needed ex. "200 mg sodium"
Structure/function claims
a. These describe the role of a nutrient or dietary ingredient in affecting the normal structure or function of human body i. Ex. "calcium builds strong bones" b. May characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function i. Ex. "fiber maintains bowel regularity" or "antioxidants maintain cell integrity" c. May describe general well-being from consumption of a nutrient or dietary ingredient d. They may also describe a benefit related to a nutrient deficiency disease, like vitamin C and scurvy e. Has an effect on a specific disease or class of diseases f. Has an effect on the characteristic signs/symptoms of specific disease or class of diseases g. An effect on an abnormal condition associated with a natural state or process, if the abnormal condition is uncommon or can cause significant or permanent harm h. Belongs to a class of products that is intended to diagnose, mititgate, treat, cure, or prevent a disease i. Is a substitute for a product that is a therapy for a disease j. Augments a particular therapy or durg action that is intended to diagnose, mititgate, treat, cure, or prevent a disease
Relative claims
a. This compares the nutrient level of the product to the nutrient level of a reference food b. It must be similar to the reference food (like potato chips for potato), or dissimilar but in the same product category as the reference food (like pretzels for potato chips)
Implied claims
a. This describes the food in a manner that suggests that a nutrient is absent or present in certain amounts i. High in fiber ii. "healthy, contains 2 grams of fat" b. Some claims cannot be made without agency approval c. Implying certain things without explicitly saying it, like "high in fiber" makes you think it is good for bowel movement d. Can make in an implied claim as long as it's true
Expressed or absolute claims
a. This is a direct statement about the exact amount of a nutrient in a food i. Has 100g "x" ii. Contains 100 calories iii. Low sodium b. Some claims cannot be made without agency approval i. Should just always ask for FDA approval to stay out of trouble foresuresies
How do we treat food additives in this class?
as ingredients
Does USDA or FDA require safe handling instructions and why?
safe handling instructions for USDA not FDA because more susceptible to contamination because raw meat (like it must be refrigerated)
Examples of allowable label claims
• 100% natural • USDA ORGANIC • Low carb • Gluten free • Heart healthy • Real fruit • Made with whole grains • Fat/sugar free • Helps remove cholesterol
Food Additive
• A food additive is any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food..... • This includes any substance used in the production, processing, treatment, packaging, transportation, or storage of any food
What is a food additive petition?
• A food additive petition proposes the issuance or amendment of a food additive regulation • If a new dietary ingredient in a given food has been in use prior to October 1994, a pre-market notification is not needed as long as the new ingredient had not been chemically altered from what existed prior to October 1994
Additives in standardized foods
• A standardized food is one to which a regulatory standard has been established • Additives may only be used in a standard food if the additives are recognized in the standard as either required or optional ingredients
Registration of Food Facilities
• All domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. are required to register with the agency. • This requirement provided the FDA for the first time with a complete listing of food facilities, both foreign and domestic, allowing it to identify and locate quickly food processors whose products have been contaminated either accidentally or deliberately.
Current Good Manufacturing Practices (CGMP)
• All food establishments are required to maintain sanitary cond'ts to ensure safe production of food. • This covers cleanliness and habits of personnel, conditions of buildings and facilities, use and maintenance of equipment, implementation of prod't and process controls and conditions of warehouse and distribution. • This introduces the subject of adulteration.
Food Additive Regulation
• Before a substance may be added to a food either directly or indirectly, its use must be authorized if not GRAS • If not authorization, a petition must be submitted to FDA and approval obtained • Substances exempted from this regs: - Pesticide chemical residue - Color additives - Animal drugs - Ingredients in dietary supplements
Bottle Water Labeling
• Bottled water must be classified as one of the following: - Artesian water/artesian well water - Drinking water - Purified water - Mineral water - Spring water - Sparkling water - Carbonated water - Flavored water - Water with healthful additives - Distilled water - Tap water
What is the data required for Food Additive Petitions?
• Chemical identity and composition of the substance, including: - physical, chemical and biological properties - Minimum content of desired components - Identification of reaction byproducts and other impurities • Proposed condition of use, and specimens of the labeling • Data establishing that the additive will have the intended physical or technical effect together with data on expected effect of substance as it becomes components of the food. • Practical methods of detecting its quantities in food, as well as any substance formed in or on such food because of its use. • Full reports of investigations on safety of the food additive. • Proposed tolerances, if required to insure safety.
What is % Daily Value based on?
• Daily reference values (DRV's) - this is the values established for macronutrients that are sources of energy (i.e. fat, carbohydrate, and protein), as well as for cholesterol, sodium and potassium • Reference Daily Intakes (RDI's) - this is the values established for vitamins, minerals, and micronutrients
Difference between food ingredients and additives
• Depends on quantity used in given formulation • Food ingredients can be consumed alone as food (e.g., sucrose), additive are used in small quantities (usually less than 2%) relative to the total food composition but plays large part in the production of desirable and safe food products • Food additives are minor ingredients put in foods to affect properties in some desired way • Effects desired relate to color, flavor texture nutritive value, or stability on storage.
What are examples of direct additives?
• Direct additives (intentionally added) - Added to enhance flavor - Color - Consistency - To improve or maintain nutrition - Leavening - pH control - Palatability - Increase shelf-life
How do you get ingredient approval for direct additives?
• Direct and secondary direct food additives - Food additives lawfully cannot be marketed until a company submits a food additive petition and FDA issues a regulation authorizing the use of the food additive
Who should register for homeland security?
• Domestic and foreign manufacturers or processors • Domestic and foreign packers • Domestic and foreign storage operations • Domestic facilities whether or not food from the facility enters interstate commerce. They are also required to provide emergency contact information. • All changes to such information must be reported within 60 days. • Except for specific exemptions (packaging materials & pesticides), the registration requirements apply to all facilities that manufacture, process, pack or hold food regulated by FDA, including animal feed, dietary supplements, infant formula, beverages (including alcoholic beverages) and food additives.
FDA Regulations relating to food import
• Importers must provide the FDA with advance notice of human and animal food shipments imported or offered for import. • Notification requirements include: - eight hour deadline before the arrival into the U.S. of food shipments by water, - four hour deadline for shipments by air or rail, - and a two hour deadline for shipments by road. • Food importing companies must submit the notification information electronically to the FDA, which will use its Prior Notification System Interface and the U.S. Customs and Border Protection's Automated Broker Interface (ABI) that is part of the Automated Commercial System (ACS).
Overview of FDA/FSIS Sanitation Plan
• Establishment personnel - Employee health - Personal hygiene - Jewelry - Clothing • Building and grounds - Indoor and outdoor surfaces - Equipment storage - Waste storage and disposal - Designated separated areas • Lighting, ventilation and the environment. - Lighting - Ventilation - Filters and ducts - Water reservoirs • Water, drainage and plumbing. - Water supply, capacity and pressure - Plumbing system, including drainage - Back-flow control to prevent mixing of non-potable with potable water - Sewage and fluid disposal. • Lavatories, toilets and sanitary facilities. - Hand-washing lavatories - Service sinks -Toilet facilities • Utensils and equipment. - Construction and installation - Food contact and non-contact surfaces - Equipment drying, storage and maintenance. • Raw materials and ingredients. - Approved sources of these (Home Land Security Act) - Evaluation and separation of raw materials - Washing of raw materials • Sanitary operations and procedures. - Temperature control: cooking, cooling, storage - Washing and sanitizing of hands - Facility cleaning • Packaging and labeling - Packaging integrity - Container labeling • Pest control - Rodents, birds, insects - Infestation - Pesticides and other controls - Pest removal • Toxic and poisonous compounds - Use and storage
Rules on food claims for infants and toddlers
• FDA and FSIS prohibit use of nutrient content claims on foods intended specifically for infants younger than 2
Overview of Food Labeling
• FDA and FSIS share responsibility for assuring that foods sold are properly labeled with certain mandatory elements • The intent is to protect consumers from false or misleading information about a food's identity, quantity, composition, origin, and nutritional quality • Also, that truthful claims are made about a food's nutrient content or about its relationship to a disease or health related condition • For food marketed in the United States, all words, statements and information required to appear on a food label must be in English, except the product is distributed solely in Puerto Rico. In such cases, it could be in Spanish
GMP and The Bioterrorism Act
• FDA does not have to prove that a food is adulterated, a reasonable assumption that an imported food is as such is reason to deny entry of such foods • FDA could use prior history of problems from a certain region or company to refuse entry of a particular food into the country • FDA could refuse entry of a food if the food came from an unregistered foreign plant.
Important FDA vs USDA Labeling regulations
• FSIS requires approval of most labels before products may be offered for sale • FDA does not approve labels prior to marketing (except infant formula), but does have jurisdiction over labeling in interstate commerce • FDA requires some foods to carry appropriate warning and notice statements
Issues relating to GRAS ingredients
• GRAS Affirmation • GRAS Notification • Self determination GRAS • Indirect substances affirmed as GRAS • FDA accepts self determinations of GRAS, however, USDA can not • FDA's authority over products with self- determination GRAS begins when these products enter commerce
GRAS Ingredients
• GRAS self-determination - FDA approval or notification is not required prior to marketing or using a GRAS substance in food, except meat and poultry products • GRAS Affirmation - FDA on its own initiative or as the result of a petition may affirm the GRAS status of a substance - To do this FDA will publish a notice in the Federal Register, giving name, use and limitations of the substance
How USDA labeling differs from FDA labeling
• Handling statement is required for perishable foods • Safe Handling Instructions are required when the meat or poultry portion is not ready-to-eat • No 1/16" minimum type size • Not governed by the Fair Packaging and Labeling Law • Metric units not required in net weight labeling
Direct additives definition
• Its quantity in a food must not exceed the amount reasonably required to accomplish its intended effect • It must be of appropriate food-grade and be prepared and handled as a food ingredient - ex. road salt is cheaper than food grade salt, but you must use only food-grade salt and food-grade packaging materials
How do you get ingredient approval for Food contact substances?
• Lawfully may be marketed without first seeking FDA concurrence that the ingredient is GRAS • FDA has proposed a rule that it would review summary data relating to a GRAS notification and it would concur or reject the company's GRAS determination
How do you get ingredient approval for GRAS ingredients?
• Lawfully may be marketed without first seeking FDA concurrence that the ingredient is GRAS • FDA has proposed a rule that it would review summary data relating to a GRAS notification and it would concur or reject the company's GRAS determination
Key Sections of the Bioterrorism Act of 2002
• New regulations on facility registration • Prior notice of food imports • Administration detention • Record keeping
Standardized and Substitute Foods
• Non-conforming foods are generally not permitted to use standardized names, exceptions are authorized to allow for healthier versions of standardized foods. Ex. "reduced-fat cheddar cheese" • The deviation must be adequately described by an approved nutrient content claim • The substitute food must meet the requirements for the specific claim and for nutrient content claims in general • The substitute food must comply with the relevant standard in all other respects • The substitute food must not be nutritionally inferior • Performance characteristics remain same, or dif must be noted on label in legible print
Indirect food additive
• Not directly added or intended to be in the food but get there via contact materials -you know it's going to get into the food, but you must make sure that it does not have technical effect -cannot be prevented -must be in trace amounts -not needed for process of food, no technical effect • Must have no technical effect on the food • Becomes a part of a food in trace amounts during production, processing, packaging, transportation or storage • Must not exceed prescribed limits in food • If no limits are prescribed, it must be a quantity that is reasonably required to accomplish the desired effect - Must not be intended to accomplish physical or technical effect except as permitted by the applicable regulation - Must be of acceptable purity & GMP (good manufacturing practices) applies - Examples • Migration from packaging • Components of coatings, adhesives, paper and paperboard or other food contact substances • Certain adjuvants and production aids
Nutrition Labeling
• Nutrition labeling regulations: - Specify the serving size - Identify the nutrients that must be declared - The declarations that must be declared - The type size that must be used - The format that must be used
How to monitor additive use
• Once an additive has been approved, FDA will monitor its safe use • FDA operates a computerized database, known as the Federal Adverse Event Reporting System (FAERS) • FAERS tracks all complaints from individuals and physicians relating to an additive's use • FDA can pull the plug on an additive if FAERS indicate problems with its use
What facilities do not have to register for homeland security?
• Private residences • Non-bottled water drinking, water collection and distribution est. such as municipal water systems • Farms • Transport vehicles that carry food in their usual course of business • Restaurants • Retail food est. • Nonprofit food facilities • USDA regulated facilities • Fishing vessels
USDA Labeling Requirements
• Product Name • Handling Statement • Net Weight Statement • Inspection legend (including Est. number for meats) • Plant number (usually for poultry) • Ingredients statement • Signature line (called name & place of business in FDA requirements) • Nutrition facts • Safe handling instructions
Serving Size
• Serving size — Nutrition labeling regulations are intended to standardize the serving size of products to facilitate value comparisons — Serving sizes are based on the reference amounts customarily consumed (RACC) • FDA has established RACCs for over 100 commonly consumed foods - Examples: all beverages (240 mL), cookies (30 g), snack foods (30 g), breads (50 g), breakfast cereal (1 cup prepared) • The serving sizes for foods are based on common household measures that approximate the RACC • Examples: - Cup, tablespoon, teaspoon - Piece, slice, tray, jar and fractions thereof - Ounces
An Ingredient
• Something that is a component part of any combination or mixture • This includes any substance used in producing, processing, treating, packaging, transporting or storing food, including any source of radiation intended for such use
Handling statement
• Special statements required for perishable products - Keep Refrigerated - Keep Frozen - Keep refrigerated or frozen - Previously handled frozen for your protection - refreeze or keep refrigerated
Product Name - USDA requirements
• Standardized name - Frankfurter - Chicken burrito • Common or usual name - Beef rib eye steak - Pork shoulder • Descriptive or fanciful name - Beef, water and potato starch product - Chicken, vegetables and cheese in pastry
Labeling and Food Allergens
• The Food Allergen Labeling and Consumer Act of 2004 requires a product to be clearly labeled if it in any way contains the following: - Milk - Eggs - Fish - Shellfish - Tree nuts - Wheat - Peanuts - soybeans
Principal Display Panel (PDP)
• The part of a label most likely to be displayed or examined during retail sale • Can contain all required features in some cases • Minimum requirements on the PDP: - Product name - Handling statement (if needed) - Net weight statement (if needed) - Inspection legend • Except for cylindrical containers with 1/3 circumference as PDP (required by law it must be facing the consumer)
How do you register for homeland security?
• The registration may be submitted electronically, via the Internet, or by paper through surface mail or by fax. Registrations may also be submitted on CD-ROM by mail. • The FDA will accept electronic registration from anywhere in the world 24 hours a day, 7 days a week.
Unavoidable contaminants
• These may be present in food despite all efforts to prevent or eliminate them • Some of these are natural contaminants and some are added as a result of environ., agricultural, industrial action • When added contaminants cannot be avoided by GMP an action level is set by FDA in the interest of public health • USDA relies on FDA regulations for action levels in meat and poultry
Sanitation Standard Operating Procedures (SSOPs)
• These were issued by both FDA and FSIS. • These are designed to ensure better compliance with existing sanitation stds. • Meat and poultry establishments and juice processors are required and seafood processors are strongly encouraged to develop written sanitation plans. • Plans must specify who is in charge of sanitation, and must require the keeping of daily records showing that the plan works.
Nutrition Facts
• This can be on the PDP • Can be on the information panel. • If either the PDP or the information panel does not have the required space for the nutritional facts, it could be placed on any panel readily seen by consumers
Secondary direct additives
• This is a substance, which although not directly added to a food, is used in a manner or under such conditions that it is likely to become a component of the food (you are aware that it is going to get into the food) - technical effect, needed for process of food - you are aware that it is going to get into the food • These are best described as processing aids. Have no effect on the final product • Examples - Polymer adjuvants used food treatment - Enzymes and microorganisms as starters - Solvents, lubricants release, defoaming agents, clotting enzymes, etc.
Color additives
• This is any dye, pigment, or substance made by a process of synthesis, or extracted, isolated, or derived from a natural source that can impart color when added or applied to the food • Certifiable color additives are man made • "Exempt from certification" colors are derived from natural sources • To market a new color additive, approval from FDA is needed
% Daily Value
• This shows how the amount of a nutrient, vitamin, or mineral - in one serving - fits into a 2,000 calorie reference diet
How do you get an additive approved?
• To market a new food or color additive, or to use an already approved additive for a new purpose or at a new level, a manufacturer must first petition FDA for approval. Additives for use on meat and poultry products must also receive FDA approval
Functions of color additives
• To offset color loss • To correct natural variations in color • To enhance color • To provide a colorful identity to a food • To protect flavor and vitamins • To provide an appeal to customers
FDA Labeling Requirements
• Unless exempted, all FDA regulated foods must be labeled to display: - A statement of identity - Ingredient statement - Name and place of business - Net quantity - Nutritional labeling - Some foods are required to carry appropriate warnings or notice statements
Infant Formula and cGMPs
•This includes practices that are necessary to ensure that the formula provides the required nutrients • That adequate testing of each batch of the formula is carried out • Timeliness of testing • Audits of the scheduled processes • Proper record keeping • Plus the other GMP practices as required for other types of food production