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FST 421 - Misbranding Final
Terms in this set (62)
Is "misbranding" defined in legislatively-derived statutory law, FDA-derived
regulations, or both?
According to the FDCA 403(a)(1), what is the basis upon which a food may be
labeling is false or misleading in any particular.
According to the FDCA 403(f), what is the basis upon which a food may be deemed
if all required labeling information isn't conspicuous to ordinary individual.
What type of information is expected to be included in the codified "Standard of
Identity" of a food?
Type of information is expected to be included in the codified "standard of identity" of a food: a codified "recipe" for a specific food with stipulated possible deviations.
RACCs (reference amount customarily consumed) are FDA guides intended to help
manufacturers do what?
They represent FDAs best estimate of the amount of a particular food that is consumed in a single eating occasion.
FDA labeling regulations require that two informative statements be included on the
PDP of a food product; what are they?
1. Two informative statements are included on the PDP (Principle Display Panel): Statement of Identity (name of food) and Net quantity statement (amount of product).
Nutrient declarations on non-beverage products are based on serving sizes listed in what type of units?
metric and common household
A health claim is permitted on food labels only if the FDA has promulgated a regulation approving that claim. T/F
Food products are permitted to bear claims for a number of relationships between a
given substance and the risk of a disease or health-related condition. Explain the
government's rationale for allowing this and provide an example of such a claim.
Purpose of allowing health claim is to permit foods, including dietary supplements, to bear certain science-backed disease-prevention claims in their labeling without their being regulated as drugs. Eg: Cheerios may reduce your cholesterol.
With respect to compliance testing for purposes of nutrition labeling regulations, the
FDA states that approved methods from this "association" are to be used for nutrient
analyses unless a particular method is otherwise specified in 21 CFR 101.9(c). What is
the name of this association?
1. AOAC (Association of Official Analytical Chemists) is used for nutrient analysis unless a particular method is specified in 21 CFR 101.9(c).
How are FDA sampling techniques designed to minimize biological variation when
doing nutrient analyses for testing compliance with nutrition labeling regulations?
1. FDA sampling techniques designed to minimize biological variation when doing analyses: Composite sample
With respect to the enforcement of federal food statutes and regulations - what
materials are included in the definition of "labels" and "labeling"?
Label: a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this
Labeling: all labels and other written, printed or graphic matter on or accompanying a product.
FDA regulations specify two areas on a product's label where required information
may appear - what are these two areas called?
PDP, and IP.
What is the difference between the "Standard of Identity" and the "Standard of
Quality" for a food? Your answer should include examples of the types of information
each standard contains.
Standard of Identity: defines what a given food is, its name, and the ingredients that must be used or may be used in the manufacture of the food. Eg: Meat Stew, Deviled Ham
Standard of quality: are minimum standards only and establish specifications for quality requirements. Eg: the number of blemished peas allowed in a product sold as canned peas.
In what order are the major ingredients of a food product to be listed in the
"ingredients statement" of that product's label?
it has to be major ingredients descending order by predominance by weight.
What is the definition of a "health claim" - as stipulated in the 1990 NLEA?
"Health claim" - as stipulated in the 1990 NLEA (Nutrition Labeling and Education Act) characterizes the relationship between a food substance (or dietary supplement) and risk of disease; using the "significant scientific agreement" standard to determine that nutrient/disease relationship.
FDA regulations implementing the 1990 NLEA specify 15 "mandatory" "nutrients".
Quantitative measures of these mandatory nutrients are to be listed as part of the nutrition
information on the product's label. Name six of these mandatory components.
Six mandatory nutrients: vitamin A, vitamin C, dietary fiber, saturated fat, sodium, and protein.
Does the FDA specify the analytical methods to be used for nutrition labeling compliance testing? Explain your answer.
Yes, the FDA specifies the analytical methods for nutrition labeling compliance testing. The methods is used to determine whether or not the nutrient content of the "unit" making up that lot meet the standards declared in their Nutrition Facts Panel. If the nutrient content of the units does not meet the standards, then the product is misbranded and illegal.
What is the most unique aspect of the ingredient listing for a chemical preservative?
The most unique aspect of the ingredient listing for a chemical preservative is that the declaration must contain both the common or usual name and the function of the preservative.
Explain the difference between a "natural" and an "artificial" flavoring.
"Artificial" flavoring: any substance imparts flavor that is not derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof.
"Natural" flavoring: the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional.
The "net quantity of contents" of a food package must be stated in what units?
The "net quantity of contents" of a food package must be stated in both metric (grams, kilograms, milliliters, liters) and U.S. Customary System (ounces, pounds, fluid ounces) units.
List four "voluntary nutrients" that may be included on a product's NFP.
Calories from Saturated Fat, Polyunsaturated Fat, Soluble Fiber, and Potassium.
What is the basis of the jelly bean rule?
It says that just because foods are low in fat, cholesterol, and sodium, they cannot claim to be "healthy" unless they contain at least 10 percent of the Daily Value (DV) of: vitamin A, vitamin C, calcium, protein, fiber, or iron.
What label statements must appear on the principal display panel?
Label statements must appear on the principal display panel (PDP) are Statement of Identity (name of food) and Net quantity statement (amount of product).
Misbranding is the statutory term for what?
FDCA violations relating to the labels and the labeling of food products.
What is the "principal display panel" (PDP) of a food package?
Means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.
The classification of "certified" and "non-certified" apply to what kinds of food
The term "healthy" fits into which category of FDA regulated claims?
-low in fat, saturated fat, cholesterol, and sodium
-contain at least 10 percent of the Daily Value (DV) per RACC of one or more nutrients (for single item food) or of two nutrients (for a main dish product) or of three nutrients (for a meal product) of vitamin A, vitamin C, calcium, iron, protein, or fiber.
-exempt from "10% rule" are certain raw, canned and frozen fruits and vegetables and certain cereal-grain products if they do not contain ingredients that change the nutritional profile, and in the case of enriched grain products, conform to the standards of identity, which call for certain required ingredients.
Color additives may be classified as "straight colors" or as "lakes" (among others).
What is the difference between a straight color and a lake?
Straight colors: are color additives that have not been mixed or chemically reacted with any other substance.
Lakes: are formed by chemically reacting straight colors with precipitants and substrata, and for food use must be made from certified batches of straight colors.
What dictates whether or not a product has a "characterizing flavor" for regulatory purposes?
Section 403 of the FDCA details conditions for which a food shall be deemed
"misbranded" in parts (a) through (x). State, or explain in your own words, four of the
provisions given in parts (a) through (x).
1. FDCA §403: A food is misbranded if:
(a) its labeling is false or misleading
(b) it is offered for sale under the name of another food
(c) it is an imitation of another food and does not declare "imitation" on the label
(d) its container is misleading by the way it is made, formed, or filled
Explain what is meant by the "Identity Statement" of a food and tell where on the
package (IP or PDP) it may be located (if it may be located on either the PDP or the IP
then state that)
"Identity Statement" is the standardized, common, or usual name of the food; or a fanciful name generally used by the public for that particular product. The identity statement should accurately identify or describe either the basic nature of the food or its characterizing properties or ingredients, using simple and direct terms. "Identity Statement" is located on PDP.
Explain what is meant by the "Signature Line" of a food and tell where on the
package (IP or PDP) it may be located (if it may be located on either the PDP or the IP
then state that).
Include name, street address, city, state/province, and postal code of the responsible party. If the
responsible party is an entity other than the manufacturer, then a phrase such as "distributed by"
or "imported by" must precede the signature. It would be located on the IP.
How is the nutritional quality of a food product related to whether or not that
particular product must to be labeled as an "imitation"? (be specific in your answer)
"Imitation labeling" is required if a food is a substitute for and resembles another food but is nutritionally inferior to that food. To be specific, in the case of standardized foods, the food is defined as having certain characteristic. If the product meets that standard, then it is the "food." If the new product does not meet the standard, and it is nutritionally inferior to the standardized food, and it purports to be the standardized food, then it is an "imitation." In other words, the "food" can be considered to be the established product, the "imitation" would be the newer product which purports to be the established product but which does not meet the criteria used to establish the identity of the original established product/food.
What classes of ingredients may be declared, in a product's "ingredient list", using a
"collective (generic) term"?
Spices, Flavoring, and Coloring.
Chemical preservatives must be listed in the ingredients section by their common or
usual name along with what other type of information?
Description of the function.
Name three "major food allergens" as stipulated in the Food Allergen Labeling and
Consumer Protection Act.
Eggs, Wheat, and Peanut.
The FDA promulgated regulations establishing a system that allows industry to
determine the "Serving Size" declaration for their particular product. The system is
composed of two basic elements. What are those two elements? (i.e. what information
does the government provide, in the CFR, for companies to use in determining a
product's "serving size"?)
serving size that reflects the amount of food customarily consumed and is expressed in a common household measure.
The energy content of a food, as included in the Nutrition Facts Panel, must be declared in what units?
What are the primary sources of data that were used to establish the RACCs found in the Code of Federal Regulations.
(i) Serving sizes used in dietary guidance recommendations or recommended by other authoritative systems or organizations;
(ii) Serving sizes recommended in comments;
(iii) Serving sizes used by manufacturers and grocers; and
(iv) Serving sizes used by other countries.
Summarize the Supreme Court's opinion in the United States v. 88 Cases ...
Bireley' s Orange Beverage case. Start your answer by stating the verdict, then explain the basis of the verdict, and then the ramifications for future misbranding regulations.
It was caused by economic adulteration. The Circuit Court's decision was in favor of Bireley's. The decree of condemnation was vacated and the case remanded to the district court with orders to instruct the jury to determine "whether the Bireley product could be confused with undiluted orange juice". If the jury finds that such confusion may exist, then the Government's charge of adulteration is founded.
It showed how there needed to be guidelines for labeling, particularly name of formulated and novel foods.
What is the nature of the question asked in the Part 1 or the Four-Part Central Hudson test for assessing the constitutionality of government regulations abridging commercial speech?
at least must concern lawful activity and not be misleading. Next, we ask whether the asserted governmental interest is substantial. If both inquiries yield positive answers, we must determine whether the regulation directly advances the governmental interest asserted, and whether it is not more extensive than is necessary to serve that interest."
What is the statutory term for FDCA violations relating to the labels and the labeling of food products? (i.e. with respect to food label violations, foods are said to be what if they are illegal)
Which of the following are included in the federal definition of "label" or "labeling" - circle all of those that are included in these definitions.
Printed matter on a food's container
Graphic matter on a food's container
Relevant promotional material in the immediate vicinity of a food product Relevant promotional material distributed via the mail in the absence of the food
Printed matter on a food's container
Graphic matter on a food's container
55. Define the following terms such that the difference in the two is clearly evident. Include in your answer the location of such panels. Principal Display Panel (PDP) and Information Panel (IP):
PDP: it applies to cosmetics in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. Located in the front of the package
IP: Label statements that are generally required to be placed together, without any intervening material, on the information panel, if such labeling does not appear on the PDP.Located on the right side of the package.
Currently, the FDA relies more on the use of "common" or "usual" names of foods rather than promulgating new "Standards of Identity" for foods. (T/F)
What two pieces of information are contained in the "Standard of Identity" of those foods for which there is a standard of identity. (give two distinctly different types of information, followed by example)
- common name
- ingredients that must or may be used in manufacturers.
- An example with respect to production method would be smoking since that typically gives a distinctive characteristic.
- Vanilla extract
Common or usual names for foods may be established through what mechanisms?
21 CFR 101.4 (a)?
Foods of foreign origin imported into the United States, including those in their "natural state" and those no longer in their "natural state", must be marked to indicate the country of origin of the food. (T/F)
What is the legal difference between a "natural flavor" and an "artificial flavor"? (your answer must include examples of each class of flavors)
Artificial: any substance imparts flavor that is not derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof. ex: petroleum.
Natural: he essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional. ex: zest from an orange.
Color additives required to be listed by the FDA fall into two categories - what are they?
those that are subject to FDA's certification process and those that are exempt from the certification process.
FALCPA requires food manufacturers to label food products that contain protein from a major food allergen in one of two ways - explain the two ways.
The first option for food manufacturers is to include the name of the food source in parenthesis following the common or usual name of the major food allergen in the list of ingredients in instances when the name of the food source of the major allergen does not appear elsewhere in the ingredient statement.
The second option is to place the word "Contains" followed by the name of the food source from which the major food allergen is derived, immediately after or adjacent to the list of ingredients, in type size that is no smaller than the type size used for the list of ingredients.
Is there a DRV for sodium - if so, what is it?
Is there a DRV for salt-if so, what is it?
According to the FDA, the Nutrition Facts Panel "Serving Size" is to be interpreted as which of the following? a) a recommended portion size b) a standardized, reference, unit of measure.
What is the difference between a "health claim" and a "dietary guidance statement?"
Both health claims that meet the SSA standard and QHCs characterize a relationship between a substance and a disease or health-related condition (see 21 CFR 101.14). Both elements of 1) a substance and 2) a disease are present in a health claim. Dietary guidance does not contain both elements (and therefore does not constitute a health claim, but may contain one element or another. Typically, dietary guidance statements make reference to a category of foods (i.e., a grouping that is not readily characterized compositionally) and not to a specific substance.
Which of the major food components is the most energy dense (i.e. has the highest energy per gram)? (i.e. protein, fat, carbohydrate, water)
The macronutrients -- fat, protein and carbohydrates -- are high in energy density.
Non-mandatory/non-voluntary nutrients may only be included in the Nutrition Facts Panel if an appropriate disclaimer is also included. (T/F)
What are "Daily Values" and how are they used in the declaration of nutrients?
Daily Values are comprised of two sets of reference values for reporting nutrients in nutrition labels—the Daily Reference Values (DRVs) and the Reference Daily Intakes (RDIs). Declaration of nutrients by ?
A "health claim", by statutory definition, has two essential components, what are they?
- a substance
- a disease or health related claim
Which of the following two classes of health claims has the greater scientific evidence to support the claims? "Qualified Health Claims" or "NLEA Authorized Health Claims
NLEA authorized health claims
As put forth in Central Hudson, and used in Pearson v. Shalala, the federal courts have determined that the Constitution accords a lesser protection to commercial speech than to other constitutionally guaranteed expression. (T/F)
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