Food Law Final

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.

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)

"Misbranded"

Explain the difference between "natural" and "artificial" flavoring

"Natural" flavoring is described as coming from something that was once living "Artificial" flavoring is derived from synthetic material or does not meet requirements of "natural"

In Pearson v. Shalala, FDA's failure to define "Significant Scientific Agreement" violated what Administrative Procedure Act's prohibition?

"Significant Scientific Agreement" was far too vague of terminology to be used according to the APA. They needed to come up with a much more qualitative argument for that exactly was not in agreement.

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 --Relevant promotional material in the immediate vicinity of a food product

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"?)

--Reference amounts customarily consumed per eating occasion (RACCSs) for specific food product categories. The FDA established procedures for converting RACCs into appropriate label serving sizes --Procedures for determining serving sizes for use on product labels derived from the reference amounts Think of a serving size as a "standard unit" or "standard amount" for a particular food. For consistency, regulations require that nutrients be reported per standard unit. So calories, cholesterol, protein, etc. are all reported based on the designated serving size for a product. Must be expressed in a common household measure (units) so an average consumer can readily put it into context

As specified in FDA's 2001 "Guidance to Industry," what is the agency's current thinking on the labeling of foods developed using genetic engineering/bioengineering? (Note that FDA's thinking in this area does not appear to have changed since the publication of the 2001 guidance document.)

--The FDA acknowledges that if an issue exists for a bioengineered food or a constituent of a bioengineered food regarding how the food is used or consequences of its use, a statement must be on the label to describe the issue. -- Over the past 25 years the FDA has issued public notices, held public meetings, and addressed thousands of written stakeholder comments pertaining to its policy regarding the safety and labeling of bioengineered foods. --The FDA has established guidelines for those manufacturers who wish to voluntarily label their foods as being made without the use of bioengineered ingredients.

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 common or usual name of the major food allergen must be followed by the food source in parentheses in the list of the ingredients. This will occur the first time the major food allergen is listed and does not have to be repeated each time the name of the specific food allergen appears. --Examples: "lecithin (soy)," "flour (wheat)," and "whey (milk)" There may be a section after or near the ingredient list called "Contains". After the word "Contains", there must be listed the name of the food source from which the major food allergen is derived. --Example: "Contains Wheat, Milk, and Soy." A "contains" statement is not required on a food label. Also, the common English name may only be listed in the contains statement and not in the list of ingredients. Therefore, you must read the list of ingredients and any "Contains statement" carefully.

The Supreme Court, in Central Hudson Gas & Electric Corp. v Public Service Commission of New York (1980), stipulated three criteria that must be met in order for government regulations that restrict commercial speech, that is neither unlawful nor misleading, to be permissible. What are those three criteria?

--The government must have a substantial interest. --The regulation must directly and materially advance the government's substantial interest. --The regulation must be narrowly tailored.

An NLEA-authorized health claim is permitted only if FDA has promulgated a regulation approving it and setting forth the conditions under which it may be used. Provide one example of a "condition" that will be dictated by the FDA (be specific).

--establishing a minimum amount per serving of the nutrient the health claim is based on --establishing a minimum amount for certain other nutrients that may be negatively associated with health-related conditions.

Name three "major food allergens" as stipulated in the Food Allergen Labeling and Consumer Protection Act.

-milk -fish -soybeans -tree nuts -egg -wheat -peanuts -crustacean shellfish

Is there a DRV for sodium - if so, what is it?

6g salt a day (2.4g sodium)

A "health claim", by statutory definition, has two essential components, what are they?

A food claim must have two components, the first will be a substance (what is in the food that gives it an effect) and the disease or health condition that it applies to.

In the Bireley's Orange Beverage case, how did the appellate court answer the question "To whom must the food appear better than it is?"?

Appellate court said- the whole public, ignorant, unthinking, easily misled public who just make purchases without thinking or analyzing

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?

Association of Analytical Chemists International (AOACI)

Why are health claims always phrased in terms of "may reduce the risk" of some disease or health-related condition rather than in terms of absolute prevention.

Because a food claiming that it will definitely do something can be misleading, as a food will not "absolutely" prevent a disease or condition

List four "voluntary nutrients" that may be included on a product's NFP.

Calories from saturated fat, polyunsaturated fat, monounsaturated fat, soluble and insoluble fiber, sugar alcohols, other carbohydrates, potassium, % vitamin A present as B-carotene, other essential vitamins and minerals established by the RDA

Color additives required to be listed by the FDA fall into two categories - what are they?

Certified and uncertified food color additives. Certified are like "Blue 3 or Red 40", uncertified would be like caramel or beet coloring.

What classes of ingredients may be declared, in a product's "ingredient list", using a "collective (generic) term"?

Collective terms can be used with spices, flavorings and colors. Can only be used when they are used one or more as a group/collective ingredient as an ingredient for something else. If they are being sold individually as a spice, flavor or color, package must have ingredient list. Examples of collective terms "spices" "artificial flavoring" "natural flavoring"

Nutrient declarations on non-beverage products are based on serving sizes listed in what type of units?

Common household measurements

What is the legal difference between a "natural flavor" and an "artificial flavor"? (your answer must include examples of each class of flavors)

Defined in the CFR - a natural flavor is 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, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional." Artificial flavors are those that are made from components that do not meet this definition. Essentially, the flavors can be the same, but artificial flavors are derived from synthetic ingredients.

In what order are the major ingredients of a food product to be listed in the "ingredients statement" of that product's label?

Descending order by weight Ingredients must be listed by "common or usual name" in descending order of predominance by weight. Ingredients present in quantities of 2% or less dont need to be listed in descending order but must be following a statement such as "contains _% or less of the following" at the end of the ingredient list. On the PDP or IP

What is the difference between a "health claim" and a "dietary guidance statement?"

Dietary guidance statements tend to focus on general dietary patterns, practices, and recommendations that promote health. Typically, dietary guidance statements refer to a category of foods rather than to a specific substance. Dietary guidance statements can be made without FDA review or authorization before use, but the statements must be truthful and must not be misleading.

The "net quantity of contents" of a food package must be stated in what units?

English and metric units located in the bottom 30% of the PDP

Common or usual names for foods may be established through what mechanisms?

FDA approval

A health claim is permitted on food labels only if the FDA has promulgated a regulation approving that claim. T/F

False (can have qualified or authorized body statement)

Non-mandatory/non-voluntary nutrients may only be included in the Nutrition Facts Panel if an appropriate disclaimer is also included. (T/F)

False!

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)

Fats are the most energy dense. Carbs - 4 cal / g Protein - 4 cal / g Fat - 9 cal / g Alcohol - 7 cal / g Water - 0 cal / g

What is the government's rationale for its current policy stating that any color added to a food, for the purposes of coloring, is an artificial colorant - even if the colorant is from a natural source such as beet juice?

Firstly, regulations and limitations regarding "natural" are currently very limited. VERY different from "organic". A "color" is anything added to the product that imparts a color on the final product and must be listed as a colorant. No colorants can be named "natural" based on the premise that foods are not naturally that color, something was added to "alter" the product, and therefore cannot be considered natural. A color additive is any dye, pigment or other substance that can impart color to a food, classified

By definition, the FFDCA puts radiation (as used in the processing of foods) into what legal category?

Food Additives

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):

Front panel with name PDP Right side of package includes ingredients IP

The term "healthy" fits into which category of FDA regulated claims?

Health claims- "healthy" is classified as an "implied nutrient content claim" and these have specific regulation. A healthy food nust be: -low in fat and saturated fat -contain limited amounts of cholesterol -contain limited amounts of sodium -cannot exceed 480 mg per serving for single item foods and 600 mg per serving of meal-type foods - has to contain at least 10% of %DV per RACC of one or more of vitamin A, C, calcium, iron, protein or fiber (jelly bean rule") (exempt from this rule are some raw, canned and frozen fruits and veggies and certain cereal grain products

FDA labeling regulations require that two informative statements be included on the PDP of a food product; what are they?

Identity of food Quantity of contents

According to the FDCA 403(f), what is the basis upon which a food may be deemed "misbranded"?

If all required labeling information is not conspicuous to ordinary individual

Would the Bireley's Orange Beverage product, as labeled, be "misbranded" under current regulations? Clearly explain the rationale for your answer.

If it ONLY said "Bireleys Orange Beverage" if wouldn't be misbranded, would be potentially misbranded if it sold it as a juice, would need to say how much percent juice. The bireleys only has the word juice listed in the ingredients and the percent IS listed.

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)

If the product meets a certain 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." Some foods are nutritionally superior imitations that use food innovations, so as not to deter consumers from not buying a nutritionally equal or superior product because it says imitation, the "new" product must only be labeled if it is a substitute or resembles the other food AND is nutritionally inferior to that food. Nutritional inferiority: any reduction in the content of an essential nutrient that is present at a measurable amount.

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?

It actually contains two questions: whether or not the speech concerns lawful activity and whether or not the speech is misleading. If the speech in question concerns unlawful activity or if the speech is misleading, then it is not protected by the 1st Amendment to any extent (i.e governments are completely free to restrict its use). If the speech in question concerns lawful activity and it is not misleading, then the Court moves on to part 2 of the Central Hudson test.

What is the most unique aspect of the ingredient listing for a chemical preservative?

It must be listed as its common name and why it is in the product- its function

Is "misbranding" defined in legislatively-derived statutory law, FDA-derived regulations, or both?

It's defined in both

According to the FDCA 403(a)(1), what is the basis upon which a food may be deemed "misbranded"?

Its labeling is false or misleading in any particular way

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).

Label is misleading or false in any particular way Suggested way of memorization- "a product is misbranded, and therefore illegal, if its labeling is false of misleading in any particular." If it is offered for sale under the name of another food If it is an Imitation of another food without declaring "imitation" on the label Standardized food that does not comply with standard If the container is misleading by the way it is made, formed or filled Label fails to include common or usual name

With respect to the enforcement of federal food statutes and regulations - what materials are included in the definition of "labels" and "labeling"?

Labels are physically attached to the product and labeling is anything associated with the product. Both must be associated with direct proximity to the product

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).

Located on the PDP, "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. When the nature of the product is obvious, a fanciful name commonly used by the public may serve as the identity statement" Consumers need to be able to determine, easily and accurately, what they are buying and manufacturers need and want to inform consumers of the identity of their product.

Chemical preservatives must be listed in the ingredients section by their common or usual name along with what other type of information?

Must be listed with a separate description of its function, can be expressed using a very broad term such as "to help protect flavor" "preservative" "mold inhibitor" etc

Provide an example of an "authoritative body" that could provide an "authoritative statement" that could serve as the basis of an "authoritative statement health claim."

NLEA National Institute of Health (NIH) National Academy of Sciences

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 claim

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)

Name and composition

Does the FDA specify the analytical methods to be used for nutrition labeling compliance testing? Explain your answer.

No, but they will tell you what test they will use and it will be the legal standard

FDA regulations specify two areas on a product's label where required information may appear - what are these two areas called?

PDP (Product Display Panel) IP (Information Panel)

Explain the mechanism through which food manufacturers can market foods that bear specific science-backed disease-prevention claims without having them regulated as drugs.

Quick answer: If they use an FDA approved health claim they can bear the claim ( in proper formats ex "may reduce risk of" "in combination with"), but if they did not the FDA would then have to regulate it as a drug

How are FDA sampling techniques designed to minimize biological variation when doing nutrient analyses for testing compliance with nutrition labeling regulations?

Random Composite Sample

RACCs (reference amount customarily consumed) are FDA guides intended to help manufacturers do what?

Serving size that reflects the amount of food customarily consumed

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).

Signature line located either on the PDP or the IP (but most typically on the IP) and is contact information for the individual/company/corporation responsible for that product (i.e., "manufacturer, packer, or distributor"). Signature lines typically include name, city, state, and zip code

What are the primary sources of data that were used to establish the RACCs found in the Code of Federal Regulations.

Sources of data come from survey answers from the 70s/80s covering people ages 4 and above. RACCs are values codified by the FDA for different classes of foods, and represent the FDAs best estimate of the amount of a particular food that is consumed in a single eating occasion, they are NOT the same thing as the "amount customarily eaten during a meal", an "eating occasion" does not have to be a meal

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 given food is, its name and the ingredients that must be used or may be used in the manufacture of the food (essentially a codified "recipe") Standard of quality = a specification that has to be met for labeling.

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.

Statement must include a specific food and a specific disease/illness. -Soluble fiber may help lower cholesterol -Eating Cheerios as part of a high soluble fiber can lower cholesterol.

What label statements must appear on the principal display panel (PDP)?

Statement of identity Net quantity/volume statement

Misbranding is the statutory term for what?

Statutory term for FDCA violations relating to the labels and labeling of food products

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: color additives that have not been mixed or chemically reacted with any other substances (ex. Blue 1) Lakes: color additives formed by chemically reacting straight colors with precipitants and substra. Lakes are typically made from certified batches of straight colors (ex. Blue 1 lake) are made when soluble straight colors (dyes) are reacted with metallic salts to form colored insoluble complexes, usually done to improve functionality

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)

TRUE

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)

TRUE

What are "Daily Values" and how are they used in the declaration of nutrients?

The % Daily Value (%DV) shows how much of a nutrient is in one serving of the food. The %DVs are based on the Daily Values for key nutrients, which are the amounts (in grams, milligrams, or micrograms) of nutrients recommended per day for Americans 4 years of age and older. The %DV column doesn't add up vertically to 100%. Instead, the %DV is the percentage of the Daily Value for each nutrient in one serving of the food.

What is the "principal display panel" (PDP) of a food package?

The PDP is required by and defined by the Fair Packaging and Labeling Act. States that the PDP is the panel of the package the consumer will see when the product is displayed for retail sale. The size of the PDP determines the minimum font size for quantity of contents declaration

What dictates whether or not a product has a "characterizing flavor" for regulatory purposes?

The characterizing flavor is the flavor, if there be one, that is implicated as the primary recognizable flavor on the label for that product. Sometimes I may refer to a "characterizing flavor" (which is the correct legal term) as a "descriptor flavor." Therefore the product has a characterizing flavor if there is some sort of labeling that makes direct or indirect representations that the product will have some sort of "recognizable flavor" for example: dark chocolate almond. Additionally if an artificial flavor is added that simulates, resembles or reinforces the characterizing flavor, the name of the food on the PDP needs to be accompanied by the common or usual names of the characterizing flavor AND with words "artificially flavored" "artificial and natural flavors" "artificial vanilla" etc.

The energy content of a food, as included in the Nutrition Facts Panel, must be declared in what units?

The energy content of a food according to FDA regulations are to be declared in units of "Calories" with a capital "C" as compared to "calories" with a lower case. Can be declared in Kilojoules if desired but the energy content in Calories has to be listed after in parentheses

What is the basis of the jelly bean rule?

The government definition of healthy is being low in fat, and cholesterol and the jelly bean fits all these criteria. Jelly beans have no fat or cholesterol, but they also do not have any beneficiary nutritional value. Thus, jelly beans are not able to be labeled as healthy. It requires that a food have some nutritional value to be labeled as such. I think it was 10% of the DRV

The classification of "certified" and "non-certified" apply to what kinds of food ingredients?

This applies to colorants. For "certified" color additives, each batch is tested by the FDA such as Blue No.1. Color additive certification is the process by which FDA assures that newly manufactured batches of color additives meet the identity and specification requirements of their listing regulations. Cannot be declared using a collective term, must be listed by common or usual name such as "FD&C Blue No. 1" "Blue 1" A "non-certified" colorant is something like beet juice and can be declared using a collective term, but most often if alternative colorants are used such as beet juice or grape skin extract the common or usual names are used because it is more appealing

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.

Total Calories, total fats, calories from fats, Trans fats, saturated fats, total carbohydrates, dietary fiber, protein, sugar, sodium, vitamin A, vitamin C, calcium, iron, % of daily value and absolute amount

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)

True

How do FDA and USDA regulations differ with respect to the labeling of non- irradiated foods containing irradiated ingredients?

USDA: must indicate that the product uses an ingredient that was irradiated in a non-irradiated product. Have to show irradiated symbol (radura) as well FDA: you do not have to specify if a non-irradiated food contains a, irradiated ingredient (irradiation is a method of food processing)

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.

Verdict: Decision in favor of Bireley's. The decree of condemnation was vacated and the case remanded to the district court for further proceedings not inconsistent with this opinion. The jury instructed to determine "whether the Bireley product could be confused with undiluted orange juice" (and if the jury finds there is confusion then the government charges adulteration) This was decided on the basis that that the US presented evidence that Bireleys contains no vitamin C and this could cause scurvy in children potentially and an experiment with guinea pigs (drinking orange juice with vitamin C or Bireleys orange beverage and the Bireley ones died in "agony"), the court decided the "shocking" testimony/evidence was not necessary or proper. The court rejected the strict grammatical application based on common sense and the precedent from previous cases that the language of the FDCA provision was comprehensive and precise. Ramifications:

What type of information is expected to be included in the codified "Standard of Identity" of a food?

What ingredient must be in the food or what may be in the food (recipe) and Identity statement (what you call it-- Common or usual name) first established in 1938

What is the nature of the question asked in the Part 2 or the Four-Part Central Hudson test for assessing the constitutionality of government regulations abridging commercial speech?

Whether the Government's objective in restricting the speech is an important one (is the Government's objective substantial?) "The asserted governmental interest to be served by the restriction on commercial speech must be substantial"

What is the nature of the question asked in the Part 4 or the Four-Part Central Hudson test for assessing the constitutionality of government regulations abridging commercial speech?

Whether the proposed Government restriction on free speech is the least restrictive means by which the Government can achieve its stated objective. "The regulation may not be more extensive than is necessary to serve that asserted interest

What is the nature of the question asked in the Part 3 or the Four-Part Central Hudson test for assessing the constitutionality of government regulations abridging commercial speech?

Whether the proposed Government restriction on free speech will directly foster the stated government objective. "The restricting regulation must directly advance the asserted governmental interest in limiting commercial speech"

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.

b) a standardized, reference, unit of measure.