General FDA Requirements for the Food Industry

Y. Martin Lo, Ph.D.University of Maryland

Fifteen U.S. agencies regulate food safety

Top two federal regulatory units:

U.S.D.A.F.D.A.

U.S. Code (Public & Private Laws)http://www.gpoaccess.gov/plaws/index.html

Code of Federal Regulations (CFR)http://www.gpoaccess.gov/cfr/index.html

Most FDA Regulations: Title 21

Most USDA Regulations: Title 7 & 9

Where to find Laws and Regulations?

Regulatory References

Definition of Food Standards

Regulatory Information - CFR, Policy

Memos, Directives, Inspection Acts

FDA vs. USDA Label Approval

Requirements

Panel Requirements

Principle Display Panel (PDP) - the

panel the consumer sees first

Information Panel - first usable panel to

the right of the PDP

What is information panel labeling?

The “information panel labeling” refers to 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.

These label statements include the name and address of the manufacturer, packer or distributor, the ingredient list, nutrition labeling and any required allergy labeling.

What is the prohibition against intervening

material?Information that is not required by FDA is considered intervening material and is not permitted to be placed between the required labeling on the information panel (e.g., the UPC bar code is not FDA required labeling).

What type size, prominence and conspicuousness is

required?For information panel labeling, use a print or type size that is prominent, conspicuous and easy to read.

Use letters that are at least one-sixteenth (1/16) inch in height based on the lower case letter "o".

The letters must not be more than three times as high as they are wide, and the lettering must contrast sufficiently with the background so as to be easy to read.

What type size, prominence and conspicuousness is

required? (cont.)Do not crowd required labeling with artwork or non-required labeling.

Smaller type sizes may be used for information panel labeling on very small food packages as discussed in 21 CFR 101.2(c) & (f)

Different type sizes are specified for the Nutrition Facts Label.

The name of the food statement

The statement of identity is the name of the food. It must appear on the front label, or PDP / alternate PDP.

Generally, this is considered to be at least 1/2 the size of the largest print on the label.

Place the statement of identity on the PDP in lines generally parallel to the base of the package.

Modified Statement of Identity

Labels must describe the form of the food in the package if the food is sold in different optional forms such as sliced and unsliced, whole or halves, etc.

Imitation Product

Generally a new food that resembles a traditional food and is a substitute for the traditional food must be labeled as an imitation if the new food contains less protein or a lesser amount of any essential vitamin or mineral.

Use the same type size and prominence for the word "imitation" as is used for the name of the product imitated.

More Required Features

Signature Line - use only name of

company, city, state and zip code

Net Weight - Location, Wording, Size &

Spacing, Retail vs. Foodservice

Inspection Legend - Meat vs. Poultry

Net Quantity of Content

The net quantity statement (net quantity of contents) is placed as a distinct item in the bottom 30 percent of the principal display panel, in lines generally parallel with the base of the container.

What name and address must be listed on the label?

Name and address of the manufacturer, packer or distributor. Unless the name given is the actual manufacturer, it must be accompanied by a qualifying phrase which states the firm's relation to the product (e.g., "manufactured for "or "distributed by").

What name and address must be listed on the label? (cont.)

Street address if the firm name and address are not listed in a current city directory or telephone book;

City or town;

State (or country, if outside the United States); and

ZIP code (or mailing code used in countries other than the United States).

Where should the country of origin be declared on an imported food?

The law does not specifically require that the country of origin statement be placed on the PDP, but requires that it be conspicuous.

If a domestic firm's name and address is declared as the firm responsible for distributing the product, then the country of origin statement must appear in close proximity to the name and address and be at least comparable in size of lettering.

If a foreign language is used anywhere on the label, all required label statements must appear both in English and in the foreign language.

Ingredient Statements

Ingredient Statements

Listing ingredients in descending order of predominance by weight means that the ingredient that weighs the most is listed first, and the ingredient that weighs the least is listed last.

Use a type size that is at least 1/16 inch in height (based on the lower case “o”) and that is prominent, conspicuous, and easy to read. 

Preservatives

When an approved chemical preservative is added to a food, the ingredient list must include both the common or usual name of the preservative and the function of the preservative by including terms, such as “preservative,” “to retard spoilage,” “a mold inhibitor,” “to help protect flavor,” or “to promote color retention.”

Example: “INGREDIENTS: Dried Bananas, Sugar, Salt, and Ascorbic Acid to Promote Color Retention”

Food Allergens

Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)

milk

egg

fish

Crustacean shellfish

tree nuts (see table)

wheat

peanuts

soybeans

Does FALCPA provide any specific direction for declaring the presence of ingredients from the three food

groups that are designated as "major food allergens (i.e., tree nuts, fish,

and Crustacean shellfish?")

Yes. FALCPA requires that in the case of tree nuts, the specific type of nut must be declared (e.g., almonds, pecans, or walnuts). The species must be declared for fish (e.g., bass, flounder, or cod) and Crustacean shellfish (crab, lobster, or shrimp).

“Contains…”If a "Contains" statement is used on a food label, the statement must include the names of the food sources of all major food allergens used as ingredients in the packaged food.

For example, if "sodium caseinate," "whey," "egg yolks," and "natural peanut flavor" are declared in a product's ingredients list, any "Contains" statement appearing on the label immediately after or adjacent to that statement is required to identify all three sources of the major food allergens present (e.g., "Contains milk, egg, peanuts") in the same type (i.e., print or font) size as that used for the ingredient list.

If You Failed to Label Allergens…

A company and its management may be subject to civil sanctions, criminal penalties, or both under the Federal Food, Drug, and Cosmetic Act if one of its packaged food products does not comply with the FALCPA labeling requirements.

FDA may also request seizure of food products where the label of the product does not conform to FALCPA's requirements.

In addition, FDA is likely to request that a food product containing an undeclared allergen be recalled by the manufacturer or distributor.

More Required Features

Handling Statement

Safe Handling Instructions

Nutrition Facts Panel

Inspection Legends & Safe Handling Instructions

Meat Legend

Poultry Legend

Other Terms

Serving Suggestion - must be next to all

pictures of the product

Geographic Terms - if no standard in the

regulation, then use brand - made in ...

Product Standards

USDA has product standards in the 9

CFR & the Food Standards & Labeling

Policy Book which can be found on line

(www.gpo.gov,

www.fsis.usda.gov/About_FSIS/labeling_&_consumer_protection/index.asp

)

Product Standards

USDA has finished product standards

(i.e. lasagna & meatballs) & FDA has

standards for ingredients (i.e. cheddar

cheese & enriched flour)

Product Standard Examples

Lasagna with meat & sauce: 12% meat

Lasagna with meat sauce: 6% meat

Meat lasagna: 12% meat

Meatballs: must contain 65% meat, no more than 12% binders or extenders

Poultry salad: at least 25% cooked poultry

Nutrition Panels

Nutrition panels are required on all retail

products unless you fall under one of

the exemptions

Specific guidelines for the format

Specific guidelines for the serving size

Nutrition Facts Panel

What are the minimum type sizes and other format requirements for the Nutrition Facts label?

Daily Value (DV)

The following table lists the DVs based on a caloric intake of 2,000 calories, for adults and children four or more years of age.

In order to calculate the % DV, determine the ratio between the amount of the nutrient in a serving of food and the DV for the nutrient. That is, divide either the actual (unrounded) quantitative amount or the declared (rounded) amount (see next section) by the appropriate DV.

The nutrients listed below may be omitted from the list of nutrients and included in a single sentence when present at “zero” levels in a food. This is done by putting the label statement (“Not a significant source of _________”) immediately below the listing of vitamins A and C, calcium, and iron.

Bilingual Nutrition Panel

Variety Packs e.g. Cereals

As Packaged/As Prepared Dual Recipes

Serving Size

Serving size determined from RACC Tables (Reference Amount Customarily Consumed)

Can be discreet, non-discreet, meal or other

Serving size needs to be as close to the RACC amount as possible

Serving Size: How to Start?

Locate the appropriate food category and Reference Amount Customarily Consumed (RACC) for your product in the two tables in Section 101.12(b) of the food labeling regulations. Table 1 is for infant and toddler foods. Table 2 is foods for the general population.

FDA established RACCs for 139 food product categories, and these values represent the amount of food customarily consumed at one eating occasion.

Serving Size: How to Start? (cont.)

Determine the serving size for your multi-serving product using the RACC for the product (21 CFR 101.9(b)(2),(3), and (4)). The serving size is expressed as a common

household measure followed by the equivalent metric quantity in parenthesis (e.g., “1/2 cup (112 g)”).

Acceptable household measures are listed in order of appropriate use in 21 CFR 101.9(b)(5).

Rounding rules for metric quantities and a few additional format options are included in 21 CFR 101.9(b)(7).

Suggested RACCs

Single Serving Container

Trans Fatty AcidsTrans fatty acids should be listed as “Trans fat” or “Trans” on a separate line under the listing of saturated fat in the Nutrition Facts label (see figure). The word “trans” may be italicized to indicate its Latin origin. Trans fat content must be expressed as grams per serving to the nearest 0.5-gram increment below 5 grams and to the nearest gram above 5 grams. If a serving contains less than 0.5 gram, the content, when declared, must be expressed as “0 g.”

Labels for Infants and Small Children

Nutrition Facts labels for foods specifically for children less than 4 years do not provide % Daily Values for the macronutrients or footnotes.

Foods specifically for children less than 2 years of age must not present information on calories from fat and calories from saturated fat and quantitative amounts for saturated fat, polyunsaturated fat, monounsaturated fat and cholesterol.

In both cases, % Daily Value is declared only for protein, vitamins, and minerals.

Permitted AbbreviationsFood packages with a surface area of 40 sq. in. or less available for labeling may use the following abbreviations in the Nutrition Facts label:

Small BusinessIf a company produces $51,000 worth of food, but had a total gross sales for all products, food and non-food, of $490,000, do they have to nutrition label?

 Is a manufacturer that produces institutional and restaurant foods required to provide

nutrition information?

Foods which are served or sold for use only in restaurants and other establishments in which food is served for immediate consumption are exempt from nutrition labeling.

However, if there is a reasonable possibility that the product will be purchased directly by consumers (e.g., club stores), nutrition information is required. 

Are spices, coffee, and tea required to be nutrition labeled?

The regulations provide for an exemption for foods that contain insignificant amounts, as defined in 21 CFR 101.9(j)(4), of all of the nutrients and food components required to be included in the nutrition label.

Exempted foods include coffee beans (whole or ground), tea leaves, plain instant unsweetened instant coffee and tea, condiment-type dehydrated vegetables, flavor extracts, and food colors.

Nutrient Claims

Cannot make a claim unless it is defined in

the 9 CFR or 21 CFR & must have NFP on

label

Supplements are not foods and fall under

another regulation

There are 2 types of claims-absolute &

relative

Absolute Claims

These claims are defined in the 9 CFR

for meat & poultry products and 21 CFR

for FDA products

The product must meet the

requirements for the claim or you

cannot use the claim on your label

Absolute Claims

Examples of absolute claims would be

lean, low fat, a good source of Vitamin A

Claims are based on the RACC’s

Relative Claims

These claims are compared to another

product & the % or fraction difference is

on the label

The comparison product depends on

which claim you use

Relative Claims

These claims are also based on the

RACC amounts

Examples of relative claims would be

lite, reduced, less, and lower in

Antioxidant Claims

The antioxidant nutrient must meet the requirements for nutrient content claims in 21 CFR 101.54(b), (c), or (e) for “High” claims, “Good source” claims, and “More” claims, respectively.

For example, to use a “high” claim, the food would have to contain 20% or more of the Daily Reference Value (DRV) or RDI per serving.

For a “good source” claim, the food would have to contain between 10-19% of the DRV or RDI per serving (21 CFR 101.54(g)(3)).

Example: Beta Carotene

Beta-carotene may be the subject of an antioxidant claim when the level of vitamin A present as beta-carotene in the food using the claim is sufficient to qualify for the claim.

For example, if the claim is “good source of antioxidant beta-carotene,” then at least 10% of the RDI for vitamin A must be present as beta-carotene per serving (21 CFR 101.54(g)(3)).

Health Claims

Health claims on food labels are claims by manufacturers of food products that their food will reduce the risk of developing a disease or condition.

For example, it is claimed by the manufacturers of oat cereals that oat bran can reduce cholesterol, which will lower the chances of developing serious heart conditions.

Atopic Dermatitis Risk 100% Whey-Protein Partially Hydrolyzed Infant

Formula and Reduced Risk of Atopic Dermatitis

Cancer Risk Tomatoes and/or Tomato Sauce & Prostate,

Ovarian, Gastric, and Pancreatic Cancers Calcium and Colon/Rectal Cancer & Calcium and

Recurrent Colon/Rectal Polyps Green Tea & Cancer Selenium & Cancer Antioxidant Vitamins & Cancer

Qualified Health Claims

Cardiovascular Disease Risk Nuts & Heart Disease Walnuts & Heart Disease Omega-3 Fatty Acids & Coronary Heart Disease B Vitamins & Vascular Disease Monounsaturated Fatty Acids From Olive Oil and

Coronary Heart Disease Unsaturated Fatty Acids from Canola Oil &

Coronary Heart Disease Corn Oil & Heart Disease

Qualified Health Claims (cont.)

Cognitive Function Phosphatidylserine & Cognitive Dysfunction and

Dementia

Diabetes Chromium Picolinate & Diabetes

Hypertension Calcium & Hypertension, Pregnancy-Induced

Hypertension, and Preeclampsia

Neural Tube Birth Defects 0.8 mg Folic Acid & Neural Tube Birth Defects

Qualified Health Claims (cont.)

Example: Calcium

Calcium and osteoporosis health claim: “Adequate calcium throughout life, as part

of a well-balanced diet, may reduce the risk of osteoporosis" or

"Adequate calcium as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life." (21 CFR 101.72(e))

Ex: Calcium + Vitamin D

Calcium, vitamin D, and osteoporosis: "Adequate calcium and vitamin D

throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis" or

"Adequate calcium and vitamin D throughout life, along with physical activity, may reduce the risk of osteoporosis in later life." (21 CFR 101.72(f))

HACCP

Hazard Analysis and Critical Control Point

Preventive, not reactive

A management tool used to protect the food supply against biological, chemical and physical hazards

Applicable to all phases of food production, including basic agriculture, food preparation and handling, food processing, food service, distribution, and consumer handling and use

Commercially Sterile Packaged Foods

Clostridium botulinum

Thermal (Heat) Distribution/Penetration

IS REGISTRATION AND PROCESS FILING THE SAME FOR U.S. FIRMS AND FIRMS

LOCATED IN OTHER COUNTRIES?

Yes, registration and process filing is the same for all commercial acidified and low-acid canned food processors located in the United States and processors in other countries. However, processors in other countries need to register and file processes only for those foods that are to be imported into the United States.

2002 – Public Health Security and Bioterrorism Preparedness and Response Act (The Bioterrorism Act)

Requires all food manufacturers, domestic and foreign, that produce food for consumption in the U.S. to register with FDA.

Requires notification to FDA before any food is imported into the U.S.

Allows FDA to detain adulterated foods.

Prohibits “port shopping”

2011 – Food Safety Modernization Act

Amends Food Drug and Cosmetic Act of 1938

Regulatory paradigm shift from “reaction to outbreaks” to “prevention of outbreaks”.

Three Major Food Laws for FDA-regulated foods:1. 1906 Pure Food and Drug Act*2. 1938 Food, Drug and Cosmetic Act3. 2011 Food Safety Modernization Act

* Replaced by 1938 FDCA

2011 – Food Safety Modernization Act

Four Main Themes of the Legislation

Prevention

Inspections, Compliance, and Response

Import Safety

Enhanced Partnerships

Thank You!

Y. Martin Lo, Ph.D.; ymlo@umd.edu

Process Authority for Acidified and Low Acid Canned Foods

Maryland HACCP Coordinator

Editor-in-Chief, Journal of Food Processing and Preservation

Editor-in-Chief, Food Science and Nutrition