Help with Nutrition Claims

If you wish to claim specific health benefits from your product, the FTC and FDA may like to know about it.  There are three broad categories that health claims can go into.  Several new FDA websites help with the confusion.  Health claims such as "reduces cancer" or "decreases chance of heart disease" is a health claim which must be extensively documented with clinical trials. It is by far the most difficult claim.  Structure or function claims such as "supports heart health" which are made on the label are easier to justify as there are thousands of substances which can satisfy this wishy - washy statement.  Label claims are investigated by the FDA.  If you make claims in advertising materials or on your website, then the FTC has jurisdiction.  Generally recognized as safe and effective (GRAS) is a new FDA safe area.  A substance which will be added to a food needs pre-market approval by the FDA unless its use is GRAS.  There is a long list of substances which have extensive research which you can borrow to assume the ingredient is GRAS.  The websites are:
FDA site for health claim information
FDA site for GRAS claims
FTC site

Equipment which applies labels to the bottle

	United States Food and Drug Administration
	Olive oil is the edible oil expressed from the sound, mature fruit of the olive tree - FDA
	The Food Label: U. S. Food and Drug Administration FDA Backgrounder May 1999

Almost all food labeling regulations are enforced by the US Food and Drug Administration (FDA). One exception is the Country of Origin Marking Requirement that is enforced by the US Customs Service, but even that regulation can be en­forced by the FDA. The major focus on food labeling in the United States today is on nutrition. Olive oil companies must comply with regulations on:

	Nutritional labeling
	Net weight declarations
	Metric declarations
	Country of origin marking requirements
	Labeling in two languages
	Product descriptions

Nutritional Labeling Regulations

  Nutritional Labeling Regulations became effective August 6, 1994.  

Nutrient Declarations

21 CFR Section 101.9 sets out and explains all the nutrients that need to be declared on the food label, as well as those that may be declared. There are a few exemptions for products that have no significant food value, i.e. less than 5 calories per serving, and for products in very small containers.  For the lat­ter, there must be a telephone number or an address on the la­bel that the consumer can contact for nutritional Information.

FDA has specified that the following nutrients must be declared on a label: calories. Total fat, saturated fat, cholesterol,

Sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and Iron. However when a product contains insignificant amounts* of seven or more of these nutrients, such as olive oil, only the following nutrients must be declared:  total calories – calories from total bat – total fat – saturated fat – total carbohydrate – protein – sodium, and nutrients present in more than insignificant amounts.

*An “insignificant amount” is defined as an amount that allows a declaration of zero in nutritional labeling, except that for total carbohydrates, dietary fiber, and protein, it shall be an amount that allows a declaration of “less than one gram.”

Additionally, the serving size and the number of servings per container must be declared.  The serving size is declared in a common household measure and in grams or milliliters (if product is fluid).  For olive oil the serving size would be 1 tablespoon (15mL) When a company decides to add a declaration to the simplified format, such as "monounsaturated fat", then the statement "Not a significant source of…” must be added, as shown on the next page. 

Calories must be expressed to the nearest 5calorie incre­ment up to and including 50 calories. and in 10calorie increments above 50 calories. Amounts less than 5 calories may be expressed as zero (0). In determining Caloric Content, one may calculate calories by using specific Atwater factors (i.e., the Atwater method) given in Table 13 "Energy Value of' Foods-Basis and Deriva­tion," by A.L. Merrill and B.K. Watt, USDA Handbook No. 74. This book is available from: Division of Nutrition, (Center for Food Safety & Applied Nutrition (HFF 260), FDA, 200 C Street SW, Washington, DC 20204. 

Calories from Fat must be expressed to the nearest 5­caloric increment up to and including 50 calories, and in 10­caloric increments above 50 calories. Amounts less than 5 calories may be expressed as zero. 

Calories from saturated fat are not required. This declaration is voluntary  Total Fat (total lipid fatty acids expressed as triglyc­erides) must be declared in grams to the nearest ½ gram increments below 5 grams and to the nearest gram increment above 5 grams.  Under ½ gram may be expressed as zero (0) 

Saturated fat (sum of all fatty acids containing no double bonds) may be declared as 0 if there is less than ½ gram per serving. 

Polyunsaturated fat is a voluntary declaration unless there is a declaration for monounsaturated fat, or a statement is made about fatty acids or cholesterol on the label.

Monosaturated fat is also a voluntary declaration, unless there is a declaration of polyunsaturated fat, or a statement is made about fatty acids or cholesterol on the label. 

Cholesterol need not be declared if there is less than 2 milligrams per serving.  If it is not declared, a footnote is required stating: "Not a significant source of cholesterol". For 2‑5 milligrams, the declaration must be: "less than 5 milligrams." Over 5 milligrams, the declaration must be to the nearest 5-milligram increment. Alternatively, if the cholesterol is less than 2 milligrams per serving, it can be declared as zero.

Sodium must be declared. Under 5 milligrams per serving, the declaration is zero. Between 5 and 140 milligrams the declaration is the nearest 5-gram increment. Over 140 milligrams the declaration is the nearest 10 gram increment. 

Carbohydrate or Total Carbohydrate must be declared to the nearest gram. Under 1/2 gram, the declaration is zero. 

Protein must be declared to the nearest gram. Under 1/2 gram, the declaration is zero. Under I gram may be declared as "Less than I gram." Footnotes: Most olive oil companies are expected to include information on their labels on polyunsaturated fat, monounsaturated fat, and cholesterol. Therefore, they will have to include the following footnotes on their label: "Not a significant source of dietary fiber, sugars, vitamin A, vitamin C, calcium, and iron." "Percent Daily Values are based on a 2,000 calorie diet."

Format for Nutritional Label

There are two illustrations below indicating the format for the nutritional label for olive oil In the first illustration, the percentage of daily value is based on the actual amount of each nutrient before rounding. The percentage of daily value for total fat is 2 1 %. This percentage is based on the actual fat in a tablespoon, namely, 13.6 grams. In the second illustration the percentage of daily value for total fat is 22% which is based on the amount declared on the label, i.e. 14 grams. FDA states that "The percent shall be calculated by dividing either the amount declared on the label for each nutrient or the actual amount of each nutrient (i.e., before rounding) by the Daily Recommended Value (DRV) for the nutrient." The Daily Recommended Value for total fat is 65 grams, and for saturated fat, it is 20 grams. %When one divides 13.6 grams by 65 grams the result is 21%. When one divides 14 grams by 65 grams, the result is 22%. Likewise for the saturated fat, when one divides the actual amount, for example 1.88 grains, by 20 grams the result is 9%. When one divides the declared saturated fat of 2 grams by 20 grams the result is 10%. The rules permit one to exceed the fat content declared by 20% because of normal product variation. A 9% declaration would cover all oils with a saturated fat content up to 2.15 grams. A 10% declaration would cover all oils with a saturated fat content up to 2.4 grams. In choosing one's label, one should know how much variation to expect in the product by conducting laboratory tests. While the rule clearly states that a company can calculate the percentage Daily Value on the basis of actual amounts of the nutrients or on the rounded declarations, the preamble to the rule directs manufacturers to maintain the greatest consistency in their label declarations, e.g. between grams declared and percentage of daily value declared. As the Daily Recommended Value of total fat (65 grams) and saturated fat (20 grams) are not declared on the Olive Oil Labels below it appears that this consistency aspect is not relevant. Serving Size Declaration/Servings Per Container

Illustration 1.

Illustration 2.  

Serving size is 1 tablespoon(15ml). One tablespoon is actually 14.786 ml. Either 15 ml or 14.786 ml can be used in calculating the number of servings in a container, and the number of servings are rounded to the nearest whole number. In using the actual value of 14.786 ml to a tablespoon, the number of servings per container will be as follows: 1 liter -68, 500 ml  34, 250 ml - 17, in three liters- 203; and in a gallon - 256 servings. If one calculates serving sizes on the basis of 15 ml per tablespoon, there will be one or more fewer servings per container.

Nutrient Content Claims

 21 CFR, Section 101.54 sets limitations on the use of terms that describe the nutrient value of a product, terms like: "high", "rich in", "excellent source of', etc.  If there is no Recommended Daily Intake (RDI) or Daily Recommended Value (DRV) for a nutrient, then one is not allowed to use a descriptive term like "high in" to describe the nutrient on the label. For example, there is no RDI for mono­unsaturated fat. Therefore, one cannot describe olive oil as being "high in", or a "good source of" monounsaturated fat.

Light or Lite

21 CFR, Section 101.56 deals with the nutrient content claims for "light" or "lite". "Light" or "lite" may be used on an olive oil label provided: it describes some physical or organoleptic attribute of the food such as texture or color and it is stated in such a way (e.g. "light in color" or "light in texture") that it clearly conveys the nature of the product; and the attribute (e.g. color or texture) is in the same style, color and at least one-half the type size as the word "light" and in immediate proximity thereto. If a manufacturer can demonstrate that the word "light" has been associated, through common use, with a particular food to reflect a physical or organoleptic attribute (e.g. light brown sugar, light corn syrup, or light molasses) to the point where it has become part of the statement of identify, such use of the term "light" shall not be considered a nutrient content claim subject to the requirements for such claims." It does not ap­pear that any company could substantiate that the word "light" has been associated, through common use, with olive oil to reflect a physical or organoleptic attribute in the manner described.  

Sodium Content Claims

Olive Oil can make a "Sodium Free" claim. "Sodium Free" means that the food contains less than 5 milligrams of sodium per serving. A disclosure statement must accompany the claim: "See nutrition information for fat content." If the food is naturally sodium free, this must be so declared, e.g. "A sodium free food."

Salt Free, No Salt Added

Olive Oil can make a "Salt Free" claim. Salt is not sodium. It is sodium chloride. A "salt free" claim can be made only when the food is also a sodium free food.

Nutrient Content Claims for Fat, Fatty Acid, and Cholesterol

Content of Foods

21 CFR, Section 101.62 sets out the regulations on nutrient content claims for fat, fatty acid and the cholesterol content of foods. Olive oil cannot make any claims relative to fat content. It cannot claim to be "low in saturated fat" because the regula­tions state that for a food to make this claim it must have less than I gram of saturated fat per serving and the saturated fat only accounts for 15% or less of the calories in the food. Olive oil cannot claim to be "high in monounsaturated fat", because nutrient content claims can only be made if there is a recommended daily value for monounsaturated fat. FDA seems to limit nutrient content claims on fatty acids to such terms as "saturated fat free", "low in saturated fat", and similar expressions. Although it permits truthful and non-mis­leading graphic devices to amplify or explain nutrition infor­mation, it states that the supplementary information must be consistent with the requirements for nutrient content claims.

Cholesterol Content Claim

Olive oil can make "Cholesterol Free" and "No Cholesterol" claims provided that the food contains 2 grams or less of satu­rated fat and the label discloses the level of total fat in a serv­ing in immediate proximity to the claim in type size no less than 1/7. the size of type in the claim. The disclosure statement is not necessary if the cholesterol free claim is only made on the information panel containing the Nutrition Facts. An example of a cholesterol free claim on the principal display panel would be

A Cholesterol Free Food
Contains 14 g of fat per serving
See nutrition information for fat content.

 Implied Nutrient Content Claims

21 CFR, Section 101.65 differentiates between implied nutrient claims and claims that do not imply the presence of nutri­ents. This Section of the rules applies the same guidelines for implied nutrient claims as pertain to transparent nutrient con­tent claims. NAOOA is unaware of any "implied nutrient content claims" being made by any olive oil company.

Appropriate Claims

For non-nutrient content claims, FDA only requires that they be accurate. "100% Pure" and "All Natural" are not nutrient content claims. As long as they are accurate they are per­mitted. The North American Olive Oil Association agreed not to use the word "Pure" or "100% Pure" as part of the name of the product. FDA has decided to maintain its current policy not to restrict the use of the term "natural" except for added color, syn­thetic substances, and flavors as provided in 21 CFR § 10 1.22. Additionally, the agency will maintain its policy regarding the use of "natural" as meaning that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food. Thus, olive oil companies in the US may use the term "Natural" on their olive oil labels. A claim that olive oil is cold pressed or naturally cold pressed is appropriate on the label of Extra Virgin Olive Oil. The Agreement to Monitor Olive Oils also states that the term "cold pressed" is to be restricted to "virgin olive oil", and the members of the associations that have signed this Agreement are subject to the terms of the Agreement.

Health Claims

FDA will promulgate regulations authorizing a health claim only when it determines that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, and that the claim is sup­ported by the totality of publicly available scientific evidence. Health claims are not allowed on any product that contains more than 13 grams of fat per serving. Thus no health claim is allowed on an olive oil product.

If you wish to claim specific health benefits from a dipper, sauce, or dressing, the FTC and FDA may like to know about it.  There are three broad categories that health claims can go into.  Several new FDA websites help with the confusion.  Health claims such as "reduces cancer" or "decreases chance of heart disease" is a health claim which must be extensively documented with clinical trials. It is by far the most difficult claim.  Structure or function claims such as "supports heart health" which are made on the label are easier to justify as there are thousands of substances which can satisfy this wishy - washy statement.  Label claims are investigated by the FDA.  If you make claims in advertising materials or on your website, then the FTC has jurisdiction.  Generally recognized as safe and effective (GRAS) is a new FDA safe area.  A substance which will be added to a food needs pre-market approval by the FDA unless its use is GRAS.  There is a long list of substances which have extensive research which you can borrow to assume the ingredient is GRAS.  The websites are:
FDA site for health claim information
FDA site for GRAS claims
FTC site

Net Weight Declaration

The net weight or net contents declaration must be in the bottom 30% of the principal display panel. There are specific type size requirements. All information appearing on the prin­cipal display panel must be clear and conspicuous. In no case may the letters or numbers be less that one-sixteenth of an inch. Exemptions to this type size requirement are not relevant to olive oil containers or labels. Under proposed regulations, olive oil labels may use the words "net" or "net contents" before the weight declaration or they may simply use the weight declaration. Fluid ounce dec­larations are used for sizes under one pint, but are optional for sizes one pint and over. The largest unit of measure must be stated in metric and English measure. Either can be first. For example, one can state: Net I pt 0.9 fl oz (500 mL), or it can be reversed and read: 500 mL (I pt 0.9 R oz). It appears that the following declarations would be acceptable: Net 1 gallon (3.785 L) or 3.785 L (1 gallon) Net 3 qt 5.4 fl oz (3 L) or 3 L (3 qt 5.4 fl oz) Net 1 qt 1.8 fl oz (I L) or I L (1 qt 1.8 fl oz) Net 1 pt 0.9 fl oz (500 mL) or 500 mL (1 pt 0.9 fl oz) Note that the word "Net" is not required but can be used.

Country of Origin Marking Requirements

Country of Origin Marking Requirements are set out in 19 CFR 134.11. Unless excepted by law, section 304, Tariff Act of 1930 as amended (19 U.S.C. 1304), requires that every arti­cle of foreign origin (or its container) imported into the United States shall be marked in a conspicuous place as legibly, indelibly, and permanently as the nature of the article (or container) will permit, with the English name of the country of origin.   19CFR § 134.35 exempts from the country of origin mark­ing requirements those products that are substantially changed by manufacture in the United States. If they are substantially changed in another country then that country is the country of origin. 19CFR§134.46 specifies that when a geographic representation appears on a label that would mislead the ultimate pur­chaser as to the actual country of origin then there must appear, in close proximity, the actual country(s) of origin preceded by "Made in", "Product of", or other words of similar meaning. When an extra virgin olive oil imported from one country contains extra virgin oils from several countries, then each of those countries must be listed on the label in the country of origin declaration. It is also permissible to list the country from which the product was imported, but not without listing the country or countries where the extra virgin olive oils were produced. A country of origin declaration could appear as follows: Imported from _____________________ Contains extra virgin olive oils from ________________,___________and _______________; or Packed  in __________________

Product of ______________,___________________,________________

Words of similar meaning can also be used to declare the country of origin but it is not sufficient to only declare

"Imported from _____________ or "Packed in ____________________

The origins of extra virgin olive oils that are blended in the United States to produce a new extra virgin olive oil must also be declared on the label. The importer of bulk extra virgin olive oil must certify to US Customs that if it packs the oil, it will put the country of origin on the label, and if it sells the oil to a packer, it will in­form the packer of its obligation to put the country of origin on the label. The blending of a refined olive oil with extra virgin olive oil to produce 'olive oil' appears to be a substantial change. The country where the blending takes place is then the country of origin. 'Olive oil' is not refined olive oil, nor is it extra vir­gin olive oil. Refined olive oil is not a consumer product. It does not have an olive taste. It is bland, colorless, and odor­less. Extra virgin olive oil is a premium product that is imme­diately consumable upon pressing. It undergoes no refining. It cannot contain any refined olive oil. It has distinctive compo­sitional, nutritional and sensory characteristics. Rules for determining country of origin declarations may change as a result of the international harmonization project being carried out under the World Trade Organization (WTO). The United States is participating in this project. It is unlikely that the project will be completed before 2000. The Customs regulations on country of origin do not con­trol advertising messages. Advertising is subject to the juris­diction of the Federal Trade Commission. It has not issued any rules restricting references to foreign countries in advertising. Statements, however, must be truthful.

Labeling in Two Languages

When labels contain words or statements in a language other than English, FDA regulations specify that all required information on the label must be in both languages. 21 CFR § 101.15 (c) (2) reads in part: "If the label contains any representation in a foreign language, all words, state­ments, and other information required by or under authority of the act [FD&C Act] to appear on the label shall appear thereon in the foreign language..." On the Nutritional Label both languages can be used in the one "Nutritional Facts" box. It is a little crowded but the regulations permit it.

Lot Codes

All olive oil products should be marked with a lot code. If the government determines that there is a violation of its regu­lations that requires product to be withdrawn from the market­place, the only way to limit the extent of the recall is by isolating it to a particular lot or lots. If there arc no lot codes, there is no way to limit the recall  The "Agreement to Monitor Olive Oils and Olive Pomace Oils Sold on the US Market" also requires the member companies of the Signatory Associations, that is, essentially all packers of olive oil, to use a lot code on each container of olive oil or olive pomace oil.

Product Descriptions

Product descriptions are regulated by Section 403 (a) (1) of the FDA&C Act which states that: "A food shall be deemed to be misbranded if its labeling is false or misleading in any particular ..”  Not only the product description must be accurate but all the information presented on any part of the label must be accurate and consistent with the product description. Contradictory information on a label makes it misleading. If the principal display panel describes a product as Pure Olive Oil, and the information panel describes it as "Natural Prod­uct, Being Extra Virgin Olive Oil..." it is contradictory and misleading. Use of the product descriptions "Extra Fine Olive Oil" and "Extra Fine Quality Olive Oil" are misleading. It is conceiv­able that these terms could be used on a label as advertising superlatives as long as they are not part of the product's name, but when used as product descriptions they do not conform with the international standards for olive oil. Use of the product description: "Olive Pomace Oil Contain­ing Extra Virgin Olive Oil" is confusing and misleading. It conveys the false notion that the consumer is getting a product that is better than "Olive Pomace Oil". By definition, Olive Pomace Oil contains virgin olive oil, be it extra virgin or not, and calling special attention to the presence of extra virgin olive oil is misleading. Use of the product description "Pure Olive Oil with Extra Virgin Olive Oil" is likewise misleading. However, if one is stating that the "Pure Olive Oil" is enriched with "Extra Virgin Olive Oil", as opposed to simply "Virgin Olive Oil" then the extra virgin olive oil may be considered the characterizing ingredient. In that case, the percentage of extra virgin olive oil must be declared on the label. Pure Olive Oil, by definition, is a blend of refined olive oil and virgin olive oil. It cannot contain rectified oil, that is, re­lined olive pomace oil. If a company declares on the principal display panel that its product is Pure Olive Oil, and then on the information panel describes the ingredients as pure and recti­fied oil, the product is misbranded. All the words in the product description "Olive Pomace Oil" should be of equal size. The word "Pomace" should not be smaller or less conspicuous. Designating Extra Virgin Olive Oil as: "Highest Grade"; Virgin Olive Oil as: "Medium Grade"; and Pure Olive Oil as "Lowest Grade, chemically washed, Second Press" is confus­ing and misleading to the consumer. There is no basis in any standard for these classifications. It is also inaccurate to described Pure Olive Oil as "chemically washed" because it con­veys a false image about the safety of the product. To describe Pure Olive Oil as Second Press is inaccurate as well. A claim that olive oil will not burn at high frying tempera­tures is misleading and dangerous. It subjects the packer to greater liability for law suits stemming from fire damage and physical harm that could occur from a consumer overheating olive oil.

Name and Place of Business

The name and place of business of the manufacturer, packer, or distributor of olive oil must be conspicuously shown on the label. It may be placed on the principal display panel or on the information panel. Street address, city, state and zip code are required. However, the street address may be omitted if it is shown in a current city directory or telephone directory. The address can be in the US or abroad. The zip code is not needed for an address abroad.

Ingredient Statement

No ingredient statement is required on an olive oil because the product has no ingredient other than olive oil.