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A customer of ours used the 4-4-9 calculation to validate calories on our Nutrition Facts and got a different value than what we show. How do I explain the difference?  (February 2012)

The 4-4-9 method is just one of five methods FDA allows for calorie labeling on Nutrition Facts. This method is the least accurate of the five because it uses "average factors" – 4 calories per gram for carbohydrate, 4 calories per gram for protein, and 9 calories per gram for fat. These "average factors" generally overstate calories because specific ingredients often contain fewer calories than the average factor would indicate. For example, dextrose (a carbohydrate) contains 3.4 calories per gram, not 4 calories per gram as the 4-4-9 method would indicate.

The five methods FDA allows for calorie determination are: (1) a 4-4-9 calculation; (2) an adjusted 4-4-9 calculation where insoluble fiber is subtracted from the carbohydrate total before multiplying by 4 (since insoluble fiber does not impact the calorie value of foods); (3) specific Atwater factors; (4) other specific food factors approved by FDA; and (5) bomb calorimetry.

Food Consulting Company uses a database nutritional analysis with Atwater or other food factors for most of the ingredients and relies on an adjusted 4-4-9 calculation for those ingredients where specific food factors are not available. Over time we have found this to result in a more accurate (and lower) calorie value than the simple 4-4-9 calculation used in most laboratory nutritional analyses.

Is the use of "natural-identical flavor" appropriate in USA? I only found guidelines in CFR (Code of Federal Regulations) for "natural flavor" or "artificial flavor." I think natural-identical flavor is mostly used as a standard for Europe.  (January 2012)

You are correct. There is not a classification for "natural-identical flavors" in the U.S. The term natural-identical (or nature-identical) is used in Europe for a particular class of flavors that are synthetically produced, but chemically identical to substances found in nature. In the U.S., these synthetically-derived nature-identical flavor ingredients need to be labeled as artificial flavors.

For the FDA definition of natural and artificial flavors, see the U.S. Code of Federal Regulations at 21 CFR 101.22.

If one is making a product consisting of three simple ingredients with no salt, sugar or preservatives added, how extensive does the nutrition statement have to be for the label on such a product?  (December 2011)

It depends on the profile of the finished product per serving and whether nutrient content claims are made. If the finished product has no significant nutrients to list (i.e., all label values are zero) and no nutrition claims are made, the Nutrition Facts panel can be omitted. Spices and teas for example do not always require that the label includes the Nutrition Facts.

If the profile is such that at least 8 of the mandatory nutrients can be listed as zero, then a simplified format can be used. See Nutrition Facts examples in the simplified format.

What should a serving size be for a retail baking flavor? There are so many uses from cookies to smoothies, which would have significantly different serving sizes and nutrition information?  (November 2011)

The Code of Federal Regulations (CFR) does not include a specific reference amount customarily consumed (RACC) for baking flavors. FDA’s Food Labeling Guide in section L62 includes suggested RACCs for a number of product categories not included in the CFR. Products marketed as flavor substances for baking would most closely resemble flavoring oils with a suggested RACC of 1 tsp (__g).

In this scenario, it would be helpful to consumers to include a second column within the Nutrition Facts that shows nutrition information for other intended uses (such as smoothies). See an example of a dual declaration Nutrition Facts Label.

How much alcohol can be used in an FDA-regulated food product, and how is it regulated?  (October 2011)

Ethyl alcohol is generally recognized as safe in foods but only for specific uses including: in the extraction process as a solvent for certain colors (21 CFR 73) and flavors (21 CFR 169), in defoaming agents for coatings (21 CFR 176.200), and as an antimicrobial agent on pizza crusts prior to final baking (21 CFR 184.1293). FDA considers flavored beverages with traces of alcohol (<0.5% by volume) from flavoring extracts or natural fermentation to be "non-alcoholic."

The Tax and Trade Bureau (TTB) regulates the labeling of alcoholic beverages including distilled spirits, malt beverages, and wine with 7% or more alcohol by volume. Beverages such as diluted wine and cider which have an alcohol content of less than 7% by volume and are not defined in the Federal Alcohol Administration Act, are subject to the labeling requirements of the Federal Food, Drug, and Cosmetic Act and Fair Packaging and Labeling Act; therefore they must follow FDA labeling rules. See Compliance Policy Guide.

Is enriched flour "natural" in Canada?  (September 2011)

No. Per Canadian regulations, "a natural food or ingredient of a food is not expected to contain, or to ever have contained, an added vitamin, mineral nutrient, artificial flavouring agent or food additive." For discussion on this topic including natural requirements in the EU, join us on the LinkedIn Food Label Community.

What label components must be on products that are only sold in farmers markets and on the Internet?  (August 2011)

There are no special provisions for products sold at farmers markets or on the Internet. Regardless of the sales channel, all foods sold in the U.S. must be in full compliance with FDA food labeling requirements that are specified in the U.S. Code of Federal Regulations.

Foods sold in farmers markets and on the Internet (like every other retail food) must be labeled with the five requirements for all foods: product identity, net contents, nutrition facts, ingredients/allergens, and company name/address.

However, small businesses may be exempt from nutrition facts labeling, but the other four label components must still be displayed in the manner specified in the U.S. Code of Federal Regulations. See an earlier Reader Q&A for more on the small business exemption.

What label information is needed to sell products wholesale? Is the same label information necessary for selling to foodservice?  (July 2011)

There are five mandatory label components required for both wholesale and foodservice items. These include:

1) product identity

2) net contents statement

3) nutrition facts (exempt on some foodservice items)

4) ingredient/allergen statement

5) name/address of the manufacturer or distributer

For wholesale items, the outer packaging (i.e., shipping containers used solely for transportation) does not require the mandatory label components, however the inner packaging does.

For foodservice items, nutrition facts may be omitted if the items will be further processed (not sold in the packaging) and do not carry nutrient content or health claims on the label or labeling. However most manufacturers of foodservice items choose to voluntarily include nutrition information because their restaurant customers are now requiring it to comply with restaurant menu labeling regulations.

What criteria must be met for a product to be labeled vegetarian? How can we label our product to alert vegetarians who do not eat dairy or egg products?  (June 2011)

Neither FDA nor FTC has any labeling regulations for vegetarian statements, other than being "truthful and not misleading." The most conservative course of action is to ensure that the product is free of any animal-derived ingredient or ingredient components and use the term "vegan" when appropriate. This means that the product has no ingredients from animal origin such as milk, eggs, honey or gelatin.

Since there are different types of vegetarians, it is also possible to include a clarifying statement defining the type of vegetarian for which the product is intended to ensure that the statement is clear to the consumer and meets the "truthful and not misleading" requirement for all labels (e.g., this product is suitable to lacto-ovo vegetarians).

For our Frozen Italian Dessert, can we refer to this collection of ingredients as "chocolate coating": sugar, palm oil, cocoa powder and soy lecithin?  (May 2011)

No. You would need to identify the above ingredients as “chocolate flavored coating” since the standard of identity for sweet chocolate (21CFR163.123) is not met. The key difference in your ingredients and those of standardized chocolate is the use of palm oil instead of cocoa butter.

Though it does not apply to this situation, it is worthy of noting that some chocolate food items that are flavored only with cocoa and not expected to contain the other elements of standardized chocolate (such as chocolate milk and chocolate pudding) can be called “chocolate” as outlined in the FDA Compliance Policy Guide.

The Compliance Policy Guide states “non-standardized food product that contains cocoa as the chocolate flavoring ingredient may bear the term "chocolate" so long as it can be demonstrated that consumers have long recognized that the food product may be made from cocoa and do not expect it to contain some other chocolate ingredient.”

Is there a U.S. labeling regulation that establishes the allowable variance for the analyzed value vs. what is printed on the label? If so, what is the specific regulation?  (April 2011)

Yes, FDA regulations published at 21CFR101.9(g) specify two classes of nutrients; the allowable variance is different for each. Regardless of the class, the analyzed value is derived from a composite sample of twelve consumer units, with one unit coming from each of twelve different randomly chosen shipper cases.

Class I nutrients are nutrients added to fabricated foods for the purpose of fortification, such as vitamins, minerals, protein and dietary fiber. For this class, the analyzed value must be at least equal to the label value.

Class II nutrients are naturally-occurring nutrients. For this class, the analyzed value for the "beneficial nutrients" (vitamin, mineral, protein, total carbohydrate, polyunsaturated fat, monounsaturated fat or potassium) must be at least 80% of the label value and the analyzed value for the "nutrients to limit" (calories, sugars, total fat, saturated fat, cholesterol or sodium) must not be greater than 120% of the label value. These allowable variances are commonly referred to as the "80/120 rule."

I am working on a Canadian label with a sugar-free claim. The product has less than 0.4g sugar and 2g carbohydrate. Does this product qualify for the claim?  (March 2011)

In Canada, only products that are both sugar-free (less than 0.5g sugar per serving) and calorie-free (less than 5 calories per serving) qualify for a "sugar-free" claim.

Though the calorie content of the product wasn't included with your question, using the standard factor of 4 calories per gram of carbohydrate, your product likely contains at least 8 calories per serving. Therefore, a sugar-free claim would not be permitted on this product in Canada.

In the U.S., a product qualifies as sugar-free if it has less than 0.5g sugar per serving and per reference amount for the product category. The claim can be made on the product label providing two conditions are met: (1) the calorie profile is also disclosed on the label (either low calorie, reduced calorie or not a low calorie food), and (2) the product does not include an ingredient that is a sugar or is generally understood by consumers to contain sugars unless that ingredient appears with an asterisk linked to a statement such as "adds a trivial amount of sugar" below the ingredient statement.

I work for the Anchorage school district for student nutrition and we have students that have an allergy to MSG. I need to know if it is used in CN-labeled foods?  (February 2011)

Whenever MSG (monosodium glutamate) is added to a food, it must be declared in the ingredient statement. This is true for foods labeled for the Child Nutrition (CN) program or any other foods. There are some ingredients, however, that contain naturally occurring monosodium glutamate. This naturally occurring substance is the result of a free glutamate that combines with sodium in processing to create monosodium glutamate. Some ingredients that contain free glutamate are: yeast extract, autolyzed yeast extract, disodium inosinate, disodium guanylate, and hydrolyzed vegetable proteins.

Our sales team wants to create a food package that would be equally acceptable in Mexico and the U.S. Is this do-able?  (January 2011)

We consulted with Mexican colleagues who confirmed that yes, it is possible to have a single food label that satisfies the requirements of both U.S. and Mexico. Of course, the label must be bilingual.

Mexico has new food labeling regulations, known as NOM-051, that went into effect on January 1, 2011. There are several new requirements including a calculation for the Mexican Recommended Dietary Intake (RDI) when different from the U.S. Daily Value (DV) and a quantitative ingredient declaration for any ingredients that are highlighted on the label. A U.S. bilingual label can be used as long as the additional mandatory information for Mexico is also included.

When a product like Fruitabu or V8 vegetable juice says "contains a serving of fruit" or "contains a serving of vegetables" what does that mean? What methodology are they using, because when you look at the NLEA serving sizes or the USDA serving size for a fruit or vegetable, the calories, total sugar and fiber are inconsistent with how the product is labeled?  (December 2010)

FDA does not define serving sizes for food groups (i.e., fruits, vegetables, grains). FDA’s Reference Amounts (the NLEA serving sizes) are the amounts customarily consumed; they are defined for 135 product categories (i.e., breads, crackers, puffed cereals, high fiber cereals). These Reference Amounts do not necessarily correlate with serving sizes for food groups. Serving sizes for food groups vary depending upon which food group system you use: diet exchanges, Child Nutrition program information, USDA's MyPyramid information for a 2,000 calorie diet, or the NLEA serving sizes.

The number of servings for a particular food group can be listed on the label as long as it is truthful and not misleading. The method used to calculate or determine the number of food group servings needs to be listed or referenced by a symbol near the statement of the number of servings. For example:

A FULL SERVING OF FRUIT IN EACH 8 FL OZ GLASS^†

 

^†Each 8 fl oz glass provides ½ cup of fruit. USDA's MyPyramid recommends a daily intake of 2 cups of fruit for a 2000, calorie diet.

Can my product (an aseptically shelf stable ready-to-eat pudding) that is made in the U.S. and labeled for sale in Canada state "2% or 1% or less" in the ingredient statement? (November 2010)

Canadian regulations make no mention of an "X% or less" clause for ingredient statements. In the U.S., the clause "2% or less of the following" (or 1.5%, 1%, or 0.5%, as appropriate) can be used at the end of the ingredient statement to list minor ingredients in any order. Canadian regulations specify that ONLY specific classes of ingredients can be shown at the end of the ingredient statement in any order. For these specific classes of ingredients in Canada, the "X% or less of the following" clause could be used, but it is not common practice because it significantly lengthens the ingredient statement given the English-French bilingual labeling requirement.

In Canada, the specific classes of ingredients that can be shown in any order at the end of the ingredient statement include: spices, seasonings and herbs (except salt), natural and artificial flavors, flavor enhancers, food additives, and vitamin and mineral nutrients and their derivatives or salts.

For more information about Canadian ingredient labeling, consult the Canadian Food & Drug Regulations (FDR), Section B.01.008. For information about U.S. ingredient labeling, consult the U.S. Code of Federal Regulations (CFR), Title 21, Part 101.4.

How many milligrams of Vitamin C can I add to my beverage without having to declare "ascorbic acid (Vitamin C)" under the beverage's ingredient listing?

(October 2010)

If ascorbic acid is added to the beverage, it must be listed in the ingredient statement. Furthermore, if the function of the ascorbic acid is as a preservative, this must also be disclosed in the ingredient statement (i.e. "ascorbic acid to preserve freshness" or something equally descriptive).

According to the Code of Federal Regulations at 21 CFR 101.4, all food ingredients (except incidental additives as defined in 21 CFR 101.100) must be listed in descending order of predominance by weight. Rules for declaring spices, flavorings, colors and preservatives can be found in 21 CFR 101.22.

Could you give me the current status on labeling for gluten-free products. What are the rules? (September 2010)

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) mandated that FDA establish a definition for the term "gluten-free" and uniform conditions for its use in the labeling of foods. FDA has published a proposed rule for "gluten-free". 

In this proposed rule, the use of the term "gluten-free" is voluntary. However, it will not be allowed for foods that contain any species of the following prohibited grains: wheat, rye, barley or a crossbred hybrid of these grains. Furthermore, a "gluten-free" claim will not be allowed if the food contains 20ppm or more gluten. If the food is inherently free of gluten, the claim must acknowledge that all foods of that same type are gluten-free (i.e., "all milk is gluten-free" or "milk, a gluten-free food").

Our ingredient supplier insists that insoluble fiber does not need to be included in total calories, however this would not make sense in context of the 4-4-9 formula. Is it allowable to have insoluble fiber listed as part of carbohydrates on the Nutritional Facts Panel but not included in the calorie consideration? (August 2010)

In the U.S., your ingredient supplier's approach is allowed according to FDA regulations. In Canada however, this approach is not allowed.

For the U.S., FDA allows several different methods for calorie determination [21 CFR101.9(c)(1)(i)]] such as general factors or specific Atwater factors. Most companies use the general factors 4-4-9 (4 calories per gram for carbohydrates and protein and 9 calories per gram for fat). It is allowable but not required to subtract insoluble fiber from the total carbohydrate value for the purpose of calculating calories. Insoluble fiber must be included in the Nutrition Facts Panel if any claims about insoluble fiber are made -- otherwise it is a voluntary nutrient. If insoluble fiber is shown, companies can choose whether or not they subtract the calories from this type of carbohydrate. To list the fewest number of calories and to avoid confusing consumers, you can subtract the insoluble fiber from the carbohydrates before applying the 4-4-9 formula but then you would not want to include the optional 4-4-9 footnote on the Nutrition Facts Panel.

For Canada, it is unacceptable to subtract the weight of dietary fiber from the weight of carbohydrate prior to applying the 4-4-9 formula when calories for the specific fiber source have not been determined. To date, Health Canada has only approved reduced calorie levels for wheat bran (0.6 calories per gram) and specific inulin sources (2.2 calories per gram).

I am using all natural ingredients in a package. It says it has vanillin in it. I think vanillin is a compound, so does that mean I cannot say "all natural ingredients"? (July 2010)

Vanillin is typically a synthetically-derived compound (artificial flavor). FDA does not allow a "natural" claim for products that contain artificial flavors, added colors (from any source), or chemical preservatives. See June 2008 Food Label News for further discussion about "natural" claims on FDA, USDA and CFIA-regulated products.

Which is better for getting the most accurate results: lab or database analysis? (June 2010)

FDA does not require a specific method of analysis for Nutrition Facts, but the Agency does require label values to be accurate within the tolerances specified in the Code of Federal Regulations.

When performed correctly, the database method is typically a better predictor of the nutritional analysis from multiple production runs than a single laboratory analysis. This is because the database method uses the statistical average for commodity products that can vary with growing conditions and other factors. FDA actually encourages the use of nutrient databases as a low-cost alternative to laboratory analysis. In fact nearly all Food Consulting Company clients choose this approach; exceptions are for products that contain ingredients for which nutrient data is not available or for foods that undergo processing where the nutrient changes cannot be confidently predicted.

When you select database analysis you will provide your product formulations, raw material specifications, and processing information to us under strict  confidentiality. We will analyze your product to determine the 100-gram data.

With laboratory analysis you will provide us with the 100-gram data lab report. Contact Us if you need a referral for a new lab analysis.

In both cases we use the findings of the analysis to develop the Nutrition Facts panel for your product. As part of this work we determine the FDA-regulated serving size and servings per container, then calculate the nutrient profile per serving, apply the rounding rules, and determine percent daily values for the required Nutrition Facts panel components. Finally we produce a camera-ready Nutrition Facts panel formatted according to your package dimensions and FDA specifications. This is what you provide to your printer, artist, or package designer.

Can you reference me to the section of the CFR that deals with synthetic and/or artificial substances that are exempt in trace amounts as food processing aids? Also include information on secondary synthetics (synthetic and/or artificial substances that are exempt due to being ingredients in ingredients)? (May 2010)

Ingredient exemption information can be found in 21 CFR 101.100 - Food; exemptions from labeling. Under this provision of the Code of Federal Regulations, incidental additives present in a food at insignificant levels with no technical or functional effect in that food are not required to be listed in the ingredient statement.

Incidental additives are:

• ingredients that are incorporated in the food as an ingredient of another food

• processing aids which are added during processing but removed, converted to a normal constituent of the food at normal levels or are present at insignificant levels

• substances migrating from equipment or packaging

Insignificant level means there is no technical or functional effect at the level used.

Incidental additives should always be listed in the ingredient statement when they are allergens (i.e. soy lecithin as a lubricant on equipment), when they are sulphiting agents at detectable levels (greater than 10ppm), or when the manufacturer is uncertain if the additive is functional in the finished product (for example, a preservative could be functional when incorporated as an ingredient of another food).

We have four different flavors of a beverage packaged in a box. Do we need four different nutritional statements on the box or can we just put the nutrition info on each bottle instead? (April 2010)

The regulations specify that labeling must be placed on the retail sales package. This enables the consumer to be informed when they make their purchasing decision. For a multi-pack, the labeling needs to be on the outer package unless there is a transparent wrapper that joins the individual packages together so that the labeling can be seen on the individual packages at the point of purchase.

The labeling can also be on both the outer and individual packages. If the labeling is on the outer package only, then the individual packages must include a phrase to indicate that they are not labeled for individual retail sale. This is true for both USA and Canada.

What does FDA require regarding redemption value labeling for beverage containers? (March 2010)

FDA does not regulate this aspect of beverage labeling. Rather, it is regulated by the individual states. The requirements vary depending on type of container (plastic, glass, aluminum, etc.), contents of the container (carbonated, non-carbonated, juice, etc.) and if the container is marketed as single or multi-serving. The Container Recycling Institute maintains a website at bottlebill.org that outlines the various requirements for U.S., Canada and worldwide.

If lecithin is present, does soy need to be claimed as an allergen? (February 2010)

Yes, for FDA regulated foods, if lecithin is derived from soy then soy needs to be listed in plain, common English within the ingredient statement. In addition, soy would also be included if you are using a separate "Contains" allergen statement.

In FDA Guidance Specific to Soy Lecithin, FDA specifies that if lecithin is derived from soy then the plant source of the ingredient (soy) must be included in the ingredient name within the ingredient statement. Additionally, if you are using a separate "Contains" allergen statement, soy must be included with all of the "big eight" allergens (eggs, milk, soy, wheat, peanuts, tree nuts, fish, crustacean shellfish) present in the product.

For additional information read June 2006 Food Label News report about allergen labeling for incidental additives.

When we designed our bags for popcorn, we naturally used the label warning from our contract manufacturer "Manufactured in a facility that also processes peanuts, tree nuts and milk ingredients." Our contract manufacturer is no longer using nuts in their products and we are thinking about eliminating the peanut warning. However, to do this economically and not create a whole new printing plate, we would also need to eliminate the warning about milk being processed in the factory. Is it OK to eliminate the milk warning or does that violate a code or present a serious risk to those with milk allergies? (January 2010)

The use of an allergen advisory statement such as the one you use "Manufactured in a facility that also processes peanuts, tree nuts and milk ingredients" is voluntary so you are free to eliminate the statement or any other allergen advisory statement from your labeling if you choose.

For more information on allergen labeling, see FDA's Guidance for Industry regarding food allergens or a Food Consulting Company article that helped companies prepare for allergen labeling when the Food Allergen Labeling and Consumer Protection Act went into effect on January 1, 2006.

If you sell foodservice products to restaurants by the case, are you required to label each 'package', 'packet' or 'bottle' in the case? (December 2009)

No, you are not required to label the individual units within the case. The required labeling for foodservice items (product identity, net quantity of contents, ingredient statement, and signature line) can be on either the individual units or on the shipping container; it does not have to be in both places.

Foodservice items are exempt from nutrition facts labeling, except when a nutrient content claim is made. If a company elects to label individual units and uses the exemption for Nutrition Facts labeling, then it is wise to include a label statement such as "not labeled for individual retail sale."

Can we label our agave syrup as a natural low glycemic sweetener in the U.S.?  (November 2009)

This question has two parts: "natural" and "low glycemic." As outlined in last month's Food Label News, FDA does not restrict the term "natural" on food labels provided the product is free of artificial flavors, chemical preservatives, or added colors (from any source). The FDA has not defined the term "glycemic." If you use the word "low" with "glycemic," you must have authoritative basis for the claim and include the reference on your label to ensure that the label is truthful and not misleading.

Rather than labeling a product as "low glycemic," we suggest using a statement such as Agave Syrup: glycemic index = X, compared to Granulated Sugar: glycemic index = Y. This is a statement of fact (provided you have research documentation to substantiate your values) and provides the consumer with comparison data without using the descriptive phrase "low."

Can enzymes used in dough conditioners in a bakery product be declared by a class name "enzymes" or must they be declared by the actual name of the enzymes in the Ingredient List?  (October 2009)

The enzymes used in dough conditioners need to be listed in the ingredient statement by "common or usual name" (actual name of the enzyme). This is true for both USA and Canada.

I have a new product and need help with food labels. Do I need to send a sample of my product to you? What information will you need from me? (September 2009)

Food Consulting Company uses database analysis of a product’s recipe formulation so a sample is not needed. Database analysis is a lower cost alternative to laboratory analysis and is an excellent predictor of a product’s nutritional content.

To produce the nutritional information for your product, Food Consulting Company needs information about your recipe formulation, processing and packaging. The regulatory specialist who will be working on your project can help you determine the specific information you will need for your recipe formulation, your processing and your packaging.

View an example.

Will either the LEAN Act or the MEAL Act affect supermarket foodservice operations?  (August 2009)

LEAN Act and MEAL Act are separate bills introduced to the U.S. Congress that would require mandatory nutrition disclosure in certain restaurant/retail food service establishments. In June 2009, the bills were subject to compromise in the U.S. Senate and the compromise is to be a component of health reform legislation currently being debated.

Very little detail about the compromise was made public and so the answer to the original question is not known. It might be helpful though to consider how FDA has defined the term "restaurants" per FDA's Restaurant Labeling Guide:

• The term "restaurant" applies broadly to establishments where food is served or sold for immediate, on-site consumption (e.g., institutional food service establishments such as schools, hospitals, and cafeterias; transportation carriers such as trains and airplanes; delicatessens and catering operations with facilities for immediate consumption on the premises).
   

• The definition of "restaurant" extends to establishments where foods are generally consumed immediately where purchased or while walking away (e.g., lunch wagons, cookie counters in a mall, vending machines, and similar foods sold from convenience stores); and food delivery systems or establishments where ready-to-eat foods are delivered to homes or offices for immediate consumption.

See Food Label News archive (April 2009, June 2009, July 2009) for reports on LEAN, MEAL and compromise.

I heard that stevia can now be used in conventional foods (and not just dietary supplements). If true, are there special considerations I need to be aware of for labeling?  (July 2009)

Only rebaudioside A (RebA), an isolated component of the stevia plant is allowed by FDA for use in conventional foods. In December 2008, FDA responded to notices from Whole Earth Sweetener Company LLC and Cargill Incorporated requesting GRAS status for rebaudioside A purified from Stevia rebaudiana (Bertoni) Bertoni. In both responses (1,2) FDA stated that the agency has no questions at this time regarding the conclusions that rebaudioside A is GRAS under the intended conditions of use.

The ingredient statement needs to indicate the presence of the purified form "RebA" - "stevia" is not appropriate labeling nomenclature for this ingredient.
                           

My products are syrups and fruit toppings; what determines if the label should use 'fluid ounces' or 'net weight' to declare net quantity of contents?  (June 2009)

The Code of Federal Regulations says that the 'net quantity of contents' statement is to be expressed in terms of fluid measure, weight, numerical count, or a combination of numerical count and weight or fluid measure. The statement is to be in terms of fluid measure if the food is liquid, or in terms of weight if the food is solid, semisolid or viscous, or a mixture of solid and liquid. If syrups are pourable and do not contain solid pieces of anything the net quantity statement will be in terms of fluid measure as in the U.S. gallon of 231 cubic inches and quart, pint, and fluid ounce subdivisions as appropriate for the product container. If the fruit toppings are a mixture of syrup and pieces of fruit the net quantity statement will be by weight in terms of pound and ounce.

Exception to the above regulations is possible; if there is a firmly established general consumer usage and trade custom of declaring the contents of a liquid by weight, or a solid, semisolid or viscous product by fluid measure, it may be used. In all cases 'net quantity of contents' statement must facilitate value comparisons by consumers and must not cause consumer confusion.

In addition to stating the U.S. Customary System terms (ounces, pounds, and fluid ounces,) food labels must show the net contents in Metric System terms (grams, kilograms, milliliters, liters.)

FDA's Food Labeling Guide (http://www.cfsan.fda.gov/~dms/flg-toc.html) gives more information about net quantity of contents.
                           

What is the 2400 milligram Daily Value for sodium based on?  (May 2009)

The Institute of Medicine's most recent (2004) Recommended Dietary Intake for sodium established 1.5g per day as the Adequate Intake (AI) and 2.3g per day as the Upper Limit (UL).

The Recommended Dietary Allowances, Tenth Edition (1989) recommended that daily intakes of sodium chloride be limited to 6g (2.4g of sodium) or less. This 2.4g recommendation correlates with the 2400 mg Daily Value for sodium established for nutrition facts panels that became mandatory on food labels in 1993.

Does your company offer shelf life testing?  (April 2009)

Yes, Food Consulting Company offers a Shelf Life Evaluation service. A food technologist determines shelf life by testing a product sample for pH, water activity, moisture, solids, and other components; the findings are used along with specifics about the product ingredients, processing methods, and packaging to determine the product shelf life.

Although labeling regulations do not include a requirement for shelf life, voluntary inclusion of a freshness date (Best Before or Use By) on labels encourages retailers to rotate products and lets consumers know when the time is up for highest product quality.
                                   

I have seen products with a Nutrient Content Claim (NCC) stating "0 grams trans fat." I have not found this claim to be one of the approved NCC claims. Is the claim illegal or allowed?  (March 2009)

 "0 grams trans fat per serving" is a factual statement, not a defined nutrient content claim. Factual statements have always been allowed on labels provided the information is truthful and not misleading. "0 grams trans fat per serving” is truthful as long as the food contains less than 0.5 gram (1/2 g) of trans fat per serving. "0 grams trans fat" without qualification (i.e., "per serving") is an incomplete factual statement and should not be used on labels, unless the product is in a single-serve container.

While "0 grams trans fat per serving" can be used on labels, "trans fat free" cannot be used. Per FDA regulations the term "free" is a nutrient content descriptor. The regulations regarding the use of nutrient content claims are specific; they are intended to ensure that the descriptive terms that characterize or compare nutrient levels are used consistently for all types of food products and are thus meaningful to consumers. Nutrient content claim descriptors apply only to nutrients or dietary substances that have an established daily value; no daily value has been established for trans fat.

In addition to "free," the existing regulations disallow claims about trans fat using the following terms: Free, Zero, No, Without, Trivial Source of, Negligible Source of, Dietarily Insignificant Source of, Low, Little, Few, Contains a Small Amount of, Low Source of, Reduced/Less, Lower, Fewer, and any synonyms of these words.

Note: If a statement of fact related to a nutrient is made outside the Nutrition Facts panel for a product that exceeds threshold levels of total fat, saturated fat, cholesterol and sodium, then the disclosure statement "See Nutrition Information for [name of nutrient] Content" is required.
                                   

I've heard that you can't make a low-sodium claim on a product that contains cholesterol. Is this true?  (February 2009)

A low-sodium claim can be made on a product that contains cholesterol, but depending on the amount of cholesterol you might have to include a disclosure statement.

A disclosure statement is required for nutrient content claims (e.g., low sodium, fat free, sugar free) if certain other nutrients exceed set thresholds. The nutrients and thresholds are: 13.0g fat, 4.0g sat fat, 60mg cholesterol, 480mg sodium. These values are for Reference Amount Customarily Consumed (RACC) per labeled serving. The rules for foods with small serving sizes and main dish/meal products are different.

A disclosure statement calls consumers' attention to one or more nutrients in the food that may increase the risk of a disease or health-related condition that is diet related.

The disclosure statement identifies the nutrient that is present above the prescribed level, e.g. "See nutrition information for cholesterol content." This statement must be placed immediately adjacent to the claim in boldface type and a type size at least as large as the net quantity of contents declaration.

Is there a regulated definition for high protein, as a percentage of protein in a serving?  (January 2009)

Yes. Per the Nutrition Labeling and Education Act of 1990 (NLEA), "high protein" is a regulated nutrient content claim and the word "high" means greater than or equal to 20% Daily Value (DV). The Daily Value for protein is 50 grams. Therefore, a food that contains 10 grams of protein (or more) per serving, can be described as high protein.

If a high protein claim is made, the %DV for protein must be stated within the Nutrition Facts. The %DV must be calculated based on the corrected amount of protein per serving (also known as protein digestibility corrected amino acid score, or PDCAAS). This is the actual amount of protein per serving multiplied by the amino acid score corrected for protein digestibility.

Any time a nutrient content claim is made, a disclosure statement is required if certain other nutrients exceed set thresholds; the nutrients and thresholds are: 13.0g fat, 4.0g sat fat, 60mg cholesterol, 480mg sodium.
                                   

I am launching a line of side dishes and some will contain bacon. Are they covered by USDA or FDA labeling rules?  (December 2008)

The Food Safety and Inspection Service (FSIS) of USDA has authority over meat and poultry products and processed egg products. FDA has authority over all other foods.

When meat or poultry is part of a mixed dish product (e.g., pepperoni pizza, chicken noodle soup, side dish with bacon), the product might fall under FDA rather than USDA regulations. Where it falls depends on the formulation.

In general, mixed food products with more than 2% cooked meat or poultry (3% raw) are regulated by USDA; products with 2% or less cooked meat or poultry (3% or less raw) are regulated by FDA. To determine which labeling regulations apply to the side dish with bacon, consider the weight of bacon in the formulation.

I would like to know how many new labeling regulations will be in effect on the January 1, 2010, uniform compliance date?  (November 2008)

FDA established January 1, 2010, as the uniform compliance date for food labeling regulations that are issued between January 1, 2007, and December 31, 2008. FDA sets uniform compliance dates to minimize the economic impact of labeling regulation changes.

FDA does not publish a summary list of updated/new regulations due on a uniform compliance date. This means labelers are themselves responsible for staying informed on all labeling regulations activity. Food Label News reports on updated and new regulations as they are proposed, opened for comment, and as they are made final. Food Consulting Company offers services to help labelers meet compliance dates as economically as possible.

Labelers also have the option of reading the daily Federal Register and making frequent visits to FDA's website since all regulation changes are announced in both locations accessible through the Internet.
 

Since fish/aquaculture are excluded from National Organic Program standards, is labeling fish and seafood with the term "organic" acceptable in the U.S.?  (October 2008)

An official from USDA's Agricultural Marketing Service (AMS) told Food Consulting Company that USDA has no jurisdiction over how organic is used outside of the rules of the National Organic Program (NOP). Current NOP rules say that aquatic animals shall not be included in the program and therefore NOP has no restriction on using the term "organic" on a fish label at the present time as long as the USDA Organic seal is not used.

Fish is an FDA-regulated food product and FDA requires that all labeling is truthful and does not mislead the consumer. Therefore the food labeler needs to decide if the organic claim on a fish product meets consumer expectation for organic.
 

In the August Q&A you said high fructose corn syrup should be labeled as glucose-fructose syrup in Canada. Can I also label it as glucose-fructose syrup on my U.S. labels for the same product?  (September 2008)

No, the required nomenclature for this ingredient for U.S. regulated food labels is high fructose corn syrup. Reference Code of Federal Regulations in Title 21, Section 184.1866.
                    

I've heard that Canada does not allow high fructose corn syrup in food products. Is this true?  (August 2008)

Canadian food regulations do not prohibit the use of high fructose corn syrup. However Canadian regulations differ from U.S. regulations regarding nomenclature for this ingredient.

The Canadian Food Inspection Agency "Guide to Labelling and Advertising – Basic Labelling Requirements" specifies that the ingredient equivalent to high fructose corn syrup is to be listed as "glucose-fructose" on Canadian food labels.

Food labelers using high fructose corn syrup/glucose-fructose as an ingredient may find Food Label News archived articles from June 2008 helpful.
                      

I frequently get incomplete nutrition information from ingredient suppliers and my nutrient analysis program only helps part of the time. How can I get complete information?  (July 2008)

When complete and accurate nutrition information is not provided by ingredient suppliers or readily available from a particular database, accurate values must be obtained through a process of due diligence.

Food Consulting Company has posted an article on the due diligence process. The content was presented by Karen C. Duester, MS, RD, company president, to the nutrition study group meeting of the National Restaurant Association in May 2007 and included in a 2007 article published in DBC Dimensions. Read due diligence article.

Is St John's wort allowed in a beverage at any level? (June 2008)

No, this botanical is not allowed for use as an ingredient in a beverage; this is explained in a January 30, 2001, "Dear Manufacturer" letter.

In the letter, FDA explains that in order for a substance, such as the botanical St John's wort, to be added to food, the substance must be GRAS (Generally Recognized as Safe) or be an approved food additive. Food additives require pre-market approval by FDA; data demonstrating safety is submitted by the petitioner to the agency in a food additive petition. If the petition is accepted, the agency issues food additive regulations. The regulations specify the conditions under which the additive has been demonstrated to be safe and how it may lawfully be used.

St John's wort is not a GRAS substance or an approved food additive.

I see butter listed on ingredient statements alone sometimes and sometimes followed by a parenthesis around the butter ingredients e.g., (cream, salt). How should I list butter in my ingredient statement?  (May 2008)

If the formula includes unsalted butter, it is correct to simply list "butter" (or specify as "unsalted butter") in the ingredient statement in descending order according to total weight compared to other ingredients. However if the formula includes salted butter, the salt in the butter must be factored into the ingredient statement in one of two ways.

The most concise way to accurately list the salt in salted butter is to determine the salt weight vs. cream weight and then add the salt weight to the salt contributed from other ingredients. The "butter" and "salt" from all sources will then be listed in correct order according to their weights compared to other ingredients.

The other option for listing salted butter (a composite ingredient) is to list the butter in descending order by weight followed by a parenthetical listing of the sub-ingredients, e.g., "butter (cream, salt)."

For a product that contains multi-component ingredients (e.g., cherry pie contains fruit filling and crust, both with sub-ingredients), does FDA require that the ingredient statement show each ingredient with sub-ingredients in parentheses, or is it ok to list the subcomponents one time in order by total weight in the whole product?  (April 2008)

FDA regulations allow a product that contains multi-component ingredients to use either a "composite" ingredient statement or an "expanded" (parenthetical) statement. Which type to use depends on the goal for final label appearance and on the availability of the formula breakdown for multi-component ingredients.

The "composite" ingredient statement is generally a cleaner, more concise ingredient statement that helps present a product in the best possible light within the law. This type of statement identifies each ingredient one time, in descending order based on each ingredient’s total weight in the whole product.

Ingredient suppliers usually do not provide exact formula breakdowns for multi-component ingredients, but may provide a range, e.g., 60% to 70% sugar. The ingredient statement developer must then be able to use the percent range information given to create a truthful ingredient statement. This requires skill in understanding FDA ingredient labeling regulations and in applying the information provided by suppliers of multi-component ingredients.

Unless a client requests otherwise, Food Consulting Company normally prepares a composite ingredient statement. The exception is when a labeling client (or their supplier) is not able to provide adequate information for multi-component ingredients.
 

Do nut oils and soybean oil have to be declared as allergens on food labels?  (March 2008)

FDA food labeling regulations require that the source of the oil is identified (soybean oil, peanut oil, walnut oil, etc.) in the ingredient statement. Per FDA guidance related to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), if a "Contains" statement is used after the ingredient statement, then all of the "big eight" allergens contained in the product need to be in this statement - tree nut and legume (soy or peanut) oils are no exception unless the oil is highly refined and therefore free of the allergenic protein.

For background, FALCPA exempts highly refined oils and ingredients derived from highly refined oils from allergen labeling. FDA does not have a regulatory definition for highly refined oil, however the Agency refers to the Senate Report that accompanied FALCPA that describes a highly refined oil as one that is refined, bleached and deodorized.
 

If a company is using a safe lubricant like beef tallow or lard to lubricate pans for baking, or is using those animal products in the packaging of the product, does FDA require that these additives be listed in the ingredient list?  (February 2008)

Pan release agents are generally considered to be processing aids and therefore are typically exempt from ingredient statement labeling for FDA-regulated foods. However when release agents contain an allergen (milk, eggs, wheat, soybeans, peanuts, tree nuts, fish, and shellfish per the Food Allergen Labeling and Consumer Protection Act of 2004) the lubricant should be listed by the common or usual name in the ingredient statement. In addition, if omitting an ingredient would cause the product to be misbranded because its label is misleading or not truthful (e.g., the product is commonly understood to be vegetarian or labeled as such but a release agent from an animal source is used), then the presence of the release agent should be disclosed in the ingredient statement.

Is it a requirement that vitamins and minerals (Vitamins A and C, Calcium, Iron, etc.) in the Nutrition Facts be reported using even numbers? If yes, what is the logic for this, and what is the rule?  (January 2008)

FDA regulations specify "rounding rules" for the % Daily Value of vitamins and minerals. When the rules are properly followed the % Daily Value for a nutrient can be an even or odd number. Per FDA regulations for vitamins and minerals (Vitamins A and C, Calcium, Iron, etc.), round the Daily Value to:
   - nearest 2% if less than 10%
   - nearest 5% if between 10% and 50%
   - nearest 10% if greater than 50%
If the Daily Value is between 1 and 2%, the % Daily Value may be stated as 0% or 2%. 

Does the nutritional labeling have to be printed in black? (December 2007)

Per the Code of Federal Regulations, the Nutrition Facts panel must be in black or one color type printed on a white or neutral background with the intent that it is very easy to read. However, the other required labels components (ingredient statement, signature line, etc.) can use inverse printing as in light type with dark background. In all cases, the information must be readable and compliant with regulations for minimum type size and specific placement. For compliance checks on your label prototypes select Label Compliance Review service.

Are sample food packages required to include Nutrition Facts or other food label components? (November 2007)

Food samples do not have to be labeled with any of the required label components as long as the product package clearly identifies the product as a sample. For example, the product packaging can include the words "not labeled for retail sale."

It doesn't matter if the samples are distributed by mail, handed out, or offered for taste testing in a retail store or other public place.

A company may voluntarily include some or all of the required label components on a food sample package, but if all five label components are not presented in the manner FDA specifies, the label must state "not labeled for retail sale" or equivalent wording.

Providing retail-ready samples is often a smart choice in achieving the objective of a sample campaign; there is widespread consumer interest in knowing the ingredients and nutritional value of purchased foods.

To have retail sale ready sample packages, the five required label components are: statement of identity, statement of net contents, Nutrition Facts, ingredient statement with allergen labeling compliance, and name and address of manufacturer, packer or distributor. For help with FDA compliant food labels select Full Label Compliance service.

Is FDA approval of food labels required? If yes, does Food Consulting Company include this step in my label order?  (October 2007)

FDA does not require or provide a service for the Agency’s approval of food labels. However, labelers must comply fully with the labeling regulations on their own or through the help of their choice. Food Consulting Company helps you produce 100% FDA compliant labels with Full Label Compliance and Label Compliance Review.

The requirements for food labeling are detailed in the Federal Food Drug and Cosmetic Act, Code of Federal Regulations, Food Labeling Guide, Food Allergen Labeling and Consumer Protection Act, and in FDA guidance documents all of which can be accessed at www.fda.gov.

The Agency learns of non-compliant labels on foods via random checks and checks during inspections, and through tips from consumer groups, individual consumers and competitors.

FDA issues warning letters to food packagers when violations are discovered; the Agency directs food packagers to correct non-compliant labels or face further FDA action.

What is the legal definition for "trans fat free?" Can a restaurant or product make this claim?  (September 2007)

To date, FDA has not established a definition for "trans fat free." Therefore this claim cannot be made on food labels or on menus and menu boards, or in food marketing.

Per FDA regulations the term "free" is a nutrient content descriptor. The regulations regarding the use of nutrient content claims are specific; they are intended to ensure that the descriptive terms that characterize or compare nutrient levels are used consistently for all types of food products and are thus meaningful to consumers. In general, nutrient content claim regulations apply only to nutrients or dietary substances that have an established daily value; no daily value has been established for trans fat.

In addition to "free," the existing regulations disallow trans fat claims using the following terms: Free, Zero, No, Without, Trivial Source of, Negligible Source of, Dietarily Insignificant Source of, Low, Little, Few, Contains a Small Amount of, Low Source of, Reduced/Less, Lower, Fewer, and any synonyms of these words.

FDA regulations do allow the Nutrition Facts to state 0g trans fat when the serving contains less than 0.5 gram (1/2 g) of trans fat, and a separate factual statement "0g trans fat per serving" can be used elsewhere on the label. Menus can also make this statement about a menu item when it is true and factual.

FDA continues to conduct research and consider scientific evidence that may influence the use of nutrient content and other claims for trans fat on food labels and menus and in marketing.

I want to highlight that my dessert topping with 1.5g fat and less than 0.5g trans fat per serving contains only a small amount of partially hydrogenated oil compared to competing brands that contain almost all partially hydrogenated oil. Can I highlight this with my simplified Nutrition Facts panel?  (August 2007)

You are puzzled about the specifics of the trans fat labeling rules, and Food Consulting Company agrees the rules are tricky.

Per the rules for simplified Nutrition Facts [21CFR101.9(f)], you are not allowed to report trans fat as a separate line item under total fat in the Nutrition Facts panel when trans fat is 0 (0.49g or less per serving); however in some cases the rules do require a declaration of trans fat in the "not a significant source" statement.

You also have the option of using a standard Nutrition Facts panel [21CFR101.9(c) rules]. These rules require that when total fat is a reportable amount, saturated fat and trans fat must both be listed as separate line items within the Nutrition Facts panel.

See examples of correct and incorrect Nutrition Facts panels here.

In either case (simplified or standard) you may state "0g trans fat" on the front label panel but be aware, under current rules, your product label may not state "trans fat free" or "no trans fat."
 

My product (non perishable grain) was stamped with an incorrect and too early "best before" date. Does FDA allow me to use a sticker to cover the incorrect information with the correct date?  (July 2007)

Per FDA's Food Labeling Guide it is permissible to use stickers to make changes in labeling, therefore you can correct the best before date with an over-sticker.

Best before/shelf life labeling is not an FDA requirement. However if used the information must be truthful and not misleading; truthful and not misleading is a minimal requirement for all label statements and information.

Voluntary inclusion of a freshness date on labels encourages retailers to rotate products and lets consumers know when the time is up for highest product quality. Food Consulting Company believes that including best before/shelf life labeling is a wise consumer-friendly business practice.

Food Consulting Company offers Shelf Life Evaluation. A food technologist will test your product sample for parameters that affect the shelf life (pH, water activity, moisture, solids, others); these findings will be used along with specifics about product ingredients, processing methods, and packaging to determine the current shelf life of your product and help you reach your shelf life goal.

I would like to sell my product in grocery stores/gourmet shops. What service do I order to make sure my label meets FDA label regulations?  (June 2007)

To sell an FDA-regulated product by retail in the United States the product label must contain five label components. These are: statement of identity, statement of net content, Nutrition Facts, ingredient statement with allergen labeling compliance, and name and address of manufacturer, packer or distributor. Labeling rules state where each component must be placed, minimum type size requirements, and more.

Food Consulting Company's Full Label Compliance service takes the product information you provide and produces the required components for you. The service includes nutrition analysis, a Nutrition Facts panel, an ingredient statement including allergen labeling compliance, and help with product naming and label claims. The package also includes label layout instructions and a final label review.

You have options to successfully produce FDA-compliant labeling:

• Food Consulting Company can help you from start to finish with Full Label Compliance. With this choice, once you supply the necessary information for a product you will receive ready-to-print label components and a guarantee for accuracy.

• Produce your labels by referring to the FDA website. Use FDA resources (Code of Federal Regulations, FDA Guidance Documents, and FDA's Food Labeling Guide) and contract with Food Consulting Company for Ongoing Regulatory Support to get expert advice as needed.

• Refer to FDA's food labeling resources (Code of Federal Regulations, FDA Guidance Documents, and FDA's Food Labeling Guide) for detailed information on labeling requirements and proceed to produce your product label. Submit your final label work to Food Consulting Company for Label Compliance Review to assure FDA compliance.

Can I use my product label to tell how my food fits into MyPyramid guidelines?  (May 2007)

FDA has not issued formal guidance on using MyPyramid on food labels, but in conversations with Food Consulting Company the Agency has referred to USDA's guidance document to explain how MyPyramid can be used on FDA-regulated food labels.

In 2005 USDA published a Statement of Interim Policy Guidance entitled "Use of the USDA MyPyramid Reference on Meat and Poultry Labeling and Whole Grain Claims."

In part, the USDA guidance advises labelers:

• MyPyramid replaced the Food Guide Pyramid in 2005; food labels referencing the old graphic (Food Guide Pyramid) need to be revised to eliminate this outdated reference.

• MyPyramid uses discreet numbers in common household measure, i.e., cups and ounces (not numbers of servings).

• MyPyramid references on food labels should be based on the 2,000 calorie level when stating the amount the product provides toward the recommendation for a major food group.

• MyPyramid references to whole grain that state or imply a high or increased amount (example, excellent source of whole grains) cannot be used on food labels. However, truthful and not-misleading statements of fact that do not characterize the specific level of whole grains can be used.

For more information on FDA food label claims, see the Center for Food Safety and Applied Nutrition webpage at http://www.cfsan.fda.gov/~dms/lab-hlth.html, or contract with Food Consulting Company for One-time or Ongoing Regulatory Support.

If a product does not contain any allergens should you still put "Allergens: Contains none" on the label?  (April 2007)

Allergen labeling of foods is required by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). The Act identifies the "big eight" food allergens (milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans) and specifies how labeling is to be done. According to the Act, a "Contains" statement is not required to indicate the presence of allergens as long as allergens that are present within the package are listed by common or usual name in the ingredient statement.

Furthermore, the statement "Allergens: Contains none" risks being misleading and therefore discouraged. The "big eight" allergens account for 90 percent of food allergies and it would not be wise to suggest that a product does not contain any of the other possible allergens.

I manufacture spreads in collaboration with a restaurant and the restaurant name is the prominent name on the label. Whose address should be used in the label signature line?  (March 2007)

Either entity’s name with address can be used in the signature line.  If the restaurant name/address is used, it needs to be preceded with the words "Manufactured for" or "Distributed by" or similar wording that expresses the facts.  If the manufacturer's name/address is used, no lead-in is necessary.

For reference, this question is covered in the Code of Federal Regulations (21CFR101.5).

I would like to import a product from Europe for sale in both the USA and Canada; what should I be aware of so that my label will be allowed in both countries?  (February 2007)

It is not possible to create one label that will satisfy both USA and Canadian labeling requirements because: each country has different requirements for formatting the Nutrition Facts, the rounding rules are different, in some cases the units for reporting nutrients differ, and the countries have established different Daily Values for some nutrients.

Also, the requirements for ingredient/allergen declarations are different, and there are some differences relating to net contents statements, nutrition/health claims, and other aspects of the label.
 

I'm launching my first food product; I have heard about a small business exemption for nutrition labeling. How can I find out if I qualify?  (January 2007)

FDA explains the small business exemptions for nutrition labeling at www.cfsan.fda.gov/~dms/sbel.html. In brief, the product launcher may use the exemption if the product will be sold only by retailers that have total annual gross sales of not more than $500,000, or annual gross sales of foods of not more than $50,000. A low volume exemption might apply if the product launcher/company meets certain requirements for number of employees and number of product units that are sold annually in the United States. For some exemptions, a notice must be filed annually with FDA.

When considering an exemption for nutrition labeling it is very important to understand that product labels must still be in compliance with other FDA labeling regulations such as, but not limited to, ingredient statement and allergen labeling.

Also, if any nutrient content claim (e.g., "low fat"), health claim, or other nutrition information is provided on the label, or in packaging or advertising, the small business exemption is not applicable for the product.

Product launchers who choose to forego the small business nutrition labeling exemption, and instead opt to include Nutrition Facts:

• better meet consumers' expectations for product information; consumers are accustomed to knowing such things as servings per container and serving size, calories and fat grams per serving, etc. They will wonder why the nutritional information isn't on the label and consequently may lose interest in the product.

• position the new product as one that is intended to have a serious market presence.

• enable the company to highlight nutrition information in labeling and advertising.

• open more doors for product distribution; many retailers will not be able to carry products that are not labeled with Nutrition Facts.

• make a smart up-front investment; once the Nutrition Facts label is developed, it is good for thousands of product unit sales.

If MSG is a sub-ingredient of an ingredient I use and is present in a very small amount in my product, do I have to list it on my label?  (December 2006)

Yes, FDA requires that all ingredients, including sub-ingredients that have a functional or technical effect, be included within the ingredient statement. Monosodium Glutamate (MSG) always has a functional or technical effect (flavor enhancement) and so it must be listed.

If a company does not want to include monosodium glutamate in the ingredient statement, then the manufacturer should look for an ingredient to purchase that does not contain this flavor enhancer.

Note: Monosodium Glutamate must be listed by its full name; MSG as an abbreviated acronym is not acceptable.

If my product does not contain significant amounts of one or more of Vitamin A, Vitamin C, Calcium, and Iron, can I report other vitamins/minerals in this space?  (November 2006)

Yes, labelers can voluntarily list other vitamins and minerals that naturally occur in a food and for which a Reference Daily Intake (RDI) or Daily Reference Value (DRV) has been established, regardless if the four required vitamins/minerals (Vitamin A, Vitamin C, Calcium, and Iron), are or are not listed in the table of nutrient values.  The voluntarily declared values are to be listed after the required vitamins/minerals and in a specific order.

Nutrition labeling laws require that Vitamin A, Vitamin C, Calcium and Iron be declared in the table of nutrient values in the Nutrition Facts.  However when any or all of these nutrients is/are present at "zero" levels in a food (defined as less than 2% of the RDI), then the "not a significant source" statement can be used instead of separate line items; the "not a significant source" statement must be placed directly beneath those vitamins/minerals that have been listed in the table of nutrient values.

Any vitamin or mineral that is added as a nutrient supplement or for which a claim is made in labeling or in advertising must be declared in the table of nutrient values.

Which is best for getting nutrient values for my product, laboratory or database analysis?  (October 2006)

FDA does not require a specific method of analysis for Nutrition Facts, but the Agency does require label values to be accurate within the tolerances specified in the Code of Federal Regulations.

When performed correctly, the database method is typically a better predictor of the nutritional analysis from multiple production runs than a single laboratory analysis. This is because the database method uses the statistical average for commodity products that can vary with growing conditions and other factors. FDA actually encourages the use of nutrient databases as a low-cost alternative to laboratory analysis. In fact nearly all Food Consulting Company clients choose this approach; exceptions are for products that contain ingredients for which nutrient data is not available or for foods that undergo processing where the nutrient changes cannot be confidently predicted.

When you select database analysis you will provide your product formulations, raw material specifications, and processing information to us under strict  confidentiality. We will analyze your product to determine the 100-gram data.

With laboratory analysis you will provide us with the 100-gram data lab report. Contact Us if you need a referral for a new lab analysis.

In both cases we use the findings of the analysis to develop the Nutrition Facts panel for your product. As part of this work we determine the FDA-regulated serving size and servings per container, then calculate the nutrient profile per serving, apply the rounding rules, and determine percent daily values for the required Nutrition Facts panel components. Finally we produce a camera-ready Nutrition Facts panel formatted according to your package dimensions and FDA specifications. This is what you provide to your printer, artist, or package designer.
 

I'm planning to sell my products by internet. Do I need a Nutrition Facts Panel?  (September 2006)

Yes. There are no special provisions for internet/mail order sales. By law, all foods sold in the U.S. must be in full compliance with FDA nutrition labeling requirements that are specified in the U.S. Code of Federal Regulations, regardless of the method of sale.

For reference, this question is covered in FDA's Food Labeling Guide (http://www.cfsan.fda.gov/~dms/flg-toc.html).
 

What is FDA's stand on GMO labeling?  (August 2006)

In consumer and industry press, GMO is the commonly-used acronym for Genetically Modified Organisms. GMO foods are those produced through bioengineering. FDA guidance  states that the agency has "no basis for concluding that bioengineered foods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding."
 

FDA position on label statements about foods that are not genetically-modified
FDA does not generally allow food labeling such as "GMO-free" because this would imply that the absence of bioengineering makes a product safer or superior to comparable products. FDA has indicated that statements about foods that do not contain ingredients produced from bioengineered foods could avoid or minimize such implication by using the following statement: "We do not use ingredients that were produced using biotechnology."
 

FDA position on label statements about foods that are genetically-modified
FDA does allow manufacturers to use informative statements in labeling of foods that contain ingredients produced from bioengineered foods, e.g., "Genetically engineered" or "This product contains cornmeal that was produced using biotechnology." These statements are optional. However, if a bioengineered food is different in any way from the food it resembles (e.g, nutritional, organoleptic, or functional characteristics), then FDA requires that the label states how the food is different. The example FDA cites is high oleic acid soybean oil from soybeans developed using biotechnology to decrease the amount of saturated fat.

FDA's bottom line on GMO labeling (as on all food labeling) is that a food cannot be misbranded in any way. A food is misbranded if its labeling is false or misleading.
 

Where can I find information on the U.P.C. barcode?  (July 2006)
 

The U.P.C. barcode is not a regulatory requirement, but as a practical measure it should be included on your food label. Retailers will generally not stock your product without it. The first step in getting a barcode is becoming a member of GS1 US Partner Connections (previously Uniform Code Council). Once you become a member, you will receive a company prefix for use in creating your own U.P.C. barcodes. See www.uc-council.org for more information.
 

Food Consulting Company offers this free service to help clients and site visitors get answers to important questions. To get a personalized, timely answer to your one-time question or for ongoing regulatory support, see Services.

Each month, the Food Label News editor chooses a new question to be answered as space permits. Submitters of the top three questions during the current calendar year (in terms of value and broad appeal to Food Label News readers) will be acknowledged with a $25 thank you check in January of the following year.  [Submit Your Question]