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Timestamp: 2018-11-16 21:22:27
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Reader Q+A | foodlabels
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Nutrition Facts Rounding Rules | Use up Existing Labels? | Hangtags | Sub-ingredients for Baking Powder | Incomplete Data for Nutrition Facts | Organic Labeling
What are rounding rules for actual quantities and % Daily Values for all mandatory nutrients declared in the Nutrition Facts label, per the new 2016 regulations? (June 2017)
Nutrients that were not changed in the 2016 Nutrition Facts label regulations follow existing rounding rules. Added Sugars follow the same rounding convention as Total Sugars, and FDA has released Draft Guidance with recommended rounding increments for Vitamin D, Calcium, Iron and Potassium.
See a quick one-pager on FDA rounding rules.
Can you use existing labels if a raw material changes? (May 2017)
Can I attach a tag to a jar of fruit spread since I do not have room for a conforming Nutrition Facts label? (April 2017)
Manufacturers are not required to include a Nutrition Facts label on a package that has less than 12 square inches of available label space (jar sides and lid) provided: 1) no nutrition claims are made on the label or in advertising and 2) no extra label space was added via hang tag or any other means. In this case, an address or phone number must be provided (e.g., "For nutrition information call 1-800-123-4567") so that consumers can obtain the nutrition information upon request.
Two of my frozen bread formulas include baking powder although my ingredient list does not include the sub-components of the baking powder (sodium bicarbonate, potassium tartrate, cornstarch). Do the sub-ingredients need to be included within the ingredient statement in the U.S.? (March 2017)
I want to use the new Nutrition Facts format now but cannot get all the required values from my ingredient suppliers. Do ingredient suppliers have the same compliance dates for new label regulations (7/26/18)? In the interim, can I note on the label that Potassium and Vitamin D are unavailable? (February 2017)
The new nutrition label regulations pertain to manufacturers and distributors that sell food at retail. Ingredient suppliers who do not sell food at retail are not obligated to provide this information. Because partial values are not allowed within a Nutrition Facts (either original or new), you can only adopt the new format once you have values for Potassium, Vitamin D and all other required nutrients.
The reality is that ingredient suppliers will begin making this nutrition information available earlier than the compliance dates recognizing that it is necessary to satisfy their customer requirements. Compliance dates are July 26, 2018, for manufacturers with $10 million or more in annual food sales and one year later for manufacturers with less than $10 million in sales. You will want to request this information from your ingredient suppliers now if you wish to phase into the new Nutrition Facts format ahead of schedule.
Can we say "made with organic ingredients" on the front label if the product is made with 80% organic ingredients? (January 2017)
The National Organic Program has set strict production and labeling requirements for four categories of products with organic claims based on the percent of organic ingredients.
- "100% Organic" must contain only certified organic ingredients
- "Organic" must contain at least 95% certified organic ingredients
- "Made with organic [insert up to three ingredients or ingredient categories]" must contain at least 70% certified organic ingredients
- Processed products with less than 70% certified organic ingredients may identify the specific ingredients that are organically produced in the ingredient statement but may not use the term "organic" on the front of the package.
Food labelers who want to include any mention of organic on their labels should consult the National Organic Program rules to understand the full requirements.
Recycling Claims | Labeling Flavors | When is Lab Nutrition Analysis Recommended | When to Use "Contains 2% or Less" | Defining Whole Grains | Net Contents in Canada | Restaurant Menu Labeling Postponed | Is a U.S. Address Required on Food Labels | Organics Free of GMOs? | Use of the Term "Fresh" | "About" in the Serving Size? | "Hand-crafted" on an FDA Product
What are the allowable recycling claims that can be put on my label for a composite can made of paperboard with steel ends? (December 2016)
According to the Federal Trade Commission (FTC), a recycling claim for a food package containing multiple components is acceptable provided the package has clear instructions for consumers about which pieces are recyclable. If a package requires disassembly before recycling, it is necessary for specific directions to also appear on the label. FTC has issued documentation called "Green Guides" to assist marketers with claims about the environmental attributes of their products that are truthful and non-deceptive. See FTC's website for the most recent version of the "Green Guides".
If I'm using a natural caramel flavor for a muffin I'd like to call a "Caramel Muffin", how do I indicate on the front of the package that it's flavored and not formulated with actual caramel? (November 2016)
When natural flavor is used in a formula instead of the actual ingredient that the flavor is derived from, the product must be labeled as "naturally flavored" or "flavored" immediately adjacent to the actual ingredient. Therefore, in your example, the product must be called "caramel flavored muffin" and simply "caramel muffin" is not acceptable. This requirement applies to every location where the flavor name is listed on the package (other than the ingredient list).
"Flavored" may be in a smaller type size but not smaller than ½ the size of "Caramel" and in no instances less than 1/16th of an inch in height. When both upper and lowercase letters are used, base the type size requirement on the lowercase letter "o". This will assure that all letters are large enough.
When is lab nutrition analysis recommended? (October 2016)
FDA requires Nutrition Facts label values to be accurate within the tolerances specified in the Code of Federal Regulations, but does not require a specific method of analysis to determine the values. When performed correctly, database analysis is typically a better predictor for nutrient values as it uses the statistical average for commodity ingredients. There are, however, certain situations that may warrant lab testing.
Lab analysis is a snapshot of nutrient values for a single sample, representing a single point in time. As a result, be cautious when using lab testing to determine Nutrition Facts label values and consider multiple testing points throughout the year to capture variability in your ingredients and process.
In some instances, lab analysis is recommended:
Unique ingredients for which nutrition data is not available
Special processing that affects nutrient composition when the changes cannot be confidently predicted
Tool for validation of extensive nutrient content claims
Tool for assessing effect of shelf life on product claims (e.g., vitamin loss)
The lab analysis can then be analyzed against and incorporated into database results, creating a robust analysis of Nutrition Facts label values.
If our ingredient supplier provided us with an ingredient statement that includes "contains 2% or less of each of the following: ...", is it ok for us to simply list all of the ingredients in our ingredient statement or is the "contains 2%" phrase required? (September 2016)
The Code of Federal Regulations requires that ingredients be listed in descending order by weight in the formula unless they are present at 2% or less (and then they can be in any order following the "contains 2% or less" phrase). In your example, when a formula has an ingredient that uses the "contains 2% or less" phrase for sub-ingredients, it is not acceptable to remove the phrase unless your supplier provides you with the exact order of predominance.
If the ingredient supplier provides additional formula information, it is often possible to develop more concise, consumer-friendly ingredient statements. For example, it may be possible to remove the collective name of an ingredient and list all sub-ingredients separately within the overall ingredient statement. Also, in situations where two or more ingredients use the "contains 2% or less" phrase, it is often possible to combine some or all of these sub-ingredients into an overall "contains 2% or less" phrase for the recipe. Beware: these options often require extensive calculations and knowledge of food labeling regulations.
Does a product need to be made of 100% whole grain to be labeled as "whole grain" or does it just need to have a certain percentage? (August 2016)
FDA specifies that a product labeled "whole grain" be made from 100% whole grain ingredients. This is based on the 2006 Draft Guidance for Industry in which FDA asserts that products labeled with "100 percent whole grain" not contain grain ingredients other than those the Agency considers to be whole grains (contains all the parts of the grain, i.e., the bran, endosperm and germ). For example, bread labeled as "whole grain" or "whole wheat" can only be labeled as such when it is made entirely from whole grain flour or whole wheat flour, respectively.
As an alternative to a simple whole grain claim, manufacturers can make a factual statement about the level of whole grain in a product (e.g., 10 grams of whole grain per serving). This type of statement can be used even when less than 100% of grains in a product are whole.
What are the rules about declaring net contents in Canada? (July 2016)
Canadian food labels must express net quantity declarations in metric units of measure. Non-metric units may also be used as long as the metric is placed first and there is no intervening information between the two including marks, punctuation, parentheses or brackets.
When declaring volume it is permissible to use U.S. fl oz as long as they are clearly indicated on the packaging. Note: when calculating metric volume from U.S. fl oz, 1 U.S. fl oz = 1.041 Canadian fl oz and 1 Canadian fl oz = 29.574 mL.
I heard that FDA has postponed the requirement date for restaurant menu labeling. Is this true? (June 2016)
Yes, it was postponed and the revised compliance date for restaurant menu labeling is May 5, 2017. As part of the Affordable Care Act in 2014, FDA finalized rules that require restaurants and similar food establishments to provide nutrition information to consumers. The original compliance date was December 1, 2015. However, the omnibus appropriations bill passed through the House and Senate in December 2015 required FDA to issue final guidance on menu labeling before setting a compliance date. The final guidance was published in the Federal Register on May 5, 2016, resulting in a compliance date of May 5, 2017 - one year from the date of publication.
I have heard that you always need to have a U.S. address on your food label but I can’t find the regulation that requires this. Can you clear this up for me? (May 2016)
21 CFR 101.5 states that the manufacturer, packer or distributor name and place of business must be displayed prominently on every food label. If a product is manufactured outside the U.S., it is acceptable to label the address of its origin including the country name. However, there is also a mandate specific to dietary supplements in Section 403(y) of the FD&C Act [21 U.S.C. 343(y)] referenced in FDA guidance that requires a U.S. domestic address or phone number for the purpose of adverse event reporting.
I would like to know the federal law requiring that organic food products be free of "any" genetically modified seed or ingredients. Is there such a law? (April 2016)
Yes, National Organic Program rules specify that genetic engineering (GE) is prohibited for products that claim Organic on food labels. In fact, USDA organic regulations require that farmers and processors show they do not use GE seeds or ingredients and they are protecting their products from cross-contact with these substances. USDA's National Organic Program certification takes extra care to ensure that production standards and manufacturing practices are followed.
Provided all aspects of the organic product and handling process are followed correctly, the product’s status is Organic – even if there is an inadvertent presence of GE material. There, however, is no tolerance level for the inadvertent presence of a GE seed or ingredient. If such material is detected, the certifying agency is responsible for working with the organic producer to identify the source and implement steps to avoid future contact.
Are there any regulations governing the use of the term "fresh" as part of a brand name, e.g., "Fresh Expressions"? (March 2016)
FDA defines the terms fresh, freshly frozen, fresh frozen and frozen fresh in the Code of Federal Regulations. "Fresh" conveys that the food is unprocessed - this means that the food is in its raw state and has not been frozen, subject to thermal processing or any other form of preservation. This applies to all label claims including the brand name.
The regulation specifically allows for the term fresh to be used on foods that contain added waxes or coatings, use approved pesticides post-harvest, are washed with a mild chlorine or acid solution, are raw foods treated with ionizing radiation, require refrigeration, or are widely recognized by consumers to be pasteurized (for example, milk). Reference: 21 CFR 101.95.
Are words like "approximately" or "about" allowed in the serving size for Nutrition Facts labeling? For example, "approx. 3 cookies" or "about 3 cookies"? (February 2016)
The term "about" or "approximately" should not be used for serving size declaration when there are discrete units in a multi-serving package. For packages with discrete units such as cookies, the weight of one cookie and the Reference Amount Customarily Consumed (RACC) is used to determine the correct serving size.
The RACC for cookies is 30g. When the weight of one cookie is 50% or less of the 30g RACC, then the serving size is the whole number of cookies closest to 30g. For example, if one cookie weighs 11g the serving size would be "3 cookies (33g)." Reference: 21 CFR 101.9(b)(2)(i).
Is there regulation against using the phrase "hand-crafted" for an FDA packaged product? (January 2016)
"Hand-crafted" can appear on the principle display panel for an FDA-regulated food provided it accurately reflects the facts and does not mislead consumers. You will want to be sure that your processes are consistent with what hand-crafted is generally understood to mean. Note that misuse of this type of label statement is more likely to garner FTC attention because it is related to advertising and product promotion.
Statement of Identity | Ingredient Statement Descriptors | Viscous Hot Sauce | One Label for U.S. & Mexico? | Phase-in for Label Changes? | %DV for Protein in Canada | %DV for Protein in U.S. | Maxing Out Food Additives | DVs for Vitamins & Minerals | "Low Carb" Claims? | Accuracy Requirements for Supplement Facts | Declaring a Propylene Glycol-based Flavor
I know there are requirements for the "statement of identity" but what part of the product name counts as the "statement of identity"? I can’t find a definition for that term. (December 2015)
I have a product that is made with hand-peeled green chiles. Is it allowable to list it as "Hand-Peeled Green Chiles" in the ingredient statement, or is only "Green Chiles" acceptable? (November 2015)
21 CFR 101.4 states that the common or usual name must be used in ingredient labeling. In this case, the common or usual name is "green chiles." Descriptions such as hand-peeled, pure, extra premium and Grade A, are not acceptable for use in ingredient statements.
You may, however, add a starburst or other graphic call out on the principle display panel that states "made with hand-peeled green chiles." This allows you to include important marketing messages and product features and still maintain a compliant ingredient statement.
I have a viscous hot sauce. Should it be labeled by weight or volume? (October 2015)
21 CFR 101.105 states that if the food is liquid, the statement shall be in terms of fluid measure; if the food is solid, semisolid, viscous, or a mixture of solid and liquid, the statement shall be in terms of weight. In general, these regulations are designed to help consumers evaluate their cost/value without confusion.
Exceptions are possible: if there is a well established custom of declaring liquid by weight, or a solid, semisolid or viscous product by volume, it may be used.
Can I create a single label for my food product that will work for distribution in both U.S. and Mexico? I know it would need to be in both English and Spanish. (September 2015)
Until recently this was allowable for some circumstances. However, several changes in Mexico's NOM-051 regulations as of August 2014 no longer make it possible to create one label that will satisfy both countries' requirements.
My supplier changed one of the ingredients we use in our product, resulting in small changes to our ingredient statement and nutrition facts. Is there any phase-in period so that we don't have to discard the packaging we have in stock? (August 2015)
There is no phase-in period for new labels, as they must accurately reflect the contents of the package. However, under certain circumstances FDA will agree to enforcement discretion on a case-by-case basis.
Very minor changes to the nutrition facts and/or ingredient statement (with no affect on allergens) may qualify for FDA enforcement discretion where the agency could allow a phase-in period for labels. You must request and get approval to this special circumstance.
To request enforcement discretion from FDA, submit name of product(s), current labels and proposed label changes, number of current labels, dollar amount of inventory, estimated time to use current inventory, and an explanation about why enforcement discretion is requested. Submit requests to Felicia Billingslea (HFS-820) at 5100 Paint Branch Parkway, College Park, MD 20740 or email to felicia.billingslea@fda.gov.
Last month you covered % Daily Value for Protein in U.S. Are there differences for Canada? (July 2015)
To determine the Protein Rating you need two pieces of information: 1) Protein in a Reasonable Daily Intake and 2) Protein Efficiency Ratio.
Protein Rating = Protein in a Reasonable Daily Intake x Protein Efficiency Ratio
Reasonable Daily Intake is determined through a hierarchy of sources 1) a direct listing from Schedule K of the Food and Drug Regulations, 2) use of the Reference Amount found in Schedule M of the Food and Drug Regulations, 3) consultation with Health Canada on a case-by-case basis. Once obtained, the Reasonable Daily Intake is multiplied by the percentage of protein in the food. This part of the equation is generally relatively straightforward.
If Protein is listed at 5g on the Nutrition Facts Panel and the Daily Value (DV) for Protein is 50g, why is the %DV less than 10%? Isn’t 5g equal to 10% DV? (June 2015)
The percentages vary because calculating %DV for protein is not a simple mathematical calculation. Rather, it is the actual amount of protein per serving multiplied by the amino acid score corrected for protein digestibility, known as Protein Digestibility Corrected Amino Acid Score (PDCAAS). The resulting PDCAAS value is then divided by the 50g DV to determine the %DV for
PDCAAS uses two pieces of data, both of which vary from protein to protein:
1) Amino acid composition of the protein – A complete protein contains all of the essential amino acids required for human nutrition while an incomplete protein lacks one or more of the essential amino acids.
2) Digestibility of the protein – Values are based on published data, where highly digestible proteins have a higher value than those with lower digestibility.
Once both pieces of information are considered, the final PDCAAS value is a range from 0 to 1, where 1 is the highest quality protein. For example, milk protein and egg whites have a PDCAAS value of 1. To calculate the PDCAAS for a mixed food product, the mixed food amino acid score is multiplied by the mixed food protein digestibility value. Note: The listing of %DV for protein in Nutrition Facts is only required when protein claims are made or when the product is intended for children under 4 years of age. For products intended for children 1-4 years of age, the %DV for protein is based on PDCAAS. For products intended for infants (up to 12 months), the %DV for protein is based on a completely different methodology: Protein Efficiency Ratio (PER).
The Code of Federal Regulations (CFR) defines threshold amounts for individual anti-caking agents (silicone dioxide: 21 CFR 172.480; calcium silicate: 21 CFR 172.410). The CFR does not address a combined value, however the general provisions for direct food additives (21 CFR 172.5) state that the level must "not exceed the amount reasonably required to accomplish its intended technical effect in food."
Of interest, Part 172 of the CFR references Food Additives for Direct Addition to Food for Human Consumption. Within Part 172 is Subpart E for Anticaking Agents with the specifics for calcium silicate and silicon dioxide. Part 184 of the CFR references Direct Food Substances Affirmed as Generally Recognized as Safe (GRAS), and 21 CFR 184.1(d) states "The listing of more than one ingredient to produce the same technological effect does not authorize use of a combination of two or more ingredients to accomplish the same technological effect in any one food at a combined level greater than the highest level permitted for one of the ingredients." Because the anti-caking agents you ask about are included in Part 172 for food additives and not Part 184 for GRAS ingredients, Part 172 is most germane in answering this question. However the conservative approach would be to follow the direction in the GRAS section for food additives as well, ensuring the combined value does not exceed the highest level permitted for one of the ingredients.
Yes, this can be found in 21 CFR 101.9. In addition, see Quick References for a helpful one-pager that shows the differences between current and proposed regulations for U.S. Nutrition Facts Labels.
Despite being on the regulatory agenda nearly a decade ago, FDA has still not defined nutrient content claims for carbohydrates. Therefore, it remains not allowable to use the words "free" or "low" (or their synonyms) to describe carbohydrate levels. For example, no carbs, carb free, and low carb are unauthorized nutrient content claims and are not permissible.
"Xg carbs per serving" is allowed as a statement of fact as long as it is simply a repeat of information from the Nutrition Facts Panel and does not include qualifying language. For example, "Just 3g carbs per serving" or "Only 3g carbs per serving" implies that the level is low and is therefore not permitted.
To read earlier reports from Food Label News on this topic, enter "carb" in the search box.
We are using a Propylene Glycol based flavoring in our candy. What does the ingredient statement need to say? (January 2015)
Your propylene glycol-based flavoring will either be declared as a natural flavor or an artificial flavor, based on definitions found in 21 CFR 101.22 (a)(1) and (3). If the propylene glycol functions solely as a flavor carrier, then it becomes incidental in the final food and therefore does not need to be included in the ingredient statement for your candy. If however, the propylene glycol found in the flavoring continues to function in the finished product, then it must be declared within your candy's ingredient statement.
Allowable Net Weight Variances | And/or Ingredient Labeling | Signature Line Qualifiers | "Margarine" in Canada | Net Weight for Lollipops | Calories on Supplier Spec Sheets | %DVs for Omega-3s | Product Naming for Juice Drinks | Requirement to Disclose Function of Additives | %DV for Nutrition Facts | Rounding for Nutrition Facts Servings Per Container | Options for Signature Line
In both U.S. and Canada, is there an acceptable upper limit variance for the declared net weight? For example, if your declared net weight is 100 grams, can your package contain 130 grams and still be compliant? (December 2014)
In both countries, the allowable variance (both plus and minus) for the net quantity of contents statement depends on the declared weight or volume. For a package with a declared net weight of 100g, the allowable variance is +/- 7.2g for U.S. and +/- 4.5g for Canada.
In the U.S., allowable net weight tolerances are established in NIST Handbook 133, Appendix A, Table 2-5. See a previous Reader Q&A for more details on U.S. tolerances for net weight statements.
In Canada, allowable net weight tolerances are detailed in Section 38 of the Consumer Packaging & Labelling Regulations, Schedule I, Part III.
FDA does not give permission to use "and/or" ingredient labeling for calcium caseinate, milk protein concentrate, or milk protein isolate. If all three are listed in the ingredient statement, all three must be present in the product.
Per 21 CFR 101.4, FDA allows "and/or" labeling for specific groups of ingredients for manufacturing flexibility: fats and oils that are not the primary ingredient, leavening agents, yeast nutrients, dough conditioners, firming agents, wax/resin and fish protein ingredients. For those ingredients that qualify for "and/or" labeling, any one or combination of the ingredients may be present in the product.
The net weight statement is always based on the edible portion of the food only. In your case, the net weight statement would include the candy only and not the wrappers, sticks, or other packing materials. Reference: Code of Federal Regulations 21 CFR 101.105(g).
Per FDA regulations at 21 CFR 101.9(c)(1), the calorie content may be determined by five different methods. Total carbohydrates minus the total value for dietary fiber is not allowable if the dietary fiber consists of both soluble and insoluble fibers.
The most accurate approach is to use an adjusted 4-4-9 calculation (one of the five approved methods). In this approach, just the insoluble fiber is subtracted from the total carbohydrate value before multiplying by 4 kcal per gram since insoluble fiber does not impact the calorie value of foods.
It is acceptable to use a simple 4-4-9 calculation however this would yield a higher calorie value if insoluble fibers are present. For more information on calorie calculations see a previous Food Label News article.
You are correct, FDA has not established RDIs or DRVs for any of the Omega-3 Fatty Acids, therefore it is not compliant to show a % Daily Value within the Supplement Facts box. On April 28, 2014 (after you submitted your question), FDA issued a Final Rule prohibiting most Omega-3 Fatty Acid claims but indicated that the agency will not take enforcement action against companies using certain ALA claims based on the earlier Martek notification. In this ruling, FDA did not establish any Daily Values (DVs) for Omega-3s.
As you can see in the FDA Final Rule, the Martek notification uses 1.6g/day as a condition for making an ALA claim. However, the ruling does not specify that this 1.6g/day value can be used as an FDA-established value for calculating % Daily Value.
Of interest to food labelers and marketers, it is always permissible to include a factual statement about the quantitative amount of any nutrient, including Omega-3s, on a product label as long as it is truthful and not misleading. For dietary supplements, this quantitative amount (but not a %DV amount) can be included as a “below the bar” nutrient within the Supplement Facts Panel, but products labeled as conventional foods are not allowed to contain the Omega-3 quantitative amount anywhere within the Nutrition Facts Panel.
If a product contains either 1% juice or no juice at all, can the word "juice" be included on the label? I thought it had to contain 100% juice, yet I see several brands of kids’ drinks that don’t follow this rule. Are these labels in compliance? (May 2014)
For products that include more than 0% and less than 100% juice and include "juice" in the product name, the word "juice" must be qualified by a descriptor such as "drink," "cocktail," or "beverage" to differentiate it from 100% juice. For example: juice drink, juice cocktail, or juice beverage. A drink with 0% juice cannot include "juice" in the product name.
When does the function of an additive need to be included in the ingredient statement and what differentiates an incidental additive from an approved chemical preservative? I note that 21 CFR 101.100 states that incidental additives with no technical or functional effect are exempt from labeling, whereas 21 CFR 101.22(j) states that approved chemical preservatives "must include both the common or usual name of the preservative and the function of the preservative." (April 2014)
Ingredients added as chemical preservatives must always be declared by both name and function in the Ingredient Statement, i.e., potassium sorbate (to preserve freshness).
When a chemical preservative is present in a sub-ingredient, it could be considered incidental to the finished product if it loses its functionality as a preservative in the finished product. In this case, you are not required to declare it. If you are unsure about an ingredient's functional effect in the finished product, we advise that, "when in doubt, call it out." For other Reader Q&As on this topic, see here, here and here.
U.S. regulations require that percent Daily Values (%DV) of certain nutrients be displayed within the Nutrition Facts Panel. This is independent of the product’s net weight or size.
There are two categories of nutrients that require %DV. In each category there are nutrients that must be displayed within the Nutrition Facts Panel (Mandatory) and those that are generally optional (Voluntary).
1) Nutrients that require both quantitative amount and %DV: Mandatory nutrients include Total Fat, Saturated Fat, Cholesterol, Sodium, Total Carbohydrate and Dietary Fiber (Protein requires %DV when a protein claim is made). Voluntary nutrients includes Potassium.
2) Nutrients that require only %DV: Mandatory nutrients include Vitamin A, Vitamin C, Calcium and Iron. Voluntary nutrients include Vitamin D, Vitamin E, Vitamin K, Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Biotin, Pantothenic Acid, Phosphorus, Iodine, Magnesium, Zinc, Selenium, Copper, Manganese, Chromium, Molybdenum and Chloride.
If your calculations yield an unrounded number of 3.89 Servings Per Container, then you should report the Servings Per Container as "about 4" within the Nutrition Facts Panel. Note use of the word “about” to signify a rounded number. If however your unrounded number of Servings Per Container is calculated as 3.69, then you would report the number of servings as "about 3.5" within the Nutrition Facts Panel.
On the product label, our company information has been stated as Manufactured for (Company Name), Address. Is it possible to add some phrase such as "under exclusive license" in the middle, so it will come out as: Manufactured under exclusive license for (Company Name)? (January 2014)
Yes. The Code of Federal Regulations has no restrictions for adding this type of language to the distribution information as long as it is truthful and not misleading.
Nutrition Facts Layout Options | Labeling Trace Ingredients | Are Spices Gluten-Free? | Abbreviations for Organic? | Honey as Vegan? | Allergen Cross-contamination | Net Weight Tolerance | Nutrition Facts Dual Declaration | Ingredient Minimums for Labeling | Nutrition Facts for Children | Multiple Single-serve Pouches | Organic Labeling for Certification Agency
Can I choose to use either a tabular/horizontal or linear Nutrition Facts panel instead of the standard panel due to space availability on a particular product? Does FDA have any terms or conditions for using this? (December 2013)
Yes. FDA allows for flexibility in presentation of the Nutrition Facts based on package size. If the standard/vertical layout does not fit and/or the package has less than 40 square inches of total space available for labeling, there is a hierarchy of options you may consider.
If the standard/vertical layout does not fit and a package is larger than 40 square inches of total space available for labeling, then your first choice is to consider the side-by-side/split layout. If this layout also does not work, then you may opt for the tabular/horizontal layout.
If a package is smaller than 40 square inches of total space available for labeling, then you may use the shortened Daily Values footnote, approved abbreviations, and/or the Not a Significant Source statement in either the vertical or horizontal orientation. Very small packages that will not accommodate either the vertical or horizontal column display may use the linear layout. See examples of Nutrition Facts Labels based on package size in Quick References.
We are using a tiny amount of tricalcium phosphate (~0.2%) in the production of one of our sugar products that we sell retail. The purpose of this ingredient is to aid in process flow. Do we need to list tricalcium phosphate on the finished product label? (November 2013)
There are situations where ingredients are added and need not be declared on the finished product label because they qualify as incidental additives or processing aids. See Reader Q&A May 2010 for complete definitions.
A client with celiac disease who is carefully following a gluten free diet has concerns about ingredient labeling when he sees the word "spices". Does he need to avoid foods that have "contains spices" on the ingredient label? (October 2013)
Spices are by definition gluten-free. A consumer following a gluten-free diet can feel comfortable eating food that contains spices, provided the manufacturer is reputable and has followed all FDA labeling requirements. If in doubt, a consumer can always call the company's customer service line to verify.
FDA defines spices as "any aromatic vegetable substance in the whole, broken, or ground form, except for those substances which have been traditionally regarded as foods, such as onions, garlic and celery; whose significant function in food is seasoning rather than nutritional; that is true to name; and from which no portion of any volatile oil or other flavoring principle has been removed. Spices include the spices listed in 182.10 and part 184 of this chapter, such as the following: Allspice, Anise, Basil, Bay leaves, Caraway seed, Cardamon, Celery seed, Chervil, Cinnamon, Cloves, Coriander, Cumin seed, Dill seed, Fennel seed, Fenugreek, Ginger, Horseradish, Mace, Marjoram, Mustard flour, Nutmeg, Oregano, Paprika, Parsley, Pepper, black; Pepper, white; Pepper, red; Rosemary, Saffron, Sage, Savory, Star aniseed, Tarragon, Thyme, Turmeric. Paprika, turmeric, and saffron or other spices which are also colors, shall be declared as ‘spice and coloring’ unless declared by their common or usual name." (21 CFR 101.22)
If a spice blend contains added ingredients (for example salt or sugar, or a carrier such as wheat starch) then those ingredients must be called out separately in the ingredient list and any allergens need to fully comply with the allergen labeling requirements.
My client wants to use OG as an abbreviation for organic in the ingredient statement (for example, stating OG Cocoa Butter instead of Organic Cocoa Butter). They said someone from the confectionery field told them that this type of abbreviation was okay. Is that right? (September 2013)
No. There is no provision in the organic labeling rules to abbreviate Organic as OG. Find the National Organic Program rules here. More reader questions about organic can be found here and here.
We have developed a line of Sauces, two of which have honey in the ingredients. We want to have a Vegan call-out on our label. As I researched this online, it appears that many in the Vegan community do not consider honey to be Vegan. Can we legally make a Vegan claim if the product has honey? (August 2013)
Neither FDA nor FTC has any labeling regulations for vegetarian or vegan statements, other than being "truthful and not misleading." There is a popular understanding that honey is not allowed in a vegan diet, although this is a subjective area and may not be consistently adopted. A clarifying "contains honey" statement near the "vegan" call-out would help to ensure that the manufacturer is making truthful and not misleading statements while giving consumers the information they need to make informed decisions.
I'm using dry lentils in a product and the supplier is telling me that lentils are a rotational crop for wheat and therefore may contain wheat. Does this mean that I need to declare wheat in the Allergen Statement? Or is this an incidental additive that would not contribute any meaningful amount of gluten to the finished product? Any insight you could share would be greatly appreciated. (July 2013)
In the case you described, the possible presence of wheat is unintentional. Therefore, listing wheat is not required in either the Ingredient Statement or a separate Allergen (Contains) Statement.
You may wish to include an allergen advisory statement such as "May contain wheat" or "May contain trace amounts of wheat due to rotational crop farming practices." For further information on allergen advisory statements see a previous Reader Q&A. In addition, information can be found in the FDA’s Food Labeling Guide
I need to know what is the allowable weight tolerance for a pre-packaged food product. For example, if we are declaring a net weight of 5 oz. can we sell products with a weight lower than 5.0 oz. in the U.S.? What are the FDA regulations on net weight tolerance? (June 2013)
While FDA does not provide a specific allowable tolerance for Net Weight, this matter could come under FTC jurisdiction. FTC has proposed regulations that would unify USDA and FDA Net Contents labeling and incorporate information found in the National Institute of Standards & Technology (NIST) Handbook 133.
NIST Handbook 133 specifies that the average net quantity of contents in a lot must at least equal the net quantity declared on the label. Plus or minus deviation is permitted when caused by unavoidable variation in weighing and measuring that occur in good manufacturing practice. The maximum allowable variance for a package with a net weight declaration of 5 oz is 5/16 oz. Packages under-filled by more than this amount are considered non-compliant.
FDA requires that nutrition information shown on the package is for the product as sold. You are also allowed to include a second column to the right of the "as packaged" information that shows the "as prepared" values. This is called a dual declaration panel.
For example, if you sell dehydrated potatoes the nutrition information must be for the amount of uncooked dehydrated potatoes needed for one serving. A second column can be added to show the nutritional values when milk and butter are added to make the finished product. See graphic examples of dual declaration Nutrition Facts Labels.
All ingredients that are used in a food must be disclosed in the Ingredient Statement on the label. Ingredients must be listed in descending order of predominance by weight. A statement such as "Contains 2% or less:" may be used at the end of the Ingredient Statement and ingredients thereafter do not need to be listed in order of predominance. Processing aids and incidental additives that have no functional or technical effect in the finished product are exempt from ingredient labeling. See a previous Reader Q&A for more information about incidental additives and processing aids.
While FDA has special requirements for nutrition labeling of products intended for children under the age of 2, children 2 to < 4 years old, and pregnant/lactating women, there are no special labeling requirements for children 4 years old and older. The Daily Values (DVs) to use are those required for the general population.
Reference Daily Intakes (RDIs) vary with age and gender, however FDA has established a single set of Daily Values (DVs) for use in nutrition labeling on products intended for adults and children ages 4 and up. These values are based on the reference caloric intake of 2,000 calories. Reference: 21 CFR 101.9(c)
Saturated Fat, 20 g
Cholesterol, 300 mg
Total Carbohydrate, 300 g
Dietary Fiber, 25 g
Sodium, 2,400 mg
Potassium, 3,500 mg
Vitamin K, 80 mcg
Thiamin, 1.5 mg
Riboflavin, 1.7 mg
Vitamin B6, 2.0 mg
Folate, 400 mcg
Biotin, 300 mcg
Phosphorus, 1,000 mg
Copper, 2.0 mg
Manganese, 2.0 mg
Molybdenum, 75 mcg
Chloride, 3,400 mg
We have 54 single serving pouches each weighing 0.9 OZ that go into a carton. The nutrition facts serving size on the carton is labeled 1 pouch (26g). Which is correct for the net weight statement? (February 2013)
54 – 0.9 OZ (25.5g) Pouches, 48.6 OZ (3LB 0.6 OZ) 1.37kg
54 – 0.9 OZ (26g) Pouches, 49.5 OZ (3LB 1.5 OZ) 1.40kg
Regulations for serving size in nutrition labeling and regulations for net weight labeling are different and in some cases produce different values for the same package. When the serving size in the Nutrition Facts panel is greater than 5g, the regulations require that the gram weight be rounded to the nearest whole number. However, regulations for net weight labeling require that the product weight not be overstated, and therefore cannot automatically be rounded to the nearest whole number.
If you use the USDA organic symbol on your food labels, are you required to also have a statement indicating the certifying agent? Assuming you follow the USDA National Organic Program rules, have the appropriate certification and show the organic symbol but do not have the name of the agent on the label, what are the possible consequences (i.e. penalties, not being able to import, not being able to sell, etc.)? (January 2013)
Foods labeled as "Organic" including those with the USDA Organic symbol on the package must list the name of the certifying agency with the phrase "Certified organic by (certifying agency)" on the Information Panel, immediately below the Signature Line. If you have failed to list the certifying agency on the package, you will need to work with the agency to correct that. Be aware that ignoring compliance issues could result in discontinued organic certification by your certifying agency, among other possible consequences.
Some operations are exempt from USDA organic certification, including organic farmers who sell $5,000 or less. All other operations that handle or process organic products, including blending, packaging, or labeling must be certified.
In the event a product certified as organic is missing the name of certifying agent, the agency will likely issue a non-compliance warning and the company must work out an action plan to correct the labeling error. This could include a temporary re-stickering of the information until future label reprinting can occur.
If the product is not certified organic and not exempt from certification, but is labeled as organic, the fines can be up to $11,000 per violation.
Multiple "Contains" Statements | Is Vitamin E Required? | Country of Origin Labeling | Disclosing Sugar Alcohols | Gift Pack Food Labels | Meal Replacements | Declaring Flavors | Are Restated Nutrition Facts Nutrient Content Claims? | Preservatives as "Natural"? | Serving Size for Uneven-sized Pieces | Using 4-4-9 for Calorie Calcs | Nature-identical Flavor in U.S.
For an already printed box, we’d like to add a stamp that says Contains Milk as the box is supposed to say Contains Milk and Wheat but currently only says Contains Wheat. We would like to put the stamp under the statement that says "made on shared equipment with products containing milk, soy, tree nuts, etc." Can we do that? (December 2012)
Per FDA guidance, the Allergen (Contains) Statement must contain all "Big 8" allergens present and needs to be placed immediately after or adjacent to the Ingredient Statement; it cannot be preceded or interceded by an allergen advisory statement. See questions 13, 14 and others in the guidance.
According to my reading and understanding of the FDA guidelines, Vitamin E does not need to be included in the Nutrition Facts Panel unless a claim is made about it on packaging or when it is added as a supplement. Is this correct? The FDA guidelines are so detailed! Just wanted to make sure I get it right. (November 2012)
When a U.S. company distributes or imports a product and declares its name and address within the signature line of the product, FDA guidance says that the country of origin must appear in close proximity to the signature line in at least comparable size lettering. If, however, a foreign manufacturer is listed within the signature line, then the country of origin is part of the address and the words "Product of" can be shown after the signature line or any other conspicuous place on the label.
Please note that the country of origin statement is not a requirement of the Federal Food, Drug & Cosmetic Act, therefore there is no official FDA regulation concerning its placement and use. However, the Tariff Act of 1930 does require the country of origin statement and it is codified into the U.S. Customs and Border Protection regulations under 19 CFR 134.
Contrary to FDA-regulated foods, USDA-regulated foods must show the country of origin statement directly under the product name as specified in 9 CFR 327.14.
References: FDA Food Labeling Guide (Sec. 4, No. 11) and FDA Compliance Policy Guide (Sec. 560.200).
Sugar alcohols, like all other low and reduced calorie sweeteners, must be declared in the ingredient statement by common or usual name (e.g., sorbitol, maltitol); it is not allowable to identify these ingredients as "low calorie sweeteners" within the ingredient statement.
Note also that two of the sugar alcohols - mannitol and sorbitol - along with polydextrose (which contains small amounts of bound sorbitol) require a label statement such as “Excess consumption may have a laxative effect” when certain threshold amounts are exceeded. See 21 CFR 172.841 regarding polydextrose, 21 CFR 180.25 for mannitol, and 21 CFR 184.1835 for sorbitol.
The outer label for a gift pack sold at retail must contain all five of the required label components with one exception: the nutrition information may be included either on the outer label, inside the package, or attached to the outer package. See 21 CFR 101.9(h)(3).
Even when the nutrition information is placed inside the gift pack, the outer gift package must bear the following, which some companies choose to do via a hang tag:
– product identity (contents of the gift package using allowable product names for each component)
– a net contents declaration (contents of each component, as well as contents of the entire package)
– a listing of all ingredients contained in the package
– the signature line (name and address of the responsible party)
Is there a standard to call an FDA or USDA product a "meal replacement"? (July 2012)
Although there is no standard definition for “meal replacement”, there are four references in Title 21 of the Code of Federal Regulations for this term:
– 21 CFR 101.12(b), Table 2: relating to Reference Amounts Customarily Consumed for milk and milk-based drinks (meal replacement is one example given)
– 21 CFR 105.66(e): relating to label terms suggesting usefulness of meal replacements as low calorie or reduced calorie foods
– 21 CFR 122.345(h): relating to folic acid fortification
– 21 CFR 172.380(c): relating to Vitamin D fortification
The ingredient statement of the food to which the flavor is added may declare the flavor as “natural flavor” or “artificial flavor” as long as the flavor additive meets the applicable definition in 21 CFR 101.22.
Note that ingredients such as salt, monosodium glutamate, and protein hydrolysates must be declared by their common or usual name. Also note that, per FDA regulations, an ingredient such as dehydrated onion, dehydrated garlic, onion powder, garlic powder, or celery powder must be declared by its common or usual name (not as a “natural flavor.”) USDA, however, has guidance that allows the powdered form of onion, garlic, and celery to be labeled as a “natural flavor."
Yes, that is correct. If you make a statement of fact such as “0g trans fat per serving” on the front-of-pack, this is enforced as a nutrient content claim and you are required to include the disclosure statement when your product exceeds threshold levels of total fat, saturated fat, cholesterol and sodium.
Regulations specific to your question are outlined in 21CFR101.13(c) and 21CFR101.65(a). Also of interest, FDA issued several warning letters related to this issue in February, 2010. See an April 2010 Food Label News article and our March 2009 Reader Q&A for earlier reports on this topic.
I plan on distributing a jarred tomato sauce to my friends, family and through a farmer’s market. I want to label it as “All Natural.” However, the bulk tomato sauce I buy has some preservatives added to extend the shelf life. Must I include the preservatives on my label even though I cook it for hours? (April 2012)
Yes, if preservatives are used in a product or as a sub-ingredient of another ingredient, they must be declared on the label. Therefore, if you want to have an all natural product, you will need to source a bulk tomato product that does not contain preservatives.
FDA’s policy for “natural” indicates that this claim can only be used when a product contains no added colors from any source, no artificial flavors and no preservatives. Read about the difference between natural on U.S. and Canadian regulations in the Food Label News archives (Oct/Nov 2009).
The RACC for chocolate and most other candies is 40 grams. We translate this to serving size by selecting the ounces that is the closest to 40 grams. In this case 1.5 ounces (at about 42.52 grams) is closer to the 40 gram RACC than 1 ounce (at about 28.35 grams). Putting it all together, if the Net Weight of the entire package is 6 oz (170g) and there are typically 7 to 9 pieces in the tray, then the Serving Size line on the Nutrition Facts would be written as:
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.
Facts Label for a Simple 3-ingredient Item | Serving Size for Flavoring | Alcohol in Foods | Enriched Flour in Canada | Farmers Markets and Internet | Wholesale/Foodservice Labeling | Vegetarian Labeling | Chocolate Coating | Allowable Variance for Nutrition Labeling | Sugar-Free Labeling | MSG Labeling | Combo U.S./Mexico Labels
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)
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.
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)
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.
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 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).
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.”
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."
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.
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.
Fruit/Vegetable Servings | "2% or less" Ingredient Statements for Canada | Declaring Ascorbic Acid | Labeling for "Gluten-Free" | Insoluble Fiber and Calories | "Natural" or Not? | Database vs. Lab Analysis | Ingredient Exemptions | Inner and Outer Labeling | Labeling for Recycling | Lecithin as an Allergen | Allergen Advisory Statements
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 2,000 calorie diet.
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.
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.
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.
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.
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.
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
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 U.S. and Canada.
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.
For additional information read June 2006 Food Label News report about allergen labeling for incidental additives.
NOTE: FDA withdrew the above guidance document on February 22, 2013, because the exercise of enforcement discretion stated in the policy no longer reflects the agency's current thinking. FDA believes that companies have had ample time to comply with the requirement and that enforcement discretion is no longer applicable.
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)
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.
Labeling for Foodservice | Agave Syrup as Natural Low Glycemic Sweetener | Enzymes in Dough Conditioners | Product Info Needed | Supermarket Take-aways | Stevia in Foods | Net Contents | Daily Value for Sodium | Shelf Life Testing | Is "0g trans fat" allowed? | Disclosure for Cholesterol | Definition for High Protein
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). 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 U.S. 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.
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:
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.
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 and liters).
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)
"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.
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.
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.
USDA or FDA? | Uniform Compliance Date | Labeling Fish as Organic | Getting Ingredient Data | U.S. & HFCS | Canada & HFCS | St. John's Wort in Beverages | Butter as an Ingredient | Composite Ingredient Statements | Nut & Soybean Oils | Release Agents | Rounding Rules
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 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.
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.
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)
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.
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. Find the due diligence article in Quick References.
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)
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.
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)
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%.
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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)
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.
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.
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.
See examples of correct and incorrect Nutrition Facts panels in Quick References.
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.
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.
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.
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."
For more information on FDA food label claims, see the Center for Food Safety and Applied Nutrition webpage, or contract with Food Consulting Company for One-time or Ongoing Regulatory Support.
NOTE: MyPyramid was the USDA food guidance system when this answer was published in May 2007. It has since been replaced with MyPlate. However, the concepts discussed above remain relevant.
Furthermore, the statement "Allergens: Contains none" risks being misleading and is 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.
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).
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.
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 have decided on their own not 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..
MSG Ingredient Listing | Voluntary Nutrients | Lab or Database Analysis | Internet Sales | GMO Labeling | U.P.C. Barcode
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.
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.
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.
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 position on label statements about foods that ARE genetically-modified:
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.