UPDATED NOVEMBER 2016: This post reflects several updates in 2016 to incorporate the FDA’s new nutrition facts format and a few other things that people have been asking about. Enjoy!
Having designed gourmet food packaging for well over a decade now, we frequently reference the FDA website regarding their food labeling regulations and requirements. To say there is a lot to know would be an understatement. If you’ve ever searched for information there you’ve likely gotten lost in pages upon pages of food packaging legalese and obscure reference codes whose sources are difficult to locate. We know we’re not the only ones, so we pored over the FDA Food Labeling Guide in its entirety and condensed the basic requirements into this simplified, easy-to-understand reference list.
There are many exceptions, exemptions and variations to the rules for specific product types, so be sure to check out the full FDA Food Labeling Guide for complete details. Each content section below contains links to the corresponding information on the FDA site for further elaboration.
Let’s first define a few things:
Principal Display Panel (PDP): The part of the package most likely to be seen first by the consumer on the retail shelf. If two or more surfaces qualify for this definition, they both are considered Alternate PDPs.
Required content for the PDP: Statement of Identity (what the product is) and the net quantity statement (amount of product). If alternate PDPs exist, this information must appear on each of them. For more detail, see the Statement of Identity and Net Quantity Statement sections below.
Information Panel: The panel directly to the right of the PDP as seen by the consumer. If this panel is unusable (e.g., gusseted box, folds, flaps, etc.), then the Information Panel is the next panel immediately to the right.
Required content for the Information Panel:
Note: there can’t be any other information or design elements between the required Information Panel content.
- Name and address of the manufacturer, packer or distributor. Unless it’s the actual manufacturer whose name and address are on the package, the name and address must also include the firm’s relation to the product—e.g., “manufactured for” or “distributed by.” If the firm’s name and address are listed in a current city directory or phone book, you can omit the street address and just include city or town, state, ZIP (or mailing code for outside US). The product’s country of origin is not required if manufactured in the US, but it is required for all imported foods. If you’re including the country of origin it must be located close to the firm’s name and address and be about the same size.
- Ingredients listed in order of greatest to least by weight. Must be on same panel as the name and address, but can be located before or after nutrition facts and name and address. You can list sub-ingredients of a food in parentheses following it—e.g., SEMISWEET CHOCOLATE CHIPS (SUGAR, UNSWEETENED CHOCOLATE, COCOA BUTTER, SOY LECITHIN [EMULSIFIER], VANILLA)—or factor in all sub-ingredients as main ingredients listed in order of greatest to least without naming the original ingredient that the sub-ingredients comprise.
- Nutrition Facts: see the Nutrition Facts section below for more detail on this.
- Allergen labeling if applicable. There are eight major allergens that are required to be listed if contained in the product’s ingredients: milk, egg, fish (must list species), crustacean shellfish (must list species), tree nuts (must list specific nuts), wheat, peanuts and soybeans. You can either list name of food source within the ingredients in parentheses following name of major food allergen—e.g., “whey (milk)”—or you can place the word “Contains” followed by source(s)—e.g., “Contains: milk, egg and almonds.”—immediately after or adjacent to ingredients. The allergen text must be at least as large as the ingredients text.
If you’re including advisory allergen labeling—e.g., “May contain…” or “Processed in a facility that also processes…”—this is not required, but it must be factual and not misleading. As this information is not required, it is not permitted to intervene with required information.
In determining the labeling area size of a package, unusable areas such as flaps, closures, shoulders and necks are excluded. Bottoms of boxes that are easily seen by consumers are included in the total area (e.g., frozen food boxes). The labeling area size is determined by the total area available for labeling on the container, not just the size of the label applied to it.
- Alternatively, you can place all the required Information Panel content on the PDP.
- The required Information Panel content may be split up onto two Information Panels if there is insufficient space (sufficient space is determined by the entire labeling area on the package regardless of design elements and non-required information used) as long as the information in each section is kept together and not split up among the two panels (e.g., firm name and address are on the same panel, ingredients are on the same panel).
- If the labeling area is less than 12 in² (77.42cm²), you can include a phone number or address to access nutrition information—likewise if the container is unusually shaped with no sufficient labeling area.
Type Specifications for Information Panel Content
(See Nutrition Facts section below for its own type requirements.)
- The type size must be at least 1/16 inch (1.6mm) tall based on the lowercase letter o (or uppercase O if using all capital letters).
- The height of letters can’t be more than 3x their width.
- All required information must have sufficient contrast and be easily legible.
- If you’re using a foreign language anywhere on the package, all required information must be in both English as well as the foreign language.
- Artwork can’t be misleading and can’t detract from the prominence of the required information.
FDA link: General Requirements, Ingredient Lists.
As mentioned above, the Statement of Identity is the name of the food. It must be prominent—which is considered to be at least half the height of the largest text on the label—and bold, as it is one of the most important features on the PDP.
The name of the food is its name as determined by law or regulation. If none exists, then it must be the “common or usual” name of the food. If that doesn’t exist, then use a reasonable, descriptive name that is clear and not misleading. Common or usual names must be used when a food has one, otherwise it’s considered misleading.
Brand names (e.g., logos) are not part of the food name and should be reasonably less prominent than the food name.
“Fanciful names” that are commonly used and understood are permitted as the Statement of Identity when it’s obvious what the food is (e.g., “Vanilla Wafers”).
The Statement of Identity must also describe the form of the food if it is sold in different forms, e.g., sliced, half or whole.
A product’s name can be different from its Statement of Identity. For example, if you call your cracker product “Snackadeedles,” this would likely be the largest text on the PDP, and the actual name of what the food is (e.g., “crackers”) should be half the height of Snackadeedles.
FDA link: Statement of Identity.
This is the amount of the product. It must be in weight, measure or numeric count (e.g., 10 cookies). If in weight or measure, the amount must be in both US and metric versions. The metric version may be located before or after the US version, or above or below it. The metric equivalent in grams rounds to the nearest whole number.
Type size is determined by the area of the PDP (width x height if rectangular or square; or 40% of product height x circumference if cylindrical). Required type must follow the Type Specifications above and be at least the smallest size permitted based on the PDP’s area:
≤ 5 in² (32.26cm²)
> 5 in² (32.26cm²) but ≤ 25 in² (161.29cm²)
> 25 in² (161.29cm²) but ≤ 100 in² (645.16cm²)
> 100 in² (645.16cm²) but ≤ 400 in² (2,580.6cm²)
> 400 in² (2,580.6cm²)
Then your minimum type size is:
1/16 in (1.6mm)
1/8 in (3.2mm)
3/16 in (4.8mm)
1/4 in (6.4mm)
1/2 in (12.7mm)
Reference the Labeling Area section above for more details on what parts of the package constitute labeling area and what parts do not.
Nutrition Facts are required on most food packages with labeling (there are a few exceptions), and must be located together with ingredients and name and address on either the PDP or the Information Panel. If there is no room on the Information Panel, then it is required to go on the next panel to the right, or if no room there, then on any panel visible by the consumer.
In 2016 the FDA released its update to the nutrition facts format. We cover both the old and new formats below, because you can still use the old format until July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales). EDIT: As of July 13, 2017, the FDA has announced that they will extend the compliance deadline. They will release more information on the specific new dates soon and we will update here.
The Nutrition Facts content must always be enclosed in a box shape with at least a 1/2-point rule and must have sufficient contrast such as dark print on light background. Light print on dark background may be used as long as there is still sufficient contrast. The box background must be neutral (no graphic elements).
The FDA’s examples are in Helvetica, but any legible font may be used. Condensed fonts are permitted as long as all type requirements are still met.
Nutrition Facts Type Specifications—OLD FORMAT
Table headings (e.g., Amount per Serving, % Daily Value) must be at least 6-point type, and key nutrients must be at least 8-point type.
“Nutrition Facts” must be the largest text in the panel (larger than 8 points) and should extend the width of its box in Full Panel Format. (See below for other permitted formats.)
There is no specific thickness required for the three horizontal rules that separate the main section.
You may use type sizes no smaller than 6 points or all uppercase text as long as it is at least 1/16 inch (1.6mm) tall.
Nutrition Facts Type Specifications—NEW FORMAT
The FDA has provided detailed examples of each table format, so instead of repeating all that verbally here, I’m just going to link to their example straight from the source since it’s so thorough. FDA new nutrition facts font sizes and details.
The main changes to the new format are:
- The numerical value for “Calories” is the largest information in the table
- Added sugars are called out
- The %DV footnote has changed
- Vitamins A & C are no longer listed
- Vitamin D and Potassium are listed
- RACCs (Reference Amounts Customarily Consumed) have changed for some foods. Find the new RACCs here.
- Some DVs (Daily Values) and RDIs (Recommended Daily Intakes) have changed. Find the new DVs here and the new RDIs here.
Nutrition Facts Formats
Reference the FDA Label Formats page (old format, but still a lot of applicable information) and the new format examples page for examples of Nutrition Facts formats.
If there is not enough room for the Nutrition Facts Full Panel Format:
If the labeling area is greater than 40 in² (258.06cm²), you can use the Side-by-Side Format where the footnote is to the right of the Nutrition Facts box.
If labeling area is 40 in² (258.06cm²) or less, you can:
- Eliminate the entire footnote, including only the Percent Daily Values Footnote.
- Use the Linear Format (text in a box) if the tabular or column format does not fit.
- Use the following abbreviations: serv size, servings, fat cal, sat fat cal, sat fat, monounsat fat, polyunsat fat, cholest, total carb, fiber, sol fiber, insol fiber, sugar alc, other carb. If DV is abbreviated in its table heading, the Percent Daily Values Footnote needs to say “Percent Daily Values (DV)” with DV in parentheses.
- Place the Nutrition Facts label on any panel on the package.
If there is insufficient vertical space (e.g., less than 3 inches (76.2mm)) you can use the Tabular Format (horizontal).
Cellophane windows on boxes and visible parts of cellophane bags are considered labeling area if any labeling is on it—including non-required information such as a price callout label. If there is no labeling on the cellophane, then it’s not considered part of the labeling area.
If the Nutrition Facts contain less than the following amounts, you can omit their listings on the Nutrition Facts and say “not a significant source of…” and list the nutrients (in at least 6-point size).
fat cal < 0.5g
sat fat < 0.5g
trans fat < 0.5g
cholest < 2mg
sugar < 1g
vitamin A, vitamin C, calcium & iron < 2% RDA
Use of the Calories Per Gram Footnote is optional under any circumstances.
You may use the Simplified Format which lists only the five core nutrients (calories, total fat, sodium, total carbohydrate and protein) and declare any amounts that are significant enough to be listed if at least 8 of the following are insignificant:
Calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, calcium, iron, vitamin A (if old format), vitamin C (if old format), Vitamin D (if new format), Potassium (if new format).
This format can be used regardless of labeling area size, as its use is determined by the nutrient content.
If you’re using the simplified format, you must include “not a significant source of…” and list all of the nutrients that are not a significant source if nutrition claims are made, vitamins and minerals are added, or any non-required naturally occurring nutrients (e.g., potassium) are declared.
FDA link: Nutrition Facts, Label Formats.
The FDA states that it will likely not pursue any minor mistakes in nutrition labeling if the mistakes are unintentional. Once any errors are realized however, they should be corrected in future printings.
Mail order retail food must adhere to same requirements as in-store retail food.
If nutrition labeling is not required but the product has nutrition labeling anyway, the nutrition labeling needs to follow all the same required rules.
Foods that do not require nutrition labeling are: whole or ground coffee beans, tea leaves, plain instant unsweetened instant coffee and tea, condiment-type dehydrated vegetables (e.g., dried garlic), flavor extracts and food colorings.
If spices have nutrient levels significant enough for labeling, then nutrition labeling is required.
If the product doesn’t have nutrition labeling, it can’t have any other nutrition or health claims.
Nutrition Content Claims
A Nutrition Content Claim is any statement regarding a nutrient level in the food—e.g., low fat, high in fiber, fat free.
There are only certain claims usable that are approved by the FDA. Any others may not be used.
Claims can’t be more than 2x as prominent as the Statement of Identity.
Nutrition labeling (i.e., Nutrition Facts panel) is required for nearly all claims. No nutrition claims can be made if no nutrition labeling is present.
There has been new regulation in gluten-free labeling: any product with a gluten-free claim must have less than 20 parts per million of gluten.
FDA link: Nutrition Content Claims.
Handy Tools for Determining Nutrition Facts Numbers
Nutrition Facts rounding amounts rules.
Percent Daily Values calculations.
This article/blog is provided for information purposes only and does not constitute professional advice nor does it substitute for your reading and reviewing the applicable language from the FDA regulations or obtaining advice from the appropriate professional regarding what is and is not required by the FDA regulations. This article/blog is not intended to provide advice and direction on how to comply with the FDA requirements. The reader of this article/blog is urged to read the FDA regulations and/or obtain the appropriate professional advice on the FDA regulations. No professional, business or other advisory or economic relationship is created herein, and in some states these materials may be considered advertising.
132 responses to “FDA Food Labeling Guide Made Easy”
Do you provide private reviews to companies? One of our client need a review for a new product.
Yes we do! I emailed you with more info.
Wonderful article, really simplifies the information in a clear way! I’m wondering if the nutrition facts linear format (paragraph format) must also be in a box shape with a 1/2 pt rule?
Glad you found the article helpful!
Yes the nutrition facts linear format needs to be in a box shape (square, or horizontal or vertical rectangle) with a 1/2 point rule.
Can you show me in the FDA Rules where it says that it needs to be a rectangle. All I can find just says it needs to be in a box
A box by definition is a rectangle. A square is also a rectangle.
can you review the food package design to see if it meets the regulations? How much is your fee?
Sent you an email with more information!
I came across this article searching for information and it’s been a great help!! I’m wondering if you know a couple of things about “country of origin?” If you’re packaging cocoa and some comes from the US and some comes from Mexico, can you say “Product of USA and Mexico?” I’m never sure what to do when there is more than one country of origin. We could do check boxes, but that would slow down production. Do you know? Also, if you’re packaging the cocoa in a bottle made in China, do you have to say “Bottle product of China?” Or is it just the food item? (It’s so confusing!) Thanks for any help!
Great questions! You inspired me to write an article with these answers. You can read it here:
I found your article very helpful and I am interested in getting our company nutritional facts reviewed before launching. Could you provide a quote and we look forward to your reply. Thank you!
Just emailed you!
Thanks for such an informative article.
We are interested in selling a pet food(sun dried shrimps-organic) from East Africa in the USA market.We have already registered with FDA but have a challenge with FDA food label review.How can you help and how much will that cost?Would you also advise on the best yet affordable packaging?
I just sent you an email with more information!
We produce chocolate candies from bar chocolate not beans. We have labels printed for each product that we mfg. from cremes, clusters, barks, solids, filled, coated and on and on. This causes a need for hundreds of labels. Is there any way to come up with a standard label that would cover all of the ingredients we use and put this label on everything whether it has the ingredient or not included in the specific candy. In other words one label covers all candies and include the standard allergen statement on the bottom of the ingredient label. I am from the state of PA. and the rules/regulations seem enormous.
Example – white chocolate, milk chocolate, dark chocolate, dark milk chocolate = chocolate
Palm oil, coconut oil, vegetable oil, olive oil = oil
all creme filled candy no matter which flavor = flavorings
peanuts, hazelnuts, walnuts, almonds, pecans = nuts
any and all dairy products = dairy products
any and all flours = flour
Label would than say – “chocolate, oil, nuts, dairy products, flour, flavorings”
Standard Allergen Warning
There is no easy solution for this type of situation. According to the FDA you have to indicate the specific name of the food on the front of the package, and its nutrition facts and ingredients on the back. You can print all the nutrition facts/ingredients for any possible product in the package as long as the name of the nutrition facts matches the name of the product on the PDP. See L21 on this page: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm064904.htm
You can’t simplify the ingredients as that would not be accurate.
I’m in a process of designing the label for my product. I will need assistance reviewing it for accuracy. Can you help?
Hi Lorraine – Yes, sending you an email with details.
I have a logo and website but I was wanting assistance in having a USDA label designed for meat products. Your article is very helpful but as you know the labeling process is not easy.
Could you please send me info on prices etc.
Hi Melissa – just sent you an email!
Good afternoon Jenn,
We are currently in design for a packaging adaptation from EU to US/ Mexico. Is it possible to have a packaging that can serve both countries at the same time using the same PDP ( nutricional information box, ingredients, and name of manufacturer?) I read somewhere that if you adapt the US nutritional information box (Already being bilingual for our target market) it can serve both countries, is this true?
Also can you send us some information on your consultation services etc.
Yes you can have a bilingual package. The FDA specifies that all the required information be the same size in both languages, and if any foreign language appears on the package then all the required information must also be in the foreign language as well.
We can’t advise on EU or Mexico regulations.
I sent you an email with information on our consultation services.
Very helpful information. I’m wondering though, does the FDA have any restrictions on when to use non-gmo or gluten free callouts? Can we just use these on the labels without it being certified? I’ve seen GF certified and Non GMO certified and I’ve also seen packages that just have these callouts without the certification on the back.
Regarding non-GMO, use of The Non-GMO Project logo requires certification from them, however the proof of certification does not need to be on the package. If you want to say on a package that the food does not contain any GMOs, the statement has to be true and not misleading, and you must be able to prove it if the FDA questions the statement.
The FDA released a guidance on the labeling of GMO statements on packages. It was published in 2001 so some things have changed since then such as consumers are now familiar with the term GMO and non-GMO. (The Non-GMO Project was founded in 2007). The FDA has not updated the guidance since 2001 and it contains only nonbinding recommendations. You can read it here: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm059098.htm
Regarding gluten-free statements, it is voluntary to make such statements however foods labeled on or after August 5, 2014 (when the FDA made their final ruling on the subject) must contain less than 20ppm gluten. The food label does not need to contain any information to back up the claim, however you must be able to prove it if the statement is questioned by the FDA. If the food is inherently gluten-free, there shouldn’t be any issue; however if the food is made from ingredients that were processed to remove the gluten, you must have evidence of this.
very valuable comments. Thanks ……
please see my below concerns-
1. Is FDA allows to label CHOCOLATEY instead of CHOCOLATE FLAVORED on Product Name?
2. Is GMO Free can be labelled on the Pack Design?
1. The FDA states that identity statements must be accurate and not misleading. “Chocolatey” is vague – is it made with chocolate or is it just flavored with a chocolate flavor? It sounds like it is the latter based on what you said, so if that is the case it is probably safe to use the word “Chocolatey” to describe the product as long as you have an identity statement that clearly states what the product is – e.g., “Chocolate-flavored XYZ.” Additionally, if artificial flavor is used, in certain instances (but not all) require the principal display panel to state that the product is artificially flavored.
2. GMO-Free labeling is permitted as long as the product meets that criteria AND you have proof to back up your claim. Use of The NON-GMO Project logo however requires certification from them. This logo may not be used unless your product has been certified by them.
We do FDA compliance reviews for food packaging. If you are interested in this let me know.
I am bring a herbal supplement to the USA market and wanted a label review. Please could you send me some details on services you offer?
Emailed you info.
Thank you for highlighting the key aspects of proper labeling!
I am interested in a label review.
I just emailed you information about this.
Would need help in expert review of my product on labeling. Can you help?
Can we use the new Nutrition Facts guidelines now… or do we have to wait until 2018?
Per regulation you can officially debut the new nutrition facts format in retail as of July 26, 2016. However I saw a package with the new format yesterday in a grocery store!
Thank you for this helpful info! I have a specific situation that I am finding puzzling, though, and having trouble finding a solid answer.
I’m designing a label for a rectangular box, and in the design I prefer the art actually continues across the primary panel (which has the common name, brand name and weight), onto the label directly to the right. So, in effect, you can only see the entire design when looking at both panels.
I wonder if there are any exceptions to the requirement that the Nutrition Facts appear to the right of the PDP? My total label area is almost 50 sq. inches.
I believe the answer to this is no – the way I read the rule is that a second Principal Display panel would have to have all of the info (common name, brand name and weight) again. But…maybe? 🙂
Hi Andy, there is an exception if the panel immediately to the right is not usable, then it can be the next panel to the right. Sounds like that would not be the case in your situation. If you have an alternate PDP then it needs to each contain all the required PDP information as well as the other PDP. An alternate PDP must meet the definition of a PDP: “the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.”
Can you tell me whether the order of ingredients on front of package for infant foods (e.g. kale, pear, spinach puree) must be the same as the order of the list of ingredients that is near the Nutrition Facts label? Or can the front of package read in a different order than the ingredient list?
If it is not an ingredient listing on the front of the package, to my knowledge the listing of ingredient callouts does not have to go in order by weight. Note that we don’t specialize in infant foods, so it’s possible that regulation may be different.
Regardless, the information on the package can’t be misleading. So if kale is only a small portion of the ingredients and you have “KALE” large on the package and show a big bunch of kale, that would be misleading. This is an exaggerated example, it could be less drastic and still be misleading. Even just listing them not in order by weight could very well be perceived as being misleading. I recommend being on the safe side and listing those ingredients in order on the front.
What is considered to be misleading is often a gray area, and it’s very costly to correct these issues after the fact. Additionally, any litigation against the manufacturer based on misleading packaging could be detrimental to the business.
Thanks so very much for your reply. I appreciate it and have a couple of calls into infant food makers to see what their common practice is.
What about certification stamps , specifically talking about Kosher. I couldn’t find anything regarding that topic on the FDA regulations. We currently have the Kosher stamp on the PDP. Can it stay there for the new label?
The package would need to follow the specifications of the certifying Kosher agency. FDA does not govern Kosher regulation other than that if you are claiming the product is Kosher then it needs to be factual and clear, and not confusing or misleading. Typically the Kosher logos are placed on the PDP or the information panel of a food package.
What is the actual size in inches of the full size label
The nutrition facts panel doesn’t have a specified area size. Rather the minimum sizes are given as font points as noted.
We´re in the process of exporting our product to the US. However, we still have plenty of doubts about regulations. We already register at the FDA website. We designed a label already, but would be great if we could get some expertise advice on that. Could you please give us a quote for reviewing our label to see if it meets the FDA criteria?
Hi Joel – Just emailed you more info.
This is a great article! Only wish I came across this before making my first label, but have learned a lot. I’m working on a new label now – can you please send me some details on the services you offer?
Just sent you an email and here is our capabilities list: http://jenndavid.com/about-us/capabilities/
My name is Lisa. I am a fellow designer who is creating packaging labels for a client. The client has plastic microwaveable containers and wants wraps to be done on these so they aren’t typical boxes or cans, I don’t see anywhere on the site that talks about this kind of packaging. I’m not sure what would be considered the PDP in this case, or where I would put nutrition labels since the top is what you see first. I’m also a little unsure of what kind of nutrition facts label I am supposed to be using. Can I use any format (vertical, tabular) as long as it works with the design? Would you happen to have any information on nutrition labels for this kind of situation?
Whichever panel faces the consumer on the shelf is the PDP. Some packages may have alternate PDPs—e.g., more than one PDP. If this is the case then the information panel is a panel immediately to the right of any PDP. If the PDP is the top panel of the package, then the information panel the side of the package immediately to the right of the PDP. If there is not enough space on that panel or if the panel is unusable, then the information panel is the next panel immediately to the right (or, in the case of not enough space, the required information can be split across two panels).
The nutrition facts format used depends on the amount of total labeling area available on the package. See the Nutrition Facts Formats section of this article for more information on that.
I’m Valeria, I’m italian and I’m making a linear display for my product. The package is small, and the linear d. is the only one suitable. I’ve struggled with the FDA guide and the new rules. After a while I think I’ve done a good job, but I still wonder…
It seems that the footnote has disappeared from the linear display, or at least this is what I see from the official example. Anyway I cannot find the recommendation/rule where this is officially stated, so I still cannot feel confident to delete the footnote.
What would you suggest? Thanks so much, and my compliments for this website!
It’s in the Federal Register of the changes. If you go to this link and search for “the footnote” it’s the 2nd instance in the search, on p4: https://www.gpo.gov/fdsys/pkg/FR-2016-05-27/pdf/2016-11867.pdf
“Removing the requirement for the footnote table listing the reference values for certain nutrients for 2,000 and 2,500 calorie diets.”
I am thinking that Valeria is probably referring to the DV footnote on the linear package. There is no footnote required on the linear format.
Great information and beautiful work! I am also a graphic designer launching my own personal Ginger Elixir. As you mentioned that there are some products that are exempt from having to list the Nutritional Label. Would you know if Elixir are on the list. I have a Shrub in the fridge that doesn’t contain a Nutritional Label and I think this product somewhat lives in that same space. Thanks for your help in advance!
Elixir does not suffice for a statement of identity. It needs to explain what the drink actually is, e.g.: juice, juice blend, juice drink, juice with added ingredients… Or, if not a juice, just be as accurate as possible, e.g.: water with ginger and spices, or coconut water with ginger. I have no idea what the ingredients of this product is, so find something that is applicable to your product. Hope this helps!
The specific products that are exempt from nutrition labeling are the following: whole or ground coffee beans, tea leaves, plain instant unsweetened instant coffee and tea, condiment-type dehydrated vegetables (e.g., dried garlic), flavor extracts and food colorings.
There is also a small business labeling exemption and you can read more about that here: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm2006867.htm
I already stumbled onto the small business labeling, so I am glad I am heading in the right direction.
There are only 4 ingredients, tons of ginger, honey, lemon and whole leaf tea. It is meant to be drunk over a few days as it is pretty intense and strong.
I am going to include in my ingredients, hopefully that will do.
Thanks again and let me know your thoughts.
Hi Annie – if you qualify for the small business nutrition labeling exemption then that should be sufficient.
Do you have sources for people or companies that can do the nutritional facts panel for my company? I have all of the figures that go into it, but need it to be put in the us regulation format for 2017
I get contacted often by people looking for just the information to be put into the nutrition facts label. Whoever is designing your food labeling should be able to do this for you. Also your nutrition analyst should be able to provide the information in a panel format to include on the labeling. I know a lot of people also use recipal.com to create them, so that could be a DIY option for you.
Could you send me pricing for your FDA Labeling services. As well as what that all covers?
Hi Joelyn – sent you an email with more info!
Hi! I have an obscure question. I have a line of beverages that have all the same nutritional information (calories, vitamins, etc.) the only difference between them is the source of color (whether it is Fruit and Vegetable Juice for color or FD&C colors). I was hoping to print only one universal label (back panel). Is it legal to use one nutrition facts box and in the ingredient statement declare all ingredients which incorporates a “may contain” or “Contains one or more of the following” statement?
The FDA permits the use of and/or labeling only in the case of fats and oils where the added fats or oils are not the predominant ingredient and only if the manufacturer is unable to predict which fat/oil will be used. So this type of labeling would not be applicable to your situation for colors. You would need to list the actual ingredients specific to each product.
Could you send me pricing for your FDA Labeling services. I need some assistance in Nutrition Facts size proper usage.
I emailed you info on this.
Hi,nice helpful article.
can you use capital letters for all labeling on the facts panel
Question about the address:
Do we need to put the manufacturer’s address as in the address of where we produce our product? OR, where I, the manufacturer work and receive mail for my business? Those are two different addresses.
So, production address or office address?
The FDA states: If a person manufactures, packs, or distributes a food at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such food was manufactured or packed or is to be distributed, unless such statement would be misleading.
I’m only in the planning stages of my business right now and I’m already sinking in information. Very grateful for your article! I live in Dubai and am wanting to sell my product in the US but need to make sure I’m ticking all the FDA boxes. I am wondering what the nutritional label regulations are for a tea product that also contains dietary ingredients such as herbs and acai? Is it only whole tea leaves that are exempt from some labeling or is it all tea products? And also, is it a requirement to have a disclaimer when using any of these type of dietary ingredients stating “this product is not intended to diagnose, treat, cure or prevent any disease”? Many thanks for your help.
Only dietary supplements are subject to the FDA disclaimer (https://www.fda.gov/aboutfda/transparency/basics/ucm194357.htm). The disclaimer does not apply to food products, however the types of claims you can make on a food versus a supplement are different.
Tea leaves and unsweetened instant teas are exempt from nutrition facts labeling. If you’re adding anything else then the product is required to have nutrition facts.
Do you have any information or direction on where to look for putting “new” or “new look” on packaging? We have a new seasoning formula for an existing product. We also are updating our packaging with a new design along with the new nutritional panel and want to put something along the line of “Fresh new look, same great seasoning”. I believe it is six months or less to be able to have “new” on the front but I am not sure on “New look”. Thanks in advance.
This aspect is not regulated by the FDA to my knowledge. However all package labeling needs to not be misleading. So as long as you can back up your claim that the packaging or formula is considered “new” then that should be fine. I’ve never heard of the FDA cracking down on a new packaging claim though so I think you should be safe! I would say 6-12 months is sufficient for a new changeover and thereafter it would be established as the regular packaging/formula, but that is just my opinion.
The labeling of “New” is not regulated by the FDA but it is by the Federal trade commission
Thanks for the info, Janet!
I see that 6 months is generally considered the period for a “new” or significantly reformulated product. They do not address new packaging except to say that a packaging change alone does not make the product a new product. I would recommend to follow the same time period for a “new packaging” or “new look” claim.
I found your article very informative.
But I need some assistance regarding on proper labeling.
May you send me pricing for your FDA Labeling services?
thank you so much!
Hi Angelica – just emailed you some info!
Do hibiscus tea flowers require nutritional labeling? I saw that tea leaves do not require the nutrition labeling. I was wondering if it is the same for flowers.
If your package is greater than 40 in², can you use the shortened footnote?
In the new nutritional facts format, there is only one footnote and it can be removed on packages for 40 square inches or less.
In the old nutritional facts format, there is the %DV footnote, the “Your daily values” footnote, and the calories per gram footnote. The latter is optional on any size package. Packages with 40 square inches or less may use only the %DV footnote. Packages larger than 40 square inches are required to use both the %DV footnote and the “Your daily values” footnote.
Regarding the Statement of identity and this statement:
As mentioned above, the Statement of Identity is the name of the food. It must be prominent—which is considered to be at least half the height of the largest text on the label—and bold, as it is one of the most important features on the PDP.
When i go to the https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4bf49f997b04dcacdfbd637db9aa5839&ty=HTML&h=L&mc=true&n=pt21.2.101&r=PART#se21.2.101_13
it seems to have removed the “at least half the height of the largest text on the label”
(d) This statement of identity shall be presented in bold type on the principal display panel, shall be in a size reasonably related to the most prominent printed matter on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed.
I often don’t see packaging coming close to meeting the 1/2 the size recommendation, do you think the FDA scraped this?
Thanks for your note.
Half the height was never in the CFR code. It is in their guidance, where they say that by prominent and in a reasonable relative size, that they generally consider that to be at least half the height of the largest lettering on the label.
I have read most of the FDA webpages regarding food labelling for a new product that we are launching in Mexico and the US. Your summary is the clearest presentation that I have found thus far. Thank you!
A question regarding RACC guidelines: we have a condiment of sliced chile peppers and olive oil packaged in a small 140 gm net wt jar. It’s intended to be used a tsp at a time. Do you think we can use the “minor condiment” category which fits our serving size best (5 g) ? Or do we have to use the “fresh or canned chile pepper” category with a serving size of 30 g?
It sounds to me like your product is intended for use more as a hot sauce in which case I think it would be fine to classify it as a minor condiment. Often times in RACCs there can be a gray area where your product is not clearly identified by the categories provided. As long as you can defend your position if questioned, and the information on the package presents it in the way your are categorizing it, then you should be fine. To be absolutely sure however it’s best to check with a food legal specialist.
I was wondering if the list of ingredients have to be all upper case as in all letters have to be capitalized?
The ingredient list may be in all caps, mixed case or sentence case (or all lowercase even) as long as the height of the lowercase letter “o” is at least 1/16″ tall. If using all caps it is based on the height of the uppercase letter “o.” So if using anything but all caps, the ingredient list will take up more room because overall the letters need to be larger. This is why you see most ingredient lists in uppercase especially on smaller packages.
If a product that we import contains an advisory statement in foreign language stating “kelp was harvested in areas where shrimp and crab inhabit”, will that need to be translated to English as part of the label?
Hoping you can advise.
Advisory statements are optional and only the mandatory labeling information is required to be in both languages whenever any foreign language appears on a label.
How to make a statement on the label about the allergens, when we are not processing the products in the facility but only packing the product that might contain allergens in the facility.
An advisory allergen warning is entirely optional and there is no required format for this as long as it’s factual and not misleading. Since it’s not required it can’t intervene with the required information on the info panel.
You could say “Product packed in a facility that may contain allergens” – best to list those specific allergens if possible. Or to be extra clear you could say “Processed in an allergen-free facility” if that is true, followed by the “Product packed in…” statement. Whatever is clear and easily understandable and factual.
Thanks for the reply.
Do we need different checklists for Food Labeling from various departments in the company like Quality, R&D and Sales etc. If so do we have any special formats for those checklist? where can i get that information for creating food labeling checklist for each department in the company.
That would be entirely up to your internal team. There is no checklist requirement as far as FDA regulation goes, regarding food labeling.
Great post! Clarifies lots of questions. However, I read on FDA that Statement of Identity and Net Quantity must be parallel to the base of the package, however we see brands out there that don’t follow this rule. Is there a loop hole to that?
That’s true, however many products on the market are not 100% compliant. I would also venture to guess that the FDA would likely go after greater offenses on labeling. However if there was a greater offense cited then all noncompliant aspects of the labeling would need to be corrected.
Hello! Great post. And Great question Mrs. Gonzalez. I am too a Gonzalez with a question. I am interested in importing a product from Latin America but the label is not parallel to the base of the package. It is clear, but vertical or perpendicular to the base. What is the best way to check with the FDA if they approve this specific product?
As long as the labeling and information follows the FDA requirements, it doesn’t matter if the label is applied vertically on the container or horizontally.
So happy I just came across this article. I sent you an e-mail. We have an olive oil company and this new food label is seriously throwing us for a loop. How are so many olive oil companies able to get away with semi-compliant nutrition labels? I’m talking even imported products. We are importing our oil to the U.S. We want the vertical format but it’s too wide for our bottles. The small linear format is too long. Is there any way to create a comb of two of the food labels? Like, make the vertical nutrition format in a 6 point font? I see so many companies do this but have no idea if it’s within the regulations.
Also, we are considered a small business, however, we are importing our products. The info. panel is less than 40 sq. in. on our square bottles.
Note that the labeling area that affects what nutrition facts panel format you can use is the labeling area of the entire package – not just the info panel area. Also the entire labeling area means the total area of the package that can be labeled, not just the size of your label (if using a label). So for example if your bottle can use a maximum 9×6″ label but you choose to use a 7×5″ label, then your total labeling area is 9×6″.
It is not permitted to mix up two nutrition facts formats or to use one at a size smaller than the minimum requirements.
If your labeling area is < 40 sq. in., you can use the linear format if the tabular format doesn’t fit. The box for the linear format can be changed to make it tall and skinny to fit your panel. You just have to meet the minimum font size requirements. Sometimes on smaller labeling areas, you need to get creative to make the required information fit, such as by using condensed fonts or decreasing spacing. As long as you’re meeting the minimum size requirements, the size is compliant. Best, Jenn
Greetings and thank for a great article!
My question is can you place the KOSHER symbol in front of the food packaging?
You would need to refer to the specific usage guidelines from the certifier, for the specific type of Kosher symbol you’re using.
Can you help me? I wish to avoid Neotame in my foods. It has been on the market for 20 years but it is not listed on any label as far as i can see. It is also not sold in markets. The only conclusion i can come to is that being 10,000 times as sweet as sugar it is added to our foods without any label notification. Is there a minimum below which label notification is not required? Is this possible?
Developing ingredient declarations for a food product comes from a food scientist so that is not part of our area of expertise. Good luck in your search for information.
If a foodservice product contains multiple units and the product will require further processing before being sold, is it compliant for the individual units to not be labeled? Can the outer box have the statement of identity, name of business information, net quantity, ingredient statement, and allergens and the inside units just say “Not for retail/individual sale”? Also, because the product is not being sold to the consumer as is and requires further processing before being sold, can the product exclude the NFP from packaging?
That sounds fine to me, and that’s how it would be for a retail food product with units that aren’t for individual sale. I don’t see any issue with this approach based on what you’ve noted here.
For an ecommerce website/app, do the nutrition facts we put on the website have to match the nutrition label exactly, borders and all? Thank you!
No, the nutrition facts on the website do not have to be in an identical format to the packaging. As long as the information is accurate, there are no guidelines for nutrition facts format on the website.
Where brands often run into trouble regarding FDA compliance on their website is when they make claims on their website that aren’t permitted by FDA regulation under any circumstances, and the website URL is listed on the packaging.
Very nice condensed Labeling Guide! Easy to follow and seems on point with FDA’s expectations.
From your experience, what is FDA’s guidance/requirements regarding reduction of “white space” within the Nutrition Facts Label? This would apply to medium packages or those with cramped labeling space when the Simplified format could not be utilized and one most use the standard format. I have researched the topic but couldn’t find anything definitive.
Your help would be appreciated.
In the new nutrition facts formats, FDA does give specifications for amount of leading in come cases. https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/UCM513883.pdf
Aside from that, our view is that it’s OK to reduce whitespace as long as you’re still meeting the minimum font sizes and line weights, the letters are not more than 3x in height than width (based on the letter “o”), letters and elements are not running into each other, and everything is still legible. This has always been our practice. However, it’s important to note that as mentioned, the FDA only addresses spacing (to my knowledge) in what I’ve linked above.
I found your article very clear and helpful; I am interested in getting our package design reviewed for a new product, before launching.
Could you provide you fee to review it?,
We look forward to your reply.
We no longer provide compliance reviews as a standalone service. Instead we bundle that into our design work.
i make chilli sauces but have found out i need to put the ingredients i list in the right order . could you give me some examples of this please as i find it a bit complicated,plus i have had tests for nutritional value too,does this need to be in a box and in black? is there anything else i need to know as i am re doing my lables and want to get it right this time.
thanks for your help
Your questions are answered in the article if you read it thoroughly.
Here are a couple links you might find helpful:
Note that the 2nd link is before they introduced the new nutrition facts format, so for that part you want to reference the new nutrition facts format requirements: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm
We produce a herbal tea and sell it online. It is packed in a rectangular box. Do we need to comply with FDA requirements in respect of the labeling and nutrition contents.
We will be very thankful for your comments.
Yes even products that are sold online need to comply with FDA food packaging regulations, unless if you are filing for a small business exemption. Often with tea, it can use the simplified nutrition facts format.
Wanted to know if you can check my beverage product..(5 similar drinks.)
To be done to satisfy all the FDA and U.S regulations, for Import to the U.S
I would need a full review of the product.
And printed out with all the ingredients % according to the U.S regulations.
Please notify me if this can be done in a short period of time?
And your price for 5 drinks.
We no longer provide standalone compliance reviews. Rather, compliance is built into the food packaging design work that we do.
This is Michael from 8/27/18. We have to ensure the Nutrition Facts design meets the new requirements for point size on pdf’s. I can calculate the height for various point sizes but how is this applied? For example, is it based on the lowercase “o” or another standard (such as upper case lettering that is found in FDA’s examples). We are unsure since FDA has no reference that I can find.
I’m not fully clear on what you’re asking here. A pdf can be opened in illustrator and you can see the font point sizes to verify. You can also use a point-to-mm conversion and measure manually on a printout. Point sizes differ between fonts, so this would not be an exact method. FDA specifies point sizes not height for the nutrition facts, so it’s best to verify that the correct point size is being used by examining the digital artwork. If you worked with a designer, that person can verify for you. Hope this helps.
Yes. FDA food labelling is done to make things simpler for the customers who are buying the product. All these guidelines are helpful to the consumer to understand the products in & out. Thanks for sharing, Keep posting!
Great article to really simplify dense text. Do you know what spices have nutrient levels significant enough for labeling? Or where I could get that list? I can’t seem to find it anywhere.
Hi Lydia – you would have to look at the nutrition values for each spice used per the serving size of your product.
Is the website of the company suffice as an alternate to physical address in the packaging label?
If 1) the physical address can be found on the website, 2) the city, state and Zip are listed on the label, and 3) the URL on the label doesn’t intervene with the required info on the info panel, then one could perhaps argue that the internet is a “city directory” if any issues arose.
This is the perfect guide for anyone for food labeling. Thanks for creating this amazing content for us. Easy to understand totally impressed. Keep it up with good work.
Is it ok to use PO Box as business address on the label?
thank you so much for your reply.
If I have my business on the Yellow Page listing.
I can just have company name, City, State, Zip code on the labels correct?
Yes, if the street address is found in the YP listing, then it is permitted to leave off the street address on the packaging.
I work for a small beverage company and our film labels are about 9 square inches.. I had used the following link
but can no longer find this exact page or example any longer on the FDA site… I saved it and when I did a search it brought me here to this site as you have it posted as well… Do you know if the FDA has once again changed their formats… I just finished resizing all our labels to this format to meet their specs… Hoping it’s still there… How can one comply if they keep changing the rules?
Below is the FDA link, page 6
Linear Display for Small Packages
(with < 12 sq. in. of labelling space)
21 CFR 101.9(j)(13)(i)(B)
but if you go to their site now you can't find it.. or at least I can't… Any help would be greatly appreciated…
Great work by the way I'm in the middle of reworking all of our 4 packs for bottles and the info here saved me a lot of time searching… Thanks for all the hard work you pit into this page.
Thanks for all the hard work you”put” into this page.
Correct, the link you included is the latest format and here is the CFR link if that is what you’re looking for:
Thanks Jenn… Nice to know it’s still valid. I am now reformatting all our 4 packs for bottles
to have the Nutrition table more prominent.
Thanks for your help.