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Tea Packaging Requirements from the FDA
Coming up with an excellent product is the most obvious hurdle to running a business. You can most certainly expect to have a plethora of other details to contend with, government regulations being one of them. When it comes to tea sold and marketed in the United States, it’s absolutely imperative that you strictly abide by the edicts of the Food and Drug Administration.
The agency is tasked with protecting public health by controlling and supervising food, drugs, and other related items. One way to ensure that people are safe from food and drugs that don’t pass muster is to implement packaging and labeling regulations. These are all detailed in the FDA’s Code of Federal Regulations, Title 21.
Bearing these requirements in mind, you need to determine whether the packaging for your tea should be labeled for resale. Take note that the packaging regulations do not apply to the following situations:
However, anytime you package your tea ahead of time and then have it on display on a shelf or counter for customers to pick up and buy, it has to be packaged according to the instructions of the FDA. Anything prepackaged and displayed, be it by a factory machine or a sales clerk, should comply with the agency’s labeling regulations.
To better understand what it is you need to do in this regard, let’s divide the discussion into the different parts of the label:
This refers to the most dominant part of the label, which gets the most view or scrutiny in retail sales. It should be big enough to include all the required information. To figure out which font
size to use, determine the principal display panel measurement. This refers to the package’s surface area bearing the information. For tea boxes, cans, or pouches, just measure the height and width of the side you’ll put this on. For cylindrical containers, the area should be 40 percent of the product of the height and circumference.
What details are included in the Principal Display Panel (PDP)?
This is a statement that consists of the legal name of the food (e.g., Twinings Herbal Tea) or the tea’s common or usual name, such as “Peppermint Tea” or “Green Tea.”
In the absence of either, a descriptive term like “FRUIT TEA” would do. In cases where the nature of the food is apparent, a fanciful name for the tea that the public commonly uses would also be allowed. That’s why “DRAGONWELL” and ‘DARJEELING” would also work.
Since tea is marketed in different forms (loose leaf, tea bag, powder, etc.), the product’s particular form must be included in the Identity Statement. It should be printed in a type size close to that of text pertinent to other parts of the Identity statement, unless the optional form can be seen through the container or is represented by an appropriate image that clearly shows what form the tea is in.
Make sure that the Identity Statement is one of the most prominent texts on the panel and that it is not placed at an awkward angle. It should be in bold type in a size reasonably close to the most dominant type on the label. It should also be placed in lines parallel to the package base when it rests on display.
The FDA requires the principal display panel to show a declaration of the content’s net quantity, expressed in weight, measure, numerical count, or a combination of these. It’s imperative that the term “net weight” be used when indicating the net quantity in weight, even if it’s in its abbreviated form, “Net Wt.” According to the American Technology Preeminence Act of 1991, the net quantity of contents must be declared in metric form, indicating weight or volume.
The Contents Declaration must be presented as a separate item on the panel, set apart by space at least equal to its text height from other information printed below or above it and space equal to double the width of the letter “N” in the type style it uses from information printed on its left or right. It should also be placed in the bottom 30 percent of the panel and aligned parallel to the package’s base in its resting position. Of course, for principal display panels that are five square inches or smaller, the content declaration no longer needs to be placed in the bottom 30 percent.
The type size should be compliant with specifications based on the area of the principal display panel. For instance, no less than a sixteenth of an inch in height on Principal Display Panels measuring five square inches or smaller. For those with a bigger area not going over 25 square inches, it should not be smaller than an eighth of an inch. For specific measurements, refer to the following:
The assumption is that it would be up to the packager to make decisions on what to put in the Contents Declaration. Still, it should be noted that a combination of numeric quantity and net weight is allowed for clarity’s sake. In cases where quantity would be the practical measure of the contents, as in the case of tea bags, it’s prudent not to assume that putting only the net weight would be enough. The logical recommendation based on what existing labels show is to indicate both the numerical count (10 TEA BAGS) and the net weight (0.9 OZ/25g).
2. Information Panel
This is the part of the label right next to the principal display panel. It usually contains information on the nutrients included, the ingredients, the name and address of the manufacturer, packer, or distributor, as well as the country of origin for imported products. If these bits of information are already reflected on the front panel, they need not also appear on the information panel. Considering that the print on the label would have to be pretty small, there are precise requirements regarding the font type and size to be used. It’s important to check out and comply with the instructions, as it can be a meticulous process.
Food labels must carry nutrition information unless exempt, which is the case with food that contains negligible amounts of nutrients, such as vitamins and minerals, and food components like calories, carbohydrates, fats, proteins, etc., as long as it doesn’t bear nutrition claims on the label, in other forms of labeling such as brochures, or in
advertising. This exemption applies to teas and herbal teas, but many tea brands still include Nutrition Facts, especially those that underline the antioxidant contents of tea.
This requirement may actually be placed on either the Principal Display Panel or the Information Panel. It should reflect a list of all the ingredients in their usual or common names, sequenced in descending order based on predominance by weight. An accurate Identity Statement like “Green Tea” or “Black Tea” on the Principal Display Panel may suffice for single-ingredient products. Even tea blends may do with just an Identity Statement as long as Camellia Sinensis is the only ingredient.
If an Ingredient List is included, it must appear on the same panel as the Manufacturer’s Name and Address.
Also, where it applies, an allergen declaration must be included in plain language, stating if the product contains or was manufactured in a facility that also handles any of the major food allergens.
The label of your packaged tea product must specify in a conspicuous manner the name and place of business of its manufacturer, packer, or distributor. In addition, the address must include the street details, city, state, and zip code. The street address may be left out if the business is listed in a current phone or city directory.
In cases where the tea is not produced by the business that appears on the label, e.g., a U.S. distributor, the name should be qualified to show its relationship to the product. Following the example given, the qualifying phrase would be “Distributed By.”
Like the Ingredient List, this detail typically appears on the Information Panel but may also be placed on the Principal Display Panel.
Besides the FDA, various government agencies, including the U.S. Customs and Border Protection, require that labels of food products of foreign origin bear conspicuous, legible, and indelible markings that will disclose the country of origin to the ultimate purchaser, e.g “Product of Japan” or “Made in Japan.”
Whenever the retail package of imported goods bears the name and address of their U.S. distributor, the word United States, or any U.S. state or city, the product’s country of origin should be indicated in close proximity and in a type size that is comparable.
Again, this information may appear on either panel.
Additional Packaging Elements
The following are other details that may be considered for inclusion:
This is a statement pertaining to the nutrient level of the product. “Gluten-free,” “sugar-free,” “high fiber,” and “low fat” are some examples. Claims have to be valid based on regulations. A Nutrient Content Claim can be displayed anywhere on the package in a type size no larger than twice the size of the Identity Statement’s font. It also follows that the package should bear a Nutrition Facts portion if there is a Nutrition Content Claim.
Food labels generally have an expiration, best-before, or sell-by date, as this is required in some states. Hence, it’s essential to check the relevant state’s food packaging and labeling regulations.
Placement-wise, the date must not mess with the labeling elements required by the FDA. It must also show at least the month and year immediately next to the explanatory phrase (e.g., best before 08/08/23).
The government does not mandate the inclusion of a barcode; however, retail stores often do. When including a barcode, take care to place it where it won’t interfere with the required elements.
These are just the most salient points of the regulations regarding the packaging and labeling of tea. Of course, the literature from the FDA is much more complicated, but the above discussion hopefully allows for better clarity regarding the basics.
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Charles Cain - Feb 18th 2010
Navigating regulations is one of the more intimidating aspects of running a business. It should be relatively simple - and sometimes seems that way - but of course everything is written by lawyers or bureaucrats and the cost in time and money if you get anything wrong can be high. The Food and Drug Administration's labeling regulations are no exception. I've waded through these with two different companies now, and I can say with conviction that I hate the FDA's Code of Federal Regulations Title 21.
The purpose of this article is to provide a little guidance based on my research and experience. I am not a packaging attorney, so I must recommend for the record that you pass your plans for tea packaging by legal council before making a large investment. That said, I have talked with many attorneys and I did stay at a Holiday Inn Express last night so here goes:
The first question you need to answer is whether your packaging must be labeled for resale. There are three ways you can avoid the packaging regulations:
If, however, you package any food product ahead of time and have it sitting sealed on a counter, shelf or display for the customer to pick up and purchase, you need to understand and follow the regulations. So whether your teas are packaged and sealed professionally in a distribution facility or by a 17 year old sales associate, anything pre-packaged and displayed should be compliant with all federal regulations on food labeling.
These regulations are listed in detail online in the FDA's Code of Federal Regulations Title 21. But since I just spent the last few hours summarizing these for Adagio's design team, I figured I'd share my findings with you. There are 8 relevant sections that you should be aware of:
1. PRINCIPAL DISPLAY PANEL
Every package must have a "principal display panel" which is defined by 21 CFR § 101.1 as "… the part of the label that is most likely to be displayed, shown or examined under customary conditions of display for retail sale". This panel must be large enough to accommodate information that is required, such as the declaration of net quantity of contents (See, 21 CFR § 101.105) and the statement of identity (See, 21 CFR §§ 101.3). Packaged tea can have more than one principal display panel.
For the purpose of determining the appropriate font size of the required contents declaration, the "area of the principal display panel" must be ascertained. This is defined as the surface area of the side of the package that bears the required information. For rectangular containers, such as the boxes, tins or pouches used for tea, the area of the principal display panel is simply the height times the width of the side where the information will be displayed.
2. INFORMATION PANEL
The information panel is the part of the label of package that is immediately contiguous and to the right of the "principal display panel". 21 CFR § 101.2. Generally, this panel includes nutrition information (if necessary), an ingredient list, a statement of the name and address of the manufacturer, packer or distributor and country of origin markings, if the product is imported. Of course, some or all of the required information may be included on the principal display (front) panel. If any of the required information appears on the front panel, it does not need to be repeated on the information (right side) panel. Most of the information required is subject to a minimum type size requirement of one-sixteenth inch in height (ingredient list and name and address). Nutrition information (if required) is subject to different type size and presentation requirements.
3. IDENTITY STATEMENT
The principal display panel of a tea package is required to bear (as a primary feature) a statement of identity, generally consisting of the common or usual name of the tea. For our purposes, the particular blend or featured flavor of the tea would be sufficient, such as "ENGLISH BREAKFAST TEA", "CARAMEL BLACK TEA", "PEPPERMINT TEA", etc.
21 CFR § 101.3(2-3) requires the use of the "common or usual name of the food; or, in the absence thereof, an appropriately descriptive term, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food.” I would interpret this to allow Identity Statements like "DARJEELING", "KEEMUN" or "DRAGONWELL" to be sufficient as stand-alone declarations. The purely arbitrary names like “BERRY BLAST”, or “WHITE CHRISTMAS” should be accompanied by a more descriptive Identity Statement like “FRUIT TEA”. In the case of flavored teas with single names, the tea type should be included in the name of the tea so as to guide the customer (in addition to the color scheme) and satisfy the packaging requirements for an accurate Identity Statement. For example, “ALMOND” should be named “ALMOND BLACK TEA”.
21 CFR § 101.3 requires that the identity statement appear on the front panel in bold type of a size "reasonably related to the most prominent type" used on the label and in lines generally parallel to the base of the package as it rests when displayed. In other words, it needs to be one of the biggest words on the panel and shouldn't be at a crazy angle.
21 CFR § 101.3(c) requires that, “Where a food is marketed in various optional forms (whole, slices, diced, etc.), the particular form shall be considered to be a necessary part of the statement of identity and shall be declared in letters of a type size bearing a reasonable relation to the size of the letters forming the other components of the statement of identity; except that if the optional form is visible through the container or is depicted by an appropriate vignette, the particular form need not be included in the statement.” I would interpret this to apply to tea bags vs. loose tea.
4. CONTENTS DECLARATION
Section 403(e)(2) of the Federal Food, Drug and Cosmetic Act (the "FDC Act") and 21 CFR § 101.105 require that the principal display panel bear a declaration of the net quantity of contents expressed in numerical count, weight, measure or a combination of numerical count and weight or measure. The declaration must: (1) appear as a distinct item on the principal display panel; (2) be separated, by at least a space equal to the height of the lettering used in the declaration, from other printed label information appearing above or below the declaration and, by at least a space equal to twice the width of the letter "N" of the style of type used in the quantity of contents statement, from other printed label information appearing to the left or right of the declaration; and (3) be placed within the bottom 30% of the area of the label panel in lines generally parallel to the base on which the package rests as it is designed to be displayed. (On packages having a principal display panel of five square inches or less, the requirement for placement within the bottom 30% does not apply.)
21 CFR § 101.105(3) requires that the term “net weight” shall be used when stating the net quantity of contents in terms of weight. This may be abbreviated but may not be omitted.
The type size of the contents declaration must comply with specifications that depend on the "area" of the "principal display panel" (See, No. 1 above regarding the "Principal Display Panel") as follows: (a) not less than one-sixteenth inch in height on packages the principal display panel of which has an area of five square inches or less; (b) not less than one-eighth inch in height on packages the principal display panel of which has an area of more than five but not more than 25 square inches.
Finally, the metric equivalent of the net quantity of contents that is declared by weight or volumetric measure is required to be included as a result of the American Technology Preeminence Act of 1991.
This section assumes that the declaration of quantity of contents (i.e. 10 TEA BAGS) will be the primary choice of the packager and allows for the combination of quantity and net weight for purposes of clarity, but does not speak to the use of only net weight without quantity where quantity would otherwise be the customary measure of the product. In the case of tea bags, I believe it is safe to assume most customers measure a package by the number of tea bags rather than the total weight of tea in the package. I have reviewed a number of the labels for teas that are prominent in the United States and determined that they usually declare the contents as a combination of numerical count AND net weight where applicable. I would recommend that the contents be declared on the front panels of the bagged tea products as follows: "10 TEA BAGS NET WEIGHT 0.9 OZ/25g e".
5. NUTRITION INFORMATION
All food labels are required to bear nutrition information presented in accordance with 21 CFR § 101.9, unless exempt. In general, foods that contain insignificant amounts per serving of all the nutrients (vitamins and minerals for which a daily value is established) and food components (calories, fat, carbohydrate, protein, etc.), as long as the food bears no nutrition claims or information on the label, in labeling (brochures, etc.) or in advertising. 21 CFR § 191.1(j)(4). The vast majority of teas and herbal teas are exempt from nutrition labeling on this basis, but many major tea brands include a "Nutrition Facts" panel, particularly those which have begun featuring the "antioxidant" properties of tea.
6. INGREDIENT LIST
Section 403(i)(2) of the FDC Act and 21 CFR § 101.4 require that the label of a food include a list of all ingredients that are declared by their common or usual names and in descending order of predominance by weight. The ingredient list must be included on the principal display panel or the information panel. An accurate identity statement on the front panel, such as "Black Tea", "Green Tea", etc., may be sufficient for single-ingredient tea or even a blend of black tea leaves so long as the only ingredient is Camellia Sinensis.
7. NAME OF MANUFACTURER/DISTRIBUTOR
Section 403(e)(1) of the FDC Act and 21 CFR § 101.5 require that the label of a food in package form specify conspicuously the name and place of business of the manufacturer, packer or distributor of the food. The statement of the place of business must include the name, street address, city, state and Zip Code. However, the street address may be omitted if it appears in a current city or phone directory.
When the food is not manufactured by the party whose name appears on the label, such as a U.S. distributor, that name must be qualified by a phrase that reveals the named party's relationship to the product, e.g., "Distributed By __________".
8. COUNTRY OF ORIGIN MARKINGS
Section 304 of the Tariff Act of 1930, 18 U.S.C. § 1304, and U.S. Customs and Border Protection regulations require conspicuous, legible and indelible country of origin markings that disclose such information to the ultimate purchaser, i.e., "Product of China" or "Made in China" on products of foreign origin. Generally, each time the container or holder (retail package) of foreign goods includes the name and address of the U.S. distributor, the name "United States" (or abbreviation) or any U.S. city or state, the country of origin's name must appear in close proximity and in comparable type size.
So there's my summary. Even this abbreviated version is painful, but not nearly as much so as wading through the regulations themselves... trust me! :)
Additional useful links:
Food Labeling Guide
Food Labeling and Nutrition Overview
Adagio Teas
Twitter: @AdagioRetail
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