How to Comply with FDA Requirements for Dietary Supplement LabelingNovember 6, 2013
Dietary Supplement Labels Prove to be Just as Information-Rich as Food Labels
We are often asked to provide an overview of the labeling requirements for dietary supplements such as vitamins, herbal supplements and other functional foods. Here is the best information we can find about the requirements for marketing and labeling dietary supplements.
What is a Dietary Supplement?
In the United States, the term “dietary supplement” is defined by Congress in the Dietary Supplement Health and Education Act, dietary supplements include vitamins, minerals, herbs or other botanicals, amino acids, dietary substances used to supplement the diet by increasing total dietary intake and concentrate, metabolite, constituent, extract or a combination of any ingredient listed above.
The Primary Display Panel on a Dietary Supplement Includes:
- Statement of identity (common name used for item)
- Brand Messaging
- Statement of net quantity of ingredients
- Nutrition labeling
- Ingredients list
- Name and address for the manufacturer, packer or distributor
If you’re trying to imagine where the Principle Display Panel (PDP) might be located on a package, just think of it as being on the part of the package that the consumer is most likely to see, and you’ll find it there.
This, along with the name and place of business as well as another separate information panel, (located immediately to the right of the PDP) is required. A supplement cannot include any other information, therefore only the essential information is presented on the PDP and can then be directly communicated to consumers. When creating a PDP label, the type style is as important as the information included so the label is easily readable. Along with ease of use, primary display labels should be both gorgeous and professional so they can attract customers and differentiate your brand from others. The Kiaro! QuickLabel label printer prints high-quality, distinctive labels in little time, making it easy to update the look of your labels and help your business grow.
Size of Letters on a Supplements PDP Label
The type size must be 1/16 (0.0625”) in height on the lower case letter “o” and must not be more than three times as high as the letters are wide. The lettering must contrast with the background color. For this reason, supplement facts panels generally and generally these labels have white backgrounds with black lettering.
Statement of Identity:
A statement of identity is used to recognize a common name which describes a single item and this must be placed on the PDP. Within the statement of identity, there are multiple requirements for identifying dietary supplements. These include: use of the term “dietary supplement” or, manufacturers can replace the word “dietary” and use an ingredient name in its place. For example, “calcium supplement” or “vitamin B12 supplement” are common supplements seen on the shelves of stores. The statement of identity must be one of the most important features on the PDP and its bold type size must be more prominent than other features on the front panel of the label, located parallel to the base of the package.
Net Quantity of Contents:
The net quantity of contents is defined as the amount of supplement in the container or package and can be expressed either in weight, measure, numerical or in both. If a net quantity is being defined in weight, it must be expressed in the metric or the US customary system. The weight is defined as the weight of the supplement itself. The weight of the container isn’t included in this measurement, except in cases where the supplement is designed to deliver results under pressure.
The net quantity of contents must be located on the product label as a distinct item on the bottom 30% of PDP, parallel with the base of the container. If the product is less than 5 square inches, the bottom 30% location is not a requirement.
How to Format the Net Quantity Statement on a Dietary Supplement Label
The quantity information should be prominent and easy to read with lettering no more than 3 times as high as they are wide and must have a background that is significantly contrasting the letter color. The type and font requirements are the same as what is listed above in the general information section.
If a net quantity is being defined in weight, it must be expressed in the metric system or the US customary system. The weight is defined as the weight of the supplement itself. The weight of the container isn’t included in this measurement, except in cases where the supplement is designed to deliver results under pressure.
Supplement Facts Panel Requirements:
A nutrition label for dietary supplements is called a Supplement Facts Panel. The required information on a Supplement Facts label includes:
- Serving size information
- Names and quantities of each ingredient
- Total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron
- Dietary ingredients with no daily value must be listed by common name
- Amount per serving (this can be worded as: amount per capsule, packet, per 2 tablets, etc.)
- Percent daily value must be declared on all dietary ingredients
For dietary supplements, this label is not required to present information regarding vitamins and minerals. A declaration is only required when the vitamin/mineral is added to the product for the purpose of supplementation or if a claim is made about them (please see the claims section below).
How to Format a Supplement Facts Panel
The formatting of the Supplement Facts panel is strictly proscribed. For example, the panel must be enclosed in a box. The title must be larger than all other print and it, along with headings, must be bolded. The type must be easy to read with black lettering and letters that are upper and lower case. If the package is less than 12 square inches in total area, all letters can be uppercased.
Ingredient Listing Requirements:
Any compound used in the manufacture of a dietary supplement is considered an ingredient. An ingredient statement is needed unless the product ingredients are listed under the supplement facts label. Ingredients are required to be listed in descending order of prominence by weight. Ingredient listings should also include the use of spices, natural and artificial flavors.
How to Format the Ingredients Listing on a Dietary Supplement Label
The ingredient list is located directly below the nutrition label with type size no less than 1/16 inches (0.0625”) in height. The Kiaro! label printer can easily print small type in legible, fine detail thanks to its 1200 dpi print quality. The Kiaro! label printer will also give you the flexibility to handle changes – you simply make a text change to your digital label files and re-print your labels instantly!
Warning Statement Requirements on a Dietary Supplement Label
Dietary supplements must include a warning statement on their packaging. This statement must be placed prominently on the information panel located on the product’s immediate container. The text of the warning statement must be: “WARNING: accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Be Careful About Making Health Claims on a Dietary Supplement Label
A claim describes a relationship between a dietary ingredient and reducing the risk of a disease or health-related condition. If a dietary supplement uses a claim on its packaging, a supplemental facts panel is required. Disclosure statements also fall under the claims category and are defined as a statement that calls the consumer’s attention to specific ingredients. Disclosure statements are required when nutrient content claims are used. For example, a disclosure statement might read, “Please see the nutrition information for sodium content”.
How to Submit Your Supplement Label for FDA Review
You will need to submit your dietary supplement to the FDA for a safety review. To do this, you must send the information to the Office of Nutritional Products, Labeling, and Dietary Supplements, Center for food Safety and Applied Nutrition and Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD20740. An original and two copies of the notification must be submitted.
A manufacturer is required to submit a notification to the FDA at least 75 days before delivering the supplement for interstate commerce. If a new ingredient is added to a supplement, the manufacturer is required to notify the FDA before it enters the market for consumer use. Note: If a supplement was developed before October 15, 1994, the FDA does not require that it be reviewed before entering the marketplace.
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