It is crucial to adhere to the regulations set by The Food and Drug Administration (FDA) and other applicable laws whereby your business is operated to ensure your products comply with industry standards and keep your consumers well-informed.
!!NB!! Labelling requirements for supplements vary from country to country. Each country has its own set of regulations that must be followed to ensure that the product is safe for consumption and accurately labeled. Ultimately, as the supplement seller, you are responsible for ensuring that your labels comply with all applicable regulations. By researching and staying up to date with the latest regulations, you can ensure that your product labels meet the requirements of the countries where you are selling them and protect your customers and your business. We do not guarantee the completeness, accuracy, reliability, or suitability of the information in this article. This article may be updated from time to time, and we do not guarantee that the information provided is fully up-to-date or accurate.
The FDA plays a significant role in regulating dietary supplements. When creating your product labels, consider the following key points:
The name of the dietary supplement (the statement of identity)
The net quantity of contents statement (amount of the dietary supplement)
The nutrition labelling (Supplement Facts)
The ingredient list
YOUR company name and full address of the business of the manufacturer, packer, or distributor. Click here for more details on the address format.
FDA disclaimer
Caution, Warning statements
If your uploaded label is missing any of these statements, our label verification Team will put any incoming order on hold and send you a message. Please read this article for more information.
We encourage you to use Supliful generic product label templates as a starting point. You are free to adjust the necessary details to comply with your local regulations.
Before we discuss the content requirements, it has to be noted that the following print areas apply for dietary supplements:
The principal display panel (PDP) shall contain:
the statement of identity
the net quantity of contents statement
The information panel (IP):
the "Supplement/Nutrition Facts" panel,
the ingredient list (unless there is not enough space, then can include on the left),
the name and place of business of the manufacturer, packer, or distributor (unless there is not enough space, then can include on the left)
The left side:
Shall include barcodes (not possible to add barcodes to PDP or IP)
Claims
Disclosure statements (i.e. “FDA has not evaluated…” and “keep out of reach…”)
Any other intervening information
NAME OF THE DIETARY SUPPLEMENT
Choose a name that accurately represents the nature of your product. Avoid misleading claims or names that imply the supplement can treat or cure diseases. You can replace the word “dietary” with a description of the type of dietary ingredient(s) in the product (e.g., “herbal supplement”) or the names of one or more dietary ingredients in the product (e.g., “bee pollen supplement”). Ensure the name complies with FDA regulations and doesn’t include unauthorized (e.g. health) claims.
Statement must be in bold, and a type size reasonably related to the most prominent printed matter on the PDP.
Brand names are not considered to be statements of identity. The statement must be placed parallel to the base of the package at the bottom 30% of the PDP.
NET QUANTITY OF CONTENTS STATEMENT
Clearly state the amount of the dietary supplement in the package. The Net Quantity of Contents refers to the amount of dietary supplement the package or container has and must be expressed accurately in both metric (g, kg, ml, or l) and U.S. Customary Systems (ounces, pounds, or fluid ounces).
The Net quantity must appear within the bottom 30% of the PDP in lines parallel to the base of the container. For smaller products you can include it elsewhere provided the statement stands out.
SUPPLEMENT FACTS
The Supplement Facts panel is a critical component that provides information on serving size, servings per container, and nutrient values. We highly recommend using the Supplement Facts provided by Supliful without making further adjustments, except for translations, if that is necessary*.
INGREDIENTS LIST
List all ingredients using the common or usual name. This includes active and inactive ingredients. We highly recommend using the ingredient lists provided by Supliful without making further adjustments. Be attentive to allergen declarations, and specific ingredient warnings (e.g. iron).
The statement should follow the Supplement Facts table if spacing allows.
COMPANY NAME AND FULL ADDRESS
A supplement label must include the name and place of business of the manufacturer, packer, or distributor. This includes providing a physical address. While an email address may be included as an additional means of contact, it cannot substitute a physical address.
The purpose of including a physical address is to provide consumers with a way to reach out to or locate the responsible party for the product.
The statement should preferably be positioned on the Information Panel, if spacing allows.
Please find further information on address options here.
CLAIMS AND THE FDA DISCLAIMER
There are several types of claims which must strictly adhere to requirements. Such claims include health claims, structure/function claims, nutrient content claims, etc. You must remember that the product sold is a dietary supplement and not a drug. The product cannot claim to be intended to diagnose, treat, cure, or prevent any disease. Each claim must have sufficient supporting scientific evidence.
Keep in mind that the following requirements also apply to symbols, icons, pictures, or other graphic material that might imply certain claims.
Health Claims:
Health claims describe a relationship between a supplement ingredient and risk reduction of a disease or health-related condition. Such claims are strictly regulated by FDA, to ensure accuracy and prevent misleading information for consumers.
Is allowed for certain dietary supplement products and certain general foods and is limited to claims about disease RISK REDUCTION, and cannot include claims about the diagnosis, cure, mitigation, or TREATMENT of disease or health-related condition. You can read more information here. Qualified health claims require FDA approval.
The type size of claims may not be more than 2x larger than the statement of identity.
Consumer Value Claims
Consumer value claims characterize the nature of the product, Organic, Natural, non-GMO, Gluten-free, Soy-Free, Dairy-Free, Kosher, Halal, Vegetarian, Vegan, etc.
Keep in mind that a product cannot claim different values without actually having evidence of compliance. Feel free to use the information displayed in our Catalog for precise characteristics.
Content Claims
These are statements that directly or by implication characterize the level of a nutrient (e.g. vitamin C) in a given product. There are specific requirements for a nutrient content level to be able to claim an “excellent source”, “good source”, “low in”, “free” and similar claims. You can find more information here.
Structure/Function Claims:
While health claims are closely monitored, structure/function claims are allowed provided certain conditions are met. These statements describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, but not with a specified disease or dysfunction. For example, "calcium builds strong bones.”
Dietary supplement labels or labelling may bear statements that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, provided that such statements are not disease claims. General well-being from the consumption of a nutrient or dietary ingredient is allowed.
It is prohibited to mention any diseases or dysfunctions explicitly or implicitly (fever, diabetes, etc)! A "disease" is damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.
You may use terms like stimulates, maintains, supports, regulates, promotes, and supplements. Read more information here.
THE FDA Disclaimer
Each Structure/Function claim must have an asterisk* at the end of the statement, to refer to the following disclaimer:
*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
The text cannot be rephrased, however, it must be adjusted depending on how many claims it refers to. If the label contains more than one claim, the disclaimer must be changed to plural: “*These statements have not been evaluated…”
There must be a solid box around the box (1-pixel wide black outline) with a white background and black letters. The text needs to be bolded.
FDA cannot be abbreviated, needs to be spelled out - the Food and Drug Administration.
Not only labels should contain this statement, but also the website/catalog/page where the product is listed if any types of claims are made!
DIRECTIONS FOR USE
Consider including the recommended dosage and any other instructions for how to use the product, or equivalent information set by the manufacturer.
CAUTION STATEMENT
Caution statements are meant to convey important information about the proper use and potential risks associated with the use of dietary supplements.
Common caution statements and warnings may include:
Keep out of reach of children: This warning is often included to emphasize the importance of storing the supplement in a safe place where children cannot access it. This is particularly important for products that may pose a risk if consumed by children.
Not for use by individuals under a certain age: Some dietary supplements may carry age restrictions, and a warning may be included to specify that the product is not intended for use by individuals below a certain age.
Pregnancy/breastfeeding warnings: If there are concerns or potential risks associated with the use of the dietary supplement during pregnancy or while breastfeeding, appropriate caution statements may be included to advise against use in these populations.
Allergy warnings: If the product contains common allergens or if there are specific concerns related to allergies, a caution statement may be included to alert consumers.
Consult a healthcare professional before use: Some dietary supplements may recommend consulting with a healthcare professional before use, especially if an individual has pre-existing health conditions or is taking medication.
If a product contains iron or iron salts for use as an iron source: “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.”
LABEL DESIGN AND FORMATTING CONSIDERATIONS
Consider the following design aspects to enhance the readability and attractiveness of your labels.
All information displayed on the labels, catalog, website, and others, must be accurate and not misleading.
The letters are at least one-sixteenth (1/16) inch in height based on the lowercase letter “o,” (Generally speaking, don’t use font size lower than 5pts)
The lettering must contrast sufficiently (it does not need to be black and white) with the background so as to be easy to read. The FDA has specific requirements regarding font size for certain information.
Use bold text for critical elements such as the product name, net quantity, and allergen warnings.
TRANSLATION
*Regulation (EU) No 1169/2011 on the provision of food information to consumers states that, where labeling is required, it should be "in a language easily understood by the consumers of the Member States where a food is marketed".
Therefore, if you are exporting products to the European Union or other destinations, labeling needs to be in the most appropriate language for the country you are exporting to.
BARCODES
‼️ Please note, that you are not allowed to add self-created barcodes on the labels! But you are allowed to legally get and verify your GTIN number via your GS1 account. Only then it can be placed on the label.
!!NB!! Remember, as a responsible business owner, you're responsible for staying informed about the ever-evolving regulations that govern your industry. While we aim to provide accurate and up-to-date information, it's crucial for you to consult legal professionals to ensure your labels meet the specific requirements for your business activities. We do not guarantee the completeness, accuracy, reliability, or suitability of the information in this article. This article may be updated from time to time, and we do not guarantee that the information provided is fully up-to-date or accurate.