Dietary supplements in the USA are very similar to natural health products (NHP regulations) in Canada and many products can be classified as both. But not all dietary supplements are natural health products and vice-versa. There are some distinct classification factors for each. Generally, dietary supplements are labeled comparably to food products in the USA. Whereas natural health products are labeled more like drug products in Canada. This blog will provide an overview of some labeling requirements for both NHPs and dietary supplements, to compare the two product types.
Principal Display Panel Aka the Front Panel
Dietary Supplements – Must list a statement of identity and net quantity on the front panel.
Natural Health Products – Must list primary brand name, Natural Product Number (NPN label requirements), the net amount of product, specify if the product is sterile and if not already apparent, list the dosage form.
Nutrition Facts and Ingredients Listing
Dietary Supplements Labeling – Dietary Supplements must list a Supplement Facts panel hosting all nutritional information including daily value as well as the list of active ingredients. The listing of ingredients should be in descending order by weight.
Natural Health Products labeling– To best align with the regulations for Natural Health Products, we recommend a line listing for each of your medicinal ingredients. This would list common name and proper name, source material, label claim amount, extract information, and any potencies. Also, a list of all other ingredients preceded by a title of “non-medicinal ingredients” must be included.
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Dietary Supplements – All health claims should be structure-function based. Claims can be notified/approved for use through the FDA’s dietary supplement notification process. Many allowable claims can be found online through FDA resources and are like food claims in that way. We recommend the product owner hold a dossier of research to support the safety of the product and efficacy for any health claim made on a supplement label. We recommend you only use approved claims on product labels.
Natural Health Products – All health claims published on natural health product labeling must be in accordance with your product license. These come from Health Canada monographs or the class 3 application process where additional research can be submitted to support the efficacy of the product or an ingredient. We recommend you only use approved claims on product labels.
Caution and Risk Statements
Dietary Supplements – The general FDA caution statement must be listed when a structure/function claim is used. Other caution statements are voluntary to protect the consumer and certain subpopulations.
Natural Health Products – All risk statements for natural health product labeling must be as per your product license. These may come from Health Canada published monographs or through the class 3 application process where they can be added voluntarily or by the regulator.
Dietary Supplements – For dietary supplement labeling, you must list the name and place of business for the manufacturer, packer, or distributor. You must list the street address if the company is not listed in a city directory or telephone book.
Natural Health Products – For natural health product NHP labeling you must list the name and address of the product license holder. You must also list the name and address of the importer if the product is made outside of Canada.
Dietary Supplements – These products must specify on the front panel that they are dietary supplements. Font size for dietary supplements is 1/16 inch in height as measured by lowercase ‘o’. You may not place any non-required label content between required label content, this is known as intervening material.
Natural Health Products – All required content that is pertinent to the consumer must be printed in both official languages, English and French. Font size for natural health products is such that the average consumer can read the label (is legible). No minimum font sizes are prescribed/limited at this time.
In conclusion, there are many differences and similarities between natural health products and dietary supplement labels, most of which are apparent if you were to hold the two side by side. It would be difficult to prepare a label that is acceptable for both Canadian and US requirements, as each label type has its own intricacies. We recommend having separate labels for these markets based on many of the above requirements.
Please reach out to our team of specialists to further discuss your dietary supplements or natural health products. We are happy to help discuss the classification, labeling, and registration for your products in North America!