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Canadian packaging and FDA guidance labeling for dietary supplements.

This article is intended to provide guidance and instruction to help businesses navigate FDA labeling and Canadian packaging for dietary supplements. Included in this document is FDA labeling guidance for required label statements; label placements; regulations for dietary supplement claims such as ‘antioxidant’ or ‘high potency’; country of origin, and Canadian packaging regulations.

FDA Labeling – Dietary Supplements

In 1994, the Dietary Supplement Health and Education Act (DHSEA) created a new regulatory framework for the manufacturing, marketing and safety practices concerning dietary supplements. DHSEA guidelines stated that dietary supplements would be regulated as food and not as drugs.1

While these forms of compliance labeling created trust in products and brands, maintained product quality and are critical to consumer safety, they have become increasing complex over the past decade. FDA guidance documents are constantly being updated with strict label requirements that must be followed for FDA compliance, to avoid customer confusion or product recalls.1

As the demand for dietary supplements has grown significantly, so too have the number of inexperienced, and uninformed individuals entering the dietary supplement market. In the United States, dietary supplement brands are not required to provide the evidence used to support their health claims before entering the market.1

Instead, it is the responsibility of the manufacturer and/or distributers to ensure that their products are safe for consumers and that all label claims are accurate and not misleading. In 2007, the FDA issued the Current Good Manufacturing Practices (cGMP) as a standardized set of manufacturing expectations. Manufacturers are required to be able to guarantee product purity, composition, and strength of all dietary ingredients.1

Improper packaging could result in large product recalls, costly fines, destroyed reputation of the company and in the case of undeclared allergens, could potentially risk the safety of your customers.

What Types of Products does FDA Labeling Apply To?

The FDA labeling requirements for dietary supplements apply to a wide range of products meant to improve overall health and well-being. Products that qualify as dietary supplements include: vitamins; minerals; herbs or botanicals; amino acids; products meant to substitute regular dietary meals; or an extract, concentrate, metabolite, constitute, or a combination of any of these ingredients.2 Dietary supplements are not marketed or regulated in the same manner as conventional food.

Required Label Statements

According to FDA labeling regulations, approved FDA labels are required to display five statements on the container or packaging. These include:2

  • The name of the dietary supplement
  • Nutritional labelling
  • Ingredient list
  • The net contents statement (total amount of product)
  • Name of the place of business, distributor or packer

Label Placement

The principal display panel should be placed on the section of the package that is most likely to be visible to consumers. The FDA regulations on supplements mandate that the name of the dietary supplement and net contents statement be placed on the principle display panel.2

The supplement facts label, or information label, is placed to the immediate right of the principal display label, unless exemptions are otherwise specified. This label must contain the list of ingredients and name and address of the place of business of the manufacturer, distributor, or packer.

FDA labeling guidance is available for proper label placement, label colors and text size.

A ‘Supplement Facts’ label must be placed to the immediate right of the principal display label and identify every dietary ingredient included in the product (Vicky Androitis/Bigstock).

Print must be easy to read and conspicuous to the consumer. FDA labeling guidelines mandate that any text on a supplement label should be at least one-sixteenth (1/16) of an inch in size and contrast with the background coloring so it is easy to read. FDA label requirements note that the background is not required to be black and white.2

FDA Allergen Labeling

To reduce the risk of possible allergic reactions, a dietary supplement label is required by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) to display an allergen statement.

FALCPA identifies eight most common allergenic food groups which are responsible for 90 percent of all allergic food reactions.3 These ‘major food allergens’ may appear as a whole ingredients or protein derived from one of the following food sources:3,4

  • Milk
  • Wheat
  • Fish
  • Tree Nuts
  • Eggs
  • Peanuts
  • Soybeans
  • Crustacean shellfish

For major allergen groups such as tree nuts, crustacean shellfish or fish, the specific type must be declared on the label (e.g. walnut, salmon, shrimp).3,4

Non-dietary ingredients such as binders of fillers must meet the same FDA packaging guidelines as food additive regulations or be GRAS (generally recognized as safe) for their intended use.5

Print must be easy to read and conspicuous to the consumer. FDA labeling guidelines mandate that any text on a supplement label should be at least one-sixteenth (1/16) of an inch in size and contrast with the background coloring so it is easy to read. FDA label requirements note that the background is not required to be black and white.2

For a product to claim it is a “high source” of an ingredient, it must contain at least 20% of the Daily Reference Value (DRV) or RDI per serving.

Antioxidant Labeling

FDA label requirements note that manufacturers may include antioxidant dietary supplement claims on their products. Labels FDA approved for antioxidant claims must meet specific nutrient amounts to claim they are either a “good source,” “high source” or contain “more” of a specific ingredient.6

Labeling FDA approved to be a “good source” of an ingredient, must contain between 10-19% of the DRV or RDI.6

“High Potency” Label Requirements

According to the FDA regulations on supplements, claims such as ‘high potency’ may be used on supplement labeling to describe ingredients that are at 100 percent or higher of the reference daily intakes (RDI). Vitamins or minerals must have an established RDI and be present at 100 percent per serving.6

High potency dietary supplement claims may only be made for individual ingredients that are at 100 percent or higher per serving. For example, “dietary supplement X with high potency of vitamin A.”3

For an entire product to claim it is high potency, (e.g. a multivitamin) the product must contain 100 percent of the RDI for at least two thirds of the vitamins or minerals listed.6

Structure Function Claims

As per the FDA labeling guide for dietary supplements, the structure function claim definition is a claim which may describe the role of an ingredient or nutrient that may affect or maintain normal functions or structures within the body. For example, ‘calcium helps maintain strong bones.’7

FDA dietary supplement labeling outlines two possible categories of structure function claims. The first are general well-being claims which outline generic benefits of consuming a nutrient. The second are claims related to nutrient-deficiency diseases, such as vitamin C and scurvy. These labelling claims may only be present if the disease is widespread across the United States.7

FDA Warning Labels and Disclaimers

FDA labeling regulations also dictate that labels must include a supplement disclaimer that the products have not been evaluated by the FDA. The disclaimer must also state that the dietary supplements are ‘not intended to diagnose, treat, cure or prevent any disease’ as only drugs may make this claim.7

Depending on the ingredients contained in the supplement, an FDA label may also need to include a warning label. For example, iron-containing dietary supplements sold in solid dosages are required to display the below warning,8

‘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.’

Labeling guidelines suggest that warnings be printed on any labeling such as package inserts to increase the likelihood it will be read. Multiple copies of the warning label can be printed throughout the packaging. Variations or alternations of a specified warning statement are prohibited.8

Country of Origin Labeling FDA

According to the FDA label guidelines, all dietary supplements must specify their country of origin.

If products, or any of the contained ingredients, originate from outside of the United States, every imported ingredient must indicate the country of origin by its English name, so it is easily identified by consumers.9

The FDA labeling laws do not regulate the statement “Made in the U.S.A.” As per the Tariff Act of 1930, the U.S. Customs Service regulates this marketing statement and must be contacted separately.9

Health Canada (Canadian FDA) Labeling Requirements – Natural Health Products

Health Canada, sometimes referred to as Canadian FDA, is the regulatory body which overlooks product packaging and labeling for natural health products in Canada.

Before being sold in Canada, all natural health products (NHPs) must meet the Canadian packaging and labeling requirements of the Natural Health Product Regulations. NHPs include herb or plant-based remedies, vitamin and mineral supplements, omega 3 fatty acids, probiotics, traditional medicines, or homeopathic remedies.12

Many everyday products such as toothpastes, shampoos or facial products may also be considered natural health products (NHPs).12

Applicants must provide detailed information regarded the health benefits, dosage, source, potency, and recommended use of their product. All products must display accurate label statements or warnings that help consumers make informed decisions.10,11

Unlike the United States, sports nutrition brands must also include evidence to support the safety and efficacy of their product to Health Canada before they can enter the Canadian market. Evidence may include published articles, journals traditional resources or pharmacopoeias.11

Additionally, any site that labels, manufactures or imports NHPs in Canada must obtain a site license.10,11

General Label Requirements

Similar to FDA labeling requirements, NHPs must include the following statements on the principal display panel: 10

  • The brand name
  • Net amount in terms of weight, number, measure, or volume
  • The natural product number
  • Dosage form

The word ‘sterile’ if the product has been sterilized

FDA Canada, Health Canada regulations on dietary supplement label placement.

Principal display surface will change depending on the dietary supplement container size and shape.

On any alternative panels, the following must be included:10

  • Lot number
  • Expiration date
  • Recommended use or purpose (Health benefits)
  • Name and address of the product license holder and importer, when applicable
  • Common name of each medicinal ingredient; including the proper or chemical name of each medicinal ingredient
  • Quantity of each medicinal ingredient per dose
  • Potency of each medicinal ingredient
  • Recommended dose
  • Recommended duration of use
  • How to administer the product
  • Risk information (cautionary statements, warnings, known adverse reactions or contraindications)
  • Recommended storage conditions
  • Any non-medicinal ingredients
  • Quantity of mercury contained, if any, listed as a non-medicinal ingredient
Note: For contrasting labels, it’s not recommended to combine red and green as they may be problematic for consumers who are color blind.10

Canadian labels can include an outer and inner label if space permits. According to Health Canada label placement regulations, one may be placed on the outside packaging of the NHP. A second, inner label should be affixed to the immediate container. If a manufacturer chooses, they may only display one label on a NHP, so long as it includes all of the information that would be placed on the inner and outer label.10
Regardless of the shape, the position of the supplement label must be in accordance with Health Canada labeling regulations. Canadian label placement will vary depending on the size and style of container.10

Product Packaging Canada

While label requirements may be similar between the U.S. and Canada, there are some notable differences in Canadian packaging and nutraceutical regulation that must be fulfilled prior to entering the Canadian market.

Nutraceutical is a slang, umbrella term that combines the phrases ‘nutrient’ and ‘pharmaceutical’ to describe products that provide health benefits beyond basic nutritional value. General categories include NNPs, functional food, or medicinal food.

Canadian packing regulations require all NHPs sold in Canada have a natural product number (NPN).

A natural product number (NPN) indicates a product is licensed to be sold in Canada and acts as a certification for Canadian consumers.

A natural product number (NPN) is assigned to each, individually approved product that will be marketed in Canada and acts as a certification that is has been authorized by the Natural Health Products Directorate (e.g. NPN 8000 0003).10NPNs should be visible on all licensed natural health products sold in Canada. If a NHP does not have a NPN, users are strongly recommended to not purchase the product.

In Canada, products must contain text in both official languages, English and French. Bilingual text must be used for statements including:10

  • Recommended use or purpose (health claim)
  • Recommended route of administration, recommended dose or recommended duration of use
  • Dosage form
  • Any cautionary statements, warnings, contraindications or known adverse reactions
  • Medicinal ingredients;
    • proper name (common name) (source), quantity, potency, extract ratio and quantity dried equivalent (as applicable)
  • Non-medicinal ingredients and their common name
  • Storage conditions, if any
  • Hazard statement and signal word (caution, warning, danger) if dietary supplement is packaged in a pressurized container
Packaging is considered child resistant when 85% or more of children in a test group cannot open the product prior to a demonstration.
Secure packaging is a required for all NHPs before they can be legally sold in Canada.

Seals, transparent wrappers or cotton swab inserts are forms of security packaging designed to protect consumers (toons17/Bigstock).

Product Safety

Similar to the United States, NHPs should include security packaging to demonstrate the product has not been opened or tampered with prior to purchase. Security packaging may include lids that remain sealed until opened, transparent wrappers or cotton swab inserts. Products must have at least one form of security packaging before they can be sold to consumers.

If the dietary supplement contains ingredients that may be harmful to children, cautionary statements and child-resistant packaging should be used.10

Last Updated: June 2 2017