Health Canada Announces Amendments to the Natural Health Products Regulations – Health Care

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On Wednesday, amendments to the Natural Health Products Regulations were published at Canada Gazette,Part II. Among other things, these amendments change the labeling requirements that govern natural health products (NHPs) sold in Canada. Health Canada has also released a new guidance document to complement the amended regulations. The new labeling requirements will come into effect in three years, and product license holders will have an additional three years from that date to relabel their NHPs according to the new requirements. Below is an overview of the new regulations.

Product Fact Table (PFT)

PFTs must be on the outer label of the PSN or, if there is no outer label, on the inner label. The following sections and subsequent information should be included in the FTP:

  • “Medicinal Ingredients”

  • “Uses”

  • “Warnings”

  • “Directions”

  • “Other Information”

  • “Non-Medicinal Ingredients”

  • “Questions?”

The PFT must be in French and English. The label may include either a bilingual chart or two charts in each official language. The guidance document also includes formatting and font requirements for the element in the FTP. The use of graphics is prohibited unless they are trademark symbols, recommended by Health Canada or required by regulation.

Exemptions from including PFTs on a label are available under certain conditions.

Allergens, Gluten and Sulphite

Amendments will require disclosure of any food allergens, gluten, and/or sulfites contained in the NHP. This must be disclosed in a statement, which must include all food allergen sources, gluten sources and/or added sulphites. Such declaration is not required if the allergen is present due to cross contamination. Additionally, if the NHP contains aspartame, it will also need to be disclosed on the label.

Flexibilities

The regulation and its additional guidance document provide several flexibilities to accommodate different types of packaging. For example, an innovative label, such as a tear-off label, can be used as a physical extension of the PSN label as long as it is only used as a single extension of the main display panel and is is readily available to consumers prior to purchase. . Condensed sizing is also permitted for small packages.

The regulations also allow flexibility as to where the PFT(s) and their information may be placed, including on an affixed flyer, insert or website. If the label area is insufficient to accommodate the entire PFT, a statement may be displayed in its place that directs the consumer to the flyer, insert, or website where the PFT(s) can be found. For example, such a statement might read: “For the complete table of product facts, including removed information, visit www.insertURL.com.”

Layout

The Amendments add formatting requirements for all required information that is displayed on an NHP label. In addition to being displayed clearly and prominently, and easily discernible for the consumer, the information required on the label must also be:

  • In single color characters of the visual equivalent type to 100% solid black characters on a white background or on a uniform neutral background with a maximum color tint of 5%;

  • In characters of a standard sans serif font that is not decorative;

  • In characters that are not in contact with each other or with the characteristics of the tables that are to be displayed;

  • If they relate to a non-medicinal ingredient, in type at least 5.5 points in size or, if condensed, at least 5 points; and

  • If not relating to a non-medicinal ingredient, in type at least 6 point or, if condensed, at least 5.5 point.

These additional requirements do not apply:

  • Batch number, product number or brand name;

  • The statements, information or declarations to appear on: (i) the inner label if the available surface is 90 cm2 or less; or (ii) the outer label, if the available area is 90 cm2 or less.

They also do not apply if:

  • The entire amount of the natural health product must be used in one day or less according to the label directions; Where

  • The immediate container of the natural health product does not contain more than three recommended dosage units.

Gowling WLG’s Food and Beverage Group and Product Advertising and Regulation Group are here to help as the NHP industry evolves towards these new regulations – please subscribe to our Food, Natural Health Products and Cosmetics Act newsletter to keep you up to date on these and other food regulation issues.

Read the original article on GowlingWLG.com

The content of this article is intended to provide a general guide on the subject. Specialist advice should be sought regarding your particular situation.

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