Natural Health Products: 53 Recommendations of the Standing Committee on Health

Recommendations re: Labelling

32. Health Canada consult with its new separate NHP Expert Advisory Committee to determine what information is to be included on the labelling, consisting of, at a minimum, the items recommended by the Advisory Panel on Natural Health Products.

Status:

1. The Expert Advisory Committee, the Transition Team, stakeholders, professional groups and the public have made recommendations regarding minimum requirements for NHP labels.
2. The NHPD recognizes that product labels should assist consumers in making informed choices with respect to NHPs.
3. Labels should assist in selecting products that meet individual needs and expectations and outline the merits and limitations of products.
4. Labels should allow consumers and others to fully understand how products are to be used and stored to ensure their maximum benefit, and to be aware of any adverse reactions or other risks associated with the use of the product.

33. NHP labelling provide consumers with all relevant information needed to make informed choices.

Status:

1. Under the NHP Regulations, the required labelling information includes all of the following:

• the brand name;
• the product number (issued with the product licence);
• the dosage form;
• if the NHP is sterile, the notations "sterile" and "stérile";
• the net amount of the NHP in terms of weight, measure or number;
• the name and address of the product licence holder;
• if the NHP is imported, the name and address of the importer (and the product licence holder);
• the common name of each medicinal ingredient and its proper name. In the case that the proper name is a chemical name, only the common name should be indicated;
• a list by proper name, or by common name if the proper name is the chemical name, that sets out the quantity of each medicinal ingredient per dosage unit, and if any, the authorized potency.
• a qualitative list of all non-medicinal ingredients (preceded by the term 'non-medicinal ingredients');
• the recommended use or purpose;
• the recommended route of administration;
• the recommended dose and, if any, the duration of use;
• the risk information relating to the NHP, including any cautions, warnings, contra-indications or known adverse reactions associated with the use of that NHP;
• the recommended storage conditions, if any;
• the lot number;
• the expiry date;
• a description of the source material of each medicinal ingredient that the product contains (for example, when the ingredient is a plant or plant material, the source material is the species and the tissue/part).
  

34. NHP labelling be standardized to provide clear and consistent product information.

Status:

1. NHP labelling requirements apply to all NHPs, therefore clear and consistent product information will be available to consumers. Recognizing that many NHPs are usually sold in small containers and that label space is limited, the Regulations include a provision for small package labelling.
2. Products on store shelves will be easier to compare.
3. Please also refer to recommendation #33.