Ask an Analyst - Consumer Health Products

Our answers pertain to consumer-directed advertising under the following:

Nonprescription Drug and Natural Health Product Advertising  

  • Food and Drugs Act and Regulations 
  • Health Canada’s Guidance Document: Consumer Advertising Guidelines for Marketed Health Products

Prescription Drug Direct-to-Consumer Advertising (DTCA)  

  • Section C.01.044 of the Regulations under the Food and Drugs Act
  • Health Canada Notice: Product Package Representations in Branded Prescription Drug Reminder Ads Directed to Consumers
  • Health Canada Policy: Advertising Campaigns of Branded and Unbranded Messages

Medical Condition/Disease State Direct-to-Consumer Information (DTCI)

  • Health Canada Policy: The Distinction Between Advertising and Other Activities
  • Health Canada Policy: Advertising Campaigns of Branded and Unbranded Messages

Vaccine Advertising

  • Food and Drugs Act and Regulations
  • Health Canada Interim Guidance: Fair Balance in Direct-to-Consumer Advertising of Vaccines

 

Question:

I manufacture a Selenium tablet and would like to advertise this natural health product (NHP) as an antioxidant for the maintenance of good health. This claim is not in my Product Licence (PL), but is one of the claims listed in the Natural Health Products Directorate Monograph for Selenium. Is this a claim that would be permissible in advertising?

Answer:

No. Based on Section 1.1 of Health Canada’s Consumer Advertising Guidelines for Marketed Health Products (Guidelines), any therapeutic claim that is used in advertising must be consistent with a product’s Terms of Market Authorization (TMA). In the case of NHPs, monographs are used as reference tools to assist with the product licence application process. Monographs are not equivalent to the TMA. Only those claims that are included in the PL can be used in advertising. So in this situation, your proposed claim would not be acceptable.

 

Question:

Health Canada has authorized my natural health product with the following Recommended Use: “Traditionally used in Herbal Medicine as a diuretic.” Can I shorten this in my advertisement to state the product is simply a “diuretic”?

Answer:

No. Health Canada issued an authorization for your product based on its traditional use and therefore, the statement “Traditionally used in Herbal Medicine” is an integral part of the Terms of Market Authorization (TMA). In order to accurately communicate the product category under which the product received its TMA, the statement “Traditionally used in Herbal Medicine” must be included in the advertisement.

 

Question:

I am a prescription drug manufacturer in the process of creating an unbranded, disease-related Facebook page that I will be sending to Ad Standards for clearance. The website will have a “Forum” section where participants can post comments and engage in conversations with other members. Does Ad Standards evaluate the entire website, including the postings in the “Forum” or can I just send in the main sections of the Facebook page for review?

Answer:

Ad Standards only reviews the advertiser’s static content and framework of the advertiser’s Facebook page. Any sections that are “live” or continually updated (such as forums) are not reviewed by Ad Standards. Ultimately, it is the responsibility of the advertiser to ensure that as a whole, the message and the information posted on the social media site comply with the applicable legislative and regulatory provisions. It should be monitored regularly to ensure that it remains compliant. The same answer applies equally to other social networking sites.

 

Question: 

Is the information regarding TMA on the Health Canada website sufficient to use as guidance when writing a commercial? Clients are reluctant to release the product licence, and if the HC site contains all the information I need, do I still need to get a copy of the entire product licence?

Answer:

In the case of Natural Health Products, Health Canada does provide an electronic version of the Product Licence (PL) on the Licensed Natural Health Products Database (http://webprod3.hc-sc.gc.ca/lnhpd-bdpsnh/index-eng.jsp). However, oftentimes the electronic version of the PL is not complete. Ad Standards requires the complete Health Canada issued PL to assess the therapeutic claims that are being made in a submitted advertisement, as well as to determine the appropriate risk statement that should be included in the ad. Please assure your clients that all documents that are shared with Ad Standards are kept strictly confidential. Should they have any concerns about releasing the Health Canada issued PL to Ad Standards, please ask them to contact us directly.

 

Question:

Is it acceptable to show someone consuming an over-the-counter drug product in an advertisement?

Answer:

Based on the provisions set out in Section 1.5 of Health Canada’s Consumer Advertising Guidelines for Marketed Health Products (Guidelines), depicting ingestion of a nonprescription drug or natural health product is acceptable as long as it is consistent with the product’s Terms of Market Authorization (TMA), i.e. the depiction accurately reflects the directions for use/dosage.

As well, particular caution should be exercised when children are depicted ingesting a health product. As outlined in Section 2.3 of the Guidelines, an advertisement must not depict or encourage unsupervised use of drugs by children or suggest that a child can self-diagnose and self-medicate. Therefore, an adult must always be present, either supervising and/or administrating the product to the child in a manner that is consistent with the product’s TMA.

 

Ad Standards Disclaimer

Finally, there are a few important points to remember. First, Ad Standards' brief answers to your questions do not replace, and don’t carry the same weight as, Ad Standards' formal response to the advertising material you submit to us for approval. You must still submit advertisements for approval. To be safe, be sure to submit them to us before, not after, you’ve produced the advertising. Second, it’s not possible for Ad Standards to provide totally comprehensive and all-inclusive answers to your questions. What you’ll read here are specific answers from us to your specific questions. Even a slight change in the facts could alter our response. And third, it should be understood that our answers to your questions are intended to provide nothing more than guidance. In the same vein, Ad Standards disclaims liability for any errors, inconsistencies or omissions.

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