Guaranteed to cure the flu … but can you prove it?

It’s cold and flu season, and with it comes plenty of products promising to help you avoid this year’s flu. In the U.S., the Food and Drug Agency (FDA) has been cracking down on companies claiming that their products can prevent the flu, without appropriate drug licensing or support for the claims made. So, are these kinds of claims permitted in Canada? That depends on the product, its licensing and the nature of the claims, all of which may be subject to the oversight of Health Canada.

In Canada, the Food and Drugs Act (Act) regulates the kinds of claims that can be made with respect to food, drug, and cosmetic products and medical devices. Certain claims are prohibited. Other claims may lead to the product being characterized as a “drug,” and will need to be supported by scientific evidence. “Food,” “drug” and “cosmetic” are all broadly defined, meaning that many products fall under the umbrella of the Act. “Food” is defined as including any article sold or represented for use as food or drink for humans, while “drug” includes  any substance sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or its symptoms in humans; (b) restoring, correcting or modifying organic functions in humans; or (c) disinfecting premises in which food is manufactured, prepared or kept. “Cosmetic” products are defined to include any substance that is manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth.

The regulatory regime makes a distinction between advertising to health care professionals versus the public/consumers. For certain diseases and disorders, the Act entirely prohibits claims that a product can treat, prevent or cure specified diseases (referred to as “Schedule A.1 diseases”) in advertising directed to the public. “Acute infectious respiratory syndromes” are Schedule A.1 diseases, meaning any claim that a product can treat, prevent or cure influenza or novel coronavirus syndrome runs afoul of this prohibition.

Not all claims related to the flu or common cold are prohibited in consumer advertisements in Canada. Claims to cold or flu symptom mitigation aren’t prohibited, meaning that products can claim to reduce the severity of your symptoms or reduce your chance of contracting a cold or the flu, if other requirements are met. Advertising a vaccine to the public as a product that “helps to prevent influenza” is permissible provided that the product has been approved by Health Canada for this purpose.

Licensing options

Based on the definition of “drug” in the Act, a product will be classified as a drug product if its labelling claims to treat, mitigate or prevent a human disease or associated symptoms. This triggers Health Canada approval and licensing requirements. The manufacturer must also have support for claims made as the Act prohibits labeling, selling or advertising food or drugs in a false, misleading or deceptive manner.

There are various regulatory approval routes for drug products in Canada based upon the risk profile of the active ingredient(s). The manufacturer may submit a drug identification number (DIN) submission to Health Canada to seek approval for an over-the-counter (OTC) drug product or apply for a Notice of Compliance (NOC) to sell a product with a new active ingredient as a prescription drug. If the product is comprised of permitted natural substances, it may be eligible for licensing under an alternate regime as a natural health product (NHP). For example, Fisherman’s Friend cough lozenges and Purell Hand Sanitizer are both licensed as NHPs in Canada.

While NHPs are still considered to be drugs, they are regulated under the Natural Health Products Regulations rather than the Food and Drug Regulations, and subject to simplified licensing and regulatory oversight requirements. Health Canada retains oversight over the marketing of these products, but the submission and compliance requirements are typically less onerous than for OTC or prescription drug products. Rather than being issued a DIN and/or NOC in advance of sale, NHPs receive a product license with a natural product number (NPN) that must appear on the product label.

To obtain an NPN, the manufacturer submits a product license application to the Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada. Safety and efficacy evidence must be submitted in support of the application; any health claims that will be made in connection with the product must be supported by the evidence. Depending on the claim made and the underlying condition, a risk classification is assigned which also determines the evidence required to support the application. For instance, “helps to relive the symptoms (e.g., sore throat, runny nose) of the common cold” is considered a claim associated with a minor disease/condition.  

To lessen the administrative burden, the NNHPD has prepared standard monographs that can be used by applicants for certain products. For example, the NNHPD has published a standard monograph for antiseptic skin cleansers for personal domestic use. If a manufacturer’s product falls within the scope of the standard monograph (i.e., appropriate ingredients and claims), they can rely on the monograph as part of their safety and efficacy submission. The antiseptic skin cleanser standard monograph permits claims like “kills harmful bacteria/germs” and “effective in destroying harmful bacteria to provide antiseptic cleaning.” NHPs are exempt from the general prohibition noted above regarding preventative claims for Schedule A.1 diseases, but like other drugs, cannot be advertised to the public as treatments or cures for such diseases.

Practice point

Manufacturers need to be aware of the claims that they are making in marketing products, to ensure that the claims don’t lead to a contravention of the Act, either because the claims aren’t allowed in public advertising or because the product isn’t appropriately licensed. For manufacturers wishing to make health claims on their products, the NHP regime can offer a middle-ground between the standard food, cosmetics and drug licensing regimes.

This article was originally published by The Lawyer’s Daily, part of the LexisNexis Canada Group Inc.

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