Cosmetic, drug or natural health product? How Canada sorts skin products

Stand in the skin-care aisle and everything looks alike: tubes, jars, pumps, promises. But Canadian law splits those products into three boxes, and the box changes what a product may claim, what proof it needs and how closely Health Canada looked at it before you could buy it. Here’s how the sorting works, using three products you probably own.

The three boxes

In Canada, personal care products are regulated under one law, the Food and Drugs Act, and fall under one of three sets of regulations beneath it. Health Canada’s guidance on the subject describes them this way:

• A cosmetic is any substance sold for “cleaning, improving or altering the complexion, skin, hair or teeth”, and the definition specifically includes deodorants and perfumes. Cosmetics follow the Cosmetic Regulations.
• A drug is any substance sold for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms, or for “restoring, correcting or modifying organic functions”, meaning how the body works. Drugs follow the Food and Drug Regulations.
• A natural health product is legally a subset of drugs: one whose medicinal ingredients are of natural origin (listed in a schedule to the regulations), or a homeopathic or traditional medicine, sold for the same kinds of purposes. These follow the Natural Health Products Regulations, which came into force in 2004.

The important thing to notice is that the cosmetic definition is about appearance, and the drug definition is about disease and body function. Where a product sits depends on what it’s sold to do, not on where it’s shelved or what it feels like.

Three products, three boxes

Take a moisturizer, a sunscreen and a probiotic.

A plain moisturizer is a cosmetic. Health Canada’s guidance uses this very example: a cosmetic may have a negligible effect that is local and temporary, “such as a moisturizer which hydrates by adding water to the epidermis” (the outer layer of skin). Softer, smoother, less dry: those are appearance claims, so no number appears on the label.

A sunscreen is a drug or a natural health product, because preventing sunburn is a preventive claim and UV filters are active ingredients. Health Canada’s sunscreen page spells it out: chemical filters such as avobenzone, homosalate, octocrylene, octisalate, octinoxate and oxybenzone are classified as drug ingredients, so a product containing any of them carries an eight-digit DIN. Mineral filters, zinc oxide and titanium dioxide, are classified as natural ingredients, so a sunscreen using only those carries an NPN. A sunscreen mixing both types gets a DIN. Either way, every sunscreen approved for sale in Canada must have one of the two numbers.

A probiotic is a natural health product. Health Canada lists probiotics alongside vitamins and minerals, herbal remedies, homeopathic medicines and traditional Chinese and Ayurvedic medicines. It also flags a surprise: certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes are classified as natural health products too.

How Health Canada decides the hard cases

Plenty of products sit on the line. Health Canada’s examples include acne treatments, antiperspirants, anti-dandruff products, fluoride toothpastes, medicated skin products, diaper rash products, antiseptic skin cleansers, sunburn protectants, skin whiteners and tooth whiteners.

For those, the guidance sets out two main factors:

• Representation. The key consideration is the claim, which the Act calls “representation for sale”. A claim can be a word, a sentence, a picture, a symbol or an implication, on the label, in a package insert or in advertising, and it’s the overall impression that counts. If the product is presented as treating, preventing or curing a condition, or as changing how the body works, it’s evaluated as a drug.
• Composition. The ingredients themselves can settle it. Some ingredients are inherently drugs; the guidance names corticosteroids (anti-inflammatory hormones) as internationally recognized drugs. Others act cosmetically up to a certain concentration and therapeutically above it.

When the two factors disagree, the guidance is clear that the intended purpose of the product takes precedence.

Two more tests help. One is level of action: a cosmetic should act on the surface and shouldn’t need to be absorbed into the body to work. Anything you swallow, inhale or inject is never a cosmetic, with tattoo ink the lone exception. The other is dosing. Drugs come with specific dose instructions, because a drug that doesn’t work carries a risk. A cosmetic is applied “as desired”, and there should be no risk from a cosmetic failing to work.

Why the box changes the claims

This is where it matters to you as a shopper. Because a drug claim requires proof of efficacy, the guidance says a certain amount of “puffery” is tolerated for cosmetics, defined as hyperbole that makes no factual claim of merit, “unless it strays into the therapeutic arena”. So “radiant”, “luxurious” and “feels renewed” live comfortably on a cosmetic. “Treats eczema”, “prevents sunburn”, “kills bacteria” or “reduces dandruff” are therapeutic claims, and a product making them is evaluated as a drug or natural health product.

That doesn’t mean cosmetics can say anything. False or misleading cosmetic claims are offences under the Consumer Packaging and Labelling Act. The difference is who checks: a drug claim is reviewed before sale; a cosmetic claim is policed after.

Why the box changes the review

Each category gets a different amount of scrutiny before it reaches you.

For a cosmetic, there is no pre-market approval. The Cosmetic Regulations require that the product be safe, be made under sanitary conditions, and that the manufacturer or importer notify Health Canada that it’s selling the product and provide the ingredient list. Health Canada also maintains the Cosmetic Ingredient Hotlist, a list of substances that are prohibited or restricted in cosmetics.

For a drug, including a non-prescription one, Health Canada assigns a DIN only after a review of the product’s formulation, labelling and instructions for use. A product that meets the definition of a drug and is sold without a DIN is not in compliance with Canadian law.

For a natural health product, the company needs a product licence, and the NPN on the label means Health Canada assessed the product and found it safe, effective and of high quality under its recommended conditions of use. At the same time, Health Canada is honest that these products are not risk-free: it lists manufacturing problems, unproven claims, interactions and side effects such as allergic reactions among the risks, and reminds people that “natural” doesn’t automatically mean safe.

What this means at the shelf

A few practical takeaways:

• No number means cosmetic. The product is sold on appearance claims, and the ingredient list is the most useful thing on the package. Health Canada reviewed neither the formula nor the claims before sale.
• DIN or NPN means a health claim was reviewed. Read that claim, and the directions and warnings that come with it. If you have sensitive skin, remember the review is about the medicinal ingredients; the base can still contain fragrance or preservatives that bother you.
• The same product can move. A shampoo that only cleans is a cosmetic. The same shampoo with a claim to control dandruff needs a DIN or NPN. Watch the wording, not the bottle.
• If a product with no number makes drug-sounding promises, that’s a reason to be skeptical.

The short version: Canada sorts skin products by what they claim to do. Cosmetics clean, improve or alter appearance, and reach the shelf with notification and an ingredient list but no pre-market approval. Drugs and natural health products treat, prevent or change body function, and can’t be sold until Health Canada has reviewed them and issued a DIN or NPN. Knowing the box tells you how much a label’s promise has been checked.