Had a reaction to a skin product? How to report it in Canada

You tried a new face cream and woke up red and puffy. Or a sunscreen left a stinging rash. Once your skin settles, there’s one more step most people skip: telling Health Canada. It takes about as long as writing a product review, it’s free, and it’s one of the few ways the regulator learns what happens after products leave the shelf.

First, take care of your skin

Reporting comes second. If a reaction is spreading, blistering, involves your eyes, or comes with swelling of the lips, tongue or throat or trouble breathing, get medical help right away. For a milder rash, stop using the product, rinse it off gently, and see your doctor or pharmacist if it isn’t clearly improving within a few days.

While you’re at it, keep the product and its packaging. The label, the lot number (the batch code printed on the container) and the ingredient list are exactly what a report needs, and what a doctor will want to see if you end up having a patch test to find the cause.

Which form? It depends on the kind of product

Canada sorts skin products into three groups, and each group has its own reporting route. The quick way to tell them apart is the label.

• Cosmetics have no eight-digit number on the label. Health Canada’s examples include shampoo, shaving cream, lipstick, hair dye, soap, moisturizer, nail polish and self-tanner. Reactions to these go to the Consumer Product Incident Report Form.
• Drugs carry a DIN (Drug Identification Number). Most sunscreens, medicated dandruff shampoos and acne treatments are drugs.
• Natural health products carry an NPN (Natural Product Number) or DIN-HM. Sunscreens that use only mineral filters fall here.

Reactions to drugs and natural health products go to Health Canada’s side effect reporting program, run by Canada Vigilance (you may also see the older name MedEffect Canada). The DIN or NPN on the label is your signpost: a number means the side effect form, no number means the consumer product form.

A few things go elsewhere. Health Canada points food and food labelling problems to the Canadian Food Inspection Agency, pesticide problems to its own pesticide incident system, and misleading advertising to the Competition Bureau.

Reporting a reaction to a cosmetic

Health Canada encourages anyone to report a cosmetic if someone has died, been injured or nearly injured, or had a bad reaction from using it. The report is made online through the consumer product incident form. You can also report problems like missing or unclear warnings, or a product that doesn’t work as intended.

The form asks for:

• what happened and when
• the product’s brand, name and other details from the label
• the type of injury and any treatment you received
• where you bought it, including order numbers or web links if you bought it online
• photos of the product, the label and the reaction, if you have them
• whether you want to stay anonymous or can be contacted for follow-up

When you submit, you get a case number and a submission number. Health Canada suggests saving a copy of your completed form so you can add information or ask about the report later.

One thing worth knowing: companies are legally required to tell Health Canada about health and safety incidents with ordinary consumer products, but for cosmetics, reporting by industry is voluntary. That makes reports from people who actually used the product more important.

Reporting a reaction to a sunscreen, medicated product or natural health product

For anything with a DIN, NPN or DIN-HM, Health Canada asks that you report a suspected side effect as soon as possible, even if you aren’t sure the product caused it. It defines a side effect, also called an adverse reaction, as “a harmful and unintended response to a health product.”

You can report online, by phone at 1-866-234-2345, by fax, or by mail to the Canada Vigilance Program. Email isn’t accepted, for security reasons. The form asks for details about the person who reacted, each product suspected (the label helps), and the reaction itself. If more than one person reacted, each needs a separate report.

Making a report isn’t an accusation. Health Canada states that reporting a side effect “does not constitute an admission” that the product caused it; a link in time is enough to report.

Why one report matters

It can feel pointless to report a patch of redness. It isn’t. Health Canada says it monitors all reports, and that collectively they help it spot rare reactions, update safety information on labels, issue warnings and advisories, and remove unsafe products from the market. For cosmetics and consumer products, the result can be closer monitoring, a safety review, a public warning or a recall.

The problem is that most reactions are never reported. Health Canada’s own figures for natural health products show the gap: 12% of Canadians who use them say they’ve had an unwanted side effect, but only 41% of those people reported it. A pattern can only show up in reports that exist.

Health Canada also recommends telling your own health care provider about any side effect, so it’s in your record and they can advise you.

Your privacy, and what’s public

Health Canada says personal information in these reports is protected under the Privacy Act. The side effect program aims to use and share only de-identified information, and the consumer product form lets you choose whether you can be contacted.

Reports about drugs and natural health products are then pooled in the public Canada Vigilance Adverse Reaction Online Database, which covers suspected reactions back to 1965. It’s interesting to browse, but Health Canada is clear that it doesn’t give conclusive information about a product’s safety. A report records a suspicion, not a proven cause.

A two-minute checklist

Before you throw anything out:

• Photograph the front label, the ingredient list and the lot number.
• Photograph the reaction, with the date.
• Write down when you started the product, how you used it and when the reaction began.
• Check the label for a DIN or NPN to pick the right form.
• Tell your doctor or pharmacist, especially if it keeps happening.

To sum up: a reaction to a cosmetic goes to Health Canada’s consumer product incident form, and a reaction to anything with a DIN or NPN goes to the Canada Vigilance side effect program, online or by phone. You don’t need to be sure the product was the cause. Keep the packaging, note the details, look after your skin first, and send the report. It’s how the next person gets a warning you didn’t.