How To Contact the FDA About an Adverse Reaction to a Product

Beth Conway Communications Director

An unhealthy or adverse reaction to a product can be anything from a simple rash or headache, to more serious impacts like hospitalization or permanent damage.

The FDA Needs to Hear from You

Last summer, the skin under my eyes broke out in a horrible rash that made my entire face throb.  After a process of elimination, I discovered the culprit was a sunscreen, and I contacted the manufacturer to let them know of my puffy, burning, red, itchy reaction. But my outreach of consumer concern shouldn’t have stopped there…

Companies definitely need to know if you’ve had a harmful reaction to their product. But so should the Food and Drug Administration (FDA). Would you be surprised to know that under current law, companies are not required to report any safety concerns they have received from customers to the FDA?

Take, for example, the recent case of WEN hair products. Over the course of several years, the manufacturers of WEN received over 21,000 complaints from their customers reporting everything from hair loss and balding to itching and rash associated with using their shampoo and conditioner – while the FDA received only 127 consumer complaints. And while those numbers vary greatly, the reported 127 reactions directly to the FDA were enough to compel the agency to take action, further investigate the product, and issue a safety alert.  Unfortunately, it took several years for the FDA to receive enough complaints to prioritize investigating WEN products.  This meant thousands of consumers were harmed before they issued the safety alert. Imagine if the FDA had directly received all 21,000 complaints!

What You Can Do to Help Ensure Safer Products

1. Report Any Adverse Reactions from a Product to the FDA

Reporting reactions to the FDA is so important because it gives the agency a heads up that a particular product might be causing health problems. The FDA really wants to know, because they need official reports like this in order to take action or to do further investigations. While you may not see an immediate action from the FDA after filing your report – over time your information combined with reports from others can really make a difference to the safety of products we use every day. And what may surprise you, is that reporting to the FDA is really simple.

The easy-to-follow steps in this video will show you how to report your reactions to the FDA on their straightforward MedWatch website. There’s also an option for downloading the form and filling it in on paper. The FDA also offers advice on submitting a report – click here.

The whole process shouldn’t take much more than about 10-15 minutes to complete. Click here to submit a report.

2. Contact Your Representative

So how do unsafe products end up on the shelves in the first place? The case of WEN is just an example of the lack of regulation in regards to cosmetics and salon industry.  The core of the problem started over 75 years ago when the Food and Drug Administration (FDA) was not given the authority to approve the safety of ingredients that go into cosmetics and salon products (other than color additives) before they are put on the shelves. As a result, today it is perfectly legal for cosmetics to contain harmful ingredients. In short, cosmetics and personal care products are woefully under-regulated. This is not okay and our representatives need to hear from us that this is not okay.

3. Join Women’s Voices for the Earth and the tens of thousands of women who are working hard to ensure products are safe, toxic-free, accessible and affordable to everyone!

THANKS!