OTC Cold Meds for Kids Under Scrutiny – National Consumers League

by Mimi Johnson, Health Policy Associate

Earlier this month, on October 2, hundreds of people interested in child and health policy convened in Beltsville, MD for the Food and Drug Administration’s public hearing on pediatric over-the-counter cough and cold (OTC) medicines.

You may or may not recall this past winter, when the FDA recommended that children under the age of two not use OTC cough and cold products. This hearing was part of the agency’s efforts to further evaluate the safety and efficacy of the products in older populations, chiefly those between the ages of 2 and 6. The panel consisted of eight medical experts from the Centers for Disease Control and FDA, and 30 people testifying – of whom I was one – representing pharmaceutical companies, public interest groups, physicians, and researchers with varying opinions. Prior to the hearing, a list of questions for those testifying to consider were made available.

The Issue

Are OTC cough and cold medications safe for children? According to the experts at the hearing, it is very difficult to study the safety and efficacy of these drugs in children. Children are not able to communicate as well as adults when it comes to symptoms. Parents, and a substantial number of doctors, feel that it’s appropriate to use OTC products to treat the symptoms of coughs and colds (there is no product that actually “cures” a cold). Still others feel that these products are not only ineffective, but also unsafe.

While the question over the safety and efficacy remains, one of the greater issues at hand is what will happen should the kid versions of these products be removed from the market entirely. Many argue that by removing these products, parents and caregivers may turn to the adult versions. Others might turn to non-traditional remedies, many of which are not regulated by the FDA at all. The unintended consequences are of major concern for all those involved in the decision making process.

Some Thoughts

So, what’s a parent to do? Regardless of what is decided by the FDA, everyone – providers, industry, public interest groups, and the government – needs to work together to educate parents, caregivers—and even kids—about the issue.

Nearly everyone agrees that first and foremost, parents and caregivers need to talk to their doctor before giving their child any form of medication or remedy. It is crucial to encourage communication between the provider and the parent, but it is also important to know that some people do not have primary care providers or their providers might be rather inaccessible. Many others might face language barriers that will prevent them from knowing if it is okay to dispense these drugs, how much they can give, what they should be aware of, etc.

Whatever (and whenever) the decision is made, we must remember that the consumer, whether a parent or caregiver, must be informed. We must tell them about the decision – why the FDA acted how it did, what this means for them and their children, and what alternatives they can turn to (which should never be adult formulations).


On October 7th, the Consumer Healthcare Products Association (CHPA) released a statement that its members would be making several voluntary changes to the labels of OTC pediatric cough and cold medicines. Through consultation with the FDA, CHPA decided to transition the labeling on these medications to read “do not use in children under four years of age.” They also stressed that antihistamines should not be used to sedate or make a child sleepy.

Their bottom line? Read and follow the label, and contact your doctor should you have any questions.

As we continue to wait for the FDA to weigh in, please check back with us – both via the blog and the health section on our Web site – for updates and resources.