Studies for Children

Children are among the largest consumers of natural products with over 50% of American parents giving their kids supplements on a regular basis. Yet, when it comes to research, children are dramatically underrepresented. 

 

Instead of child-focused trials, many formulators create products based on adult-focused research and simply reduce the dosing. But children are not just little adults; they have differences in metabolism, immune function, and other critical systems. 

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Using products on children without child-focused trials means we may be failing to use products in the most effective ways. It also means we can't quantify just how much these products support pediatric health. 

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CHILDREN HAVE THEIR OWN FORMULATIONS; THEY NEED THEIR OWN TRIALS

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Using adult-focused research to develop child-focused formulations is often seen as a way to protect children. Many believe that keeping kids out of clinical trials protects them from uncertainty. This approach, however, only holds when the test product is an untested medication.

 

By avoiding the use of investigational new drugs in children, we protect them from the unknown risks that drug may pose.​ Natural products, however, are not investigational drugs. The overwhelming majority of children are already consuming nutraceuticals, inhaling essential oils, and using herbal products.

 

IF A PRODUCT IS SAFE ENOUGH TO BE ON THE SHELVES, IT IS SAFE ENOUGH FOR CLINICAL RESEARCH. 

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Not only does leaving children out of clinical trials fail to protect them, it actually places them in harm's way. Relying on adult-focused studies to establish formulations and dosing for children is a method that is prone to error. Children's bodies aren't small adult bodies. Their bodies are still developing and function in very different ways than adult bodies. They have immature digestive, respiratory, and immune systems. Children absorb, distribute, metabolize, and eliminate natural products differently. Their dietary and lifestyle patterns differ. All of these factors play defining roles in how your product works in a child's body. 

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This means that when it comes to optimizing product dosing and administration, you need studies conducted not in adults, but directly in children. This is why the FDA and FTC guidance requires that people who are in your trials match the people who are actually using your essential oils, herbal products, or supplements. Studies on adults won't be able to accurately substantiate claims made about child health. If your product boosts immune function as kids head back to school, it needs to be studied in school age children. If it targets common childhood stressors, it needs to be tested in children experiencing those stressors. Only with trials conducted in the actual populations most likely to use your natural products can you deliver the high quality evidence your consumers–and the regulatory agencies–expect of you.