Is your product claim a drug claim? [4 of 12]
The FDA provides criteria for determining whether your product claim is a structure / function claim (which is permitted provided that you have a substantiation dossier) or a drug claim. This is part four of a twelve series discussing those criteria.
Prohibited: Claims implying that a product affects a symptom associated with a natural state or process if the condition is uncommon or can cause significant or permanent harm
This one is more complex than the first and second guidelines, and will typically require some professional guidance. The defining factor here are uncommon and can cause harm. It is common to have a few sleepless nights, especially during stressful times or when traveling. It is common to have morning sickness during pregnancy or to have mood changes and cramps during a menstrual cycle.
It is not common to have hyperemesis gravidarum during pregnancy or severe depression during a menstrual cycle. Supplements can support healthy function by addressing common complaints or frustrations that are normal during the lifecycle. Uncommon or dangerous conditions fall into the realm of pharmaceuticals as they typically require prevention, a diagnosis, a treatment, or a cure.
- For decreased sexual function
- For senile dementia
- Depression associated with the menstrual cycle
- For severe morning sickness during pregnancy
- Resolves cystic acne
Structure / Function Claims
- Promotes healthy sexual appetite
- Improves absentmindedness
- For mood changes associated with the menstrual cycle
- For morning sickness during pregnancy
- Resolves noncystic acne
What's the Difference?
The dividing line here involves commonality and severity. A healthy individual may still experience some abnormal symptoms as a result of natural processes. Hormone shifts during the menstrual cycle can create mood changes or bloating. This abnormal state is part of that normal process. It is not a diseased state. When a menstrual cycle brings about depression or anxiety, however, the abnormal state is no longer a common part of that normal process; it is a diseased state.
When an abnormal condition requires a diagnosis, prevention methods, or treatments, it is no longer part of a natural process of the body. It is a diseased state and it requires drugs which treat diseases rather than supplements which support existing healthy bodies. This is particularly the case when the condition has the potential to cause harm.
A condition may appear to be common or part of a normal process if it is widespread among peers or among a target market. Recognizing the difference between symptoms which are abnormal yet natural and symptoms which are indicators of disease or dysfunction often requires professional insight. The FDA's guideline is a condition or symptom is uncommon if it affects fewer than half of individuals in that stage or normal process of life.
When compiling evidence to substantiate a structure / function claim in this category, part of the dossier involves clarifying this guidance and confirming that the abnormal state is part of a common, natural process and not an uncommon disease state.