Garlive Recovery
Mediterranean Diet special issue

INTRODUCTION

Currently, it is widely accepted that naturally occurring substances, when provided in isolated or purified form—i.e. no longer in their original natural environment—are patentable. According to the US patent practice, it is mandatory to claim the naturally occurring substance in its isolated form.

However, in the last decades another form of patent on biological compounds has emerged, where the invention does not reside in the purification or isolation of the compound, but in determining the new function of the already known compound.

 

U.S. Patent and Trademark Office in Washington, D.C.

 

Using patent protection for a dietary supplement focuses on maintaining a person’s health. The elements of dosage, timing, and formulation of the composition may be included, to narrow the patent claims to exactly what the innovator will be manufacturing. However, unlike pharmaceutical drugs, the FDA will not allow the label of a dietary supplement to state that the product can be used for diagnosis, cure, mitigation, treatment, or prevention of a condition or disorder. 

 

For health claims to be acceptable to the FDA, the innovator must prove—with supporting scientific evidence—that the dietary supplement is intended to affect some structure or function of the human body. Acceptable structure/function claims include the following:

1_ a statement that claims a benefit related to a classical nutrient deficiency disease and that discloses the prevalence of such disease in the United States;

2_ a statement that describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, or that characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain said structure or function;

3_ a statement that describes the general well-being taht comes from consumption of a nutrient or dietary ingredient.

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