When clients seek out legal assistance about regulatory issues concerning one of their products, frequently, the first task is to determine exactly what the product “is.” Most would assume that this determination is made by simply reviewing the product’s ingredient and basing a conclusion on the ingredient’s stated purpose. In reality, it is rarely that simple nor should it be if the client is being properly advised.
Take for example omega-3 fatty acids. In only the last few months, Food and Drug Administration has made two important determinations concerning these ingredients. First, in June, FDA approved a qualified health claim that omega-3s lower blood pressure.* Then, in November, an FDA expert panel recommended that a specific omega-3 product could be used as an adjunct to statin therapy in patients with elevated triglyceride levels as a means of reducing overall cardiovascular events. Without a doubt, each of these agency actions will add to the understanding that omega-3s have health benefits. What is interesting is that one of FDA’s determinations was directed to qualified claims that can now be made for foods containing omega-3s (including dietary supplements), and the other went to a specific omega-3 product that is marketed as an approved drug.
For sure, a determination of what a product “is” will require consideration about the ingredient and where it falls into the regulatory paradigm, but such a determination also requires, among other things, a review of the product’s label and labeling to determine how it is intended to be marketed -- a process that is often more complicated and convoluted than it first appears, often turning on small details and nuances. Unfortunately, companies are frequently surprised when obtaining an opinion on how their product will likely be regulated by a government agency, such as FDA. It is too late in the process to start talking to FDA about the regulatory status of your product while the product is the subject of an enforcement action. Rather, we regularly work with and advise clients to proactively consider such issues throughout the product development process to avoid unnecessary and expensive legal hurdles later in the product’s lifecycle.
*Full disclosure: Mr. Durkin participated in this evaluation while working at FDA.
