When is a Food a Drug?
~ September 1997 No.13 ~
A question that often creeps into the discussions on functional foods, probiotics and nutraceutics is when does a food become a drug? It is easy to see where this question comes from, since the principle behind all three classes of foods is that you are eating them because they are good for your health, they can delay the onset of chronic diseases or they can shorten the duration of a disease or infection.
We may be talking about things like yogurt, garlic or tea which normally would be considered as foods. To use one legal definition, a food ”includes any article manufactured, sold or represented for use as food or drink by man, chewing gum, and any ingredient that may be mixed with food for any purpose whatever.” Yogurt, garlic, tea; they all are foods.
The problem arises when food manufacturers would like to market their particular product as a functional food, nutraceutical, probiotic. The claims that they would like to make in many jurisdictions fall under the definition of a drug. To the regulatory officials a drug is "any substance or mixture of substances manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or symptoms thereof, in man or animal (b) restoring, correcting or modifying organic functions in man or animal." Yes, it still is yogurt, garlic or tea. But if it does prevent colon cancer, lower blood pressure or decrease the likelihood of heart disease (and you want to say it on the label), then it is no different than a drug prescribed by your doctor in terms of what government approval you need. Of course there are some exceptions. Most notably in Japan.
This is the dilemma that the food manufacturers, government regulators and the consumers face. Most agree that the idea of foods being good for your health has developed faster than the speed at which the rules defining what is a food and what is a drug can be changed. As the evidence accumulates to show that there is indeed substance behind many of these health claims, and with continued pressure from the consumer and the manufacturers, there will no doubt be changes. They will always be yogurt, garlic and tea. You won't need a doctor's prescription to buy them and they may be good for your health.