Lawyers are famous for interpreting words and dissecting every comma and semicolon to make an argument that best suits their clients. When I was in law school, the joke was if you said, “Nice day, isn’t it?" to a law student, the response you would get was “It depends—define nice and define day."
It can be a field day for lawyers when asked to define the legal and regulatory aspects of functional foods because there is no legal definition in the United States. Thus, asking a lawyer to opine on functional foods is like asking the Supreme Court to define pornography. As Justice Potter Stewart said in the 1964 case of Jacobellis v. Ohio, “I know it when I see it." So it is with functional foods.
Despite the lack of a regulated definition, it is important to understand the nature of a functional food. The market is global. It grows exponentially year after year. The global market for functional foods in 2013 was worth an estimated US$43.3 billion. In 2017, it is expected to grow to $54 billion. And the United States is expected to be the fastest growing market for functional foods.
One can trace the roots of functional foods back to Japan, where certain foods are called Foods for Specified Health Use (FOSHU). In Japan, foods identified as FOSHU must be approved by the Minister of Health and Welfare after the submission of comprehensive science-based evidence to support the claim for the foods when they are consumed as part of an ordinary diet. Does that sound familiar? It should. When one makes a claim about a dietary supplement in the United States (and dietary supplements are defined as foods), one must have competent and reliable scientific evidence to support the claim being made.
But what does it mean when we don’t talk about supplements, but instead talk about traditional foods? What “functionality" can one discuss or claim? There can be a variety of types of functional foods. There can be: a) conventional functional foods such as grains, fruits, vegetables and nuts that claim specific health benefits such as “heart-healthy" and “helps maintain healthy bones;" b) fortified foods such as yogurts with probiotics and foods with folic acid that may claim to reduce risk of spinal cord birth defects; c) medical foods such as special formulations of foods and beverages for certain health conditions; or d) foods for special dietary use such as infant formula and hypoallergenic foods. All of these could arguably be considered “functional foods." When adding all those categories of products, the proverbial rabbit hole expands even farther.
So what are functional foods? Sometimes functional foods are also referred to as “nutraceuticals." There has been a lingua franca adopted in the industry to define what is a functional food or a nutraceutical. I submit that, in essence, foods become functional foods when they are fortified with additional ingredients so claims can be made about their health benefits. And not every type of food can be properly fortified. Even if we simplify our task to look only at common foods everyone consumes (e.g. orange juice, yogurt, cheese, milk, salsa, cereal), it is still a struggle to define functional foods.
Walk down a grocery aisle and one can see how many “functional foods" there are and the importance for marketers to distinguish their products from the rest of the pack. A recent stroll through my neighborhood supermarket revealed plant sterols in dairy products, probiotics in salsa and yogurt, and claims of orange juice with omega-3s that have been extracted from sardines.
So you know it when you see it, right?
Not necessarily. Not every type of food can be a functional Food. for example, what about a carbonated beverage that has added magnesium, zinc, niacin, vitamin B6 and vitamin B12? One could argue, as Coca-Cola did, that the beverage is a functional food because of all those vitamins and minerals added. In 2008, FDA said no to Coca-Cola. The agency claimed the company could not market its Diet Coke Plus as fortified with vitamins and minerals, even though it met the definition of “plus" based on the amount of vitamins and minerals it had in its drink. FDA took the position that the product was misbranded and violated the Food, Drug and Cosmetic Act because you can’t make this claim for a carbonated beverage because a carbonated beverage is a snack food and it is not appropriate to fortify a snack food and label it a “functional food."
Thus, we must refine our definition of a functional food to be a traditional food that is not a snack food that has been fortified with additional ingredients so claims can be made about its health benefits.
So if you want a piece of the soon-to-be US$54 billion market, be sure it is an appropriate type of food fortified with appropriate nutrients to allow usage of a health claim beyond what consuming the food would normally do, and also have it supported by science.
And while that might work as a definition so that you know it when you see it, there’s still room for interpretation by both regulators and industry lawyers to keep things interesting as the market grows.
Alan Feldstein, Esq., has more than 25 years of experience in advertising and marketing law; most of those years were devoted to the dietary supplement industry. As Of Counsel to Collins, McDonald & Gann , he represents many top names in the sports nutrition industry. He previously served as adjunct professor at Southwestern University teaching advertising and marketing law. His career began in the supplement industry as general counsel for a supplement company, helping take the company to US$150 million in sales. The core of his practice is assisting companies with contracts, intellectual property, claims substantiation, business operations, risk management and regulatory issues.
Looking for more information on functional foods?
Alan Feldstein will speak on regulatory considerations around functional foods as part of the Functional Foods Summit at SupplySide West. The Summit will take place on Tuesday, Oct. 6, from 1:30 to 4:30 p.m. at Mandalay Bay in Las Vegas. Visit west.supplysideshow.com/summits.aspx for more information and to get registered.