The industry needs to “embrace a bigger functional food existence,” Bass told a packed room of industry lawyers, consultants, in-house counsels and more at the InterContinental New York Times Square.
“When we sat down in 1992 to 1994 drafting this law, we were called the ‘health food industry,’” he said. “The advent of DSHEA is when we created the new category ‘dietary supplements,’ so we became ‘the dietary supplements industry.’”
Today, the industry has morphed yet again, according to Bass, into one that also includes medical foods and foods for special dietary use, all part of a burgeoning functional food, over-the-counter (OTC) market.
This is driven by a global market seeking preventive health care.
“If you go around the world, there are a few givens that are very clear. Number one, healthcare is failing everyone—the aging population, the prevalence of diabetes and other age-related syndromes.
“People and countries are looking for ways to contain costs and make people healthier, and at the same time prevent illness—that’s our mission. And it’s not just pills.”
Can mandatory product registration double the industry’s market?
Bass emphasized that self-regulation is an important step that can help the industry own double the market it has now.
“The fact is people don’t believe we want to take our own future in our own hands. The cosmetic industry did it decades ago, the over-the-counter drug industry does a pretty good job at it—we’re not doing a good job at it,” he said.
A way to eliminate, or at least lessen, the suspicion against the industry is through mandatory product registration, Bass argued.
There’s no hope for effective fraud prevention unless the government knows what is on the market, and this can be achieved through a comprehensive registry of products the industry commercializes.
“There is no way that FDA can effectively support you if they don’t know what’s on the market. And I don’t care about all the fancy arguments and the paranoia. The fact is the OTC drug industry went with it without a problem,” he said.
“The resistance to registering products is just not understandable to me anymore.”
A call for parity of FDA and FTC claims
Bass’ opening remarks were not all just industry wake-up calls. He also argued that there should be parity between FDA and FTC claims requirements.
“FDA took the bold step of saying ‘from now on, we’re going to interpret 403(r)(6), which is the structure/function section, to mean the same thing as FTC’s.'
“That was great for a while, until somebody came into FTC about 10 or 12 years ago and said ‘we don’t care what FDA says…we want the same science you do for drugs,” Bass added.
The way to approach this is by having the industry engage with FTC to discard its clinical trial rule, and to stop demanding through warning letters what the law does not.
“Let’s join with FTC to get a rational policy, a guidance that doesn’t make you do what FTC itself says you don’t need to do—you don’t need new clinical studies for every new claim.”