In our 2012 overview of the U.S. nutrition market, NBJ found opportunity to ask some pointed questions about the future of dietary supplements under the auspices of DSHEA, the Dietary Supplement Health & Education Act of 1994. Is DSHEA a strong or weak piece of legislation? Is it still appropriate, given the scale and impact of the supplement industry on public health? Is pre-market approval really the end of the world, or could supplement stakeholders learn something from the controlled environments of pharma? Or should those stakeholders stop pursuing research outright? These are not yes/no, either/or questions, of course, but we hoped for mental progress in asking them as such.
We posed these questions to some of the smartest minds around—Al Powers of NOW Foods, Dan Fabricant of FDA, Steve Mister of CRN, Marion Nestle of New York University, and leading lawyers from across the country—to figure out what’s working for supplement regulation in 2012 and what’s not. We also asked these thought leaders to envision a post-DSHEA world and humor specific changes in the law as open windows toward a speculative future with less acrimony between industry and regulator and much more faith and goodwill between manufacturer and consumer. To see what surfaced in the reporting, find the full story here.
Loren Israelsen, executive director of the United Natural Products Alliance and an architect of DSHEA, was one mind left out of this discussion, so NBJ feels fortunate to have his thoughtful and reasoned response as a separate editorial inside our September issue. We’d love to hear more voices on this topic and keep fostering the discussion. Please reach out directly to Marc Brush, NBJ’s editor in chief, if you have an opinion ready for the spotlight on our website, or leave your comments below.
The cover story of the June/July issue of NBJ titled “Considering a Post-DSHEA World” raised important questions about the relevance of the Dietary Supplement Health & Education Act in 2012. Is DSHEA working? Should it be amended or strengthened? Thought leaders from this industry, FDA, academia and the legal profession offered opinions and perspectives on these questions. The answers were well informed, insightful, and yet very different. These questions go something like this: “Is science friend or foe?” “Should FDA pre-approve products and/or product claims?” “Are supplements foods or drugs?” “Where is the line between disease and non-disease claims?” “Do research investments pay off?”
The purpose of this follow-up article is to pose this question: “Knowing what we know today, would we have written DSHEA differently?” And, to add a further question: “If we had to write a new DSHEA built to last for the next 20 years, what assumptions would we have to make about the future?” This is exactly what we had to do when DSHEA was first drafted in 1992, 20 years ago.
To begin this process, I catalogued the comments of the experts to see what patterns or themes might emerge. Here’s what I found:
Theme 1: The binary legal definition of food v. drug is still a real issue.
Theme 2: The concept of structure-function claims has evolved significantly in two ways. First, a large percentage of structure-function claims are seen as generic, and, second, the primary vocabulary used to describe structure-function claims has sanded off the fine distinctions consumers look for on product labels. Example: “To support or to promote ___”. Today, “condition-specific” claims are the new structure-function claims. As a historical note, “statements of nutritional support” is the correct name of this class. “Structure-function claim” and “condition specific claim” are industry created terms.
Theme 3: There is widespread resistance to amending DSHEA, and yet there is frustration that DSHEA cannot seem to get the bad actors out of the marketplace.
Theme 4: We are of two minds when it comes to the role and value of science and dietary supplements. Industry veterans and those who work closely with the ideological base of the industry are convinced that belief is more important than science. Post-DSHEA companies and executives tend to believe in science and the power of that science to build new markets and develop new consumers. This theme most directly touches the soul of the industry. It is the faith v. reason debate.
Has DSHEA changed?
No. In fact, it’s remarkable that a law of this significance has never been amended, despite multiple efforts to do so. What has changed are the external realities that have grown up around DSHEA, such as the advent of the internet, the rise of bioterrorism, globalization of supply chains, personalized and genetics-guided medicine, direct-to-consumer advertising of prescription drugs, vastly better analytical capabilities, and the emergence of designer steroids. These and other events have led to the passage of legislation and development of regulation that has fundamentally changed the neighborhood in which DSHEA was built and the one in which we now live. Today, DSHEA cannot be understood as a stand-alone piece of legislation, but rather as one tall building in the skyline of food and drug regulation, as well as pop culture and technology.
World 1: A traditional, belief-based world view little affected by science or the daily news. Those who live in this world are often there by necessity occasioned by illness or tragedy. Many are medical refugees. This part of our DSHEA community fought tirelessly for DSHEA, and while they may chafe at the tightness of regulation, they can live with it.
World 2: The post-DSHEA part of our industry sees this law as a laboratory to experiment with new ideas, technologies, scientific advances and consumer trends. DSHEA is the greenhouse—a place to invest time, money (often someone else’s) and ideas which can be developed and then exported to other markets. In short, DSHEA is a valued and efficient incubator, but not their motherland.
World 3: There is a third group for whom DSHEA does not appear to exist at all. This group exploits and extracts with no interest in reinvesting into the DSHEA community but only grifting. This is the no-DSHEA territory which is a barren and dry place. Most of the frustrations expressed by regulators, media critics and ourselves are a result of the actions of this group. What to do about it should be the topic of another article.
DSHEA , 20 Years from Now
I envy no one given the task to think through a DSHEA model for the next 20 years. What will that world look like? Older and more obese people living with chronic conditions, but with personalized medicine providing astonishing levels of knowledge about our DNA and our medical destiny? Where will our plants grow? If global warming continues, there may be vineyards in Norway, but very few fish in the ocean. How will we deal with genetically modified foods? Can you even avoid them? Will label claims be a thing of the past? Will there even be labels on products? Perhaps we will buy products with edible cellulose skins that mimic an apple skin or orange peel with a tiny microchip to display holographic product information. Who knows?
The DSHEA debate should continue. It’s an important one. It would be wise to start thinking about DSHEA 20 years from now and imagine the what-ifs, knowing that some of them will become realities.