The good news is that we have enough images in the rear view mirror of our own modified DeLorean to help us navigate the road ahead. But there are also a lot of unanswered questions.
The main story line? In the face of challenges new and old, a number of old ways of doing business are no longer effective or relevant. New ideas, new players and new technologies to communicate and interact with a broader and changing demographic will help us achieve a future filled with continued growth and sustained relevance.
FDA: Guidance instead of regulations?
For starters, the big bang caused by the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994 has now evolved into a fairly predictable set of commercial trade and regulatory patterns—and now that we’re on the other side of DSHEA’s 20th anniversary—we see that these patterns are both useful and instructive.
Regarding the long awaited, revised new dietary ingredients (NDIs) guidance, the document is done, but when will we see it? What does it say? Has the Food and Drug Administration (FDA) moved in our direction? And if not, what can be done?
Sadly, in a true back-to-the-future move, FDA is already using much of this draft guidance as its regulatory standard. Many government agencies use guidance as workarounds to issuing regulations. This is a convenient move for FDA. Thus, it’s critical for industry to rally to ensure that the intent of DSHEA—and not the agency’s intent—becomes law. This will not be easy, and the task ahead should not be underestimated.
The GMP Gap
Also of concern are two good manufacturing process (GMP) patterns we see: the growing void between GMP-compliant and non-compliant companies, as well as the agency’s apparent nit-picking during section 111 inspections. As the good get better, the non-compliant appear to be stuck. This comes at the same time that an ongoing cascade of warning letters reveal that a lot of players still don’t get it: We are a regulated industry that requires adherence to a specific regulatory structure in order to be a part of responsible industry.
GMP compliance is not inexpensive and should be celebrated and supported by industry and acknowledged by FDA.
Companies that can’t or don’t want to comply with reasonable standards should get out of the business—and we need to work with and support companies that adhere to GMPs, obtain third-party certification of compliance, commit to ongoing staff training and who are prepared to pay for quality. Period.
The 115th Congress: Education and engagement
The direction and temperature of the new Congress, with Republicans gaining control of the Senate, does not foreshadow any imminent threats to industry.
Who will emerge as new industry champions in the Senate? Notable was the symbolic passing of the torch of leadership from retired Sen. Tom Harkin and long-time advocate Sen. Orrin Hatch, to New Mexico’s Sen. Martin Heinrich at the end of the last session. But Sen. Heinrich is entering only his third year of service in the Senate—it will take a while for him to move into the roles that Hatch and Harkin held for more than 20 years.
We note that Sen. Hatch’s move to chair the highly influential Finance Committee could provide tremendous foreign business development opportunities for our industry. UNPA has already held meetings with key Hatch staffers about these issues and will continue to work with the senator and his staff to help realize these important trade opportunities.
At the time of this writing, we are studying the new members of the key committees in both the House and Senate, and these assignments will go a long way in determining how our agenda plays out over the next few years.
Perhaps most important, 20 years after DSHEA, less than 2% of the current congressional staffers were on the Hill back then. They do not possess any institutional knowledge about this legislation, the history of regulation and enforcement that surrounds it and the public support that helped make it a reality. Also troubling is that they get their industry information from the same, often-critical national mainstream media we read. Continued staff education and face time—both at the federal and state office levels—is imperative if we are to create productive working relationships with our elected representatives.
More on FDA and FTC’s emerging role
With personnel changes in the administration and in Congress, restaffing at FDA is part of the natural cycle. The agency has been and will continue to see a large turnover, and the prospect of a continued “lock up” within government is likely. Political gridlock often equals regulatory delay.
Is the agency committed to the implementation of DSHEA as we understand DSHEA? Will the lack of collaboration we see in Congress lead to new and unintended misregulation of our industry?
Meanwhile, the Federal Trade Commission (FTC) appears to have no such personnel issues and is the more present challenge for industry, as we see stronger and more aggressive actions from it. This agency seems clear on what it wants to do through various consent orders and actions. Perhaps it is taking over for gaps at FDA, but regardless, FTC is now a permanent part of the regulatory landscape and requires our attention and monitoring.
Old and new media and consumer education
Consumer confidence in dietary supplements seems to have taken a tumble over the last year or so, at least in certain categories, and mainstream media is a contributor to this. The well-worn pattern with old media is that we see repeated cycles of good and then bad coverage and then more bad coverage—“unregulated industry!”—being the common theme. The pattern continues with repeated, often futile responses from industry—an echo effect that plays out over and over again.
The three product categories that drive the majority of the negative media? Sports nutrition, weight loss and ED, the polite way to reference erectile dysfunction.
As an industry, we need to reset these conversations by looking to new media, bloggers and the emerging voices in these diverse outlets as a way to state the facts and tell our stories. The old guard, with its entrenched writers and perspectives, will continue to lose its grip on these conversations, while fresh, young and increasingly millennial media voices are emerging. We should be talking to them, and they need to get to know us. It’s time to stop engaging in endless, unwinnable land skirmishes and create a broader strategy that allows us to rethink and win this game.
A new relationship with China
In another back-to-the-future scenario, we’re seeing patterns that played out in the United States many years ago around compliance, supply chain issues and negative media, this time from the world’s largest economy and the industry’s largest ingredients supplier: China. In the old model, China sold us exactly what we were willing to pay for, with the attendant risks of poor quality, spiking and adulteration.
The new model is to engage Chinese executives in an ongoing conversation about personal engagement, mutual respect and shared responsibility for quality products. The old ‘don’t ask, don’t tell’ model must give way to one of openness, transparency and partnership.
How to get the industries to talk to each other more effectively? How to train a new generation of young Chinese business leaders to strengthen the resolve of their ingredient manufacturers to understand that responsible U.S. companies are not just interested in the lowest price?
GMOs and the battle for natural
As the heated discussion about GMO labeling moves from the state level to the federal level this year, pro-labeling advocates face a monumental and very expensive fight on Capitol Hill. UNPA supports federal labeling of these products and recommends that organic standards, created through the hard-won Organic Foods Production Act of 1990, serve as the touchstone and foundation for GMO labeling.
Do we have the heart and means to continue to support state initiatives or an eventual federal solution?
The definition of natural, currently tied to a voluntary labeling bill that is certain to be reintroduced this year, is or should be an important issue. Unqualified natural claims are the old pattern and are coming to an end—which is why GMO labeling is crucial. The new model is a qualified natural claim backed by an underlying process and system.
What happens if/when we lose the word natural? What is the likely consumer fallout if the one word that has defined this industry for more than 40 years begins to lose its meaning?
Protecting our future: emerging products
Our legacy will be judged in part by our ability and willingness to protect emerging product categories, such as probiotics, omega-3s, food-form nutrients and marine algae. These are major and emerging growth areas but are facing regulatory uncertainty and challenges, which are to be expected. Key issues: regulatory sector management and supervision by industry, getting the product quality and standards right, assuring the reliability of the global supply chain of ingredients, and substantiating product claims.
To be successful, we need to bring in additional resources to advocate for and protect these important categories. We would note GOED’s ongoing omega-3 education campaign as a useful case study, and we think CoQ10 would stand to benefit from such direction.
Ready to step into Doc Brown’s time machine for a wild adventure? You already have. Welcome to 2015, and welcome back to the future.