Circumstances and the cast of players in 2016 could combine to create a perfect storm in Congress to pass legislation to fundamentally change FDA's dietary supplement regulatory framework, or to have members largely leave the industry untouched, trade group executives say.

In interviews and in email responses to questions, executives from the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance commented on their expectations for legislative and regulatory developments that could affect supplement manufacturers and marketers in the year ahead. The potential for legislation from Sens. Dick Durbin, D-IL, and Richard Blumenthal, D-CT, to tighten supplement industry regulation, including adding provisions to FDA reform bills by House Energy and Commerce Chairman Fred Upton, R-MI, or a Senate version, and for additional enforcement activity by FDA and the Department of Justice are prominent on the trade groups' radars.

Commenting for CRN was President and CEO Steve Mister; for NPA were Executive Director and CEO Daniel Fabricant, Senior VP for Scientific and Regulatory Affairs Corey Hilmas and Government Affairs Director Michael Kelley; and for UNPA were senior political advisors Patricia Knight and Peter Reinecke, who made their remarks jointly.

Congressional concerns or bright spots you expect in 2016?

CRN: First, we’re aware that Senators Durbin and Blumenthal plan to introduce legislation that would amend DSHEA. We have a good working relationship with both these senators, and there are likely some aspects of their legislation that we may agree on, so the question will be whether the changes they offer are the appropriate solution to legitimate concerns, or whether they are just burdensome requirements that don’t benefit the consumer. We’re also keeping watch on the Senate Special Aging Committee as it has an ongoing investigation into dietary supplement making claims for cognitive function and anti-aging. We’re poised to protect the responsible industry as needed.

UNPA: The heightened scrutiny of the supplement industry in 2015 can only be expected to carry over into 2016. It is unlikely there will be legislation enacted given that most of 2016 in Washington will be consumed by presidential politics, but there certainly could be hearings, amendments considered and a generally negative climate. This is especially true if the Food and Drug Administration “innovation” bill (21st Century Cures legislation in the House) gets out of the Senate Committee on Health, Education, Labor & Pensions and onto the Senate floor, during which there would be plenty of opportunity for amendments. And in 2017, reauthorization of the FDA user fees for prescription drugs and medical devices will also provide much opportunity for consideration of dietary supplement issues.

It is important for industry leaders to be thoughtful when evaluating any proposals put forward. Now is not the time for knee-jerk opposition but rather looking for opportunities for positive change that build consumer confidence and grow the market.

NPA Kelley: [Members of Congress are] hardly here this year, which is the case every other year. But there isn’t a whole lot left to do and you have a lame duck president who wants to see things get done and [the 21st Century Cures Act] is a huge legacy item for Chairman Upton.

If there's going to be action on legislation, it probably will be in the first quarter, maybe in the first four months. After the super Tuesday primaries in March, it becomes a little clearer about the candidates and things really do kind of grind to a halt in DC on the legislative calendar.

NPA Fabricant: Blumenthal and Durbin have "said it before, but the issue is they had a piece of legislation they wanted to move last Congress that kind of got to put to rest on procedural grounds. There was never real debate about it. It’s a little more concerning this time given the makeup of Congress. You have an election year, you have so many different forces at work and then the biggest thing is that we no longer in the Senate have that leader on the committee with jurisdiction as a champion of the industry. [Former Iowa Sen. Tom Harkin is] no longer there. In a lot of ways it's a whole new world.

I think what we're going to see and what we've seen already is [floor introduction of amendments allowed under majority leader Mitch McConnell, R-KY, after not being allowed when Harry Reid, D-NV, was majority leader]. If a committee didn’t sign off on amendments, they weren’t even allowed on the floor. What I think you're going to see is a much more open process. You're going see amendments on the floor and they're not necessarily going to be brought up to committee. They're going to be brought up on the floor in a kind of flash-bang, quick kind of moment. You've got to be ready for that and we're certainly ready for that.

NPA Kelley: All it has to be to be an amendment on a bill in an open process is germane if they don’t pass it from committee. All it has to do is have the words FDA or NIH in there and it will be germane" to regulation of supplement manufacturing and marketing.

CRN: From a positive perspective, CRN has some proactive congressional initiatives including urging Congress to allocate appropriate funding for the new Office of Dietary Supplement Programs at FDA; working with the Congressional Dietary Supplement Caucus to expand both its membership and Congress’ awareness of the benefits of supplements; and to continuing growing our PAC which provides new opportunities for access and relationships.

What do you expect from state lawmakers and other officials that could affect the industry?

UNPA: Given the increased activity of state attorneys general, that 2016 will bring additional attempts by state legislators to enact supplement-related legislation.

CRN: it goes without saying that the states will be a hotbed of activity following last year’s engagement with the state attorneys general. Many states may try to introduce dietary supplement specific-bills addressing concerns that were raised by the AGs last year. There is already activity in New York, Massachusetts, New Jersey, and Illinois, and we expect more throughout the year. CRN is already actively engaged in these states, and CRN intends to guard against negative legislation.

What do you expect from the Department of Justice in 2016 about policing the supplement market? In particular, do you see more DoJ criminal prosecutions on the horizon?

NPA Fabricant: We're happy with them doing more in 2015. The bigger thing is, are they going to bring some more prosecutions? It's one thing to get the product recalled and defined, but with those issues you've got to have hides nailed to walls, otherwise you don't stop people from doing it.

We want to see some swift, strong enforcement action and tell these guys this isn’t where you sneak drugs in the marketplace.

FDA's got tools. They’ve got tools they can use … they’ve got mandatory recall so let's see it. I'm still the only one to have written a mandatory recall letter on the food side [for DMAA-tainted supplements] and that's going back a few years when I was there. This I would say is a bigger issue.

The big issue is what's different? It's great you went after some people and you sent them a warning letter, but how many of these are resulting in criminal prosecutions? Federal felony prosecutions? Where's that happening? I think the short answer is it's not, and until it's done on a consistent basis I wouldn't expect to see any change in the marketplace.

UNPA: Our best estimate is that DoJ will continue to pursue bad actors. And that’s a good thing.

CRN: We are pleased to see the joint actions between DoJ, FDA, and other government agencies, to focus on getting the illegal products out of the marketplace – the companies responsible for these illegal products are the ones who pose the greatest risk to consumers, and cause the most harm to the legitimate industry. We are expecting more enforcement announcements from DoJ and state AGs. CRN is engaged with numerous state AG offices at various levels in a number of ways, and has been for close to a year.

What is your thinking on FDA publishing a revised new dietary ingredient notification draft guidance?

CRN: With regard to the NDI draft guidance being released, for us and for our member companies, the sooner the better. The lack of clear direction from the agency on this issue continues to produce uncertainty in the industry, and inexplicably seems to provide an excuse for some companies not to file NDI notifications on even clearly new ingredients. However, it’s possible that we won’t see the NDI draft guidance released until a new permanent director is named for the Office of Dietary Supplement Programs. That’s understandable, but unfortunate, as it leaves the industry in limbo.

UNPA: As it has for over a year, FDA has said that a new draft is due out shortly. We certainly hope the agency will publish a new draft shortly that substantively addresses the concerns that UNPA, the other trade associations and leaders in Congress have expressed with the original draft. We would guess that we will see the revised guidance sometime later in 2016, and it will be a mixed bag.

NPA Fabricant: There is the whole notion of regulatory transparency on what to expect and when to expect it, but you're telling me it takes five years to revise a draft guidance? Unless that thing is going to be 1,000 pages long, and I can tell you it's not going to be 1,000 pages long, what's the holdup there?

I guess they're really busy over there. I not sure with what, but they're really busy. I think [ODSP acting Director] Bob Durkin's done a very good job. This should be a priority, but for whatever reason it's kind of been put on a back burner.

Other guidances, rules or regulatory activities from FDA that would affect the supplement industry? Now that DDSP is an office, do you expect more from FDA on supplement industry regulation?

UNPA: We not only expect more from DDSP being an office, we urge there be more. We also support the kind of efforts that Sens. Orrin Hatch and Martin Heinrich called for in their letter to the Department of Justice and the recent actions taken by DoJ and others to crack down on criminal violators.

CRN: Since the Division of Dietary Supplement Programs was elevated to Office status, there will be an expectation for increased enforcement directed at the supplement industry. We support and welcome enhanced enforcement. It’s incredibly important for the legitimate companies that FDA does what’s necessary to rid the marketplace of illegal products and rogue players.

NPA Hilmas: The industry is not really sure how [the Food Safety Modernization Act final rules are] actually going to handle dietary ingredients because they've really never come out and asked for meetings specifically with the industry on how they're going to enforce it, how they're going to handle every aspect of dietary ingredients for use in supplement. FSMA is the other big one that probably will get clarity sometime in the 2nd half of 2016.

NPA Fabricant: We're certainly going to push for clarity on FSMA. Are all districts going to treat all critical control points the same? We don't know that. Is identity a critical control point? I think you can make the case that it is and you can make the case that it isn't, but we'd like a little bit of clarity form the agency as to how they're going to look at it because, otherwise, I think an ingredient for a cereal is different than an ingredient where the final input is a dietary supplement. They have had nothing specifically about critical control points on dietary supplements. Nothing at all.

NPA Hilmas: We have asked for meetings specifically to discuss how they're going to handle dietary supplements under FSMA because we're under the assumption that they're going to handle it differently. That's sort of the scuttlebutt, but so far they've been really silent on it.

Additionally, anything else that you expect 2016 might bring for the industry?

CRN: At CRN we’re going to continue to move forward on initiatives to foster responsibility among our members (like our voluntary programs), to demonstrate their commitment to their customers, and to help regulators, retailers and consumers better navigate the marketplace. These efforts ultimately address industry’s accountability to consumers and enhance confidence in the products.

UNPA: UNPA has been and continues to be very engaged with elevating quality standards for industry through its November 2015 summit on analytical testing and its upcoming Feb. 23-24 summit in Salt Lake City on increasing the transparency of and accountability for raw materials and the supply chain. The goal of the February summit is to provide attendees with the information and resources needed to implement new systems and technologies and integrated quality practices leading to product integrity and competitive fairness.

It is likely FDA will continue its work to define “natural.” Congress is likely to continue an effort to reach an acceptable agreement on GMO labeling—although that will be tough as both sides can stop an agreement and neither side seems willing to make substantial compromises. However, meetings held by Agriculture Secretary Vilsack and [Campbell Soup Co.'s] announcement that it is in support of mandatory labeling may start to allow for heightened conversations around this issue.

Supplement Market Regulatory Forecasts Vary From Stormy To Quiet

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