“Some people look at these and say the future is dark and we may be going down. That’s not how I see it,” Harkin told an audience at the recent Expo West trade show in Anaheim, CA.
Record of success
Harkin gave the keynote address at the annual meeting of the American Herbal Product Association where he also received an AHPA Lifetime Achievement award. Harkin, who was a Democrat from Iowa, along with Sen. Orrin Hatch, R-UT, who is still in the Senate, have long been the industry’s two main supporters in Congress and were instrumental in the writing and passage of the Dietary Supplements Health and Education Act in 1994. From that vantage point, he gave a view of what he sees as a long record of industry success on Capitol Hill.
“There is no doubt that DSHEA has been a great success. My message to the federal government was very simple: Cut out red tape, take down roadblocks and allow these people to do their good work to keep people healthy,” he said.
Harkin said the industry and its supporters have been uniformly successful in fending off efforts to hamstring DSHEA. Those efforts have helped to create a thriving industry.
“DSHEA improved access to these products and helped the industry grow from $8 billion to more than $34 billion,” he said. “We didn’t rest on our laurels. Together we successfully defended DSHEA.”
Among the victories Harkin recounted were the addition of adverse event reporting (AER) requirements in 2005 specific to and appropriate for dietary supplements; the opposition of Sen. John McCain’s effort in 2010 to have an approved list of dietary ingredients drawn up; and successfully opposing a 2013 dietary supplements labeling bill introduced by Senators Dick Durbin, D-IL and Richard Blumenthal, D-CT.
Harkin said the industry also prevailed in what has been perhaps the most pointed challenge to future growth, that being the draft New Dietary Ingredient Guidance first issued by FDA in 2010. If the guidance had been adopted as originally written it could have placed significant new burdens on companies and could have served to stifle innovation. Harkin and Hatch met with FDA officials and convinced them to amend the guidance to take into account the many serious objections raised by industry. These included whether filing requirements ought pertain to new ingredients only (the industry’s point of view) or to any new finished products that contain new ingredients, what changes made to the processing or specifications of an existing ingredient might trigger the need for an additional NDI notification and what is the status of “bio identical” synthesized ingredients. The rewritten guidance is in the process of internal FDA review and should be reissued “soon,” or so agency officials have said for a couple of years. Whether that means the rewritten guidance will be issued sometime this year is anyone’s guess.
“What they came up with was not only not in accord with the intent of Congress but clearly violated the law as written,” Harkin said.
Plan for the future
Harkin has been out of Congress since the last midterm election and Sen. Hatch has announced that this term will be his last. Harkin said it’s imperative that the industry continue to work diligently to develop new representation on the Hill, and he laid out a five-part framework for how the industry should conduct itself going forward:
- It’s crucial that the industry maintain a strong bipartisan support in Congress. In the Senate there is still Hatch, and also Sen. Martin Heinrich, D-NM. In the House he mentioned Rep. Frank Pallone, D-NJ and Rep. Jason Chaffetz, R-UT. The industry needs to keep working to seek out new and younger champions.
- Keep up the work to educate and engage newly elected members of Congress and in particular their staff. Harkin said very few, if any, staff members (who do most of the substantive work) are left on the Hill from the days when DSHEA is written.
- Keep customers informed and engaged when their access to healthful products is challenged.
- Companies need to hold themselves and their peers to the highest quality standards.
- Be open to change.
Harkin said that he has seen a welcome ramp up in enforcement activity in recent years. In the initial years after DSHEA was passed, there seemed to be little enthusiasm on the part of FDA personnel to engage with the law’s provisions.
“I’m glad to see that FDA is using the tools we gave them rather than relying on false assertions that DSHEA ties their hands,” Harkin said.
Overall, Harkin said that the current climate contains significant challenges to the long term growth prospects of the dietary supplement industry. But that has always been the case, and the industry has prevailed.
“Keep engaged and keep out in front of theses of the changes that are coming. More and more people are taking charge of their own health and that trend is going to continue and accelerate in the years to come. I think the future is going to be even brighter,” Harkin said.
Since his retirement Harkin has been working on setting up the Harkin Institute for Public Policy and Citizen Engagement at Drake University in Des Moines, IA. Among other things the institute will work on helping to empower people to make their own health decisions and to support that shift including by making the transition to organic agriculture eaiser for farmers and by making healthier choices available in children’s school lunches.
“I may have retired from the Senate but I haven’t retired from this fight,” Harkin said.