The previous Executive Interviews have all been with people within our industry. This very special interview is with someone outside our industry, but without whom most of us would not be in business. Senator Orrin Hatch (R-Utah) has been a tireless champion of the dietary supplements industry: he co-wrote and introduced the bill that became DSHEA in Congress, helped shepherd it through Congress, and has stood up for the industry in the face of repeated assaults in the legislative branch of government, as well as giving the regulatory agencies the occasional hot foot when they are particularly slow to enforce the law. The Senator has a personal belief in the benefits of supplements, and works hard to keep them readily accessible to the American public. We asked the Senator about the most relevant issues the industry is facing today, such as AER’s and the threat of pre-market approval, and he gave us his frank replies.
How did you first become interested in dietary supplements and natural products and how they are regulated by the government?
More than 150 million Americans regularly consume dietary supplements as a means of improving and maintaining their healthy lifestyles, and I have consumed dietary supplements for most of my adult life and can attest to the health benefits they provide. In addition, supplements are a major industry in my home state, and the economic benefits this industry provides to Utah are considerable.
For years, I witnessed the FDA’s long-standing antipathy toward dietary supplements lead the agency to twist the law and block the sale of a variety of supplements. It became clear that the only way to ensure supplements were treated fairly by the FDA was to provide the agency with a clear regulatory framework, a more seamless process similar to what other industrialized nations had adopted. That’s what led to the Dietary Supplement Health and Education Act (DSHEA).
You were the driving force behind the passage of DSHEA. It has been nearly 12 years since the law you authored has been enacted. From your viewpoint, does DSHEA still stand up to your expectations?
I think the basic framework remains solid, although I have been disappointed that the FDA has not moved very quickly to implement the bill. Unfortunately, the FDA has only recently started using some of the tools in DSHEA, and some aspects have yet to be implemented.
In your opinion has the FDA fulfilled their commitment to fully implement the law? And if not, how have they failed?
In a word, “no”, but I must say in the past few years the situation has improved dramatically. Senator Harkin and I have urged FDA for years to step up enforcement, and we have worked through the appropriations process to obtain more money for enforcement.
Take good manufacturing practices, for example. The law calls for FDA to publish GMPs to help assure that each batch of dietary supplements are produced in a sanitary and wholesome fashion. This would be the frontline of assault against unsafe or improperly manufactured products, ensuring they are potent, sanitary, properly labeled, and that what the label promises is contained in the bottle. Every other major product line regulated by the FDA – such as drugs and medical devices – are subject to industry specific GMP rules. A lot of the problems we have heard about could have been avoided if good manufacturing practice regulations were in place and enforced.
The FDA has also been reluctant to enforce the law in terms of the black and white requirements of the law that product labels clearly state what is in the bottle. Many athletes, for example, found to be using banned substances say the banned products were not listed on the product. There are suspicions this is not the case, but FDA's enforcement of this section of the law would clear that up once and for all.
Supplements are also illegal if they are adulterated or sold using false or unsubstantiated claims. But it wasn’t until late 2003 that the FDA started to really go after the bad apples in the industry, seizing millions of dollars worth of product and blocking the sale of several companies who were skirting the law.
In short, the FDA has done more to regulate supplements in the last three years than it has in the past 12 years. It’s only starting to use the tools we gave them in the law, and we are just starting to see the law work.
In the past few sessions of Congress attempts have been made to amend DSHEA. Do you believe DSHEA should be amended or modified? Do you think that changes to DSHEA are inevitable?
As I said, it is difficult to know if a law needs to be changed if it has yet to be fully implemented and enforced. But, generally, I do not believe changes should be made.
That being said, if there are ways it can be improved (which very few if any of the legislative attempts you cited are) I am open to considering it. That is why I am working with Senator Durbin to develop legislation that would mandate serious adverse event reporting for dietary supplements and other over-the-counter products. This will give the FDA access to more data to help monitor which products might be potential product risks.
Opponents to DSHEA have argued that the FDA does not have sufficient authority under DSHEA to regulate the industry. Many within the industry believe that the FDA’s action of taking ephedra off the market is a prime example of the authority that the FDA has to protect the public. Does the FDA really need any additional statutory authority to protect the public?
Every FDA Commissioner to serve since we passed DSHEA has said the law provides sufficient authority to act to protect the public.
Many people raise ephedra, on both sides. Frankly, I don’t believe ephedra is a good case study of the law, the industry, or the agency's enforcement. Everyone agrees action was too slow, and the reasoning for that is very complicated and would take too long to discuss here. If the agency had been more aggressive about enforcement across the board, many of the questions inherent in implementation of any new law could have been worked out earlier.
But, let’s be clear about what DSHEA outlines for removing products from the market. It says that a supplement can be marketed as safe unless it “presents a significant or unreasonable risk of illness or injury under conditions of use or labeling.” However, to alleviate any concerns that House Democrats had when the bill was passed, we added an “imminent hazard” authority so that the Secretary of Health and Human Services could take immediate action against any supplement he or she feels is unsafe — no questions asked — and later convene an administrative proceeding to justify the action taken. This authority was not present prior to DSHEA.
The action on ephedra – nearly 10 years after DSHEA was enacted – was the first time that FDA has ever used the “unreasonable risk” standard. That is simply too long.
You, along with Senators Harkin and Biden, were instrumental in the passage of The Anabolic Steroid Act of 2004 which took certain products, like Andro, off the market. With all the talk about steroids, do you foresee additional products being prohibited to be sold as supplements and added to the Controlled Substances list?
Steroids cannot be sold legally in the United States, and that is a DEA issue, not an FDA issue. To the extent that there was uncertainty about whether precursor steroids like androstenedione were supplements or not, some have tried unfairly to put this problem at the feet of DHSEA.
However, I argued for years that steroid precursors – although some have been marketed as a dietary supplement – are illegal under the controlled substances act. Because the DEA and FDA were so slow to act and clear up this matter, I worked with Senator Biden to amend the CSA to make certain that these precursors – and any steroid look-a-likes that chemists develop in the future – are treated like steroids, and thus, illegal.
In the recent past, Senator Durbin has attempted to amend DSHEA to require pre-market approval of supplements and to mandate mandatory adverse event (AERs) reporting. Where do you stand on any type of legislation that would require pre-market approval of products and ingredients for the industry? What is your stance on a mandatory adverse event reporting system?
I am adamantly opposed to pre-market approval for supplements. Consumers would be hurt, and it would be the death knell of this industry. FDA approval is an extremely costly, lengthy process. The majority of supplements cannot be patented, and there would be no financial incentive for manufacturers to undergo that approval process. In addition, all recognize that the vast majority of supplements are safe, and have been used safely for centuries if not millennia. That is why DSHEA “grandfathered” supplements on the market as of the date of enactment, and set up a process for FDA pre-notification (as opposed to pre-clearance) for those products.
With respect to AERs, I support a properly crafted mandatory serious adverse event reporting system for supplements.
Regarding AERs, what would you say to those within the industry that claim that such a system would either be too burdensome, or would result in millions of unsubstantiated AERs being reported? Is there a need for a mandatory AER system and if so, how do you believe it should be constructed?
At the outset, let me say I will do my best to make certain the new system is constructed in the least burdensome manner. There are many factors at play here. Generally, it is important to recognize that the industry is maturing, and with that maturity and the 12 years of experience we have had under DSHEA, most have come to recognize that responsible regulation is not a bad thing. The responsibility goes in both directions. The FDA has to be fair, and the industry has to do its part as well.
I must point out that there is a voluntary system already, so many companies are comfortable with reporting adverse events and have a system in place to handle it. In the bill I am working on, we are aiming for a standardized process with clear rules, so manufacturers will know what to expect. The fact that there is a voluntary system is one reason I believe a mandatory system would not result in a flood of reports, as some have alleged. In addition, since most supplements are safe, as I have discussed before, there is no reason to believe they would start being unsafe, and thus cause a flood of reports. Finally, reports would be limited to serious events only, which would limit the reporting.
I can see there are clear benefits to a mandatory system, the primary one being the signal it shows to public health authorities that there may be a problem.
To what extent and with what type of focus should industry be more active in 'policing itself' etc.
By and large, the industry does “police itself” by selling safe products to the public. If the FDA had been doing its job from the beginning, this question would never have been raised. I believe DSHEA, fully enforced, would sift out any unsavory few in the industry that might be breaking the law and hurting consumers.
I have been supportive, though, of trade association policies that have benefited the industry as a whole.
What can the natural products/supplement industry do to better support your and their efforts and interests with Congress?
I would say the same thing that I say to every industry that meets with me: get involved. Meet with legislators and make sure they know your views on the major issues that affect you. Even better, you should invite legislators to see how the industry works on the front lines by visiting your place of business, your factory, or your warehouse. Do whatever you can to personalize your message and drive home why your issues matter to this particular member in his state or district.