- Speech by
Norman E. "Ned" Sharpless, MD
Acting Commissioner of Food and Drugs - Food and Drug Administration
FDA/CFSAN College Park Campus
(Remarks as prepared for delivery)
Thank you, Cara, for that warm introduction and thanks to everyone for participating in today’s very important public meeting.
The topic of today’s session – is of particular importance to protecting the public health and the work of FDA.
Although I’m new to FDA, protecting and promoting the public health has been central to my professional work throughout my career.
As some of you know, before coming to FDA, I was the director of the National Cancer Institute at NIH. And before that, I was a cancer researcher and cancer doctor, treating patients with hematologic malignancies, for nearly 20 years in academia.
During that time, I ran a successful NIH-funded lab studying the molecular mechanisms of cancer and aging, and I also was director of a large Comprehensive Cancer Center.
I’m thrilled to be at FDA and part of a team that uses science to develop policies and regulations that help make Americans more knowledgeable and safer.
Few of FDA’s responsibilities affect as many Americans on a daily basis as our work in the foods arena, which includes issues of food safety and labeling, but also issues of nutrition and diet.
As a physician, I’ve long seen the profound impact of diet and nutrition on human health and the importance of good research in this area.
A related aspect of this – and a priority of FDA’s oversight responsibilities -- is our subject of today’s meeting, the dietary supplement market.
Today, more than 75% of Americans use dietary supplements regularly. That number has grown significantly in recent years, and the market and products have changed and grown enormously as well.
It’s now been almost 25 years since the majority of FDA’s authorities specific to dietary supplements were solidified in law with the passage of the Dietary Supplement Health and Education Act of 1994 (or DSHEA).
I think it’s clear to everyone here today that the dietary supplement market does not look like it did when DSHEA was signed into law.
In October of 1994, the industry was estimated to be worth four billion dollars. Today, we’re looking at an industry with annual sales exceeding 40 billion dollars.
And, thanks in part to science and innovation, the range of products today is far broader than what was on the market in 1994, having grown from about 4,000 products to as many as 80,000.
That’s pretty significant growth…
Add to this the fact that 25 years ago, we didn’t have the internet and the global reach it has provided to the US consumer, and you can get some idea of the vast changes this industry has seen.
Against this evolving backdrop, the FDA has worked to maintain an appropriate level of oversight, within the authorities granted us by Congress.
It’s essential that consumers are able to make informed and healthy choices about dietary supplements they may use.
And there is an important public health need to make sure the products are safe, the labels have correct and complete information about what’s in them, and there’s a scientific basis for claims that are made about them.
These elements are central to FDA’s mission to protect and promote the public health.
I know this is a commitment that our stakeholders share and, in fact, many of you here today have been echoing from your platforms.
We all know that there are some companies who put consumers at risk – and also risk damaging the reputation of an entire industry -- by distributing and selling dangerous or otherwise illegal products.
In my career as an oncologist, I’ve seen all too clearly the unfortunate consequences of marketers selling fraudulent products that make claims to treat, cure, or prevent disease and preying on the desperation of patients and their families.
This is an area that I know the agency has been active in for many years. We’ll continue to protect consumers by cracking down on false, misleading, and potentially harmful claims.
We’re also committed to taking action when products contain ingredients that render the products unlawful, including many drug ingredients, and when they’re not manufactured according to standards designed to ensure a quality product.
But we also understand that dietary supplements are widely used, very popular with patients and can be safe when responsibly produced and used.
FDA has an equally important role to play in allowing these products to advance public health where possible.
DSHEA was deliberately crafted to establish a careful balance of protecting consumers’ right to access safe products and accurate information, while preserving FDA’s authority to protect those same consumers against unsafe and otherwise unlawful products.
While the fundamental goals underlying DSHEA have not changed, the challenge of realizing those goals has grown to a magnitude far beyond what it once was.
The realities of today’s marketplace demand a renewed approach to regulation.
It is crucial that FDA be nimble and adaptable as we advance our regulatory frameworks in keeping pace with this rapidly growing commodity.
Now is the time to modernize our program to ensure better alignment with the realities of today’s dietary supplement market.
This past February, FDA announced some new steps we’re taking to advance our regulation of dietary supplements and modernize and reform our oversight of this important segment of our health economy.
I want to assure you that this work remains a priority and will continue.
We are taking a close look at our dietary supplement program to make sure that we have the tools we need to keep consumers safe, and that we are using these tools as effectively as possible.
We’ve established an agency-wide dietary supplement working group that is looking into our dietary supplement organizational structures, processes, practices, and procedures, and identifying where we can make improvements.
We’ve affirmed our commitment to using traditional enforcement tools when we see products and players that violate the law.
But we’ve also recently announced a new tool to address potentially violative products.
Last month, we announced the Dietary Supplement Ingredient Advisory list, a new rapid-response tool that we’ll use to alert the public when ingredients found in dietary supplements appear to be unlawful, based on our preliminary determination.
This is critical to protecting the public health – if an ingredient might be unlawful, consumers need to know so they can avoid using products with that ingredient,
And responsible industry participants need to know as well, so they can avoid selling them.
We also recently announced a Botanical Safety Consortium that we’re kicking off with our industry, academic, and government partners to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements.
This group will look at novel ways to use cutting-edge toxicology tools to promote the goal of safety that we all share.
As a researcher, I’m thrilled to see these groups come together to collaborate and learn from each other while tackling these complex questions.
Today’s meeting is another piece of our renewed focus on dietary supplement regulation and our efforts to bring it into the 21st century.
The topic of today’s meeting – responsible innovation in dietary supplements – really gets to the heart of the balance between access and safety that is at the core of DSHEA.
Our multi-pronged effort to modernize the dietary supplement program is complicated – but so is the industry.
I know that our Office of Dietary Supplement Programs is looking forward to hearing your suggestions on how we might reshape our oversight of dietary supplements.
I’m sure the conversations will be thoughtful, detailed, and productive, with views from across the spectrum of stakeholders represented here today.
I’m pleased to see the broad interest in our efforts, with participation from consumer health groups and industry trade associations, attorneys and physicians.
I know we also have representatives from our fellow regulatory agencies in other countries participating, which is very important, given the global reach of these products.
Given the interest and the packed agenda that we have before us, I will turn this podium over to Steve Tave, our director of the Office of Dietary Supplement Programs, and allow the conversation to begin.
I want to thank all of you again for your participation in today’s meeting.