FDA’s Tave: ‘Opportunity to strengthen regulatory framework couldn’t come at a more pivotal time’

By Stephen Daniells contact

- Last updated on GMT

© Getty Images / artisteer
© Getty Images / artisteer
With scientific advances and the growth of the dietary supplements industry on one hand, and the proliferation of adulterated and misbranded products on the other, the opportunity to modernize DSHEA couldn’t come at a better time.

So said Steven Tave, Director of the Office of Dietary Supplement Programs at the US Food and Drug Administration, at the International Conference on the Science of Botanicals​ at the University of Mississippi this week.

The Agency recently announced​ the inception of a range of initiatives to modernize the Dietary Supplement Health and Education Act (DSHEA), including a public dialogue process this spring to discuss possible changes to landmark law, the launch of the Botanical Safety Consortium, and ways to reinvigorate the NDI process.

Tave told attendees that, while that statement was issued by Dr Scott Gottlieb, who recently stepped down as FDA Commissioner, the statement was an agency policy.

“The work that he [Gottlieb] talked about was agency work, and it continues even after his departure,”​ said Tave.

“I want to emphasize here that we’re talking about strengthening the framework that governs dietary supplements – we’re not talking about upending it,” ​he added. “DSHEA struck a careful and deliberate balance between two twin objectives. First is preserving consumers’ right to access safe, well-manufactured, and appropriately labeled dietary supplements. Second, and every bit as important, is upholding FDA’s ability—our obligation—to protect the public from unsafe and unlawful products.

“We embrace that balance. And the strategic priorities that we’ve identified at FDA—consumer safety, product integrity, and informed decision-making—are geared toward achieving that balance.

“The original vision of DSHEA endures,”​ he said. “But I don’t know of anyone who would claim that the system is working perfectly, as it was intended, right now. So if there is an opportunity to strengthen that framework, then we need to capitalize on it. I would even argue that modernizing our oversight is the only way to preserve it.”

Initiatives

Given that he was speaking at a conference focused on botanicals, Tave made special mention of the Botanical Safety Consortium.

“This is an effort that is long overdue and it’s going to leverage our shared commitment with our colleagues in academia, government, industry, and elsewhere, to promoting safety through science,” ​explained Tave.

Stefan Gafner, PhD, chief science officer of the American Botanical Council, told NutraIngredients-USA recently​ that the goal of the committee is to have better, validated and more predictive tools to assess the safety of botanicals.

“By no means do we want to disregard the historical record. But there are new ingredients that have never been assessed. But there may be modifications to certain herbals or plants that used to be taken in a certain way and now manufacturers want to make modifications.  Those would be good candidates for these new tools,”​ said Dr Gafner.

Mandatory product listing

FDA’s Tave also discussed some of the potential ways to modernize DSHEA, including the introduction of a mandatory product listing, which would require all products marketed as “dietary supplements” to be listed with the Agency. It would also give FDA the authority to act against non-compliant products and their manufacturers and distributors, he said.

Other stakeholders at the meeting expressed their support for such a registry—which is not​ pre-market approval—and Tave noted that FDA’s fiscal year 2020 budget request included a specific proposal for this. However, not all stakeholders voiced support, with Dr Dan Fabricant, President and CEO of the Natural Products Association, telling us that such a registry would introduce liability for the industry.

Tave told attendees that estimates of how many products are on the market range from 50,000 to 80,000, which is a difference of 30,000.

“Put another way, the range of uncertainty just about how many products are on the market today is almost ten times the number of products that we know were on the market in 1994,” ​he said.

“[N]o one can credibly state that we know everything that is on the market, or even most of what is on the market. We don’t have a systematic way of knowing when new products are introduced. We don’t have an accurate picture of how the market is composed. And we don’t have a reliable way to capture trends so we can anticipate and adapt to new areas of risk,” ​he said.

A product listing would accomplish a number of goals, he said:

  • Enable FDA to identify and act more quickly against illegitimate, dangerous, and otherwise illegal new products
  • Improve transparency by helping consumers and retailers easily see whether a product has taken even the most basic steps toward compliance, and by potentially facilitating access to a wealth of information about a product’s benefits and risks
  • Boost FDA’s ability to utilize its limited resources through a more strategic and risk-based approach to things like research and inspection planning.

“Mandatory product listing will create a safer environment for consumers, and it will level the playing field for responsible industry participants,” ​he said.

“We’re at a potentially transformative time in the history of dietary supplement regulation, and when we gather here in the year 2044 to celebrate DSHEA’s 50th anniversary, I hope we can all look back and say that this was a time when we worked together to forge the best path forward,” ​concluded Tave.

DSHEA at 25

When the Dietary Supplement Health and Education Act (DSHEA) was signed into law on October 25, 1994 by President Clinton there were an estimated 4,000 products on the market and the market was worth about $4 billion.

Twenty five years later, and estimates peg the number of products at anywhere between 50,000 and 80,000 to be worth over $40 billion.

In 1994, the market was primarily domestic with an estimated 600 manufacturers in the US. Today, the global supply chain for dietary supplements and their ingredients encompasses more than 17,000 different facilities.

The signing of DSHEA also happened around the same time as the internet was just beginning to grow (Netscape was founded in April 2004, Amazon in July of 1994. Google didn’t appear on the scene until Sept 1998).

“You can’t look back at the history of DSHEA without recognizing that it became law on the eve of what we now know to be a revolution in the role of the internet not only as a source of information—and sometimes misinformation—but also as a channel of commerce,” ​said Tave.

Related topics: Regulation, DSHEA at 25

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1 comment

product list and benefits vs. risks

Posted by Don,

FDA wants a product list for transparency stating " . . . and potentially facilitating access to a wealth of information about a product's benefits and risks."

Does anyone believe that? They will spend their efforts on risks and informing consumer of them. Currently FDA limits almost all information a company can say about their product's benefits. Unless very careful making product statements (truth and facts are not important to FDA), as almost anything said can be considered a drug claim. Since information is so restrictive, it is easy to make your product illegal through information, how can FDA help the consumer know about benefits . . . ? FDA uses risks to justify potentially removing DSHEA products from the marketplace that they do not like or cause harm to drug companies.

The list would provide no useful benefit information to the consumer as FDA will likely only inform consumers on risks. If any benefit information was given it would be limited and provide "approval" for companies to use that information for marketing of the product.

And what differentiates a product with many ingredients for synergistic ability versus single ingredient products. Is FDA going to list ingredient(s) with associated risks and benefits?

We all know with any new/revised laws/policies, FDA will decrease access to benefit info and make it more difficult to stay in compliance. The consumer suffers from increased prices and reduced benefit information.

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