Fabricant on DSHEA: ‘Why are we talking about modernizing something that has never been fully implemented?’

By Stephen Daniells contact

- Last updated on GMT

As talk in the industry and at the FDA continues around the modernization of DSHEA, not everyone thinks big changes are needed. “The best thing the Agency does is inspect and test,” says NPA’s Dr Daniel Fabricant.

Speaking with NutraIngredients-USA at the recent International Conference on the Science of Botanicals at the University of Mississippi, Dr Fabricant, president and CEO of the Natural Products Association (NPA), said: “The laws work. Are they always fast? No. Are there possibly better ways to do things? Yes. The problem is we’re not seeing the data.”​  

“Does the Agency know, and does the industry know, what is the amount of inspections that need to take place that change behavior for GMPs? What are the number of NDI enforcement cases that need to take place to change the behavior?”

Mandatory product registration

The FDA 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.

One of the main ideas is the introduction of a mandatory product listing, which would require all products marketed as “dietary supplements” to be listed with the Agency. FDA’s fiscal year 2020 budget request included a specific proposal for this.

“Why would the industry introduce liability, effectively? It’s unclear how that could be used against you, especially at the State level,”​ said Dr Fabricant. “If someone submits a label that has a label error on it, the FDA may not ding you but the States certainly would.

“I’ve said this and a lot of responsible people in the industry have, the States have really been one of the biggest issues we’ve been dealing with all along. Why isn’t the Agency going, ‘Hey, we’re interested to talk about new authority but first and foremost we’re going to pre-empt the States because we want to be THE competent authority’.”

Dr Fabricant also said that the information that would be collected into a product registry is already available.

“We used to collect labels when I was at FDA on GMP inspection, on certificates of free sale. So, if those aren’t being used currently in some sort of risk management, risk analysis way, why would someone think they’re going to be used in the future?

“Everyone says that it will let us know who the good guys are and who the bad guys are, but I don’t see how [a registry] does that. All it does is put a burden on the legitimate industry to send these things in. And it may not be a significant burden, but in some cases it might be.”

The Agency has never had a problem finding a product when there’s been an issue

Dr Fabricant continued: “Certainly during my time at the Agency, it wasn’t the label that indicated the problem – obviously if there’s a disease claim on it then there’s a different story – but when we had legit safety issues, that bubbled up through the AER system or through leads or through inspections.

“The best thing the Agency does is inspect and test.”

Related topics: Regulation, DSHEA at 25

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