Progress on MPL Provisions in the Royalties Bill


Steve Mister, President and CEO of the Council for Responsible Nutrition, gave NutraIngredients-USA an overview of the sausage making process as it relates to Food and Drug Administration (FDASLA) Safety Act and benchmarks. Sen. Patty Murray, D-WA, who is chair of the Senate HELP Committee, and the group’s ranking member, Sen. Richard Burr, R-NC, introduced the original bill. The main purpose of the measure is to reauthorize fees collected by the FDA in the drug and medical device sectors.

These bills are usually boilerplate and rarely controversial. And, like spending bills to fund the federal government, they are destined to pass in one form or another. Indeed, the House’s version of the fee authorization (which contained no provision on dietary supplements) recently passed by a vote of 392 to 28.

Additional provisions added

But this year’s Senate version is different. It includes language that means, in the words of Senator Murray, to “provide long-awaited oversight of cosmetics and dietary supplements.”

The supplement-specific portions of the bill spell out a mandatory product listing (MPL) requirement, something some industry stakeholders have supported. However, the specific wording of the bill was seen as problematic, with the potential for unintended consequences.

Sir said progress was being made to address those concerns, but there had been a significant amount of what he called misinformation being circulated about the bill and the negotiations that took place.

Sir: Omnibus bills are common vehicles for additional provisions

On the one hand, Monsieur called it mere “naivety” to assume that there was anything untoward or underhanded about the way the provisions for supplements (and those for cosmetics) were included in the draft. of law. It’s no secret that the current state of the legislative process in the US Congress looks like a dead end. There is little agreement between the parties, even on fundamental issues such as the state of the country’s democracy, and little willingness to be seen to work together. But the traffic jams hold the water, and the water eventually finds a way.

“It’s a result of the fact that in the current environment in Washington, there’s so little moving that it’s difficult to get a single bill through the House or the Senate,” he added. . said sir.

He added that this is far from the first time that this particular fee reauthorization bill has been used to enact additional provisions. These fees for pharmaceuticals were first authorized in 1992, and fees for medical devices were added in 2002. So there have been several rounds of reauthorization since then, Mister said, many of which contained provisions ranging beyond the mere costs themselves.

“Last time, there were provisions relating to new prohibited acts for food. That’s how Washington works.he said.

Sir also takes issue with the scenario that the alternate version of the Stripped down Burr version is considered a trading tactic.

The FDASLA introduced by Senator Burr, which removed all provisions specific to dietary supplements, was born out of industry pressure. Mister stressed that he was not trying to put words in the senator’s mouth, but this move appears to be a bargaining tactic that has little to do with supplement industry concerns per se. . Rather, it’s about having a Senate version that mirrors the House version, which had no additional provisions from the outset.

Remaining friction points

Mister said a lot of progress has been made to refine the language of FDASLA into something the industry can support. He said there remain four action points that CRN is confident can be resolved before the bill becomes final. They are:

  1. Clarified what it means to submit “complaints”. These should be limited to what is not on the label and not extend to anything that may be said about a product on a company’s website or in its marketing materials.
  2. Limit the amount of information a company should give in advance regarding where a product is made. The business address that appears on the label should be sufficient for MPL purposes.
  3. Additional protection around confidential data, for example to protect information about proprietary blends of Freedom of Information Act research by competitors.
  4. Additional language to fill in any potential gaps that could allow the FDA to misuse registry information.

“We’re making progress on these issues, and we’re often not free to put out a press release every time we get an agreement in principle on something,”said sir.

Don’t let the perfect become the enemy of the good

The MPL is one of the things that has been mooted within the industry as one of the possible provisions for an updated version of the Dietary Supplements Health and Education Act, the so-called idea DSHEA 2.0”. Does it make sense to do this piecemeal?

Sir said that in an ideal world, a new version of DSHEA could be developed, debated, modified and adopted. But in the current legislative climate, any opportunity for a small legislative victory must be seized, without letting the perfect become the enemy of the good, so to speak.

“We have identified this as something that a responsible industry wants. I don’t think a DSHEA 2.0 version is something that can be passed at this Congress, and probably not at the next either. Is it worth waiting three, four or more years on the mandatory product list when you could do it now? » he said.

Congress will begin its summer recess tomorrow, and Monsieur said that despite the encouraging progress, there’s no way a version of FDASLA will be ready by then. But lawmakers’ staff will continue to work through August, so he said the chances of having an acceptable version of the bill in place by early September look promising.


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