Steve Mister president and CEO of the Council for Responsible Nutrition, gave NutraIngredients-USA a peek into the sausage making process as it relates the Food and Drug Administration SAfety and Landmarks Act (FDASLA). Sen. Patty Murray, D-WA, who is the Chair of the Senate HELP Committee, and the panel’s Ranking Member, Sen. Richard Burr, R-NC, introduced the original bill. The measure’s primary purpose is to reauthorize the fees collected by FDA in the drug and medical device sectors.
Such bills are usually boilerplate affairs and rarely generate controversy. And, like the spending bills to fund the Federal government, they are destined to pass in one form or another. Indeed, the House fee authorization version (which contained no dietary supplement provisions) passed recently on a 392-28 vote.
Supplement provisions added
But this year’s Senate version is different. It includes language meant, in Sen. Murray’s words, to “provide long overdue oversight of cosmetics and dietary supplements.”
The portions of the bill specific to supplements laid out a Mandatory Product Listing (MPL) requirement, something that some stakeholders in the industry have supported. However, the specific language in the bill was seen as problematical, with the potential for unintended consequences.
Mister said progress is being made to address those concerns, but that there has been a significant amount of what he termed misinformation disseminated about the bill and the negotiations that have taken place.
Mister: Omnibus bills are common vehicles for additional provisions
For one thing, Mister termed it simple ‘naïveté’ to assume that there was something untoward or underhanded in the way the supplement provisions (and those for cosmetics) were included in the bill. It’s no secret that the current state of the legislative process in the US Congress resembles a logjam. There is little agreement among the parties, even on basic matters such as the state of the country’s democracy, and little willingness to be seen to work together. But logjams hold back water, and water eventually finds a way through.
“It results from the fact that in the current environment in Washington, there is so little that moves that it’s hard to get a single issue bill all the way through the House or the Senate,” Mister said.
He added that it’s far from the first time this particular fee reauthorization bill has been used to enact additional provisions. These fees for pharmaceuticals were firsts authorized in 1992, and medical devices fees were added in 2002. So there have been multiple rounds of reauthorization since, Mister said, many of which have contained provisions beyond the mere fees themselves.
“Last time there were provisions relating the new prohibited acts for food. That’s just how Washington works,” he said.
Mister also dispute the story line that the alternative version of Stripped down Burr version seen as negotiating tactic
FDASLA introduced by Sen. Burr, one that has stripped out all of the dietary supplement specific provisions, came about as a result of pressure from teh industry. Mister emphasized he’s not trying to put words into the Senator’s mouth, but the move appears to be a negotiating tactic that has little to do with supplement industry concerns per se. Rather, it’s to have a Senate version that mirrors that of the House, which had no supplement provisions from the get go.
Remaining sticking points
Mister said much progress has been made in refining the language of FDASLA to make it something the industry could support. He said there are four remaining action points that CRN is confident can be resolved before the bill might become final. They are:
- Clarification of what it means to submit ‘claims.’ These should be confined to what’s no the label, and not extend to everything that might be said about a product on a company’s website or in its marketing materials.
- Limit the limit the amount of information a company would have to give up front in respect to where a product is made. The address of the company that appears on the label should be sufficient for MPL purposes.
- Additional protection around confidential data, such as to protect information on proprietary blends from Freedom of Information Act searches by competitors.
- Additional language to close any potential loopholes that might allow FDA to ‘misuse’ the information in the registry.
“We are making progress on these issues, and we often are not at liberty to put out a press release every time we get an agreement in principle on something,” Mister said.
Not letting the perfect become the enemy of the good
MPL is one of the things that has been bandied about within the industry as one of the possible provisions for an updated version of the Dietary Supplement Health and Eduction Act, the so-called ‘DSHEA 2.0’ idea. Does it make sense to do this piecemeal?
Mister said in an ideal world a new version of DSHEA could be crafted, debated, altered and passed. But in the current legislative climate any opportunity for a small legislative win should be grasped, without letting the perfect become the enemy of the good, so to speak.
“We’ve identified this as something that responsible industry wants. I don’t think a DSHEA 2.0 version is something that could get passed in this Congress, and probably not in the next one, either. Is it worth waiting on Mandatory Product Listing for perhaps three, four or more years when you could get that done right now?” he said.
Congress will start its summer recess tomorrow, and Mister said despite the heartening progress, there’s no chance a version of FDASLA will be ready by then. But lawmakers’ staffs will continue to work through August, so he said chances for having an acceptable version of the bill in place by early September look promising.