While Trump’s pledge to rein in bureaucracy and regulation is welcome in some quarters it is proving to be an anathema to leaders in the dietary supplement industry who have sought more vigorous enforcement by the Food and Drug Administration. For years the mantra in the dietary supplement business has been that FDA needs adequate resources to the job mandated for it by Congress.
Asking for more agency scrutiny, not less
“I think the dietary supplement industry is in a unique position in that we are actually urging the agency for more enforcement of existing laws. I think that’s unusual for a regulated industry to be clamoring for more action by regulators,” Steve Mister, President and CEO of the Council for Responsible Nutrition, told NutraIngredients-USA.
“It would not be unusual in a new administration to have a freeze until you get a new team on board, until you get a new FDA commissioner appointed,” Mister said. “But there is much we don’t know. Is this a freeze that is going to done for cosmetic reasons so the administration can say they’re shrinking the federal workforce? Is it going to be targeted to where fewer workers might be needed?”
Mister noted that the hiring freeze comes at a time when FDA has received greater demands on its staff resources. The Division of Dietary Supplement Programs within FDA was recently elevated to the status of “Office”, bringing with itnew authorities and, presumably, new demands on staff time. In response to calls for more rapid action on a variety of initiatives, including enforcement and the finalization of existing regulations, officials at FDA have often reminded industry stakeholder of the “24 FTEs” number (full time equivalents) as the current cap on staffing. In other words, you get what you pay for.
“I don’t think there is anyone within the industry that is asking the government to take away regulations that pertain to the industry. Rather what we have been asking for is a reasonable interpretation and implementation of those regulations,” Mister said.
No more staffing help
Loren Israelsen, president of the United Natural Products Alliance, has observed FDA’s work for more than two decades. He said despite the burdens that FDA must bear, under the current administration no help will be forthcoming.
“We should not expect that the dietary supplement area within FDA is going to receive any additional staffing. It’s a combination of the budget process as well as the hiring freeze and the two-for-one executive order on regulations,” Israelsen said.
For Israelsen, the question then becomes what will the dearth of resources at FDA do to the trust consumers have in the industry. The Greek chorus of industry critics in the mainstream media continues to chant the ‘unregulated’ or ‘under regulated’ refrain.
“We are concerned that in the absence of the normal regulatory control mechanisms there will be opportunity for mischief or to take advantage of a real or perceived gap in regulatory enforcement and oversight. We are looking at this through the eyes of our consumers. In light of the fact that there is a public debate about whether we are a regulated industry to begin with, how do we maintain the trust and confidence of our consumers?” Israelsen said.
Israelsen said the current climate bodes ill for any revision of the NDI draft guidance. It’s even possible that the guidance will linger on as a draft in its current form, much as the guidance on liquid dietary supplements did for a number of years.
“The most plausible scenario is that it remains in draft form and in the form it is in now down the road. We have to work on the basis of what we have seen is what we are going to get,” he said.
Mister said he hopes that one initiative that has begun at FDA that does not require more staffing will continue under the new regime. That is a move toward having inspectors’ time parceled out according to expertise rather than to what particular office an inspector is attached to. Extending that initiative could help the agency work smarter with limited resources, he said.
“We are eager regardless of whether there is a freeze in place for that initiative to continue. We have had companies tell us that they have inspectors show up who have little understanding of Part 111, and they might have been assigned an inspection merely because they are part of the Denver office, for example. We want to see a continuation of the move toward commodity based as opposed to geography based inspections. Inspectors who are familiar with dietary supplements can make smarter judgements and interpret the regulation as they walk through the facilities,” he said.