With a new administration in office and new leadership guiding FDA, it’s only natural to wonder if the regulatory environment for dietary supplements, as it relates to current good manufacturing practices (GMP) enforcement, will change—and if so, in what direction. After all, Donald J. Trump got elected president in no small part thanks to promises of “smarter”—that is to say, more lenient—regulation.
As the tea-leaf readers try to tease out where FDA may be headed on GMP enforcement, one subject of study is the pace and nature of Form 483 letters documenting concerns observed during supplement facility inspections. Why? Because if White House policy is to regulate with a lighter touch, it stands to reason that inspectors on the ground might be less inclined to dole out Form 483s for what some would argue are nominal violations.
Another consideration: Brutal budget cuts to agencies like FDA might make it harder for officials to do their jobs, regardless of whether they were aiming to do so with vigor or with an eye toward easing the weight of those “burdensome” regulations.
Too Soon to Tell
So how do things actually look on the ground? “To be honest,” says Lisa Glymph Lattimore, technical manager, dietary supplements, NSF International (Ann Arbor, MI), “I think it’s too early to analyze and interpret short-term enforcement trends.”
Marc Ullman, of counsel, Rivkin Radler (Uniondale, NY), agrees, adding that with so many of FDA’s sub-commissioner leadership spots still staffed by holdovers from the pre-Trump era, “Changes in policy or enforcement approach likely wouldn’t be seen until there’s turnover in these positions.”
Thus it looks for now like business as usual—which in the case of FDA means the usual slowness. Indeed, though “there doesn’t seem to be any change in the agency’s tone or level of cGMP enforcement since the Trump administration came in,” Ullman says, “to the extent that I’ve noticed any change at FDA, I’d say that the pace of any new initiatives by the agency has gone from its usual glacial speed to virtually nonexistent.”
One In, Two Out
But while Justin J. Prochnow, shareholder, Greenberg Traurig LLP (Denver, CO), also believes that “the passage of regulations, guidance, and other more overarching action has definitely experienced a slowdown,” he thinks it might be for reasons more complicated than the typical bureaucratic sclerosis.
“Clearly, FDA under the Trump administration has been given orders to slow down any actions initiated under the previous administration,” Prochnow says. This is no surprise, as the White House made clear from the start that it favored a policy of “one in, two out,” meaning that each new law or regulation passed must come at the expense of two existing regulations—a strategy that “has certainly slowed down efforts that had been underway,” Prochnow says.
A case in point is FDA’s request for public comments on the most recent version of the agency’s new dietary ingredient (NDI) draft guidance; changes to the definition of the term healthy under 21 CFR, Part 101.65(d), of the Food, Drug and Cosmetic Act (FD&C Act); and several questions pertaining to the definition of natural, Prochnow continues. “None of those actions is likely to move forward quickly at this time,” he says. What’s more, menu labeling requirements that were set to go into effect on May 5, 2017, and changes to the Nutrition Facts Panel that were set to take effect next July have also been delayed. “Yet companies continue to be inspected by FDA compliance officers, have products inspected at Customs, and otherwise experience day-to-day regulation in substantially the same manner,” he says.
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