Although the Food and Drug Administration (FDA) was “largely impervious to public input”, claimed Emord, were enough pressure exerted on Congress, “I would not be surprised if the FDA Commissioner either tables the NDI Guidance or withdraws it.
“Although I am not aware of an instance where the FDA has withdrawn a guidance document, I am aware of instances where it has left incomplete rulemaking proposals after being stung by intense public and political protest.”
He added: “The determination to issue the guidance is a political one. Political determinations can be reversed with a moment’s notice if the agency feels enough heat. The problem with this initiative is that politics have prevailed over science and common sense.”
Immediate coercive effect on industry
While the guidance was not legally binding, FDA’s “underlying, albeit unarticulated, objective of expanding the definition of what constitutes an NDI” had immediately rendered a large number of supplements already on the market technically unlawful, putting supplement makers between a rock and a hard place, claimed Emord.
“The guidance is presently exerting a coercive effect on the dietary supplement market causing responsible sellers to believe they must remove products from the market to avoid the risk of being charged with adulteration.
“The proposal is fundamentally at odds with the statutory provision governing NDIs and threatens to disrupt and imperil the supplement industry. The best outcome is not to seek issuance of another guidance document but to bury the one issued.”
FDA has ‘grossly underestimated’ compliance costs
Emord was speaking to NutraIngredients-USA after filing a comment on behalf of the Alliance for Natural Health USA arguing that the FDA had “grossly underestimated” the costs of compliance and breached the Regulatory Flexibility Act, which requires regulators to provide accurate estimates of the economic impact of proposals.
In a request for comment on NDI notifications published in the Federal Register on June 3 (before the new guidance was issued) the FDA estimated that each submission should take c.20 hours and predicted an annual submission rate of around 55 notifications (based on previous years’ submissions).
“There will be minimal burden on industry to generate data to meet the requirements of premarket notification …” concluded the FDA, “because the agency is requesting only that information that the manufacturer or distributor should already have developed to satisfy itself that a dietary supplement containing an NDI is in full compliance with the FD&C Act.”
Economic impact assessment
But this completely disregarded the impact of the draft guidance the FDA was poised to bring out, pointed out Emord.
An assessment conducted for the ANH-USA last month by Emory University professor of law and economics Dr Joanna Shepherd Bailey “revealed the burdens and costs to be extraordinary for the industry, indeed, imperiling it if FDA actually expects the industry to follow its guidance”, argued Emord.
“The agency has been derelict in its estimation, failing to account for the consequences that logically flow from each of its specific guidance requirements.”
100-350 hours of work per notification?
Dr Shepherd Bailey predicts the industry will have to submit 22,240 to 125,100 NDI submissions, each of which could take between 100 and 350 hours to compile.
This is based on an estimation that 40-75 percent of the 55,600 dietary supplements currently on sale will contain NDIs as defined by the guidance, each of which could require multiple filings should it contain more than one NDI.
Meanwhile safety studies could cost $450,000 to $6.6m per notification, predicted Shepherd Bailey (the lowest figure is based on a two-study genetox battery, a 14-day range-finding oral study, a 90-day sub-chronic oral study, and an ADME study in animals, as recommended by the FDA as a minimum safety requirement if firms cannot provide sufficient evidence of a history of safe use).
Click here to read Dr Shepherd Bailey's impact assessment (contained in ANH-USA’s submission to FDA).