NDI guidance public comments: Don't revise it, ditch it
While trade associations are still gathering feedback from members (and lawyers), several doctors, supplement makers and other stakeholders have now put pen to paper to express concerns about the controversial draft NDI guidance (click here to see all comments submitted to date) before the official comment period closes on October 3.
While many respondents have vented their anger, however, few have some up with specific suggestions as to how FDA officials might actually revise the guidance to make it more palatable.
Indeed, most urge the FDA to simply drop it.
Economic impact assessment
However, some commentators have made concrete suggestions.
One such is California-based health writer and dietary supplement formulator Bill Sardi, who argues that the FDA should not proceed until it has calculated the cost of compliance, and then conducted a cost benefit analysis to ascertain whether implementation can be justified.
The costs of full compliance could be astronomical, he claims: “Let's say, for a large company that has 300 lines in its catalog, you are talking $21m just for gene-tox [genetic toxicology tests at $70,000 a time] and then maybe hundreds of millions of dollars for birth-defect studies.”
NDI notifications should be for raw materials
Meanwhile, NDI notifications should apply to NDIs themselves, and not to every product or supplement manufacturer supplying a product that contains them, he argues.
“I naively thought raw material suppliers would submit NDIs and that would take care of it for all branders thereafter. But FDA wants final product (formula) testing. This seems ridiculous.”
Several commentators have made the same point. One says: “It would be more effective to have one or only a few NDI notifications being sent for an ingredient which the FDA can more thoroughly review and provide feedback or approval.”
Meanwhile, concerns about how the NDI might behave in different formulations could still be addressed, he claims: “The ingredient supplier may submit a NDI notification where they list all the forms for which the new ingredients may be used and their basis for the safety of each form.”
Dietary supplements are not drugs
While Priority One Nutritional Supplements president Danielle Baumgart does not clarify what should constitute an appropriate level of proof of an ingredient’s grandfathered status, the FDA has raised the bar too high, she argues.
“We have many old records for pre-DSHEA ingredients but even then the burden of proof as laid out in the guidance is impossible to adhere to effectively.”
Critically, the FDA’s line on grandfathered ingredients is not consistent with the intent of Congress when it passed the Dietary Supplements Health and Education Act (DSHEA) in 1994, claims naturopathic physician Hilary Back: “FDA, ignoring the intent of Congress, will reduce ingredients meeting the established grandfathered status to a very small number”
Another respondent says: “Don't erode DSHEA by turning supplements into pharmaceuticals.”
The bottom line, claims Sardi, is that the guidance is "impractical, imposes onerous and incalculable costs upon industry and consumers, would result in the withdrawal of many dietary supplements which Americans rely upon for their health, may end up being nothing more than a giant paperwork exercise without improving public health and safety, and represents issuance of yet another document from FDA that unfairly portrays dietary supplements as unsafe and adulterated.”
Click here to submit your comments to the FDA about the guidance.
