FDA again sets expected costs at level supplement industry repeatedly has said drastically underestimates spending on preparing and submitting NDI notifications. But FDA says developing scientific evidence to support a notification is separate from submitting the information to the agency.
Another year, another US Food and Drug Administration estimate of costs for new dietary ingredient notifications that the dietary supplement industry says inaccurately parses compliance with the regulation.
The agency on 15 October published a Federal Register notice that once against sets the expected costs at a level...
Along with two instructional videos, FDA provides fact sheet detailing common problems with NDINs while supplement industry awaits guidance on two hurdles for clearing the NDIN process, providing identity information and evidence of safety for ingredients.
Limited capacity and a two-to-three year timescale for reformulation could mean that many VMS supplements disappear from the market, warns EPPA partner Alexandra Bocquillion, speaking at the AESGP Annual Meeting in Warsaw, Poland.
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
Some changes the administration has proposed are a “great example of regulating by press release,” says Duffy MacKay, CHPA’s dietary supplements chief. But “after 30 years, the Dietary Supplement Health and Education Act could be modernized to serve the consumer better.”
