Welch spoke with NutraIngredients-USA at the recent SupplySide West trade show in Las Vegas, NV. During several appearances at the show Welch presented data on the rate of GMP compliance the Food and Drug Administration has seen based on its inspection reports. This year’s assessment was incomplete, Welch said, because the trade show’s dates have been moved up, and the final reconciliation of the numbers coming in from district offices won’t occur until later in the fall. Nevertheless, the picture seems clear: The industry continues to hover in a state of fitful compliance. The number of inspections with “official action indicated” observations (OAIs, the most serious violation category) continues to top 25% or so.
Ramp-up period is over
One of the sessions where Welch shared her views on this subject was the Botanical Congress hosted by the American Herbal Products Association. AHPA President Michael McGuffin, who in the past has argued that the industry needed time to come up to speed on GMP compliance, seemed to agree with Welch that the bloom is long since off this particular rose. In other regulated industries, such as foods and pharmaceuticals, McGuffin said the OAI rate is usually less than 5%.
“We have seen the violations continue to show problems in the fundamental areas. Finished product specifications—firms don’t have them. They’re not testing their products. They don’t have quality control procedures or the records that those procedures are being met. They don’t have batch records. These are the basis of a GMP system and this is coming up on 10 years after publication of the final rule,” Welch said.
On the second level of GMP compliance, Welch said it is important that companies consider who they are designating as quality control personnel. This question has started to show up on warning letters, with FDA citing firms for not having the right people in place and for not having records of how those quality control personnel were trained.
“If you have quality control personnel and they are not trained for that role, if they don’t have the proper expertise, then the operations they are carrying out really mean nothing,” she said.
Potential flood of NDI filings
On the subject of the NDI draft guidance, among the alarm bells sounded by industry is that the guidance as written would flood the agency with too many NDI notifications for it to handle. Welch said that it is premature to assess how many notifications might be coming in to the agency if the industry were to fully comply with the guidance as it stands. In its present form the guidance would mandate a notification on every new product launch that contains an NDI. Less than 1,000 NDI notifications have been filed since DSHEA was instituted in 1994, and there are estimated to be somewhere between 50,000 and 80,000 dietary supplement products on the market (no one is sure of the number).
“Anything I would say would be speculation at this point,” Welch said. “We don’t know how many new products are on the market that should have had an NDI filing. We would look to industry for that estimation.“
Welch said that she believes the agency has had a good record of turning NDI notification filings around within the 75-day time limit mandated by law. If the draft guidance brought in a flood of flings that the agency could not cope with, that would make a strong argument to Congress that FDA needs more personnel. But she said the shortfall needs to be demonstrated first, and FDA is not in a position to prophylactically add employees.