Israelsen said he believes the move is a first for FDA. “It certainly is the first time as an organized action,” he told NutraIngredients-USA.
Rapid response tool
FDA filed the import alert in early December. Titled “Detention Without Physical Examination of Dietary Supplement Products from Firms That Have Not Met Dietary Supplement GMPs,” the alert allows immediate seizure of products coming from the companies named in a list attached to the alert, two in India and nine in Mexico. The move opens the door toward the more vigorous enforcement environment that UNPA and other dietary supplement organizations have long advocated. The due process provisions written into US law sometimes make for a frustratingly long process made up of inspections, 483 notifications, warning letters and, in rare instances, injunctions. FDA now has a rapid response tool for the firms named in the action.
“Districts may detain, without physical sampling and analysis, all dietary supplement products from the foreign processors (manufacturers) as noted in the Red List of this import alert. DWPE (Detention Without Prior Examination) will be indicated when CFSAN determines that inspectional findings demonstrate the manufacture of dietary supplement products is not operating in conformity with current good manufacturing practices (GMP’s),” the alert said.
“FDA has continued to inspect both domestic and foreign firms and in the cases overseas where they’ve seen pretty significant problems the question becomes, what do you do about it? I hope this sends a message to foreign companies that are bring products in that if we find GMP problems in your facility we are going to do something about it,” Israelsen said.
The alert applies only to finished products made in the facilities of the firms named on the list. Israelsen acknowledged that as such the alert represents a small step toward addressing the problem of low quality or otherwise adulterated materials finding their way onto shelves in the US. The stream of raw materials from overseas that end up in US finished dietary supplements is by at least a couple orders of magnitude larger than the amount of finished goods that are imported. The firms on the list are obscure in the marketplace, and Israelsen said the products may have very well been intended for distribution in ethnic markets. Nevertheless, he sees the move as an important step.
Advent of FSMA
Israelsen said the alert was also interesting in light of the advent of new rules under the Food Safety Modernization Act. FSMA will apply to ingredient suppliers who were exempted from dietary supplement GMPs. The quality control of dietary supplement raw materials has up to now been the exclusive responsibility of manufacturers, who have had to comply with identity testing requirements for incoming components under Part 111. Israelsen said alerts such as the one issued in December combined with the new FSMA requirements could go a long way toward ramping up quality overall in the dietary supplement sector both at home and overseas.
“This is not significant in terms of products on the market. But this makes sense to me. I think it should be supported as part of a global effort,” Israelsen said.