Grappling with a "Great Mountain of Paperwork" (Part 1 of 2)

On a Thursday morning, the pouring rain and 500-year flood showing no signs of restraint, I leave my home city of Longmont for a two-day event in Boulder that is hosted by FDA Compliance Group: the Rocky Mountain Dietary Supplement Forum.

Thanks to a fender bender just yards from my final destinationthe posh Hotel BoulderadoI'm tardy. Minutes later, at the Boulderado's conference center, Angela Pope of FDA is schooling own-label distributors on current good manufacturing practices (cGMPs), or as one supplement executive sporting a bow tie put it bluntly later that afternoon, a "Great Mountain of Paperwork."

Pope, a Consumer Safety Officer with FDA's Division of Dietary Safety Programs, appears to be hammering home what lawyers have been highlighting for months: supplement firms slapping their labels on productsbut outsourcing their manufacturinghave a duty to comply with cGMPs.

These firms must be able to produce cGMP documentation in a timely manner upon FDA's request. That a contract manufacturer doesn't share such data with its customer is inexcusable.

"How much control do I have with bringing this product to market?" Pope urges own-label distributors to consider.

Bottom line: "You have to know what is actually being done at the contract facility, which is in effect an extension of your own firm," she wrote in a presentation that accompanied her lecture.

Loren Israelsen, president of the United Natural Products Alliance (UNPA), soberly reminds the audience that many supplement firms are violating cGMPs even though the rules have been in effect since 2007.

He contends about a third of firms are doing a stellar job complying with the regs while another third are struggling. The rest of the industry is either not capable, uninterested, or plain clueless."

We should be helping that bottom third go find something else to do," he proclaims to much fanfare (i.e., laughter from the crowd).  

The violations, Israelsen points out, are basic failures. None of this is really news to the industry. FDA officials have bemoaned lack of compliance with cGMPs for years. And our publication reported four months ago that 70 percent of firms have received Form 483s over the past three fiscal years. As readers are well aware, FDA issues a Form 483 if an inspector has found problem areas with cGMPs during an inspection such as failure to have adequate written documentation or test ingredients.

Firms that undergo an FDA inspection without receiving a Form 483 are rewarded with absolutely nothing, Israelsen makes clear. He thinks thats unfair. FDA should put something in writing for these firms so they can distinguish themselves, he argues. (I'm guessing Dr. Daniel Fabricant, FDA's top dietary supplement official, and his underlings don't believe the industry deserves a gold star for meeting its legal obligations).   

Part 2 will run Friday afternoon.