The forum, titled ‘What Does FDA Really Expect from Us?’ will be held in Boulder, Colo. On Sept. 13 and 14. It is put on by a Broomfield, Colo.-based regulatory consultancy called FDA Compliance Group.
The principals of the group, Shelly Maifarth and Martina LaGrange, are uniquely qualified to help companies sort through their compliance issues, as each has had lengthy careers as FDA inspectors.
The need for better understanding of the regulations and how to comply with them is pressing, at least from FDA’s point of view. In April, at a GMP event held by the Natural Products Association, FDA’s director of the Division of Dietary Supplement Programs, Dan Fabricant, PhD, said that although progress has been made he still was “somewhat aghast at the degree of noncompliance.”
“We’re seeing some of the same mistakes from warning letter to warning letter and that’s concerning. Whether it’s failure to prepare batch records, problems with specifications. There’s failures of adequate quality control.”
The forum will address issues such as what to expect during an inspection, when legal representation might be called for, and will delve into detail on issues such as master and batch record-keeping and common problems found during inspections.
Well-known experts in lineup
The forum includes a lineup of well-know industry experts including:
- Loren Israelsen, executive director of the United Natural Products Alliance, who will speak on recent political developments relevant to the dietary supplement industry.
- James Neal-Kababick, founder and executive director of Flora Research Laboratories, who will discuss testing issues.
- Nancy Schmidt, compliance officer in the Denver FDA office, who will lay out the regulation of the industry from FDA’s point of view.
- Jim and Justin Prochnow, shareholders with the Denver-based law firm Greenberg Traurig LLP, who will talk about how to know when it’s time to lawyer up. (Greenberg Traurig is a sponsor of the event.)
Also included on the agenda is a panel discussion in which firms that have gone through the inspection process will share their experiences with attendees.
Industry performance lacking
“We were noticing in the dietary supplement industry when FDA was coming out to do these GMP inspections that industry really was getting slammed. They really didn’t have a good understanding of what FDA wanted when they came out to make GMP inspections. They were getting 483s (warning letters) with all sorts of basic things in them,” Maifarth told NutraIngredients-USA.
Since the dietary supplement GMPs came out a lot of manufacturers just things the way they had been doing for the last 20 years, she said.
“So Martina and I were noticing this terrible trend. One of the main things we wanted in this forum was we wanted to hear from FDA itself what they expected when they come out to make an inspection, and that’s why we have FDA speaking in the very beginning.”
Nancy Schmidt, the FDA official who along with Denver FDA district public affairs specialist Devin Koontz will speak at the conference, works as a compliance officer, which is the level at the agency where decisions are made on possible enforcement actions based on what inspectors have observed in the field.
Lagrange said it is hoped that the forum will blossom into a platform for the exchange of information within industry and with FDA. It’s a model that, while uncommon in the dietary supplement world, has proved beneficial in other regulated industries.
“We’re hoping that this forum here in Colorado can become an annual meeting for dietary supplement companies to be able to learn together. There aren’t a lot of those types of organizations in the United States right now. There are a lot of those types of organizations for medial devices, pharma, blood banking, etc.,” said LaGrange.