“I think there are a lot of companies that still don’t really understand the full implications of the GMP regulations,” Crouch told NutraIngredients-USA. “There have been more than 550 citations on the lack of specifications alone since the beginning of 2013 so clearly this is an issue.”
Crouch, who was recently promoted to EAS’ senior consultant after several years with the firm, said that the failures she sees continue to be of the most basic sort.
“You see situations in which companies don’t have specifications of any sort. Or they don’t have proof that their specifications have been met before they release products. Or if they do have specifications, those specifications themselves are not up to par,” she said.
When the GMPs first started to be implemented in 2008, there was some push-back in the industry concerning how expensive and labyrinthine the rules would be in practice, and how they might place a particular burden on the smallest companies, those with 50 or fewer employees, which were supposed to be in compliance starting in 2010. Crouch said she’s sensitive to those concerns, but believes its just common good sense and good business practice to be able to know and to be able to prove that you can make a product the same way every time.
Quality challenge
Nevertheless, it can be costly implementing the required quality control procedures, especially in smaller companies that may have had a more seat-of-the-pants approach in the past. Some of these companies that have had reputations for quality within the industry have received warning letters because they couldn’t prove the reproducibility or robustness of that quality in a way that satisfied regulators. Trying to help companies get that done without breaking the bank is where Crouch comes in.
“Establishing that quality backbone is very challenging, but it can be done. It is costly so you have to figure out how to do it wisely,” she said.
“I talk to companies about what tests they will need to do, and what kind of tests they might be able to do in house. The major of dietary supplement companies tend to be small so they don’t typically have a large pool of scientific expertise in house. They often have to go out to a contract lab and do the testing with them. We can help them choose the right lab and then know what questions to ask so that they can work appropriately with them. Even if you don’t have a lot of expertise, you are still ultimately responsible for what goes on at the lab so you have to have oversight,” Croch said.
Enforcement gap
Crouch said another problem that appears over and over are rogue companies that seem to flout the regulations right from the get go. The open marketplace fostered by DSHEA coupled with a lumbering enforcement style at FDA has in her opinion created a climate in which these companies have too much room to maneuver. When reviewing the enforcement history in those small percentage of cases that proceed to permanent injunction status, it seems clear that these companies had little intent to comply in the first place and were using the flex built into the enforcement picture to their advantage.
“I think the FDA can do a better job in dealing with some of these companies. I think they have been very slow to react. I was in the industry before the regulations passed and it seemed like we waited forever,” she said.
“Now we have them and you see situations in which it can take FDA 10 or 12 months to issue a warning letter. A lot can happen in a company in a year. And then you see cases where the FDA comes back and issues a new set of 483s and a new warning letter on the same violations. In those cases where they come back and they see the same problems like they did before, I’d like to see them issue an immediate warning letter like they do when they review web sites,” Crouch said.
Crouch will speak on the importance of having compliant specifications at the Rocky Mountain Dietary Supplement Forum on Sept. 24 in Boulder, CO. For more information on the meeting, click here.