DSHEA turns 15

The devil in GMP details

23-Dec-2009 - Last updated on 24-Dec-2009 at 09:16 GMT

In the fifth and final installment of this DSHEA special, Frank Jaksch, the president and chief executive officer of Californian-based botanicals reference provider, Chromadex, outlines why he thinks current GMP inspection methodologies are unlikely to detect quality problems – at least in the botanicals sector.

“The regulation says ‘scientifically valid methods’ must be used but what does that mean?” Jaksch asks rhetorically. “We acknowledge the FDA needed to get something done in regard to this regulation but a lot of refining is needed if it is to meet its remit. At the moment there is great potential that the regulation validates poor quality.”

Jaksch believes there needs to be an incorporation of more fit-for-purpose techniques that may be peculiar to botanicals, or particular forms of botanicals. “But as it stands, FDA inspectors don’t have the knowledge to dig into the detail that is required. I am not confident they have the tools to detect the window dressing that goes on to conceal problems.”

Aside from any regulatory refining that might need to occur, Jaksch is a self-regulation advocate. “GMPs won’t fix quality problems. Industry must self-regulate on top of GMP rules to fill the gaps left by the FDA. If there was better self-regulation would we need GMPs in the first place?”

EMA

He says industry groups have not done enough in this direction and wonders why more is not being done to combat problems such as economically motivated adulteration (EMA), apparently created by a minor fringe of a largely well-functioning and well-meaning industry.

“If it is so small a problem why can we not get a grip on it? EMA is one of the first things that needs to be fixed and that means allocating budgets to get it fixed and putting the paperwork efforts in,” Jaksch says.

That said, as industry veteran, Loren Israelsen, noted in another article in this series, quality and adulteration are not altogether entwined issues, indeed they are quite different although often tarred with the same brush as has been happening frequently with steroid contamination of sports supplements.

But both need tackling by industry with or without official GMP support.

He observes that the questions such issues bring to the whole industry also provide fuel for those who would like to see the Dietary Supplements and Health Education Act (DSHEA) annulled. Again he wonders if industry is doing enough to defend its quarter.

“The fact is DSHEA is under severe attack and is in severe danger unless industry can overcome its fragmentation and do something about it.”