Small to medium enterprises (SMEs – less than 20 staff) were given two years longer to comply with GMPs than the biggest dietary supplements manufacturers, but it is feared many have yet to get their systems and documentation in order and would struggle if FDA inspectors arrived at their door.
“It is the culmination of a long road as far as getting FDA to issue and implement the regulation and we are very pleased to be at this point,” said John Gay, the executive director and chief executive officer of the Natural Products Association.
“The bigger, more sophisticated companies should always have gone first as they were the most able and ready to comply but there is concern that there are still many smaller players that are not in compliance.”
A straw poll conducted by this publication at the recent SupplySideEast trade show in New Jersey found many manufacturers aware of their GMP obligations but unsure if they would be able to meet this week’s deadline.
Gay said many smaller players remained unaware of their GMP obligations while others were implementing changes, now under the threat that FDA can perform inspections and take actions against those that are not in compliance.
“There may be some initial discomfort as companies may fail inspections and word gets out, but this regulation is vital given the threat by those who claim that we are an unregulated industry. It is the best response.”
He noted the NPA had been running GMP programs for 10 years and recently hosted a GMP seminar at an event in Las Vegas. Other industry groups offer similar services.
Contract manufacturer’s like New York-based Vitakem Nutraceutical that are commonly utilised by smaller manufacturers, are advising their clients about the increased costs of meeting the new rules.
Companies are not being helped by the lack of Food and Drug Administration (FDA) guidance to assist SMEs – promised in 2008 for 2009 but which is yet to see the light of day.
An FDA spokesperson told NutraIngredients-USA.com today: “FDA is developing guidance addressing information that the agency recommends be included in a 75-day pre-marketing notification. The guidance is being developed and reviewed internally. At this time, we do not have a projected publication date.”
That aside, there remain those that remain skeptical of the ability of GMPs to deliver on their quality promise across the dietary supplements industry.
In regard to herbal supplements, Frank Jaksch, the president and chief executive officer of Californian-based botanicals reference provider, Chromadex, said the rules remained inadequate.
“The regulation says ‘scientifically valid methods’ must be used but what does that mean?” Jaksch told this publication recently. “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.”
He added: “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?”
FDA inspections (483s) so fare have highlighted problems such as:
- Insect and rodent activity in storage areas
- Insufficient documentation of procedures and failure to document procedural change
- Lack of batch data
- Lack of corrective action plans if GMP specifications are not met
- Formulations that do not meet label claims
- Lack of identity testing
- Inadequate quality control (QC) procedures and QC staff training
- Inappropriate sample collecting methods
- Non-documented procedural change
- Failure to qualify vendors