New regulations implemented this year in the US mean that all supplement manufacturers need to comply with stringent Good Manufacturing Practices (GMPs) in order to ensure the safety and efficacy of their products.
Supplement ingredient suppliers are also making moves to have their facilities GMP certified, in a bid to facilitate their customers and ensure their own products come with the extra quality seal that will differentiate them in a competitive market.
Cognis Nutrition and Health today announced that it has received GMP registration from the independent testing group NSF International for its Covitol natural vitamin E, Vegapure phytosterols and Tonalin conjugated linoleic acid (CLA) ingredients.
According to the firm, the certification provides “an invaluable benefit” for its dietary supplement customers by facilitating the GMP compliance process for them.
“Cognis has taken the initiative to complete this rigorous process to ultimately make GMP conformance easier for dietary supplement manufacturers by making sure we’re in compliance so they are as well,” said David Hessler, quality assurance leader, Cognis Nutrition & Health.
“As a result of our affirmed compliance, this certification will help our customers eliminate the need for costly and time-consuming plant audits.”
In order to issue the compliance registration, NSF conducted a plant audit and will continue to conduct periodic audits of the firm’s facilities to ensure ongoing compliance.
NSF told NutraIngredients-USA.com that the follow-up to its certification process involves two facility audits per year – the first lasting four to five days, while the second monitoring audit lasts one day.
According to the new GMP regulations, supplement manufacturers need to qualify the ingredients they use, which involves testing to ensure purity, strength and composition, as well as audits of the ingredient supplier’s facilities.
This either means that companies need to send Quality Assurance (QA) personnel to the facilities to conduct these audits, or the ingredients suppliers can do the work for them by inviting an accredited third party to conduct an audit, explained Ed Wyszumiala, general manager of NSF’s dietary supplement programs.
This can prove costly for supplement manufacturers, who may need to fork out $4-5,000 to audit the facility of a domestic supplier – including travel costs and employee time.
Ingredients suppliers, in turn, would be faced with an influx of QA personnel coming to inspect their facilities.
According to Wyszumiala, a third party audit saves time and money for both ingredient suppliers and supplement manufacturers.
Growth in certification
A statute of the 1994 Dietary Supplements Health and Education Act (DSHEA), GMP legislation has been the missing link in governance of the dietary supplement industry. The legislation is set to provide standards specific to the dietary supplements industry for inspectors to check for purity, safety and legality in manufacturing.
The rule applies to companies - domestic and foreign alike - that manufacture, package, label, store and distribute dietary supplements in the US.
The new GMP regulations were introduced in June last year, and are being implemented in three stages.
By June 25 this year, manufacturers with more than 500 employers had to ensure that their operations are up to GMP standards. Manufacturers with between 20 to 500 employers will have an additional year to comply with the regulations, while a final deadline of 2010 is set for companies with less than 20 workers.
NSF, which is an independent, accredited testing group, has so far issued 92 GMP compliance registrations. Out of these, some 17 are for ingredient suppliers, while 75 are for supplement manufacturers. For a full list, click here.
The group said the number of companies it has certified has already almost doubled since 2006, and looks set to continue growing.
“A lot of manufacturers have spent a lot of time absorbing what they need to do to comply with GMPs. What we’re seeing now is companies making the moves to have their facilities audited,” said Wyszumiala.