TBAR has technically been open since June, but is only now officially opening - offering services for analytical method development, validation and contract analysis to raw material suppliers, finished product manufacturers and government agencies.
Demand for analytical testing services is on the rise in the dietary supplement industry due to changes in the regulatory scene, according to TBAR president and technical director Mark Roman.
"There's a lot of opportunities in the dietary supplements industry with the passing of the GMPs - where quality testing is a major factor," Roman told NutraIngredients-USA.
GMPs have shifted pressure from manufacturers to raw material suppliers and are making room for new business opportunities for companies or organizations helping others upgrade or comply. A statute of the 1994 Dietary Supplements Health and Education Act (DSHEA), GMP legislation will provide standards specific to this industry for inspectors to check for purity, safety and legality in manufacturing.
The interim GMP rule is effective August 24, 2007 and has a one- to three-year phase in period depending on the size of companies.
Companies with more than 500 employees will have until June 2008 to comply, while those companies with less than 500 employees have until June 2009 to comply. Those with fewer than 20 employees have until June 2010 to meet the demands of the regulation.
In launching TBAR, Roman is bringing with him years of experience in the field of analytical testing services. He was a long-standing contributor to AOAC International, USP and INA method development.
With a heavy focus on analytical test method validation, TBAR's capabilities include HPLC with UV, PDA, fluorescence, and evaporative light scattering detection, as well as GC with flame ionization detection. The lab also has a DEA Schedule IV license for handling controlled substances and a blank purchase agreement (BPA) with the National Institutes of Health (NIH).
The US Food & Drug Administration (FDA) does not audit laboratories unless they are testing pharmaceuticals, nor are methods for testing dietary supplements required to be standardized.
As such, some labs and their dietary supplement clients can cut corners, not ensuring the method used to test a product or ingredient is the appropriate one.
"Inaccurate or meaningless results are worse than no results at all," said Roman.
With the passing of the dietary supplement GMPs this past summer, manufacturers are now required to prove the identity, purity, and strength of their ingredients and finished products, and the FDA will require the use of scientifically valid methods.
"Validating your analytical test method is crucial in showing that the method is fit for purpose," said Roman.
As for recent contamination scandals relating to food products, Roman said this is not driving the test market for dietary supplements as much as one might think.
"Hopefully in the future all manufacturers will be testing for contamination," said Roman. "But most have focussed on what supplements do contain and not on what they shouldn't."
Based in Safety Harbor, Florida, TBAR is a privately held company based.
