GLS tailors toxicology to supplements
the dietary supplements industry pending Good Manufacturing
Practice regulations.
GLS, formerly known as the Toxicology Group, is now offering testing for companies wanting to conform to GMP guidelines.
"Determining safety for human use is critical," said new GLS general manager Dr. Aline Lindbeck, of dietary supplements, "It has not been tightly regulated in the past, but it will be in the future."
The company's name change and move into testing for dietary supplements points to satisfying a widely called for need in the industry for greater self-regulation and thus credibility. However, the industry does not want to go in the direction of drugs, which require lengthy and costly pre-market approval.
Lindbeck's background is in the pharmaceutical industry, which she told NutraIngredients-USA.com will help her take GLS in new directions as the dietary supplement industry will rely increasingly on toxicology.
GMPs and New Dietary Ingredients (NDIs) are two of the four areas GLS is concentrating on according to Lindbeck - the others focus on stability and clinical studies.
GLS is now offering its services to test methods for GMP regulation, as well as for notifying the US Food & Drug Administration about the safety of new ingredients.
"GLS works with companies to ensure that products are compliant with current and future regulations," said Lindbeck.
But what exactly constitute current and future regulations is unclear to many in the industry. Dietary supplement manufacturers have frequently complained to the FDA because the 1994 Dietary Supplements Health and Education Act (DSHEA) has still not been fully implemented.
Both part of DSHEA, GMP regulations are still on the drawing board and NDI notification requirements are misunderstood in the industry.
GMP guidelines are still in draft form and industry insiders predict the final version will be implemented next year, but this remains speculative.
NDI notification is required for all new ingredients coming to market since the act, but the industry has complained that the process is hampered and categorical definitions of ingredients are vague.
