AM Todd Botanicals provides GMP support for botanical extracts

07-Jul-2009 - Last updated on 08-Jul-2009 at 12:37 GMT

Ingredient firm AM Todd Botanicals has applied a voluntary industry standardization tool to some of its key botanical extracts, in an effort to help supplement manufacturers with GMP compliance.

The company has selected its bilberry, black cohosh, gingko and ginseng extracts as the first ingredients to meet the SIDI protocol.

SIDI, or the Standardized Information on Dietary Ingredients protocol, was set up by trade groups CRN, NPA, AHPA and CHPA as a means to assist with dietary supplement GMP compliance by providing ingredient qualification.

“It is not by coincidence that our first four SIDI dossiers target botanical extracts that are widely recognized in industry as being prone to economically motivated adulteration, or spiking – ingredients likely to be on an auditors radar screen,” said Todd Norton, chief operations officer for AM Todd Botanicals.

“Traceability and transparency are going to be paramount for manufacturers in addressing product situations like these.”

As part of its effort, the company is consolidating the four ingredients under one line, termed Defined. This now includes: Bilberry 25 percent Defined; Black Cohosh 2.5 percent Defined; Ginkgo 24/6 Defined; and Panax Ginseng 5 percent Defined.

Product specific SIDI dossiers will contain information on each of these ingredients.

SIDI

SIDI serves as a tool for ingredient qualification by:

· Integrating information on raw dietary ingredient sourcing into a voluntary, standardized system – reducing or eliminating the need for questionnaires

· Improving the audit process by providing information in a standardized format for auditors to review in advance

· Educating smaller, less experienced firms on regulations, requirements, and industry best practices

Ingredient firms stepping up

The new supplement GMP regulation, which is being phased in over a period of three years, is designed to assure the quality and traceability of dietary supplement products.

So far, all supplement manufacturers with over 20 employees are required to meet these new rules. As of next June, the regulation will be extended to apply to the smaller players too.

Although ingredient firms are not required by law to be GMP compliant, supplement firms have started to require it of their suppliers in order to lighten their own burden.

According to AM Todd Botanicals:“At the end of the day, whether statutorily obligated or not, we (suppliers) are all in this GMP environment together.”

“We believe manufacturers will begin taking a greater interest in their supply chain beyond just price point and a weak C of A. They have to. (…) With the introduction of our Defined brand, anchored with SIDI documentation, we are taking a more visible profile in positioning ourselves as being part of this industry and manufacturer-supportive supplier group,” said Norton.