Dietary supplement ingredient suppliers should approach standardizing information in their certificates of analysis as an investment that will pay off in business growth, say industry stakeholders who wrote a CofA guideline.

Getting on the same page about ingredient CofAs with manufacturers can take some work because it requires communication and understanding, but the result should be clear - getting more customers, according to Amy Caplette of dietary supplement manufacturer and direct-seller Nutrilite.

"The CofA is much like a passport," said Caplette, a group leader of quality assurance for the Amway Global subsidiary.

"The format of passports around the world is different, but the content of information is very much standardized," she added. "You can use this passport, you can use a CofA, to get into a country, to get into a manufacturer's facility."

Given that some foreign markets, notably in Europe and Japan, already regulate supplements as pharmaceutical-grade health products, meeting more rigorous CofA standards certainly can open doors overseas for suppliers.

Caplette worked with other industry stakeholders and trade associations on the CofA ¹ Guideline the Joint Standardized Information on Dietary Supplement Ingredients Working Group released in May.

The guidance intends to standardize the content and format of supplier CofAs. A template in the guidance specifies general information to include, along with the results of analytical testing on an ingredient lot or batch, and other information, such as country of origin, if applicable.

Additionally, the guidance encourages consistent communication of meaningful dates associated with an ingredient, lays out criteria to consider when accepting an electronic signature and advises how to qualify a distributor's CofA.

"It is hoped that, with use of this guideline as a foundation for mutual understanding, greater assurance of regulatory compliance will be achieved for components used in the manufacture of dietary supplement products," the SIDI Working Group says in the guidance.

Finished-product manufacturers have their own reasons for wanting suppliers' CofA uniformity. Some suppliers may carry greater levels of risk than others or may hew to different CofA standards - 100 suppliers may mean 100 different CofA formats with varying information.

"It's probably quite a job to try to figure it all out," said Andrew Shao, senior VP of scientific and regulatory affairs for the Council for Responsible Nutrition, at Natural Products Expo West in March.

Although the SIDI program was not developed with good manufacturing practices in mind, its guidelines can help "bridge this gap between the supplement GMPs and food GMPs," which cover ingredient suppliers and are considered less rigorous, Shao said at the conference.

The failure of manufacturers to qualify suppliers before accepting their CofAs continues to dog the supplement industry as FDA ramps up GMP inspections of facilities (² Also see "FDA's Reynolds Marks Top GMP Trouble Spots As Deadline Looms" - Pink Sheet, 10 May, 2010.).

Incentives For Standardization

Caplette said creating incentives for suppliers to follow CofA standards is crucial, and Amway requires suppliers to adhere to the guidance a requirement for its suppliers. Those that comply will get more of the firm's business.

"We're in the process of developing a timeline, a communication plan and a grace period in which we would notify our suppliers, provide them education on the reason why, the benefits and how to comply," she said.

Many suppliers already realize their adherence to standardized CofAs and other GMP processes is not optional, said Scott Rosenbush of ingredient distributor P.L. Thomas.

"I don't view it as really being a choice," said Rosenbush, botanicals business manager for the Morristown, N.J., firm.

"The guidance document is built around the [GMPs] promulgated by FDA. We didn't really try to go beyond the regulatory requirements. So from a strict interpretation, I think you could say the information is required, sooner or later. And from our perspective, sooner, not later."

Standardized CofAs also benefit the OTC drug industry, according to Reddy Kal of private labeler Aaron Industries and a contributor to the guidance.

"It gives at least some kind of a pathway when we have to handle the critical situations with regard to the product," such as customer complaints, said Kal, VP of quality and regulatory affairs for the Clinton, S.C.-based firm.

Kal added he would like FDA to publicize the SIDI guidance, as a means of raising industry awareness and encouraging greater compliance.

Carl Reynolds and Brad Williams, dietary supplement office executives at FDA's Center for Food Safety and Applied Nutrition, observed the process of formulating the guidance without directly influencing the content. Shao said the agency is "allowed to provide constructive input" on the guidances in progress.

The Art Of Supplier Qualification

The SIDI Working Group currently is developing a guidance on how to qualify supplement ingredient suppliers - a source of consternation since FDA's GMP final rule does not specify what exactly qualification entails (³ Also see "GMP Supplier Qualification Appears More Viable Route Than Testing" - Pink Sheet, 8 February, 2010.).

Caplette said the qualification guidance likely will be published in 2011.

Sharing information from supplier audits, as the pharmaceutical industry has begun doing through its Rx-360 consortium, may prove an irresistible strategy for the supplement industry to adopt, she added (⁴ Also see "Fight Adulteration With Supplier Qualification Guide, Supplement Industry Says" - Pink Sheet, 17 August, 2009.).

"Logistically and economically, that's probably the way the future's going to look, where there is shared audit information or shared resources for one supplier to different manufacturers," Caplette said.

- Dan Schiff ( ⁵ d.schiff@elsevier.com )

SIDI Group Expects "Passport" To Business Growth With Standardized CofA

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