The Standardized Information on Dietary Ingredients working group loses the American Herbal Products and the Natural Products associations as members, while three other trade groups continue developing best practices for qualifying supplement ingredient suppliers.

Stakeholders emphasized the schism did not stem from disagreement on the value of the working group's cross-cutting initiative, but the split underscores the difficulty in unifying the dietary supplement industry.

The Council for Responsible Nutrition's Andrew Shao discussed challenges to SIDI's efforts to help firms comply with qualifying suppliers under FDA's final rule for supplement good manufacturing practices.

The industry remains "a little bit behind" on GMP compliance and "the sense of urgency is not there yet," Shao said Oct. 14 at the Consumer Healthcare Products Association's Manufacturing Controls Seminar in New Brunswick, N.J.

CRN, CHPA and the United Natural Products Alliance remain active in the SIDI working group with AHPA and NPA leaving.

"It's down to three. So that gives you an idea of the sense of urgency that some folks have and other folks don't have around this initiative," added Shao, CRN's senior VP of scientific & regulatory affairs.

Shao's comments came a day after John Gay and Steve Mister, the respective heads of NPA and CRN, spoke on the need for industry unity at Natural Products Expo East in Boston (¹ Also see "Supplement Industry Needs Unity To Improve Advocacy Efforts - NPA's Gay" - Pink Sheet, 18 October, 2010.).

The trade groups established the SIDI coalition in 2006 to standardize the exchange of information between supplement manufacturers and suppliers, with the goal of eliminating lengthy and repetitive questionnaires for determining ingredient source and quality (² Also see "SIDI Program Will Standardize Ingredient Protocol – Supplement Trade Groups" - Pink Sheet, 23 October, 2006.).

Breaking Out Botanicals

In an e-mail, AHPA President Michael McGuffin explained the group's departure from SIDI, saying the voluntary guidelines in development likely will benefit many supplement companies but appear too broad for many botanicals manufacturers.

"In reviewing the diverse needs of AHPA's members ... we need to shift our staff resources to development of guidance and standards that are more specific to the herbal products industry and to both small and large companies," McGuffin wrote.

AHPA's exit spurred NPA to break with SIDI. The working group would lack industry-wide perspective without the herbal products organization, NPA executive Daniel Fabricant explained.

AHPA's membership is "certainly a broad sector of the industry, an important sector," Fabricant said.

At the CHPA seminar, Shao said the SIDI supplier qualification guidelines in development will feature separate sections addressing botanical ingredients, which typically are more complex than traditional vitamins and minerals.

The overall document also will include the certificate of analysis guideline published in May (³ Also see "SIDI Group Expects "Passport" To Business Growth With Standardized CofA" - Pink Sheet, 14 June, 2010.).

Shao said the working group potentially could have a draft finished by year's end, though 2011 looks more likely. The group also plans to launch a centralized SIDI website in the near future.

Shared Audits "Light Years Away"

Shao said he hopes the SIDI guidelines will help fill in the blanks regarding expectations for supplier qualification left by FDA in the GMP final rule.

However, while the agency expects supplement firms to be creative in puzzling out how to audit their suppliers, Shao does not believe industry is yet up to the task.

A shared audit system, similar to the Rx-360 consortium developed by pharmaceutical manufacturers, is "light years away" for the supplement industry, Shao said.

He added that he would like to see FDA's Center for Food Safety and Applied Nutrition "getting in the industry's face" with an ultimatum for addressing adulterated supplement products, or else stakeholders will continue to lack a sense of urgency in proactively applying GMPs.

- Dan Schiff ( ⁴ d.schiff@elsevier.com )

SIDI Group Split Reflects Supplement Industry Disparate Interests

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