Fight Adulteration With Supplier Qualification Guide, Supplement Industry Says

The Council for Responsible Nutrition calls on FDA to work with industry on a tool that will help thwart economically motivated adulteration - ingredient supplier qualification guidelines.

Andrew Shao, CRN's VP of scientific and regulatory affairs, said industry is working on developing guideline documents it plans to finish in six to eight months.

Since FDA published the supplement good manufacturing practices final rule in 2007, the industry has asked for additional guidance on qualifying ingredient suppliers.

The rule gives discretion to supplement firms to establish their own systems for qualifying vendors, saying that manufacturers must "establish the reliability" of suppliers' certificates of analysis "through confirmation of the supplier's tests or examinations" (¹ (Also see "Supplement GMPs Leave Vendor Qualification Specs In Manufacturers’ Hands" - Pink Sheet, 3 Dec, 2007.)).

CRN and other industry stakeholders submitted comments on preventing EMA after FDA opened a docket in April and conducted a May 1 public meeting (² (Also see "Supplement Ingredient Supply Trends Can Shed Light On Adulteration" - Pink Sheet, 11 May, 2009.)).

In comments to FDA, Shao said EMA is a growing issue for consumer products for multiple reasons. It is caused by "the combination of key ingredients or raw materials that are in relatively high demand but relatively low supply" and "the inappropriate reliance (intentional or not) on outdated or nonspecific test methods for identity" and lack of adequate enforcement against the bad actors, he said in an e-mail.

Shao stressed throughout CRN's comments that supplement firms need guidance on qualifying suppliers to avoid adulteration. He said with ingredient suppliers not subject to supplement GMPs, manufacturers are vulnerable to adulteration by suppliers or in the products they provide.

While the GMPs require firms to "qualify the supplier" using the supplier's certificate of analysis, the rule does not explain how, CRN says.

"Whether the decision to exempt ingredient suppliers from dietary supplement GMPs in favor of a lesser standard serves as a primary driving factor behind EMA of ingredients is unclear at this time."

The trade group notes "inadequate supplier qualification, especially among the smaller and less experienced dietary supplement manufacturers" and suppliers not being subject to GMPs "can be a contributor to sustaining a climate of EMA."

"Some of the areas for which guidelines are in need include, how to audit suppliers, setting up quality agreements with suppliers, standardization of what information should appear" on a certificate of analysis and "how to verify the information on a CofA," Shao said.

Natural Products Association acting Executive Director Daniel Fabricant said FDA should be involved with trade groups' supplier qualification guidelines, but the industry needs to be proactive and cannot wait for the agency.

"In a lot of ways, [NPA] has come up with our own guidance internally on at least how the GMP-compliant firms should qualify their suppliers," Fabricant said.

Shao said CRN has "been in close contact with FDA" on its ideas and that the agency is "very supportive of this kind of initiative."

SIDI Working Group Developing Guidelines

Shao said currently CRN is working through the Standardized Information on Dietary Ingredients Working Group to develop guidelines.

CRN, NPA, the American Herbal Products Association and the Consumer Healthcare Products Association set up the SIDI protocol in 2006 to increase information manufacturers gather on suppliers (³ (Also see "SIDI Program Will Standardize Ingredient Protocol – Supplement Trade Groups" - Pink Sheet, 23 Oct, 2006.)).

Shao said the working group, which includes trade group and industry representatives, "mapped out efforts to develop new guideline documents to assist" with qualification when it met Aug. 7 in Washington.

He said the documents should be ready within a year and the goal is for them to "serve as useful tools for the industry" and "as the basis of an industry-sponsored ingredient supplier qualification program," which is a longer-term goal. That system would be "a shared audit system," so firms have supply chain audit information available to them.

Shao said there is precedent for a shared audit program - the pharmaceutical industry's Rx-360 Consortium, which helps firms qualify suppliers.

He said the SIDI Working Group has not formally committed to moving forward as there are "administrative and logistical issues to work through first," and FDA is not "formally involved," but communication lines are open and the agency will be kept in the know.

New Adulterants, New Challenges

In its comments, AHPA suggests FDA develop resources to better track ingredients subject to adulteration, which might include FDA publishing examples of EMA and how it was detected.

Shao also discussed the limitations of relying only on testing, pointing out new challenges plague consumer product industries every day. For instance, methods needed to test for certain adulterants may not be available for use.

"With the efforts of perpetrators evolving so rapidly, consumer products companies are frequently faced with new, previously unknown adulterants," he said in CRN's comments.

"Furthermore, one cannot test for adulterants that one does not know exist," Shao added, pointing out that proper qualification of suppliers is a solution for ensuring the quality of ingredients.

Food Safety Bills Show Qualification Need

Shao also said in CRN's comments that while food safety legislation pending in Congress focuses on conventional food, supplements will likely be impacted with "substantial additional regulatory burdens."

He said the legislation is another indication of the need for supplier qualification guidance. "Provisions for third-party certification, fast-track import status and country-of-origin [labeling] all point to the need to understand and maintain integrity of the supply chain" and firms' abilities to trace back "is entirely dependent on how well users qualify their raw material vendors."

The House June 30 passed the Food Safety Enhancement Act, H.R. 2749, which has not yet been taken up by the Senate. Sen. Dick Durbin's Food Safety Modernization Act, S. 510, is a candidate for the Senate's food safety reform bill, but remains in the Health, Education, Labor and Pensions Committee (⁴ (Also see "House Passes Food Safety Bill That May Not Be Appetizing To Senate" - Pink Sheet, 3 Aug, 2009.)).

Increased Inspections Would Help With EMA

Fabricant said in an interview the most important solution to preventing adulteration is increased enforcement. "The biggest reason for [EMA] is lack of enforcement," he said. "We want to see the agency do more," though "they have definitely done more in the past few months."

"That, more than anything, is what I think stops folks from" engaging in EMA, he added.

In an Aug. 5 release, AHPA General Counsel Tony Young says FDA should be prepared to increase EMA enforcement. "Now that FDA has held its public meeting and received stakeholder comment, we should expect to see the law enforced as it was always intended to be enforced," Young said.

Shao also suggests that instead of FDA asking industry for instances of EMA through public comment, the agency should create a system for gathering information anonymously. The information collected in such as system should not be made public for reasons including that disclosure "would serve as a disincentive for industry" to provide information, he added.

AHPA Wants Clearer Definition Of EMA

In its Aug. 3 comments, AHPA says FDA should clarify the proposed EMA definition by adding: "EMA addresses products that are marketed as dietary supplements but that contain undeclared drug ingredients."

At FDA's May 1 meeting, AHPA recommended expanding the definition to include "the addition or substitution of substances intended to make an adulterated material conform to existing identity and other quality tests of the genuine article." AHPA also said it wants the definition to note the addition or substitution of substances for the purpose of "a physiological effect that is dependent upon the added or substituted ingredient."

- Katie Stevenson ( ⁵ [email protected] )