Supplement Firms Confounded By Identity Testing Waiver Process

FDA says it has not received any petitions to request an exemption from the 100% supplement ingredient identity testing requirement. Food and drug attorneys say the hassle of preparing a petition for a waiver outweighs the potential benefits

The hurdles that dietary supplement firms must clear to obtain waivers from the 100% ingredient identity testing requirement in GMPs are discouraging firms from applying, despite the incentive of reduced testing costs, according to experts.

FDA says that no supplement manufacturers have applied for the waivers. While the waivers are optional, the agency expected firms would take advantage of the chance to cut their good manufacturing practices costs.

But food and drug attorneys contend the application process is mired in complexity and unanswered questions, saying the agency has not provided sufficient information on the standards by which petitions will be evaluated and how the process will be conducted once one is submitted.

Some firms continue 100% identity testing and have not considered asking for a waiver, while others do so because they are not confident that a waiver request will succeed.

Meanwhile, FDA GMP inspections have shown that some firms are not complying with the requirement (Also see "Identity Overlooked As Supplement Firms Bypass Basic GMP Testing" - Pink Sheet, 15 Apr, 2013.).

Attorney Scott Bass, a partner and global life sciences practice head at Sidley Austin LLP in New York and Washington, said firms need less expensive alternatives to stay in business.

“Sometimes it’s not just savings. Sometimes it’s they can’t [afford to] do 100% identity testing. In that sense it’s more than savings, it’s survival,” Bass said.

“There aren’t many systems that would guarantee the same rigor as 100% identity testing.” – Daniel Fabricant, FDA Division of Dietary Supplement Programs director

In a Nov. 14 Federal Register request for comment on its estimate of the supplement industry’s annual regulatory burden, FDA said that since the GMP final rule became effective for all supplement firms in June 2010, the agency has not received any petitions to request an exemption from 100% identity testing of dietary ingredients.

FDA submitted the estimate to the Office of Budget and Management the same day. OMB relies on FDA’s burden estimates for regulated industries in identifying firms’ likely costs for complying with agency regulations.

The agency says it expects “one or fewer petitions will be submitted annually” and it estimates eight hours are needed “to prepare the factual and legal information necessary to support a petition for exemption and to prepare the petition.”

The identity testing provision of the GMP final rule applies to manufacturers that purchase ingredients from suppliers and that make their own ingredients. It requires a firm to perform its own examination to verify the identity of each batch of dietary ingredient supplies prior to use in manufacturing.

The provision allows firms to determine what tests they use for the process, which reveal the chemical profile of an ingredient.

FDA announced the testing waiver process in an interim final rule published simultaneously with the GMP final rule. The IFR has not been moved to a final rule (Also see "GMP Interim Final Rule Sets Bar High For 100% Testing Exemption – Experts" - Pink Sheet, 23 Jul, 2007.).

According to the IFR, a waiver petition should state the scientific rationale for proposed alternative testing “that will demonstrate that there is no material diminution of assurance, compared to the assurance provided by 100 percent identity testing, of the identity of the dietary ingredient before use in manufacturing a dietary supplement product when the dietary ingredient is obtained from one or more suppliers identified in the petition.” The petition must be accompanied by supporting data and information.

FDA said in the IFR that dietary ingredients are the “central defining ingredients of a dietary supplement,” and ensuring the proper identity of ingredients has “critical importance.”

The waiver process is a “chicken and egg” situation. “I think industry would want to see what a company had to do to successfully petition.” – attorney Tony Young, Kleinfeld, Kaplan & Becker

Daniel Fabricant, director of FDA’s Division of Dietary Supplement Programs, emphasizes the importance of identity testing standards and acknowledges that petitions for waivers must clear a high bar for approval.

“By and large, there aren’t many systems that would guarantee the same rigor as 100% identity testing,” Fabricant said.

An Onerous Process

The agency said that allowing testing waivers “would be consistent with our stated goal … of providing flexibility” in the supplement GMP requirements.

However, the process for requesting and gaining a 100% identity testing waiver is anything but flexible, experts say. Supplement firms so far have no incentive to invest in preparing a petition, they say.

“The petition process has the appearance of being onerous and substantial. Until a specific company determines it is in their economic interest to go through the process, there will be no petitions,” said attorney Tony Young, a partner at Kleinfeld, Kaplan & Becker LLP in Washington.

In an email, Young added that the waiver process is a “chicken and egg” situation. “I think industry would want to see what a company had to do to successfully petition.”

Further, FDA could grant a waiver that limits the petitioner to working with a single supplier of an ingredient. “That is not necessarily good business,” Young said.

Another reason that no petitions have been filed is FDA has not published guidance on the topic. In the 2007 IFR, the agency said it would publish guidance on the information and type of data to include in a petition and how it would be processed.

Bass said firms probably would be encouraged to file waiver petitions if FDA provided a defined set of standards to help companies to determine whether an alternative testing proposal could be appropriate.

The agency also could help firms in this area with a description of how the evaluation process will work, “some idea of how FDA intends to do the process and the timing,” he said.

Bass added that this year he has worked on identity testing systems with a client in the supplement and food ingredient space. “We’ve been doing a lot of work and lot of meetings with FDA and there are just a million issues that aren’t answered because there are so many practical questions.”

Although identity testing has not been the most common violation, the requirement was part of the first supplement GMP warning letter the agency issued (Also see "First GMP Warning Letter Reflects FDA's List Of Major Concerns" - Pink Sheet, 17 May, 2010.).

Comments on FDA’s estimate are due by Jan. 15, 2014.