The dietary supplement industry looks to FDA's Hydroxycut investigation for a sign on whether the agency will analyze adverse event reports more closely following a high-profile product recall.

Firms should expect more attention to their AERs, particularly for products containing ingredients similar to those in Hydroxycutproducts according to Rick Kingston, president of regulatory and scientific affairs at Safety Call International.

"It should be no surprise that companies with products that have similar ingredients found in the Hydroxycut line of products will likely receive closer scrutiny by FDA regarding whether or not their AE systems are meeting the letter of the law," Kingston said in an e-mail.

"I think things are going to get quite hectic in the supplement market as people try to identify the plethora of ingredient possibilities regarding the adverse liver effects with that product line and how it impacts the rest of the industry," he said.

However, Natural Products Association executive Daniel Fabricant does not expect a general upturn in FDA's attention to supplement AER data.

FDA will not compare other firms' AER data to the Hydroxycut reports unless evidence suggests it is necessary, said Fabricant, NPA's VP of regulatory and scientific affairs.

He added the Hydroxycut case may be ingredient-specific, but that would not make it easier to pinpoint the cause of the adverse events linked to the products.

Iovate Health Sciences voluntarily recalled 14 Hydroxycut products May 1 after FDA investigated 23 reports of serious liver-related adverse events - including one death - dating to 2002 (¹ Also see "Hydroxycut Recall Sheds Light On Pros And Cons Of AER System" - Pink Sheet, 4 May, 2009., p. 7).

FDA has not yet determined which ingredients are linked to the events, but notes no single ingredient is common across all the recalled products.

The Center for Food Safety and Applied Nutrition's dietary supplement chief, Bill Frankos, said it is "very hard" to determine which of the ingredients could be linked to the Hydroxycut adverse events.

Liver problems are rarely reported in supplement AERs, Frankos noted in a presentation at a Consumer Healthcare Products Association conference May 7 in National Harbor, Md., outside Washington (see chart: " ² CFSAN Dietary Supplement AER Data For 2008 ' next pag e).

Make Sense Of AERs

Kingston said that with medium-sized firms' deadline for good manufacturing practices compliance coming June 25, "companies can expect FDA to use the opportunity to scrutinize AE systems as well."

"That's just a reality related to the current environment of concern."

Kingston said he expects FDA to ensure firms are "documenting, tabulating, and reviewing all AERs and submitting incidents that meet the reporting requirements."

He advised firms to review their policies and procedures to ensure their AER systems "are up to speed and working as intended."

At the SupplySide East tradeshow April 27 in Secaucus, N.J., Kingston said firms should examine their AERs beyond collecting "verbatim what somebody tells you."

"Put some context around" reports received and pay attention to them, Kingston advised, adding that firms should consider all data - non-serious and serious incidents - when looking at AERs.

Supplement manufacturers should "really understand what is happening with" a product - "how people are using it, misusing it and how somebody else may be doing something to your product to put your customers at risk," he said.

Kingston advised firms to understand the context for a consumer's AER and determine how to correct any problem with a product that may contribute to an adverse event.

He said a system Safety Call plans to publish soon will help firms sort and score AERs based on a series of questions about events. The system will help firms focus on AERs most likely to show actual problems with a product and identify information showing other likely causes for a consumer's adverse event.

- Katie Stevenson (k.stevenson@elsevier.com)

Hydroxycut Recall Eyed As Trigger For Closer Look At Supplement AERs

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