Herbalife Hires FDA's Frankos For Compliance/Safety Position

Herbalife will have a leg up in terms of compliance with good manufacturing practice and adverse event reporting requirements with its planned addition of FDA's Vasilios "Bill" Frankos.

Frankos, FDA's director of Dietary Supplement Programs, will leave the agency March 19 to serve as Herbalife's senior VP of product compliance and safety starting in April. Frankos will report to general counsel Brett Chapman.

The Los Angeles-based global marketer of weight-loss, nutritional and personal care products gains Frankos at a time when compliance expertise is critical, as FDA conducts more GMP inspections and irons out the details of how those inspections are run (see ¹ (Also see "FDA To Fill Frankos' Shoes As Major Dietary Supplement Initiatives Pend" - Pink Sheet, 25 Jan, 2010.)).

Frankos should have a keen sense of agency policy on compliance issues, since he helped develop those policies, and likely still will have close contacts in FDA's supplement program.

Frankos oversaw the "full implementation" of the Dietary Supplement Health and Education Act during the GMP era, and development of the AER system, Herbalife notes in its Jan. 19 announcement.

Daniel Fabricant, VP of scientific and regulatory affairs with the Natural Products Association, said to hire someone with Frankos' expertise "only serves to benefit the firm."

Firms always are looking for more information on the agency's expectations in terms of recordkeeping and other elements of GMP and AER compliance, and Frankos should be a good source of that knowledge.

Specifically, Frankos will help improve and implement Herbalife's in-house systems for compliance, and likely will oversee the AER system, Fabricant said.

"Bill Frankos exemplifies Herbalife's commitment to providing science-based nutritional supplements of the highest quality available in the marketplace," says Michael O. Johnson, Herbalife chairman and CEO, in the release.

- Katie Stevenson ( ² [email protected] )