Herbalife Adds Longtime FDA Supplement Expert as Regulatory Challenges Mount

Herbalife, a global leader in the network-marketing dietary supplement market, will add a senior U.S. Food and Drug Administration (FDA) member to its team upon his retirement from the FDA in April 2010. Vasilios (Bill) H. Frankos, PhD, will join the Herbalife team as senior vice president of product compliance and safety, according to a January 19 Herbalife press release. Frankos is familiar to many within the dietary supplement industry for his extensive work as the director of the division of dietary supplements programs for the Center for Food Safety and Applied Nutrition (CFSAN), at the FDA.

Frankos also contributed to the creation and implementation of dietary supplement good manufacturing practices (GMPs) and the industry’s serious adverse events reporting (SAER). At the FDA, Frankos is a key player in reviewing new dietary ingredient notifications and overseeing function claim notifications. He is CFSAN’s lead scientist for dietary supplements and a toxicology expert on the National Toxicology Program (NTP) Toxicology Study Selection Review Committee. “Bill Frankos exemplifies Herbalife’s commitment to providing science-based nutritional supplements of the highest quality available in the marketplace,” said Michael O. Johnson, Herbalife chairman and CEO.

NBJ Bottom Line 

With such an extensive resume and more than two decades of experience in the dietary supplement industry, the addition of Frankos can certainly be viewed as a positive move for Herbalife. As GMP enforcement enters its third year, Herbalife has taken a proactive approach to staying on top of the ever-changing U.S. regulatory landscape by employing one of the country’s foremost experts on the topic. Additionally, as a global multi-level marketing (MLM) company that is active in many disparate markets, Herbalife is subject to a wide array of differing national policies that determine where the company may sell its products and how those products are classified. In a December 2009 Nutrition Business Journal survey of global supplement manufacturers, national rules on product claims or labels was ranked as the most crucial issue that will impact the sales of dietary supplement sales globally. With so much regulatory uncertainty looming, it is clear why Herbalife would move to partner with such an expert as Frankos.

It is not immediately known whether Frankos will be asked to assist with the company’s global regulatory affairs, though the assumption is that one of the motivations for obtaining his expertise is that he will have a hand in overseeing all product compliance as the global regulatory environment continues to change. The move is also a first for the dietary supplement industry. Mark Blumenthal, founder and executive director of American Botanical Council, told the New York Times that while it is not uncommon for high-ranking FDA personnel to retire and go work in the pharmaceutical industry, this marks the first time for a high-ranking official like Frankos to go to the supplement industry.

Related NBJ Links:
Herbalife Cuts Out Middle Men as It Moves Toward Vertical Integration
Herbalife Experiencing Stellar Sales Despite Slumping Economy
Weight-Loss Supplement Sales Plummet Following Iovate’s Hydroxycut Recall

Related Functional Ingredients magazine links:
Herbalife Begins Operations in Vietnam

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