Big Interview: Vasilios Frankos, Herbalife

Frankos on NDI guidance (part two): This really isn’t a big surprise

Related tags Ndi Ndi draft guidance Dietary supplement Food and drug administration

Doing nothing and hoping it will all go away is not a good plan ...
Doing nothing and hoping it will all go away is not a good plan ...
While many stakeholders warn that the FDA’s controversial NDI draft guidance will stifle innovation and bury the supplements trade (and the FDA itself) under a hellish mountain of paperwork, they cannot pretend they didn’t see it coming, Herbalife’s Vasilios Frankos tells Elaine Watson

Frankos, senior vice president of product compliance and safety at supplements giant Herbalife, was speaking to following the publication of the FDA’s draft guidance on new dietary ingredient (NDI) notifications.

But the contents of the document, which has been strongly criticized ​by trade associations, were not wholly unexpected, claimed Frankos, who was the director of the Food and Drug Administration’s dietary supplements division until March 2010.

This should not come as a big surprise to industry

He added: “I don’t think people can really claim to be surprised by this if they have been monitoring what the FDA has been saying on NDIs for the last few years.

“I think a lot of companies could have been doing many things to prepare, but they have been burying their heads in the sand.”

He added: “If you look at the FDA’s responses to some recent citizen’s petitions, for example that you can’t use a synthesized version of a botanical extract as in the homotaurine petition​ , or its response to the pyridoxamine ​petition ​[ingredients originally developed as drugs can’t then be sold in supplements] its position on many aspects of this guidance has already been made very clear.”

Similarly, the industry had the opportunity to engage with the FDA on the NDI process in 2004, he said. “I was involved in putting together a list of questions addressing the NDI process in 2004.

“Industry was asked for input but it did not give a lot of feedback and wanted to wait until the FDA formally put something out and then respond to that. But the questions were all those we see in the guidance today.”

Multiple filings and administrative hell?

One of the biggest misnomers about the new draft guidance, claimed Frankos, was that it imposed significant new burdens on makers of finished products by requiring NDI submissions on the supplement/formula being presented to market, and not on the raw ingredient.

But this had always been the case, he stressed. “It has always been the case that the filing is for the supplement that contains the ingredient, and not the ingredient itself, and while some people have always wanted the ingredient to be cleared so you can then put it into anything, that was never the intent of Congress.”

Meanwhile, to critics arguing that it would be an administrative nightmare​ for companies making changes to formulas to have to prepare new NDI notifications for each different supplement containing an NDI, he said:

Truthfully, there should be very little additional data required if you are just adding other ingredients such as vitamins to your product with the NDI in. What matters is whether you are adding something that is going to interact with your new ingredient, for example a stimulant added to another stimulant.”

His comments came as Hyman, Phelps & McNamara attorney Riëtte van Laack said (in the FDA law blog this week) that "the requirement that a notification be submitted even where an NDI is the subject of a previous notification appears especially problematic for the inefficiencies it would generate – and for the lack of statutory authority upon which to base such a requirement.”

Doing nothing and hoping it goes away is not​ an option …

If stakeholders are not happy with the guidance, they can say so, pointed out Frankos. “The industry does have a chance to ​[urge the FDA to] refine the guidance.”

One difficulty is that there is no requirement for the FDA to formally respond to comments from industry by issuing revised/final guidance, so those waiting to act until the FDA tweaked the guidance were taking a risk, he said.

“Technically this could stay as draft guidance forever. What the FDA has done is establish its position. Then after a period of time it might ask a company for evidence of the safety of one of its products or take a product off the market citing this guidance as its justification, which would then start a legal discussion.”

Meanwhile, doing nothing and hoping it would all go away was not an option, although that is what many companies may be tempted to do, he said.

Click here​ to read the FDA's draft guidance.

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I agree with Bill Sardi...

Posted by Anne,

Supplements are safer than tap water, aspirin, salt, even food.

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Is this guy reading the same document I am?

Posted by Bill Sardi,

Here we have a former government bureaucrat, planted inside the industry, saying everything is OK, not to worry. Look, what is happening here is that the FDA is demanding safety data on virtually every dietary supplement that has multiple ingredients, and without evidence of a clear and present danger (poison control center data does not indicate there are any deaths from supplements, and few other side effects), this guidance was released. If there is nothing troubling in the new guidance, why was it released late in the afternoon under the cloak of a holiday weekend?

For comparison, drugs are widely marketed after a relatively small group has taken the drug, and when data from broader use is tabulated, and oftentimes it is found a drug kills a lot of people (Vioxx led to the premature death of thousands). Essentially drugs have license to kill.

Now supplements have been tested in the population at large and with the exception of Ephedra (most deaths and side reactions were caused by consumers who overdoses on this stimulant) and tryptophan (from a contaminated batch produced by a Japanese pharmaceutical manufacturer). Supplements are safer than tap water, aspirin, salt, even food.

Now the FDA wants supplement companies to go back and conduct animal studies to prove their ingredients are safe when there is no evidence of a problem. Even the most dire of outcomes aside from death would be birth defects, which have not materialized.

Don't be lulled to sleep by this guy. The industry is facing a very serious threat to its very existence.

At the very least, this guideline should be adopted looking forward, not backward.

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