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Companies must walk fine line when bringing a supplement to market in US that is a drug elsewhere

By Hank Schultz , 27-Mar-2014

An example of statements from PharmaRoth that FDA might have used to determine intended use.
An example of statements from PharmaRoth that FDA might have used to determine intended use.

A company known as PharmaRoth Labs had to absorb a setback recently when it announced that FDA had objected to a New Dietary Ingredient notification the company filed on its Sucanon ingredient. The incident points out the potential pitfalls of bringing to the US market a dietary supplement that is sold as a drug elsewhere.

PharmaRoth (also known as Fero Industries) calls Sucanon a “herbal dietary supplement” that is approved as a prescription diabetes medicine in China, Peru and Mexico. It was orignally developed as a drug for type 2 diabetes by Canadian company Biotech Holdings Inc.  That company reportedly holds several patents on the ingredient.

Classified as an IND

In 2013 PharmaRoth Labs submitted its NDI to FDA. Recently the company announced that FDA had objected to the notification, stating that in the agency’s opinion, the product was a drug, not a supplement ingredient, and should go the Invesigational New Drug route.

PharmaRoth’s CEO Luis Lopez appeared to be trying to put the best face on matters for investors when he stated: "We are very satisfied with the FDA's determination, as we have always felt that Sucanon was a drug. Now that the FDA agrees with our findings, it is actually a very positive thing for the product going forward: a 'drug' designation by the US FDA has large beneficial implications on a international level. The fact that Sucanon is powerful enough to be considered a drug will make the product more acceptable in many countries."

That scenario of an ingredient being a supplement in US and a drug elsewhere is not without precedent, said attorney Bethany Kennedy of the law firm Emord and Associates.

Walking a tightrope

“There are things that are supplements here but they are drugs elsewhere. If they haven’t actually investigated it as a drug in the US and they are telling FDA they intend to market it as a supplement, I don’t think that would stop the ingredient from being approved as a NDI,” Kennedy told NutraIngredients-USA.

Alex Schauss, PhD, senior director of the scientific and regulatory consultancy AIMBR agreed, saying, “We know of a number of cases of ingredients in Australia and Europe that had drug or drug-like status and came into this country and were very careful to avoid any of the issues that could get them categorized as an IND.”

Intended use

But all of that hinges on the picture the company presents to FDA.  PharmaRoth makes no bones about the use of the product (which the company says is the "dried root of Tricosanthus," a tropical vine) as a drug.  And the company’s websites are littered with disease claims, such as “Sucanon is an oral Type-II Diabetes treatment.”

When determing the safety of a NDI, FDA relies on the information supplied in the notification.  But the agency doesn’t have blinkers on and is free to look at anything it wants in connection with the company when determining intented use.

“One of the fundamental concepts in food and drug law is intended use is key in determining what the regulatory qualification of a product is,” said Arnie Friede, an attorney who leads the food and drug practice at the Miami-based law firm Sandler, Travis and Rosenberg. “There were a number of cases in which honey was regarded as a drug because of a therapeutic phrase.” 

 “The drug claims on the company’s website would be very strong evidence of intended use. I would have advised them that they would have no likelihood that they would get an NDI. If they were to change the description of the product on their website they would have had more chance of success,” he said.

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