Science pushing regulatory boundaries, consultant says

Risa Schulman PhD

New ideas in science tend often to disrupt earlier modes of thinking. So it is with nutritional science, as researchers discover new modes of action and new delivery vehicles that increasingly push at the regulatory envelopes meant to define and confine them, said consultant Risa Schulman.

Schulman, who holds a PhD in plant biology from Rutgers University, has worked on a number of ingredient development efforts with various companies, including work on cocoa flavanols. Schulman now operates a consulting firm called Tap-Root.biz and will be speaking on the subject of Innovation without a Home at the Next Innovation Summit being put on by New Hope Natural Media in conjunction with the Natural Products Expo West trade show in Anaheim, CA in March.

Pushing the boundaries

Schulman said that nuritional science is developing in ways not anticipated by existing regulatory frameworks.  It has been true for some years that scientists working on the development of nutraceutical ingredients have gathered data that they are legally constrained from communicating to consumers because to do so would be stepping dangerously close to the line drawn in the sand by FDA on making disease treatment claims. So communicating this information becomes something of an art of saying enough to differentiate the product without raising regulatory hackles.

But that tightrope act is becoming increasingly difficult, Schulman said, as research moves into areas that have little or no regulatory history.

“There is this new generation of producst and concepts that are very much new level of sophistication. When researchers come up with novel things it can be wonderful for the consumer and for the industy. But they are running smack into the limitations of the regulations,”
Schulman told NutraIngredients-USA. “A lot of it is very novel science. Some of it is novel packaging or delvivery forms that don’t fit into standard definitons.”

Personalized medicine

One area Schulman cited as being at high risk of regulatory entanglement is the whole trend of personalized medicine.  Human nutrition is an exceedingly complex field of study, and finding a way to reliably determine what foods and what supplements best support a given consumer’s health has been an ongoing quest in the field.  

New diagnostic tools, and the potentially huge trove of data they could give rise to, are fueling the trend.  NuSkin, a network marketing company that sells beauty and nutritional products, has based its model in part on portable devices that can measure the level of carotenoids in a consumer’s system by scanning the skin and has amassed almost a decade’s worth of data with the method. New methods of measuring 25-hydroxy vitamin D in the blood have made vitmain D testing commonplace.  And a simplified method for determining the levels of omega-3s in a consumer’s system (known as the omega-3 index) has become available in recent years.

But perhaps first and foremost, the company 23andMe has offered genetic testing to consumers via a simple saliva sample and has found rapid uptake in the market for its $99 packets.  That is, until FDA shut the operation down, at least temporarily, until the company satisifies the agency on the subject of whether the test is properly classified as a medical device, as the agency asserts, and, if so, whether the company has proved to FDA’s satisfaction that the test works.

Personalized medicine is very much on the forefront and part of the trend of where consumers want to go and where the science is going. It will be customized, even to the genetic level,” Schulman said.

“There have been a number of companies that have tried this and have run into regulatory snags, most visibily 23andMe. In personalized medicine right now the only legal way to do it is through a doctor’s office. The way this will change is those companies that are fearless and pioneering are going to be the ones to meet with FDA and work something out,” she said.

New delivery modes

In her talk Schulman will delve into new delivery methods that companies are pursuing that don’t fit neatly within existing boundaries. According to DSHEA, dietary supplments are supposed to deliver their active ingredients to the blood stream via the GI tract.  But a number of companies have put their ingredients into lozenges, in which case the actives spend some time in contact with the mucous membranes of the mouth, implying that at least some of these molecules enter the blood stream that way.  And Schulman said there are other products that are even more overt in their category-stretching.

I have companies that come to me with novel delivery modes. Let’s say it’s a topical or a sublingual delivery mode. Maybe's it a mouth spray. What do you call it?” Schulman said. “These are the questions that people come to me with when there are brand new products and there are no precedents.”

Maturation of industry

Schulman said it’s a good sign that this boundary-stretching activity is occurring.  To her, it is part of the maturation of the dietary supplement industry.

“We are getting companies involved like biotech that have really fabulous science. In some cases it is completely new. Because of the very high price of making drugs, they are now looking toward dietary supplements as a potential invesment area. And that is very much a feather in our caps that they are looking here because it means as an industry we’ve built credibility.

“What’s going to be very interesting is to see how FDA responds. Eventually something is going to have to give. You could call it the third phase of this industry, similar to the period when DSHEA came in,” Schulman said.

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