Can DSHEA 2.0 fix the 'education' question?

First off, US dietary supplement regulations clearly state that a dietary supplement product cannot prevent, cure, treat or diagnose any illness.  But that distinction can quickly become strained when the results of recent research is taken into account.

It’s also a matter of debate here at William Reed Business Media about how we report on such research.  Is it a valid news story for our readership if the research pertains to a frankly pharmaceutical application?

Stillborn education idea

The real underlying issue here is the undefined meaning of the “E” in DHSEA, the Dietary Supplement Health and Education Act.  When this law, which created the dietary supplement category in the US, was put into place in 1994, at the birth of the Internet era, there was an idea that third party material could be referenced by dietary supplement manufacturers to support the efficacy of their products.

That was the ‘education’ part, but the idea was more or less stillborn.  FDA quickly came to view the use of this information as advancing medical uses for these products. The concern that some consumers might forego proven drug or surgical treatments in favor of a dietary supplement intervention.

For example, Jordan Rubin, CEO of the supplement firm Ancient Nutrition, has done a plethora of research on one of his company’s probiotic products.  But he said he is constrained from talking about most of it​​. 

“I have my own frustrations with DHSEA.  I think it’s still too restrictive.  For example, we have a probiotic supplement that is supported by 16 clinical trials.  It has been extensively studied, but the most we can say about it is ‘helps healthy digestion,’” ​Rubin told NutraIngredients-USA at the Expo West trade show in March.

Turmeric and cancer 

Another example is turmeric/curcumin.  There has been a raft of research for this highly active phytochemical in a wide range of indications. Curcumin is thought to be a potent modulator of NfKb signaling, which figures into a number of downstream indications such as the growth of tumors and chronic pain.

Much of the voluminous research on curcumin might elucidate a mechanism of action (controlling inflammation at nucleus of the cell) that could support a structure/function claim such as “promotes a healthy inflammation response.”​ But a lot of these studies are done to frank disease end points, such as the treatment of cancer.

While the purveyors of curcumin products certainly welcome the large amount of research, they can only allude to it in the most general of terms in their marketing. Using the word “cancer”​ on the website of dietary supplement product is akin to saying, “Hey, FDA!  Come and get me!”​

These questions can have legal consequences, too.  Recently Amarin, a pharmaceutical manufacturer that markets the drug Vascepa, a highly refined, almost 100% pure version of EPA, settled lawsuits with two marketers of omega-3 products. The company alleged the dietary supplement companies had cited the results of its drug research as proving the beneficial effects of their supplement products. 

Crafty study design

In their own sponsored research dietary supplement companies have to carefully craft the end points and carefully select their study populations so that the study results can be directly used to support the marketing of the product.

 One way this might be done is to study a stressed population as opposed to a disease one. An example here might be to show how a probiotic product lessens the bouts of diarrhea that many travelers experience.  It’s a way to show an actual effect without studying a population of Crohn’s disease or IBS sufferers.

Is there a fix in DSHEA 2.0?

Whether some of these questions might be cleaned up as part of the ongoing ‘DSHEA 2.0’ discussions is anybody’s guess.  Having a compelling research result of which it may not be spoken seems ludicrous on its face. But disincentivizing super expensive drug research if a consumer can opt for a less well researched (and perhaps less well made) dietary supplement is a concern, too.

So while the troubled regulatory waters churn, we here at NutraIngredients-USA still have to navigate our boat. If readers have input that could help inform how we make these coverage decisions, we’d welcome hearing from you.