Why dietary supplement makers can’t tell you about positive research
In my last blog, I spoke about health speech – how dietary supplement makers cannot talk about clinical research that relates to their products using standard medical terminology. Essentially, they can’t even distribute articles about this research. That is one of the reasons that the Free Speech About Science (FSAS) Act of 2011 has been proposed. But why do limitations on health speech exist anyway?
Two reasons: consumer protection and the legal definitions of prescription drugs and dietary supplements.
As it relates to dietary supplements, the general idea is the same: Americans need protection from potential harm. This extends beyond physical safety. It has come to include protection from extravagant claims. Depending on your view and the specific situation, this is called either “consumer protection” or “paternalism.”
Where’s the gray area between supplements vs pharmaceuticals?
The Dietary Supplement Health and Education Act (DSHEA) of 1994 amended the FD&C act to refine health speech limitations, the purpose of which went beyond simple consumer protection. At issue was the different regulations applied to drugs and supplements. To work, there couldn’t be any gray area between how the two categories were defined. Call this the legal reality. As discussed in previous posts COURTNEY PLS LINK HERE /blog/brad-douglass/there-riskreward-balance-between-drugs-and-supplements, there are some necessary and beneficial reasons for doing this (e.g. promoting medical research and spurring innovation).
But in the real world, supplements don’t fit neatly into one box and drugs into another. Supplements and drugs – and food! – cause an overlapping continuum of effects on the body. Sometimes food and supplements can help prevent disease. Often drugs are derived from herbs or botanicals.
When legal definitions do not encapsulate the real world, discretion and balanced judgment are necessary in enforcing the letter of the law. Enforcement must be reasonable. If not, claims of favoritism arise as occurs with pharmaceuticals vs dietary supplements.
Take for example, “drug claims.” As defined in law, a disease treatment or prevention claim used to promote anything (animal, vegetable or mineral) makes that thing a drug. So in the eyes of the FDA it should be subject to prescription drug approval ($$), before these claims can be made.
Cherries, walnuts and elderberry juice are drugs?
For instance, drug claims are what landed walnut and cherry producers in hot water with the FDA a few months ago. And why the FDA took the unusual action of seizing probiotics and elderberry juice from manufacturers in early June. It didn’t matter whether the claims being made were true or false, just describing (or even referencing) the research was the big no-no.
Is our safety put in jeopardy by publicizing research suggesting tart cherries may reduce inflammation and pain? No. Would a cherry orchard have the economic incentive to submit to drug approval to make such claims? Of course not. Sure, there are good reasons to uphold the current system, but here’s the point: binary law enforcement is the real danger in a world full of “ifs” “buts” and “maybes.”
And if anything can be gauged by FDA’s stubborn resistance to court decisions over the past decade objecting to its treatment of approved health claims for dietary supplements, it’s that FDA probably needs more guidance on what is fair-and-balanced judgment.
That’s where passage of the Free Speech About Science (FSAS) Act might help to provide more information to the public and help balance FDA policy. Of course there are dissenting opinions. But if you think the FSAS Act is a good thing, contact your elected officials here to support the passage of this bill.