Dietary supplement formulators are caught between a rock and a hard place when it comes to making claims on their products. Structure/function claims have served the industry well over the more than 25 years they have been in existence since the advent of the Dietary Supplement Health and Education Act.
Some in the industry argue that they have served the consumers well, too. More than a year ago NutraIngredients-USA visited the subject of the utility of structure/function claims. We talked to two noted herbalists, Dr Tierowna Low Dog and Dr Mary Hardy, who at that time felt the claims were too vague to really be of use to consumers.
History of structure/function claims
As most readers of this article will be aware, structure/function claims allow the marketer of a dietary supplement to make a claim that their ingredient or finished product supports a particular function or bolsters the well being of a given structure within the body. These claims, as demure as they might be, must still be backed by credible scientific evidence.
Structure/function claims stand in opposition to non compliant disease claims, in which marketers will claim to be able to cure, treat or prevent a disease with their dietary ingredient or finished good dietary supplement. It doesn’t matter in this case how profoundly a formulator might believe in the scientific backing for the claim they’re making. If you want to treat a disease, you have to enter into the drug development process. A number of well known drugs started out as natural products, such as some statins and chemotherapy agents. But few natural product developers go there because of the huge costs involved as well as problems in securing the right kind of patents.
Roy Upton, RH Dip Ayu, founder of the American Herbal Pharmacopoeia, who was also quoted in the 2019 article, felt that structure/function claims, even with their restricted scope and sometimes convoluted language, still provided valuable information to consumers. If a consumer was interested in bolstering their immune health, for example, they could find a product designed to promote a ‘healthy immune response.’
Demands of pandemic burst structure/function envelope
Now, however, with the pandemic crisis upon us, many in the industry are chafing at the corner that the structure/function claim regime has painted them into. Botanical-based dietary supplements, many of which derive from TCM or Ayurvedic formulas or other traditional medicine systems, have always been a square peg in the round hole of the dietary supplement industry. Many of the formulators working in the category consider these to be herbal medicines, though they can’t legally talk about their products in those terms. They would have fit much more neatly into some sort of traditional herbal medicine category of the kind that exists in Germany and elsewhere. But an effort to create such a category here during the negotiations that led up to the signing of DSHEA went nowhere.
Now, however, the urge to help consumers desperate to gain some edge against the threat of contracting COVID-19 has led some marketers who might have legitimate products to cross the line. And of course it has brought some charlatans out of the woodwork, too, as any moment of chaos will. FDA and FTC have been so busy playing whack a mole with coronavirus disease claims that they have put up a dedicated website just to list these warning letters. To date more than 40 companies within the penumbra of the dietary supplement industry have had their pelts nailed to that particular wall.
Evidence of benefit arising from pandemic data
All of the companies receiving these warning letters were de facto judged to have insufficient backing for their claims, and they are claims of a sort that under current regulations they shouldn’t have been making in the first place. With that being said, there will an enormous amount of information that will come out of this pandemic once the dust settles. Already we are seeing correlations with higher vitamin D status and better COVID-19 outcomes. Other similar correlations have surfaced in regard to vitamin K2, selenium, zinc and some probiotics.
All of that is very preliminary. At the moment here in the United States we are still in the initial phase of just trying to control the spread of the disease, keeping infected people alive and trying to figure out a viable way to restart the economy while keeping the first two objectives in mind. But researchers will have huge data sets to work with, and can also parse through what was done in the herbal treatment realm in China and elsewhere and how that affected COVID-19 outcomes in those countries.
Which brings me to the point of what will happen in the ‘DSHEA 2.0’ discussions that have pretty much been shelved during this all hands on deck time. According to Johns Hopkins University, the US has one of the worst COVID-19 mortality rates per 100,000 population, trailing only the UK, Chile and Peru.
One question to ask will be why this has been so. Diet and lifestyle must certainly play a role, and some of the issues that afflict the US population are common in the UK too: too many calories and too few nutrients. The typical American diet is especially deficient in those constituents that promote gut health, such as probiotics and prebiotic fibers, and those that control inflammation, such as a rich suite of phytochemicals and vitamins found in whole plant materials. Poor gut health and living with a state of chronic low level systemic inflammation would put your average American in a poor position to have a ‘healthy immune response.’
What claims might look like under DSHEA 2.0
Perhaps this crisis could be leveraged to further shape the discussions about what DSHEA 2.0 is going to look like. The structure/function claims setup has served its purpose, but the question needs to be asked about whether it is starting to outlive its usefulness.
With the evidence of clear benefit in some cases that will arise from this crisis, maybe industry leaders could make a case for the health promoting benefits of dietary supplements in all realms (not just immune health) along these lines: We know our products can help people in these specific ways. Why are we constrained from telling them about it in anything other than the most carefully veiled language?
In addition to allowing companies to communicate more forthrightly with consumers, a more expansive claims regime could also spur additional research into these products. Why spend the money if whatever you find out you have lock up in your desk drawer? This could be a way for the best companies to further differentiate themselves from the plethora of me-too lookalikes.
What a new claims regime might look like in its particulars goes beyond the scope of this commentary but is something we’ll delve into in the future. Some might think getting FDA to officially recognize any sort of health benefit for dietary ingredients (beyond the few approved qualified health claims) is just pie-in-the-sky thinking. But in 2020, this year that will go down in history, any number of things have come to pass that we thought we’d never see. Why not imagine one more?