Reflecting on the past year, and looking forward to next, I see a few positive reoccurring trends as well as some
emerging opportunities. Fifteen years ago, when my interest and career shifted from the pharmaceutical industry’s
perspective on nutrition to dietary supplements, the nutraceuticals industry had been riding the wave from the Dietary Supplement Health and Education Act (DSHEA) for a few years. Under this more favorable regulatory environment, new products were hitting the shelves at a near frenzied pace. Third-party literature of all sorts substantiated
some quite liberal structure-function claims. Pharma companies took notice of this growth and with their generous
Looking forward, what lessons did we learn from these market cycles and what can we expect in the year to come? From my perspective, four trends stand out: clinical substantiation,“clinical nutrition” products, nutraceuticals in healthcare institutions and some
interesting demographic shifts.
Facilitated by FDA scrutiny, the level of clinical substantiation for nutraceuticals has increased quite significantly. This is not to say
that previously launched functional ingredients and products were not supported by good science, yet some were clearly not. Many
relied on third-party literature for individual ingredients to support claims on complex final formulations. Today, more ingredients
and finished products are tested for safety and efficacy in well-designed clinical trials. These changes have been driven by the need
to address FDA requirements as well as demands of a more educated consumer and healthcare professional. This in turn builds trust
in our products.
An increasing number of well-researched“clinical nutrition” products were launched in the past year, mostly classified as medical
foods for the“management” of a specific disease or medical condition. Not unlike dietary supplements, medical foods do not require
FDA pre-market approval; however, they do require ongoing patient management by a physician (or other qualified healthcare professional) and other standards set forth by the FDA ( 5(b) Orphan Drug Act ( 21 U.S.C. 360ee (b) ( 3))). Many of the recent launches were
from traditional dietary supplement companies and distributed through the health practitioner channel. Typically, physicians expect a
higher level of clinical substantiation than consumers; plus the FDA requires all ingredients in medical foods to obtain Generally Recognized As Safe (GRAS) status. Thus, clinical nutrition products exhibit a level of quality and safety not typically seen in nutraceutical
products, continuing to raise product standards.
As addressed in my column “Challenges for Nutritional Products in Healthcare Facilities” (November 2016, Nutraceuticals
World), the demand for nutritional products in healthcare facilities is growing at a rapid pace. There are numerous unmet patient
needs in hospitals, nursing homes (and the“home care” setting) that can be addressed through aggressive nutritional intervention. Institutional applications range from wound care and pressure sores in acute care to helping prevent C. difficile infections in
long-term care. Where demonstrated efficacious and cost effective, nutritional products offer significant benefits to a wide range
of patients in healthcare facilities.
Finally, the rapid demographic shift of Baby Boomers moving to the mature phase of their lives provides numerous opportunities.
Top nutrition related needs include mental acuity, glycemic index control, muscle maintenance, cardiovascular health, sensory (e.g.,
hearing, vision, smell), dental health and weight control. Segments of this cohort have the resources, knowledge and desire to address
such health issues through nutritional means whenever possible.
Over the past year, the variety, quality and safety of dietary supplements has continued to increase. More than ever, healthcare
practitioners are realizing the benefits of therapeutic and preventive nutrition, and the needs for nutritional products for aging adults is
increasing at a rapid pace. Companies that think strategically to develop platforms factoring these and other market dynamics should
be well positioned to address such emerging healthcare needs.
—Greg Stephens, President, Windrose Partners
My sister is leery of the supplement industry and I understand why. Of course it is foolhardy to try and say anything accurate and all-encompassing about“the industry” because it is not a monolith. It has the variation of a botanical, not the general clean certainty of an isolated constituent.
There is a metaphor here: is the industry better characterized as Pinocchio or the real boy that a talking piece of
wood finally became? We’ve heard analogies of the industry before (the Wild West...a new sheriff in town) and they
suggested where things were and where they could go. We deserve to know where our raw materials come from,
The story of Pinocchio began long before the 1940 Disney film. It was first told in serial form in 1881 and 1882 and completed as
a children’s book in 1883. The very next year the Association of Official Agricultural Chemists (now AOAC International) was established so that the results of analytical testing on fertilizer could be trusted. This is worth mentioning because today AOAC works with
industry to publish Official Methods of Analysis applicable to herbal materials. It seems to me that the supplement industry is largely
disengaged from this opportunity.