54 • Nutraceuticals World December 2016
munity and beyond, CRN is part of the great impact being made for the good of the industry as a whole. I am proud to have been part
of the momentum and encourage responsible companies to join the efforts that CRN leads to uphold and solidify the integrity of our
industry in 2017 and beyond.
—Harvey Kamil, CRN Chairman, and NBTY Vice Chairman
We expected 2016 to be one of the industry’s most exciting and challenging years, and it delivered in more ways
than we could have imagined. The industry was slammed with three hot button issues within weeks of each other
from the Food and Drug Administration. FDA released its New Dietary Ingredients (NDI) guidance re-draft, a finalized GRAS rule, and its unprecedented steps to reclassify and ban the five-time acknowledged dietary ingredient
vinpocetine, an act many consider as an attempt to enforce a guidance document.
Despite these challenges, the state of our industry remains strong, with steady sales and the majority of Americans
continuing to have the confidence and trust in our products to use them on a daily basis.
As an industry, we’ve experienced real growth in the past year, allowing the Natural Products Association to take an active role in
educating consumers and policymakers in Washington and across the country about our serious commitment to manufacturing and
selling high-quality, safe, natural products.
The NDI draft guidance is one of the areas where we have to work with the FDA to ensure an outcome that benefits consumers and
the industry. We need to ensure the development and access to novel ingredients as well as ones that have been lawfully marketed.
We need to carefully monitor and potentially challenge the enforcement strategy that will emerge from a finalized NDI guidance
document that we expect to emerge sooner than later. At this point in time, we need further clarification and transparency from FDA
because of the economic impact it could levy on manufacturers and suppliers, and costs that will ultimately be passed onto consumers.
As an industry, we acknowledge the FDA as the established experts on food safety and the enforcers of food law tasked with protecting public health. However, there are some issues where we need to work together and take an even more forward and active role
to improve policies that protect consumers and ensure access to safe affordable products is not restricted.
The case of vinpocetine is a prime example of the need for clarification on FDA’s new re-draft of the NDI guidance. We must work
directly with the regulators of our industry to explain the precedent that could be set if this rule were allowed to move forward as written. NPA gave the agency a clear path as to how vinpocetine fits under the Federal Food, Drug, and Cosmetic Act in our comments,
but the industry needs reassurance from FDA that it won’t try to ban an acknowledged ingredient again. We need to understand its
enforcement strategy over NDIs. Clarification and eliminating uncertainty in knowing when to file an NDI is critical to improving
the dietary supplement industry’s future over NDIs. Hard work and continued dialogue with the agency can only net positives in our
areas of contention. Strong engagement between the industry and FDA is vital to make changes in helping to bring new, innovative
dietary ingredients to the market safely.
The incoming Donald Trump Administration presents significant opportunities for the industry, especially if we step up politically,
utilize our grassroots capabilities and increase our PAC fundraising. As the saying goes, the more things change, the more they stay
the same, and in turn, we anticipate another busy year for the natural products industry in 2017.
—Daniel Fabricant, Executive Director and CEO, Natural Products Association (NPA)
“If you do not change direction, you may end up where you are heading.” —Lao Tzu
In 2016, the dietary supplement industry woke up a bit, exchanging the old story that media, regulators and legislators just get it wrong, for a more honest assessment that acknowledges change provides opportunity to be better.
Lessons learned have generated new testing standards, voluntary registration of products and a renewed conversation about what effective regulation could actually look like in the future. That said, there is much work to be done,
and it is work that must reflect consumer concerns.
Consumer confidence in the industry has fallen to dangerously low levels. The really great supplement companies
are taking bold action relating to quality and transparency, educating consumers on their GMPs, conducting robust testing, and managing their supply chain to protect the integrity of the products they put on shelves. Consumer education is a priority in these companies and today’s customers just can’t get enough information on how products work, what the manufacturing process looks like, and
where the ingredients come from. (Imagine“Portlandia” doing an episode tracing a bottle of supplements, instead of a chicken named
Colin, back to its origin). Ours, an industry that delights in the fashionable trend of the day, must not mistake transparency as a trend.
We are watching supply chain and marketing challenges transform the food industry. Lest we forget, dietary supplements are the most
regulated of foods, so we should be more than prepared for scrutiny.
The industry is poised to dramatically impact the nation’s health and wellness. Consumer awareness of the adverse impact of nutrient deficiency, coupled with a desire to consume superfoods as nutrient-dense ingredients in dosage form, presents opportunity to
fully meet public expectations. Let’s all head in that direction.
—Karen Howard, CEO and Executive Director, Organic & Natural Health Association