(NDI) guidance is causing concern in the U.S. and around the world. If the final ruling on this guidance stands as
written today, it could cost the industry billions of dollars to comply.
Growth continues at a positive rate, with the U.S. poised to increase 4-6% in 2016 and close in on $30 billion. As
consumers demand more from their products, companies must answer the call by continuously pushing the envelope of development and refusing to settle for the status quo.
The U.S. consumer is increasingly demanding the removal of ingredients that he or she deems to be“unnatural.”
Capsugel has answered this call by continuing to offer industry breakthroughs that deliver on the promise of a
cleaner label. DRcaps capsules have become the norm for suppliers of probiotics. They can be used in place of enteric coatings, which
contain several objectionable ingredients that consumers are trying to stay away from. Furthermore, Capsugel uses food products—
like spirulina and sweet potato—to color capsules in a label-friendly way.
Capsugel is also taking technologies that have previously only been used in pharma and applying them to supplements. For
example, our Lipid-Multiparticulates (LMP) technology, previously used only in Rx for taste-masking, controlled-release and bio-enhancement, has made it possible for us to offer an enhanced consumer experience for drink mixes. In a typical powder drink mix,
most ingredients are either dissolved immediately or sink to the bottom. With this technology, we are able to offer controlled buoyancy
and taste-masking of bitter ingredients. This solution also has the side benefit of the brand owner being able to reduce sugar and
flavors in the product.
Finally, consumer demand for a USDA-certified organic capsule has never been higher. This capsule, made of pullulan, will soon be
available. This polymer is a product of fermentation of organic tapioca starch and offers improved oxygen permeability compared to
any other polymer. It is already used in powder products but will soon be available for liquids as well.
—Peter Zambetti, Director, Global Business Development, Capsugel
It’s a difficult time to make predictions given that the unlikely and unthinkable can happen, but it’s safe to say
regulation will be deemphasized when the next president takes office and the new Congress convenes. We don’t
know who will ultimately call the shots, Congress or the President, but if campaign pledges on international trade
deals are kept, we’re going to see impact on the global supply chain.
With less funding for FDA anticipated, appropriate and effective industry self-policing is essential, because our
critics aren’t going anywhere, and the pendulum will swing back in the mid-term elections. Such programs must be
inclusive of the needs and practices of small herbal companies utilizing raw herbs, and not just reflect large companies working with powdered ingredients. The progress the industry has made with better testing and more branded ingredient use
should be continued. This is a good time to amend the Food Drug and Cosmetic Act, fixing some of the problems with DSHEA. With
the Affordable Care Act in the crosshairs, there is opportunity to bring supplement benefits into the healthcare conversation.
Bizarre and deeply divisive as this election has been in the U.S., consider the global context. Some political historians are likening
these times of Brexit, Trump, demonetization in India, Russia’s interference in the U.S. election and ISIS to past times when separate
events have coalesced into massive disruption on the scale of the fall of Rome, the Black Death and World Wars l and ll. Dark and horrible times to go through, but times of innovation, progress and opportunity followed for survivors.
—Suzanne Shelton, Managing Partner, Strategic Communications, The Shelton Group
The dietary supplement industry would be wise to look at four of the key factors that led to the widely unexpected
presidential election results to get an idea about what the future might hold for us:
1. The election: Only 53% of eligible voters participated.
The industry: It appears that much of the industry does not yet adequately understand the implications of FDA’s
onerous 2016 NDI Guidance.
2. The election: The media and political pundits missed voter anger and angst that drove the outcome.
The industry: It’s too early to tell how the NDI process will play out, but a review of the agency’s statements in the guidance regarding a limited ODI list, manufacturing changes, combination products and synthetic botanicals make it pretty clear where FDA stands
on its enforcement objectives. Anyone that doesn’t take very seriously FDA’s discomfort with DSHEA and its stance on NDI triggers
does so at their own risk.
3. The election: Nobody is sure how President-Elect Trump will proceed once he’s in office—bombastic Trump or a more nuanced,
The industry: Uncertainty is the only certainty for now, and commerce does not function well in uncertain environments.
4. The election: Through his continuous use of social media, Mr. Trump was able to harness consumer skepticism and distrust
against the media to his advantage.
The industry: What if, due to cost or the hope that a lack of resources at FDA will mean little or no NDI enforcement, industry
chooses to not file required NDIs, providing the agency, Congress and the media with ample ammunition to create consumer confu-