2020 predictions: Staff changes at FDA, CBD, personalization, and the microbiome
1. Climate change & sustainability
The threat is existential. Australia is ablaze, and many leaders are putting their heads in the sand. Companies though are making efforts – some big, some small – and the “natural products” industry should be playing a key role in this. We’ve already heard about the threat to the botanical supply chain, for example, and companies like MegaFood discussing their efforts, but expect more in 2020.
Herbalgram, the publication of the American Botanical Council, dedicated a special issue to this at the end of 2019. Here’s a link: http://cms.herbalgram.org/heg/volume16/November2019.html
As the public – and younger consumers in particular – becomes more active and aware of the challenge of climate change, and the role that regenerative agriculture can play in sequestering carbon in the soil, we hope and expect more companies to make bold commitments regarding climate change and regenerative agriculture this year.
The annual budget for the Office of Dietary Supplement Programs (ODSP) has been increased by $3 million, taking the office’s budget to more than $10 million, but Congressional language suggests much of this increase will go towards inspection and enforcement rather than issues like NDI notifications (more of this next).
ODSP is also facing a small staffing challenge: Dr Cara Welch is back, and Steve Tave is still captaining the ship, but the Office lost Bob Durkin and Sibyl Swift within a few months of each other. Additional funding should hopefully see more people come onboard, but how the Agency fills the big shoes of Durkin and Dr Swift will be interesting.
Can you believe it’s almost ten years since the first draft guidance for NDIs came out? Could 2020 be the year that the revised NDI guidance is finalized and published? The Agency held a public consultation on this last year, and chatter around the topic has increased over the past 12 months, from both the industry and the Agency.
At the fourth annual IPA Workshop in DC in October, Corey Hilmas, MD, PhD, a former FDA official and now Chief Regulatory Officer with KGK Science, speculated: “I don’t think they’re going to do another redraft. I think a finalized guidance is coming… probably within 12 months.”
Yes, I held this until number 4 on the list. The dietary supplements industry is worth $45+ billion dollars, and the vast majority of this has nothing whatsoever to do with CBD-containing products. Despite CBD supplements rocketing to the top spot in the natural channel with $52 million in sales, CBD remains a minor player in the category.
Late last year, the FDA stated that – for the moment – it cannot conclude that CBD (cannabidiol) is generally recognized as safe (GRAS) for its use in human food, based on a “lack of scientific information supporting the safety of CBD in food”. The Agency also sent a raft of warning letters, mostly about unacceptable label claims.
This was followed by a wave of potential class actions against CBD companies large and small.
Politicians are pushing hard for clarity and a resolution, and just this week, a new bill proposed the inclusion of CBD under the definition of dietary supplements found in DSHEA. The bill would not prevent FDA from requiring NDI notifications, enforcing GMP compliance, and other necessary actions. And would this also only be specific to CBD and therefore, would/ could that freeze out opportunities with other cannabinoids?
What's clear is that something needs to happen and soon.
5. DSHEA 2.0
DSHEA at 25: In conversation with Scott Bass and Loren Israelsen
15-Apr-2019 By Stephen Daniells
The brilliant strategy of Sen. Orrin Hatch, the upswell of grassroots consumer pressure, and the ‘highly unusual’ personal intervention of an FDA Commissioner: The development and passage of the Dietary Supplement Health and Education Act is a fascinating...
There was a lot of talk about potential changes to the regulations last year as DSHEA celebrated its 25th anniversary, with then-FDA Commissioner Scott Gottlieb mentioning ways to ‘modernize’ the law. A few very good suggestions have been floated by various stakeholders, from a mandatory product listing to addressing the “GRAS loophole”.
Trade associations appear divided on what to do, but one of the key architects of DSHEA, Scott Bass from Sidley Austin, co-authored a paper with Pieter Cohen, MD, outlining ways to modernize DSHEA.
Some industry leaders have attempted to cool talk of significant revamps to the law, with AHPA’s Michael McGuffin telling NIU Deputy Editor Hank Schultz at SupplySide West that his organization likes DSHEA 1.0, “or, if we’re more accurate, let’s call it 1.1, because that law has been modified in the last 25 years in some pretty significant ways,” he said.
Discussions will only continue, but immediate widespread changes seem unlikely as Washington gears up for a general election.
6. Personalized nutrition
M&A activity around personalized nutrition really ramped up in 2019, with Nestlé Health Science adding Persona to its Atrium Innovations portfolio. The Swiss giant announced the acquisition of San Francisco-based LivingMatrix just last week. DSM also been busy investing in the category, including MixFit, Wellmetrix, Panaceutics, and more recently Boston-based AVA.
Nature’s Way invested in Berlin-based Baze, while GNC and Vitamin Shoppe launched personalized nutrition services, to name but a few. We’ve heard of other high-profile brands working on personalized platforms, too.
Despite the excitement, there’s still a lot of confusion around what and how we measure this, and how meaningful are some of these tests offered by these personalized nutrition players. Expect greater scrutiny by the media, but also greater interest from consumers.
7. Microbiome, prebiotics & probiotics
When Bill Gates authors an article proclaiming his hopes for probiotics, you know it’s significant. The potential of microbiome modulation to benefit human health is exploding, and investment is flooding in for all kinds of industries, including pharmaceutical companies, which are looking at the potential of pharmaceutical probiotics – or Live Biotherapeutics – for a range of disease end-points.
On the supplement side, there was some talk last year that probiotic supplement sales in the US had softened, with consumers switching to fermented foods, but there may be some movement back on this, especially with media coverage like the recent article in the Washington Post, which noted that “most fermented foods do not meet these criteria [to be classed as probiotics]”.
Prebiotics are also on the rise and 2020 could be a breakout year for that category, while terms like ‘synbiotics’ and ‘postbiotics’ are slowing leaking into the public domain.
And with companies like Viome and DayTwo growing in the personalized space, consumers will be taking much more control and interest in their own microbiomes.
8. Cellular Aging & AI
The Council for Responsible Nutrition (CRN) dedicated a whole morning at its 2019 Day of Science to healthy aging, with the focus around the nine cellular and molecular hallmarks of aging (for the review that coined these, please click here: https://doi.org/10.1016/j.cell.2013.05.039).
In the dietary supplement space, there is a lot of attention and excitement around nicotinamide riboside (with ChromaDex leading the charge with its TruNiagen ingredient), and urolithin A (with Swiss start-up Amazentis driving the research). Interestingly, Nestle Health Sciences has signed deals with both Amazentis & ChromaDex for these ingredients.
We’re also seeing more A.I. companies looking at the aging space, with Life Extension becoming the first supplements brand to launch (as far as we are aware) a product developed using artificial intelligence technology.
This is only going to accelerate and garner a lot of consumer interest.
9. The changing retail landscape
The industry continues to grow, but how and where consumers are buying their dietary supplements continues to change. Giants of the supplement retailing realm, GNC and Vitamin Shoppe, have been struggling with profitability and are closing stores, whereas as little as three or four years ago their goal was to open or acquire new locations as rapidly as possible. The Vitamin Shoppe recently debuted a new store concept, while GNC has launched dollar days around energy drink promotions. Both continue to face significant challenges.
Independent specialty retailers have been helped by the boom in CBD, which larger, more risk-averse retailers have mostly shied away from, but that will undoubtedly change if and when the risk and uncertainty around CBD is removed.
Amazon and other e-commerce platforms – and even direct to consumer brands – have benefitted from the convenience of online shopping, but not all specialty online retailers are booming. Indeed, the most recent Vitamin Study from TABS Analytics (2019) suggests that 20% online share may be the ceiling for the category.
Everyone is talking about the omni-channel approach and that shows no sign of changing, but it’s clear that some retailers will grow and some will continue to hurt.
Calls for greater transparency grow year-on-year, and those calls are coming not only from outside the industry (consumers) but also from inside, with calls for the product listing or to identify which contract lab issuing. We even seeing calls to move away from proprietary blends in the sports nutrition realm to give consumers greater insight into the actual product formulation.
From a business perspective, it can be difficult to quantify the impact of transparency, but a recent report by Pure Branding indicated that 73% of survey respondents look for brands with some commitment to transparency or consider it when shopping for products.
A bigger picture view of transparency involves how the industry is viewed by its critics. It appears the dietary supplements industry may have turned the corner on whether it is considered “unregulated”. Even the most ardent critics now acknowledge the industry is regulated (they now (justifiably) criticize the inconsistencies in enforcement of said regulation), and this could in some part be linked to greater transparency about processes and practices.
The flip side to this is the CBD category, which many will acknowledge is “unregulated” (some companies do comply with cGMPs, etc, but many products we simply know nothing about). Transparency has a huge role to play for CBD: A very simple example is that the majority of the hemp is being grown in North America so supply chain transparency and traceability should be more straightforward.
The industry has made huge strides with transparency in recent years, and it should continue and accelerate.
Have your say
What do you think about this list? Feel free to submit a comment below
Posted by Jim Lassiter,