A Regulatory Journey – Putting 2020 into Perspective

As I sat down to write this piece, it ultimately became part reflection, part snapshot. This next decade is going to be interesting for our supplement marketplace.

There were numerous conversations last year about the 25th anniversary of DSHEA and that law’s impressive longevity from any changes. Some would argue that FDA’s guidance(s) on NDIs marked the agency’s attempt to make right an aspect that they were unhappy with – the process of ensuring that a new dietary ingredient established safety prior to entering the commercial marketplace. Absent agreed guidance, many in industry took the food ingredient route and established their ingredients as self-affirmed GRAS (Generally Recognized as Safe). FDA and others (CSPI etc) have criticized this ‘easy way out’, arguing that the self-affirmation rubber stamp was grossly inadequate, but supporters argued that the NDI process was too costly, overly burdensome, and stretched authority.

In 2004, FDA issued dietary supplement Good Manufacturing Practices (GMPs) referenced in DSHEA 10 years earlier. Over the next few years, GMP inspections commenced with deficiency patterns that had many in industry, FDA and detractors concerned.

A common theme emerged in both NDI/ingredient and GMP enforcement – lack of adequate resources. Originally, industry conspiracy theorists determined that there was a certain willful neglect to enforce on the part of the agency – FDA never wanted the industry to thrive, fundamentally disagreed with the tenets of DSHEA and was giving the industry every opportunity to be exposed as a serious safety risk with a deliberate intention to not comply. Over the years, with dedicated dialogue and eventually the emergence of a more collaborative agency, specifically under its current leadership with Steven Tave as Director of the Office of Dietary Supplement Programs (ODSP), this voice was replaced with a more moderate tone that varied from ‘wait and see’ to let’s take a pass with a more friendly FDA on what a revised DSHEA could be. For many though, the original distrust remained.

The NDI debate remains intense. There have been numerous discussions about the Old Dietary Ingredient (ODI) provision and what a true grandfathered list of ingredient present in the marketplace before DSHEA would look like. There are new processing and manufacturing techniques not conceived 25 years ago – would their use mean that old ingredients were now new? If you’ve been selling an ingredient for 25 years, an expensive and potentially inconclusive process to revalidate it would be a literal deal-killer.

Plus, we’re a safe industry. While FDA and others assert that there are risky products out there, the reality is that serious adverse events remain rare, with very few ‘signal’ milestones, considering the size and scope of our industry. In fact, the only major events I can recall include FDA banning the sale of supplements containing ephedrine alkaloids in 2004, and the Hydroxycut, Garcinia cambogia – liver toxicity related recall of 2004 and 2009. Certainly there have been other issues and warnings – for weight loss and other supplement categories, but these are most often for the presence of undeclared drugs and drug analogues – not really supplement products at all, and there have been a couple ‘disagreements’ over new ingredients introduced through the body-building/sports channel.

Enter CBD, and the very volume and scope of new entries creates new risk.

Suddenly, the voices are strident, certainly not all in sync and the magnifying glass, instead of being on the $46 billion US supplements market, is on this burgeoning new group of products, and more importantly companies offering this classic ‘new dietary ingredient’.

Arguably, DSHEA 2.0 is now inexorably interwoven with the future path of CBD, and when you consider all the enforcement gaps, new rules like FSMA, the explosion of new products and channels – well, there was no way that FDA was going to keep up, let alone catch up.

This past December, Dr. Peter Cohen and attorney Scott Bass penned a piece in the New England Journal of Medicine. The key points of the article are well summarized on the United Natural Product Alliance (UNPA) here.

The article addresses the topic of NDIs and dives directly into product registration. The topic of a mandatory product registration system has come up over the years, now with increasing frequency. A few years ago, the Council for Responsible Nutrition (CRN) introduced the ‘Supplement Owl’, a voluntary label database that it suggests could form the basis for mandatory product registration. Not everyone in industry agrees, and the new CBD Wild West market will almost certainly offer its own vocal pushback.

While not everyone agrees about how the FDA is doing its job and the tools it is using, one thing that almost all of responsible industry agrees on is that FDA needs more funding. Another general agreement is that FDA needs to be more vigilant in enforcing existing regulations and rules, no matter where DSHEA 2.0 or CBD end up.

In a piece this last week, Josh Long and Natural Products Insider wrote about the recent omnibus appropriations bill signed by President Trump that provides $3 million additional funding for ODSP “towards enforcement of DSHEA (Dietary Supplement Health and Education Act) including inspection and enforcement activities.” The article notes that this increment is on top of a fiscal 2019 $7.8 Million amount, so represents a significant addition, with much of the money to be used on new hires (ODSP has 25 full time staff currently).

There are so many enforcement areas no matter which side of the universe CBD lands on that probably represent risk, so it’s not a done deal that NDIs and product registration get dealt with using incremental funds. It is though, an area where more certainty and a friendlier, transparent process makes for enhanced compliance, more submissions and presumably approvals. And, just this week Congress introduced a bill to legalize CBD–see this piece

I’d hate to be that guy that says that CBD will define any part of an uncertain future. This industry is far more than CBD, but it is CBD that is on everyone’s radar, and augmented resources or not, CBD will take a disproportionate amount of FDA’s attention, and I think that is unfortunate.

~Len

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