Israelsen, who is President of the United Natural Products Alliance (UNPA) and was one of the key architects of the Dietary Supplement Health and Education Act (DSHEA) of 1994, said this recent announcement coupled with FDA’s plans for a new regulatory pathway for CBD is “probably the news of the year. This is a really big deal.”
On hearing FDA’s proposal for an Office of Food Chemical Safety, Dietary Supplements, and Innovation, Israelsen told us that his first response was, “a wave of nausea, and that is because the number two priority in DSHEA is dietary supplements are not food additives - full stop. Congress agreed and that is one of the Ten Commandments of DSHEA, and to see those two terms next to each other under the same office, I found disturbing.
“And then I looked at ‘Innovation’ and thought, is this where risk reduction comes in because it’s the same kind of thinking,” he continued. “Food additives are chemicals that have some technical benefit, but they also come with safety risks. Now in this world of biotechnology, I’m wondering if this innovation is going to look at novel, potentially risky, unknown, where risk reduction theory is what we have to apply.
“If that is what that innovation office is doing, then we’re smack between food additives and all this other stuff that will be considered unusual, new, potentially risky, and then where does ODSP fit into all that? We do not know.
“The combination of these two major announcements in a relatively short time I believe is probably the news of the year. This is a really big deal.”
Israelsen also discussed the ongoing saga around attempts to regulate hemp-derived CBD as a dietary ingredient, a position that is not supported by the FDA. Indeed, in a recent FDA webinar, "A New Way Forward for Cannabidiol and Other Hemp Products”, the Agency stated that it wants Congress to come up with a new regulatory pathway for CBD – not food, not quite drug approval, but something closer to dietary supplements without being a dietary supplement.
“They [FDA] said what they said in their webinar,” said Israelsen. “The takeaways, as far as I’m concerned, are pretty clear now: FDA has reached the conclusion that they just can’t regulate CBD. They can’t do it for a couple of reasons: They always start with an equation, there has to be a plus and a minus. They started with CBD with a score of zero for benefit. Then you begin to look at the risks. Their conclusion is that, end of the day, we [FDA] have to allow something into the market that we consider safe enough for consumers to use, and we don’t think we can do that [with CBD]. Consequently, we’re not going to, and we’re asking the Congress to step in, and if they choose to follow our recommendation, our proposal to create a harm-reduction category or risk reduction. So, what exactly is that?
Israelsen said that tobacco is the obvious example. “There’s a public demand and interest in it. FDA says nobody should be smoking, and yet FDA is required to regulate it,” he said. “What did they do with tobacco? You tax it, you put grotesque images of what happens when you smoke, big warnings, no advertising on TV or elsewhere, behind the counter. That’s a pretty good description of what we might be seeing in terms of CBD: limited pack size, security packaging, cautions, warnings, low dose – very low doses… it would make it unattractive to consumers.”
The big question, he added, is whether Congress has any interest in doing this. As of today, there is H.R. 1629, for example, which is a very straightforward bill that seeks to establish hemp-derived products, including CBD, as lawful dietary ingredients subject to an NDI [New Dietary Ingredient] review by FDA. The Agency has already rejected several NDI notifications and has indicated it doesn’t think it can regulate it this way, which suggests H.R. 1629 is a non-starter, said Israelsen.
This then leads to a new risk-reduction category, he said.
“The bad news is that the CBD industry desperately needs resolution. It’s been five years, and companies are running out of money, they’re dropping out of the market. The fear is that legitimate companies that have made legitimate investments, and in good faith really felt that FDA would play ball, are now left holding the bag.”
The tail wagging the dog
Israelsen also discussed a proposal in California to ban titanium dioxide, TiO2, a chemical that makes capsules white.
“It is being seen as a big issue in the industry. There’s enough [use of TiO2] in the industry that it’s a great concern. It’s fairly widely used. I’m aware it’s been banned in Europe.
“My latest information is that this appears to be a done deal in California,” said Israelsen. “We’re hoping there’s a chance to negotiate with the sponsors of this in terms of a phase-in period so it can be managed in an appropriate way, otherwise you’re going to end up with a lot of dead inventory that would have to be tossed.”
UNPA Members Retreat
The conversation finished with some highlights from the recent UNPA Members Retreat in Hawaii. Watch the video for the full conversation.