The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act was re-introduced in the US House of Representatives in February with the aim of making hemp and hemp-derived CBD a dietary ingredient in dietary supplements.
Designated as HR 841, the bill directs the FDA to use its authority and resources to set a clear regulatory framework for hemp and hemp derived CBD and assure consumer protection. It has received widespread support from dietary supplement trade associations and hemp stakeholders, with NPA being the most notable dissenter for the bill because it fails to set a safe level of daily consumption.
“Our objection is on a few levels. It’s not that we don’t want FDA to act,” said Fabricant. “I think there are too many unintended side effects of doing it the way they’re proposing, which is effectively Congress lifting it up out of the FDA, moving it over and saying, ‘now you’re legal’… I don’t think we want that for hemp-CBD long term.
“I also don’t understand why they removed food from the equation. Safety is safety. The issue is that we have a drug and the drug was there first. Unless we have really good evidence that CBD was the article of the diet predating the drug, there’s going to be a rub there.
“Consumers are already assuming that FDA has rendered an opinion on CBD and become somewhat shocked when they find out they [FDA] haven’t.
“Folks have a lot of consumer confidence. Why? Tens if not hundreds of millions of people took a multivitamin this morning and didn’t give it a second thought, and that’s ultimately where we want CBD to be.
“In some ways I think FDA likes the status quo,” added Fabricant. “You’re seeing other governments moving ahead and so you’re seeing frustration [here in the US]. We’ve worked with the States and supported the States in moving ahead.”
Many states have introduced their own legislation around hemp and CBD, including a recent bill introduced in California, which received support from NPA.
The California bill includes “language to cajole FDA into working with California to establish a safe level”. *
“It’s not just the industry saying, ‘FDA what’s going on?’ It’s also the States. I don’t know too many State departments of health that have the MDs, the toxicologists, the vast amount of scientific know-how that FDA does, and yet the States are moving ahead but FDA’s confused. Come on FDA, get in the game.”
The speed limit analogy
Dr Fabricant also commented on the recent paper by Dr Pieter Cohen that found a number of banned stimulants in sports nutrition products.
“If Pieter had turned this over to FDA six months ago with the testing data, and said these same companies are on the market, then that’s newsworthy,” said Dr Fabricant.
“But it begs the question, I’m pretty sure FDA has access to the same internet as Pieter Cohen and how much time is FDA dedicating to looking at these things? They say, ‘we need new authority, we need a registry’. Well, if Pieter Cohen can find these products then the PhDs, the experts at FDA can’t spend one or two or three hours a week searching the web for these ingredients of interest?”
“The funny thing to us is that these are things [ingredients] that have been on the FDA advisory list. There has to be some teeth behind it,” said Dr Fabricant. “I hate the posted speed limit analogy, but otherwise that’s all it is: We’re posting a speed limit, but we never intend to pull anyone over.”
Dr Fabricant also discusses the recent import alert and product seizures by FDA from two firms that were deemed to be offering New Dietary Ingredients that have not gone through the notification process.
(c) The program shall develop and conduct studies intended to ascertain the general safety of industrial hemp.