I write a lot about FDA, and the things I say are admittedly not in the realm of Conventional Wisdom. See it here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, and here. So then, why listen to me when it comes to FDA? I don’t know what you were doing in 1980, but that’s when I had to start living under the thumb of the U.S. FDA, and the state version of it in California as well as many nations.
Starting then I made perishable vegan foods from tofu in Americanized forms, and many were exported. They were considered “dairy alternatives” legally, with separate regulations which always involve some governmental agency. Typically a food or dairy regulator, California even had an imitation dairy bureaucracy.
As well, since 1984 I’ve had to deal with the national FDA-type agencies in many other countries, especially Canada. I’ve spent hundreds of thousands of dollars in legal fees in a few countries, but that comes with the territory when you’re exporting perishable or frozen foods; or hempseed foods or lactose-free foods especially to Canada. One-third of sales of my company Rella Good Cheese Co. which was on the 1993 Inc 500 list of fastest-growing companies, were exports.
I’ve done battle with the U.S. FDA, the Canadian Food Inspection Agency, and Health Canada on TofuRella, HempRella, and HempNut. Also OMAFRA and the other Provincial regulators with TofuRella and HempRella. Japan with frozen tofu ice cream. As well in Rella and HempNut in England, The Netherlands, and Italy. Also Australia for tofu frozen dessert and HempNut, Switzerland for HempNut, and I imported hempseed grown in China, shelled in Germany, then shipped to California. In the 1980s I pushed back on California’s CDFA when it banned labelling it as “Soy Milk,” like what Miyoko Schinner got overturned recently. Played cat and mouse at retail with Provincial authorities because of local laws propping up the butterfat market long ruled illegal in the states, the “margarine laws.”
I was the first to commodify shelled hempseed, in 1996 as Hemp Nut. It was once considered “too generic to trademark” in the ‘90s, so generic that today you call it Hemp Hearts, the second-best term. That meant I was the first to import hempseed without a sterilization certificate just a phytosanitary certificate, as a food not birdseed. The first to include THC tests with import documents, as we had a $2 million import bond. More Pro than Bro.
I once managed a voluntary recall at Rella Good Cheese Co. before FDA forced me to, because it was the only responsible action. Due to a manufacturing problem by our co-packer, it wasn’t even our fault. That was our only recall in the 20 years of putting perishable foods on the shelf, coast-to-coast in thousands of stores in two countries.
I understood FDA labeling laws so well that only a decade ago companies paid me to review their labels for compliance before printing millions of labels. After everyone else signed off on them, I would usually find a handful of issues thereby potentially saving them a ton of money and embarrassment.
But admittedly I push the envelope, because someone has to. “If everyone is thinking alike then someone isn’t thinking.” I’m that “someone” thinking outside the box, contra to Conventional Wisdom. Many of the FDA compliance Rock Stars privately thank me and encourage me to keep talking. It’s hard for them as their clients will pay the price for their candor, so they explain what FDA wants in a way that keeps FDA happy. Not pissing off FDA is critical for compliance consultants.
But I’m not that, I rarely consult anymore so I don’t have to kow-tow to FDA. I sell nothing, and give away free of charge more than most who charge. Long retired, I only write The Richard Rose Report. Over 30,000 posts on CBD + Hemp, 80 free downloads worth tens of thousands of dollars, 180 original articles. I take no advertising or product, no sponsors or subscriptions, have no “Donate!” button. In 2017 I was the only hemp advocate to make the case to FDA for making all hemp flower products including CBD a food ingredient existing before DSHEA. In 2018 it did that, accepted it all as GRAS, all except CBD and flowers.
Therefore I’m the rare person with the history to see FDA through a unique compliance lens, and the independence to tell you the truth because I have no reason not to. Despite being the “fair and balanced“ counterpoint to the sycophantic parroting of unelected FDA bureaucrats unconstitutionally making new law, few in the media quote me.
FDA is at a crossroads because of Cannabis. Its long policy has been focused on single-molecule drugs, but that’s the antithesis of the Ensemble Effect ethos of Cannabinoid producers today.
For 51 years FDA has been the science experts the federal used to prop up the lie of Schedule 1 and “Cannabis has no medical value,” contra to Congressional intent and 47 states with 98% of the U.S. population, as well as 91% of public opinion.
Even the very founding of FDA is connected to Cannabis, the 1906 Pure Food and Drug Act was in part a response to safe, effective popular “patent medicines” of which Cannabis was often a major component. On U.S. shelves since 1830, they were made by many of today’s drug companies and dispensed by pharmacists.
So Cannabis and FDA go deep together. But its current position on Cannabis is here, here, and here. It’s still anti-science and grossly irresponsible, bordering on criminal. It is profoundly negligent of FDA to maintain Schedule 1 for Cannabis (or Psilocybin for that matter). Federally-funded PubMed has over 26,850 studies on Cannabis, and most show medical value. Plus, many times FDA has allowed medicines which later found to be quite harmful, so it’s not as though it is a zero-risk presumption.
FDA irrevocably lost the moral, scientific, commercial, and political high ground because of its stance on Cannabis. Therefore, Cannabis has the potential to vastly change FDA for the better. For the better in terms of scientific integrity, consumer response, commercialization, and attitude towards traditional medicine, herbal medicine, multi-molecule products, today’s gray market products, and products closer to the ground than the lab. More friendly to phyto medicines. FDA could mandate pharmaceutical production by batch using QR codes, full disclosure, and transparency; despite that being a Cannabis industry standard already, it’ll take a re-tooling of FDA to accomplish it now.
FDA’s mismanagement of CBD is but one unintended consequence of lying about the medical value of Cannabis for 51 years. How can they regulate a Schedule 1 controlled substance so awful it has no medical value and a high potential for addiction, but is also so safe and effective that it is on the market now anyway with few negative consequences. It’s Schrödinger’s Cannabinoid, and it lays bare the 51 year lie. So today they’re scratching their heads to figure out what the market already did years ago on CBD and cannabinoids. Even many states got it sorted better than FDA by making CBD regulated as a food, the Tenth Amendment approach to the issue.
Today, FDA is clearly broken as evidenced by the over 20,000 unregistered New Dietary Ingredients on the market with impunity, let alone the CBD and Delta-8 fiascoes it created through negligence.
My suggestion is for FDA to rule that like the hempseed oil it typically is naturally and unavoidably in, CBD is an ingredient existing before the 1994 DSHEA cut-off (called GRAS, or Generally Recognized As Safe). Then open an Office of Cannabis like NIH’s Office of Dietary Supplements. Staff it with Canna-believers not Prohibitionists.
Let it be evidence-based from a different perspective. That could be regulation based on process not end-product, for example. After a dozen millennia in human culture around the world, we already understand just how safe Cannabis prodcts are, even DEA ruled that “marijuana is the safest therapeutically-active substance known to man.” Start from that belief and approve new Cannabinoid medicines quickly and easily. Consider it reparations for 51 years of FDA lies, “our” DSHEA or XXIst Amendment.
Embrace multi-molecule products, since with 150 cannabinoids and 200 terpenes there are 30,000 possible combinations. Regulate intrastate producers like food or supplements, not drugs. Allow an easier path to approval, assume natural phytocannabinoids are safe unlike the man-made synthetic molecules FDA is used to regulating. Use best practice analytical standards. Make it easier to get products to market, not harder.
Cannabis has the potential to vastly improve public health and transform the practice of medicine for the better…. if only FDA will let it!