Cannabis Companies Push F.D.A. to Ease Rules on CBD Products

Oh my, the poor, poor F.D.A., squeezed between two conflicting planks of the GOP platform. On the one plank, promoting capitalistic endeavors regardless and on the other, the party's aversion to that evil hippie-drug marijuana and all things of it... What shall they do... It having the virtues of both promotion and regulation, betcha they'll come down with something like the folic acid example cited in the article, maybe exactly like...

Pretty much all our drug problems in the US are caused by the war on drugs. Our punishments are in inverse relation to the harm each particular drug does. (Note Portugal where decriminalization has all but eliminated OD deaths). Further, to link to another issue of the day, apparently a woman's jurisdiction over the contents of her body (her womb) - a right and just situation - is hers alone, but my jurisdiction over my own bloodstream is the gvt's biz.? Finally, while woo-woo frauds like homeopathy "medications" are permitted on the shelf (Walmart, CVS) next to evidence based medications, the FDA waste their time on THIS? Please. D.A., J.D. (criminal defense), NYC

As a cancer survivor whose maintenance medicine causes joint pain (inflammatory) and insomnia, I do use CBD (sublingually & topically) for control of that pain and sublingually or in capsule form to promote natural, no-hangover sleep. (As an asthmatic I don't smoke it, and as a singer, I can't vape anything lest the hot vapor irritate my throat). What I'd like to see the FDA do is set regulatory standards for purity, consistency and safety--which it does for OTC drugs and food, but (thanks to the mostly Republican nutritional supplement lobby) refuses to do for supplements. I'd definitely pay more for standardized and regulated CBD products. In fact, I already do: I seek out only those reputable brands made from organic US-grown hemp, third-party tested by independent labs. (Such products' packaging contains either a QR code or numerical sticker, which can be entered on websites that provide purity & composition data--including that of the soil in which the hemp is grown and extraction chemicals--for that particular batch of product). Responsible CBD boutiques (and now chain pharmacies such as Walgreen's & CVS) carry only these reputable and conscientious brands--as opposed to rebadged Chinese "white label" stuff found in vape stores, head shops and truck stops. You get what you pay for.

In January 17, 1920 the Eighteenth Amendment of the United States Constitution effectively established the prohibition of alcoholic beverages in the United States by declaring the production, transport, and sale of alcohol illegal. However, Americans wanted to drink booze so the Twenty-first Amendment to the United States Constitution repealed the Eighteenth Amendment to the United States Constitution. The Twenty-first Amendment was ratified on December 5, 1933. It is unique among the 27 amendments of the U.S. Constitution for being the only one to repeal a prior amendment and to have been ratified by state ratifying conventions. Supreme court legalizes recreational marijuana, and soon to follow recreational heroin and recreational cocaine. Americans want more drugs and alcohol.

There are so many claims of CBD oil's effectiveness in treating a variety of maladies. But if the active components are at such a low level, suspicions arise. Is the substance actually helping medically, or are its users experiencing the effects of expectations? Formal double-blind trials are called for. Even if the trials show no confirmation of those effects, the remaining question is regulating the quality of the product. And, of course, prohibiting claims that cannot be so verified. Given purity of substance being tested and maintained, even clinically ineffective substances may be marketing to believers. But without unsubstantiated hype, without user testimony as to the benefits they claim to have experienced. If it's harmless snake oil, fine. But no medical claims not verified by formal trials should be permitted.

As a physician, I would not want these products made as prescription only. As a patient, I would think it ridiculous to have to ask a physician for a prescription. As was stated in medical publications several years ago, if medicalization is simply a route to full cannabis legalization, then please leave doctors out of it. The best route is full legalization of all cannabis with regulation only of process and purity.

My wife and I have used topical creams with CBD and found them to be useless and expensive. We have sourced these products from CA and WA with help from friends and family members who are knowledgeable about the topic. There are much cheaper products already on store shelves like Arnica and Lidocaine at roughly 10% of the cost of CBD infused products. The money saved by buying the cheaper alternatives would be better spent on a full body massage from a competent massage therapist. With that said, I know of more than a couple of people who use CBD creams and report beneficial results.

Millions of us smoked pot for decades, if the stuff was medicine outside producing stupor and a high we'd certainly be aware of it. This CBD is a classic racket like copper bracelets and power pyramids. It's pitiful how we let people be taken if there is a buck for businessman in it. On this note why allowing kids to become addicted to vaping is considered ethically ok is beyond me. America you simply don't understand drugs.

Before the Pure Food and Drug Act in the 1900's, "testimonials" were used to sell useless products. Looks like we are back to those days again.

Cannabis is a Schedule 1 drug, according to the FDA. A Schedule 1 drug has NO medical use. CBD has at least 1 recognized use - 2 pediatric epilepsy syndromes. Nausea and vomiting due to HIV or cancer chemotherapy may be a 2nd. Therefore, CBD can no longer be defined as a Schedule 1 drug. Making it Schedule 2 would solve most of the problems, and would ease research into its uses and side effects.

the last quote from Gottlieb about CBD for pets being absurd definitely shows how little he knows - CBD works better for dogs than it does for humans, and that's saying something...

People should be permitted to ingest whatever they like. However, as much as the pharmaceutical industry is reviled, I would still prefer to take medicine prescribed by a doctor and manufactured in a proper facility, as opposed to seeking out a local drug dealer. Problematically, they rarely take insurance, aren't always readily available and the quality can be a tad variable.

Just about everyday I get some email tempting me to buy their CBD oil product. I just laugh. I have been making my own cannabis products (legally) for well over a decade and would never go to another source. I created my own strains, make my own products, and when the folks in my building get invited over and get to try some they always say the same thing - "what on earth is this stuff and why can't I buy this in the stores". I do this for the same reason most potheads I know grow their own - its the only way we know what was or was not sprayed on the plant, and what was or was not added to that bottle that says CBD. Cannabis oil does not pour. It is without a doubt the stickiest substance I have encountered on earth. I used to make my own hash-oil and quit because of the clean up. If I were to buy a bottle of "CBD" oil I would have to wonder wear it was grown, what was used in the ground and on top (Malathion?), what extraction method was used, what residual solvents are still there, what carrier oil is added, etc. Making my own tincture at home is no more complicated than making peppermint oil from my garden for baking. And I don't use anything that says Miracle Gro on the package:)

Who cares if it is placebo or real quite honestly. Sham surgery for meniscal tears makes those people feel better ! That was a case-control study also. Anecdotal reports of CBD working are fine. You know your body. In my line of work, many rheumatoid arthritis patients take CBD "off line" and almost all report it helps their RA symptoms. Who are we to argue with this ? Also one NYT article reported how OUR GOVERNMENT holds a patent on cannabidiol ? What gives?

Legalization of cannabis and CBD make sense only if you are willing to accept the inevitable thousands of traffic deaths caused by users each year.

Just legalize cannabis. Then we can have our THC and CBD.

How about we take cannabis off the DEA schedule, since it doesn't belong there.

After listening to a physician friend of mine (who spent his career as a non prescribing sub specialist) rave about the benefits of hemp extract gummies, I decided to give them a try to help me sleep better. I took 2 gummies a day (total of 100 mg hemp extract) at bedtime for a couple of weeks, and did, indeed, sleep much better. I did experience a significant adverse experience with the gummies, however. I have been taking 40 mg of simvastatin for high cholesterol for over a decade without any problems whatsoever. After taking the gummies for the stated time, I began to notice significant muscle and joint pain, both known adverse events associated with statin use in some individuals. I spent my career in the with a flagship pharmaceutical company (research, marketing and sales) and actually was a District Manager for one of the market leading statins for close to a decade. I am familiar with the metabolism of statins, and their potential AEs. After a little bit of research (which I admittedly should have done prior to taking the gummies) I learned that there are numerous cannabinoids that are strong inhibitors of cytochrome P450 3A4, one of the primary enzymes that metabolizes statins. Inhibiting this enzyme can significantly increase the level of statin in the system with corresponding significant increase in the probability for AEs. I am very confident that the hemp extract caused an increase in my simvastatin level and resulted in my pain. I favor CBD regulation

Legal cannabis and CBD brought to you by the people who brought you the opiate crises.

Growing your own high-CBD cannabis is the best way to get the benefits of cannabidiol and the many other constituents produced exclusively by the cannabis plant. Cannabinoids and other cannabis compounds are the safest medicines in the niches they compete with, providing high efficacy, no lethal dose, and instant relief, with low potential for addiction or dependence. The F.D.A.-approved pharmaceutical drugs CBD competes with are far worse for people, and some are easily addictive and even lethal. It's amazing that people still slag cannabis and refuse to acknowledge the fact that millions of people use cannabis to deal with dozens of ailments and find that it provides unique symptomatic relief.

In the US you can go to any supermarket and buy any one of dozens of herbal supplements, many of which are known to be quite nasty, even toxic, with little to no FDA oversight. And a lot of these supplements come with wild claims about the wonders they'll work for the consumer. Listed in the ingredients of almost any canned food product is a litany of chemicals that to this day are not really known to be safe for human consumption, but they're in the can anyway for reasons as trivial as "preserving color" or keeping the contents from separating. It's still allowed to put triclosan in toothpaste, I believe, though the chemical cannot any longer be put in hand soap! So I guess I'm wondering how many more decades must pass before all things related to cannabis will no longer be met with knee-jerk reefer madness and regulatory double standards. In the grand scheme of things CBD is far safer than half the garbage selling over the counter at a CVS.

I work in a cannabis dispensary and am continually asked by customers for "CBD oil" or "pure CBD." When I explain the difference between the FDA allowed offerings (crushed hemp seed oil) flooding the marketplace and CA regulated products that are derived from whole plant, full spectrum cannabis in our CBD tinctures and topicals, they're easily confused. The testing mandates for recreational cannabis products sold in CA are much more stringent than the FDAs, and subsequently the end product is more expensive. This in turn has a good many customers leaving with a shrug and announcing something akin to "it's cheaper on Amazon, I'll just get it there." The FDA needs to step up its game and conduct more research as well as develop rigorous testing standards for these hemp-derived CBD products being sold the public. As is, a lot of well-intended patients and customers are at the mercy of unscrupulous sales pitches from merchants for a product of inferior to questionable quality.

There is no depth to which business will not sink to make money. This CBD may or may not have any real benefit beyond profit for the seller and psychological benefit for the buyer but the key issue is what, exactly, is in the stuff you are eating, drinking, snorting or rubbing on yourself? Are ALL of its ingredients safe? Do they contain residual insecticide from hemp production? Where do the other ingredients come from - China? I wouldn't use toothpaste made in China. People will consume what they want to but our health care system is already overburdened. Let's not let more desire by "entrepreneurs" to sell unproven, unregulated and potentially unsafe products burden it more.

From bad to worse. Are we repeating the drug epidemic of the 60's? Didn't we learn from the fiasco of drug addiction in Holland?

I have both my rotator cuffs torn, CBD oil, which I thought was a scam, gives me more pain relief than Advil. I have quit taking Advil completely.

There are definite problems with interactivity with certain drugs. No question about it. I just took an antibiotic And double checked and sure enough they said there was a negative reaction with CBD. check out CEFUROXIME

Maybe it’s because people have been arrested,jailed and reputation destroyed by the governments law officers that they don’t trust the same to test and tell the truth about anything to do with hemp or cannabis.

Check out a late 19th Century Sears Catalog. The big thing in marketing was electricity. Gloves were "electric". Belts were "electric". Underpants were "electric". In the 1950s it happened with chlorophyll. Chlorophyll tooth powder. Chlorophyll breath-mints. Chlorophyll soap. Schiaparelli even marketed Chlorophyll Perfume. Not that long ago, it was Oat Bran. For a while anything edible jumped on the Oat Bran band-wagon. Then came Fish Oil. More recently, the marketing catch-word became GREEN. Slap GREEN on any old product and it sold like electricity, or chlorophyll, or oat bran, or fish oil. Starting to see a pattern? So now it's CBD. Ho-hum. Barnum (or whoever really said it) was right... https://emcphd.wordpress.com

I really want to see what happens with this. I have a rare medical condition that causes constant, 24/7 severe neuropathy . Within the online community for this condition there is a lot of anecdotal evidence that CBD can help some people enough that they can cut back the amount of other medications (almost all used off label) that help somewhat but cause severe side effects. I’m very leery of this kind of show hearing (2 or 5 minute comments aren’t going to provide much usable information) after following the similar saint/sinner approach to vaping. When an assistant professor of forensic science says “We have seen a rash of reports nationwide from people being poisoned from taking CBD products.” I would like to how many reports makes up ‘a rash’ and how are they defining poisoned? Is this about actual harm or just totaling up any calls to poison control centers that even mention CBD. When “Numerous speakers cited problems with adulterated CBD products...” I’d like to know the sampling method and what amounts of adulterants were found. With CBD helping people deal with conditions for which there are no truly effective treatments available, are the regulators going to pull the rug out from under users in order to perform lengthy clinical trials?

CBD is a specific chemical entity. While it may be a natural component it is isolated through processing. If it has any medical benefit it should be subject to the normal FDA drug approval process. There are any number of natural occurring chemical entities which have been subject to FDA approval for medical use in the past; digitalis for example. Just because CBD is found in cannabis products which may be used for recreation, is not a valid reason for giving it an exemption.

Actually, the FDA's regulatory power regarding CBD as a food additive is limited to interstate commerce. If you introduce CBD into food in a state and sell it in that state the FDA has zero enforcement power. Dietary supplements are trickier, due to a very silly law which states that if an ingredient is in an FDA-approved drug it can't be sold in a dietary supplement. Last summer the FDA approved a drug to treat epilepsy in babies that contains CBD. Therefore, the pharmaceutical companies have protected themselves. Welcome to Washington. Babies are safely taking CBD. Babies. Also, the FDA has no enforcement powers when it comes to smoking or vaping CBD. These are facts missed by the New York Times.

I guess I don't have a good feeling if and when the FDA responds to a campaign of public pressure.

Sadly, the CBD tsunami has overshadowed the safe and efficacious use of cannabinoids as pet medicine. CBD the molecule, whether from hemp or cannabis is hardly the cure-all it is claimed to be; rather we use it in very small, measured amounts (to the 1/100th of mg/mL) to help dogs and cats with cancer, seizures, arthritis and anxiety. But in most cases, it is the other cannabinoids - THCa, CBDa and THCd-9 - that do the real medical work for these very sick pets. Dogs actually have more CB1 and CB2 receptors that humans in their brains so they are easily saturated and subject to the biphasic effect - too much produces the opposite result. Much more learning is needed, along with careful regulation as most of the CBD on the market is never tested by third-party labs for purity or potency. Let's hope this government can get a handle on things before it's too late.

I am not (yet) convinced that CBD should be classified as GRAS - generally regarded as safe. That is usually reserved for food additives. In pharmacology, there is no such thing as a free lunch. Any compound that has significantly enough activity to actually have a meaningful clinical effect also has a dose response, including a minimum effective dose (where we see a clinically meaningful improvement over placebo) and a maximum safe dose (where the benefits of the drug don't increase further and/or the side effects are becoming severe enough to be of concern). The problem for CBD is that, for many uses, neither the minimum effective nor the maximum safe dose is really known; a notable exception are certain forms of epilepsy. It is really up to the FDA and the NIH to expedite preclinical and clinical safety and efficacy studies on a possibly valuable addition to the treatment of several widespread conditions such as pain and anxiety disorders. I can only hope that ideological concerns will not stand in the way of actual science.

In pharmacology, there is no such thing as a free lunch. Any compound that has significantly enough activity to actually have a meaningful clinical effect also has a dose response, including a minimum effective dose (where we see a clinically meaningful improvement over placebo) and a maximum dose (where the benefits of the drug don't increase further and/or the side effects are becoming severe enough to be of concern). The problem for CBD is that, for many uses, neither the minimum effective nor the maximum safe dose is really known; a notable exception are certain forms of epilepsy. It is really up to the FDA and the NIH to expedite preclinical and clinical safety and efficacy studies on a possibly valuable addition to the treatment of several widespread conditions such as pain and anxiety disorders. I can only hope that ideological concerns will not stand in the way of actual science.

All I want the FDA to do is to regulate what can be considered and marketed as CBD oil and put out a list of tested and confirmed CBD oil products from reputable manufacturers so we know who to trust. After that get out of the way. I depend on CBD oil to keep me calm and anxiety free throughout the day. My only problem has been figuring out which company sells the highest quality and dosage... it's been an expensive experiment for me. The calm without the high, I ask you what could be better?!

I would say this reporter knows little to nothing about CBD. There's plenty of published research showing its safety and efficacy. Obviously, there needs to be more to satisfy the doubters. I use it daily for arthritis, and it absolutely works. I take nothing but CBD for it, plus it has lowered my blood pressure and reduced my anxiety. Let them try to limit its use and it will be like prohibition and people will do everything to go around policing and move it underground. I dare say some people would leave the country because their well-being depends on it.

CBD saved my life. I had debilitating migraines everyday for almost a year. I was starting to get suicidal. I tried everything and nothing worked. A friend recommended CBD and it was a miracle. Now, I take few drops under my tongue in the morning and a few drops at night and I have my life back!

"From Michelle Peace, an assistant professor of forensic science at Virginia Commonwealth University: ”We have seen a rash of reports nationwide from people being poisoned from taking CBD products.”" If someone is having a problem with cannabis or CBD it is because there is another toxin in the product. It is not from the cannabis. Extraction of the CBD and resin is a chemical process. Perhaps the people doing the extraction are not doing a very good job of purification. White gasoline (gasoline without additives) is often used as a extraction solvent and may be the real culprit. Or, whatever solvent they are using. It is probably true that the government has no system in place to assess purity. If I am not mistaken, I don't believe the feds ever assess the purity of consumable alcohol. They tend to be more interested in the taxes they collect. It is likely the case with cannabis products as well. It is absolutely also true that some of the claims made by vendors are not scientifically proven. The CBD market has been operating somewhat like the supplement or vitamin industry in that it makes claims that are only weakly or indirectly substantiated. Humans have been using hemp and cannabis for millennia. It is only in the last 100 years that we have been persecuting the use. Likely because if allowed to be free of government oversight it would negatively affect the very profitable pharmaceutical industry.

It seems clear that we are closer to extreme ends of poles than a considered middle path when it comes to both health oriented CBD and more giddy-up THC. How much of this relates to lobbyists representing the pharmaceutical and liquor industries, a quasi- religious right, legitimate medical concern and political head-counting is unclear. What we do know is that tobacco, guns and firearms are far less regulated and relatively off the meter dangerous compared to anything related to cannabis in whatever form. America in too many ways goes out of its way to police, condemn and limit individual choice. At the turn of the 20th century, we had over the counter heavy arsenal coke and gum. Turpin hydrate of codeine elixir was given to kids for coughs through the middle of that era. it's not cynical to imagine that money, rather than making prudent choices, is the biggest issue in all of this.

Why is it that some compounds, like insecticides and herbicides can be used until proven dangerous while others, like CBD must first prove that they are safe? BTW--folic acid (considered as a model for CBD regulation) is probably not as benign as we have been led to believe. It's a synthetic form of folate, and may actually reduce uptake of folate by blocking receptors. So much for FDA review.