Will FDA Target Hemp Oil?

An update on the fight to protect CBD and hemp. Action Alert!
ANH-USA has been keeping a close watch as the FDA determines how it will treat hemp products. We’ve noted that the FDA has targeted CBD oil, a natural compound found in hemp that is now approved as a drug. But many other products could fall in the FDA’s net, including full-spectrum hemp oil, depending on how the agency decides to move forward. Luckily there is now a bill that would protect hemp-derived CBD from the FDA. Natural health advocates must come out in support of this important measure.
The bill is simple. It amends the law to provide an exemption for hemp-derived CBD and any “hemp-derived CBD-containing substance” from rules that apply to dietary supplements when there is an approved drug with that ingredient or if that ingredient is being investigated as a new drug. If approved as is, this bill would allow hemp-derived CBD supplements and hemp oils containing CBD to be sold.
Note that the other provisions of the Dietary Supplement Health and Education Act of 1994 still apply to CBD. Given that the FDA’s position seems to be that CBD is a “new supplement” (in FDA lingo, a new dietary ingredient, or NDI), this means that before companies sell CBD they will need to submit information to the FDA demonstrating that the CBD supplement can be reasonably expected to be safe.
With the explosion of the CBD and hemp market, and the recent legal changes following the 2018 Farm Bill, there is a lot of confusion about what currently is and isn’t legal. This confusion underscores the need to support this bill, so it isn’t left to the FDA to decide.
As it currently stands, the Farm Bill legalized hemp and its derivatives at the federal level, removing hemp’s classification as a controlled substance. Hemp is defined in the law as a cannabis plant and its derivates containing less than 0.3 percent THC, the psychoactive compound that causes a “high.” This means that hemp-derived CBD is no longer considered a controlled substance, while marijuana-derived CBD remains a controlled substance.
Additionally, the Senate Appropriations Committee approved language directing the FDA to issue a policy of enforcement discretion for hemp-derived CBD products.
In legalizing hemp and its derivates at the federal level, however, the Farm Bill also preserved the authority of the FDA to regulate products that contain hemp, whether it’s food, drinks, supplements, cosmetics, oils, lotions, or any number of products that have come to the market in recent years. In short, while the federal government loosened the reigns on hemp and hemp-derived CBD, all relevant FDA rules still apply to those products.
This is further complicated by the fact that the FDA approved a CBD drug. According to FDA rules, this means that CBD cannot be a supplement; nor can CBD be added to food. This has to do with the FDA back-channel we’ve discussed previously: if the FDA decides that clinical drug investigations on a compound began before that compound was marketed as a food or supplement, then that compound cannot be sold in supplements.
The FDA has affirmed the illegality of CBD as a supplement in the warning letters it has been sending out to CBD and hemp companies, though the agency seems to be focusing its enforcement on companies making health claims about CBD and hemp. The FDA’s stance has led to lawsuits in California against CBD companies for misleading consumers by marketing CBD products as supplements when FDA specifically said this was illegal.
But what does all of this mean for hemp oil? It depends. The FDA has said that hulled hemp seed, hemp seed protein powder, and hemp seed oil can be used in food, in part because they contain only trace amounts of CBD and THC. But full spectrum hemp oil contains a host of the beneficial compounds found in the hemp plant, including CBD. We don’t know how the FDA will treat these types of products; the agency is in fact in the process of determining its approach toward hemp and hemp-derived products. What we do know is that the FDA is, for now, focusing enforcement actions against CBD products making illegal health claims. But this doesn’t mean full-spectrum hemp oil is permanently safe.
Given the FDA’s history and their desire to protect the drug approval process, it wouldn’t surprise us if the agency leans toward a ban. But there is some reason for hope. In addition to the bill that has been introduced, the FY 2020 Senate Appropriations Committee encouraged FDA to allow CBD in dietary supplements and food, though with some restrictions. Notably, the appropriations report states, “The Committee expects the FDA to assert its commitment to identifying lawful federal regulatory pathways for CBD foods and dietary supplements if such pathways are consistent with protection of the public health.”
The FDA is already providing cover for a ban on all CBD products. Note that the report language asks for a pathway for CBD to be allowed in supplements “if such pathways are consistent with protection of public health.” In late November of this year, the FDA posted information to its website warning consumers of the harms that CBD can cause, including liver damage and male reproductive toxicity.
The irony should be clear. The FDA may claim that it is protecting public health (and not drug industry profits) by banning CBD products. Yet these products are safe, non-addictive alternatives to opioids, which are killing more Americans every year than traffic accidents. The FDA has this completely backwards.
We must support this bill to protect CBD and hemp oil.
Action Alert! Write to Congress and tell your representatives to support legislation to legalize CBD supplements. Send your message immediately.

41 comments

  2. Both my waif and I have been very much helped by CBD oil and will seriously miss and remember how this is denied to us if it is.

  3. FDA we have enough problems without you getting into this. The majority of Americans want to legalize CBD supplements and marijuana. The use of CBD among the older voting population has exploded and is not going to stop. Better this that addictive pills for pain.

  4. We continue to see the corruption within the FDA and its cozy ‘in bed’ relationship with Pharma. Pharma is terrified that they will lose a few dollars from the waking of a nation, the US, as the great brainwashed gradually come out of their slumber and look beyond Pharma for healing. The more Pharma pushes for pulling hemp oil from the market and the more they create more unsafe vaccines with which to poison all of us, the more they reveal their abject fear that the most uninformed nation ever might leave them behind.

  6. Maybe the greedy did not get to invest and control CBD early enough to reap the profits. The FDA is only delaying it’s availability long enough for the greedy to grasp control. Shame!

  9. Please support legislation to keep or make CBD supplements legal. So helpful for pain anxiety and sleep with no side effects!

  12. Marijuana, hemp, and all of its variants are plants that present no immediate danger to anyone, so it should be removed as a Schedule 1 drug and should only be regulated for reasons of age, just as tobacco is regulated. None of the extracts from the plant should be regulated any more than the plant itself is, just as tobacco and nicotine-based vaping products are.

  14. Please support any bill which amends the law to provide an exemption for hemp-derived CBD and any “hemp-derived CBD-containing substance” from rules that apply to dietary supplements

  18. Legalize CBD supplements!
    These products are safe, non-addictive alternatives to opioids, which are killing more Americans every year than traffic accidents!
    With big Parma costing enormous amounts for medicine, we need this! You are government is supposed to be on our side!

  20. Please support hemp oil as a supplement. We have imported and sold hemp as a fiber for along time. Why would there be any difference with hemp oil?

  24. If the U.S. public can encourage Congress to protect CBD from being criminalized, this might also be useful in getting the FDA to back off its efforts to similarly use its “back channel” to take kratom off the market by way of the Investigational New Drug process in the event a pharmaceutical drug is ever made from that herb.
    Kratom legality supporters, many of whom are already CBD oil fans, should consider joining in this effort to protect CBD products, while perhaps setting a precedent for protecting kratom.
    It doesn’t seem right for a safe natural botanical compound to be forbidden in the USA simply because a pharmaceutical company has chosen to use some constituent of it to make a drug.

  26. Please do what you can to legalize CBD supplements, A lot of people depend on them to help with chronic pain, and stay off opioids..

  28. CBD is a Godsend for people with a wide aray of issues not addressed by other products.
    It has few if any side effects.
    Please do NOT restrict this product in any way.
    Thank you.

  30. So wait a minute you’re telling me that there’s going to be regulation on hand but marijuana is completely unregulated and anyone and their brother and sister can grow it and sell it!?! Here in Massachusetts each adult in the household can on the six marijuana plants regardless of size Since the farm 2018 farm bill here in Massachusetts we have noticed that the FTA and the Massachusetts legislator don’t know what they’re doing as well as MDAR. First it’s OK to grow as much help as you want and then they squash it and burn everybody’s fields because the THC level is too high even though you can process the THC out of the CBD oil.
    Pro hemp people need to get together and get the rules straight so it’s fair for everyone from the farmers to the consumers. Goes to show that the federal government didn’t know what they were doing when they said it was OK to grow hemp because the federal laws do not match up with the individual state laws.

  31. I have tailored my letter to our Colorado representatives including that access to CBD has helped to lower deaths of opiates/meds. They seem to be interested in that aspect of hemp/CBD. Here it also provides jobs that would be lost if the FDA has its crooked ways.

  32. Please explain this sentence.all my “hemp” plants have been bred from “Marijuana” plants.This is a stupid differentiation.The plants are either compliant with the (utterly idiotic ).3 rule or they aren’t.That’s the only thing that makes any CANNABIS plant,”hemp” or “marijuana.”

  33. forgot the excerpt
    This means that hemp-derived CBD is no longer considered a controlled substance, while marijuana-derived CBD remains a controlled substance.

  34. We have used Hemp Seeds for the past 6 years and really enjoy their health be if it’s together with
    The exciting taste. We hope we will continue to benefit with it’s being available in the future.

  38. Sent messages, for what good it does. Our “representatives” work for the highest bidder, hence they are going to support their masters(big pharma which the fda is owned by. I can hardly wait for the we received your concerns but FU message that I know I will get from them

  39. I definitely support the legalization. I have used hemp oil and CBD. It has helped me better than any medications big Pharma has created.

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