Food Safety Risks Associated with CBD Oil Consumption

Program Description:

On December 5, 2019, at 2:00 p.m. (ET), The TASA Group, in conjunction with food safety expert Darrel Suderman, presented a free, one-hour, interactive webinar presentation, Food Safety Risks Associated with CBD Oil Consumption, for all legal professionals. During this presentation, Darrel discussed:

• Hemp farming and harvesting
• What is CBD (hemp) v. THC (marijuana)?
• Benefit claims
• CBD manufacturing process
• FDA regulatory process (GRAS guidance)
• Unregulated product safety
• Sales legality

Disclaimer: Please remember that if you are applying for CLE credit you must attend for the full 90 minutes of the LIVE presentation, not the ONDemand version. If a participant is seeking credit in states we are not approved to issue credit and the participating party seeking credit incurs a fee to receive said credit, it is not the obligation of TASA to remit payment for such credit. It is the participant's obligation to remit payment to the state in which they would like to receive credit.

About the Expert:

Darrel Suderman has more than 20 years of restaurant, product development, quality, and food safety experience. He also has seven years of food manufacturing and IT consulting experience. Darrel co-authored a food processing book and currently holds three patents. He has been an adjunct professor at Johnson and Wales Culinary University in food product development and has seven years of food expert witness experience.

Transcription: 

Rochelle: Good afternoon and welcome to today's presentation, "Food Safety Risks Associated with CBD Oil Consumption." The information presented by the expert is not to be used as legal advice and does not indicate a working relationship with the expert. All materials obtained from this presentation are merely for educational purposes, and should not be used in a court of law sans the expert's i.e., a business relationship where she or he is hired for your particular case.

In today's webinar, Darrel will discuss introduction, hemp farming, and harvesting. What is CBD hemp versus THC marijuana, benefit claims, CBD manufacturing process, FDA regulatory process, unregulated product safety, and sales legality. To give you a little background about our presenter, Dr. Darrel Suderman, president of Food Technical Consulting, has worked for food manufacturers and leading restaurant chains for more than 20 years. For the last seven years, Dr. Suderman has served as an expert witness consultant for both plaintiff and defense attorneys throughout the United States.

Dr. Suderman received his BS and MS degrees in agricultural education and his Ph.D. in food science from Kansas State University. He holds 3 U.S patents, co-authored a food processing book, and has written over 40 peer review in trade magazine articles and white papers. He has worked in research and development quality assurance and food safety for many of the leading restaurant chains, including KFC, Boston Market, Church's Chicken, Quiznos, Captain D's, Chick-fil-A, and Wendy's International. In addition, Dr. Suderman cofounded Business IQ LLC as business intelligence IT consulting company, which has been accepted as an official partner of SAP Software Company.

Attendees who require passcode the word for today is safety. During the Q&A session, we ask that you enter this passcode into the Q&A widget for CLE reporting purposes. The Q&A is located to the left of your screen. Please remember that if you are applying for CLE credit, you must log on to your computer as yourself and stay for the full 60 minutes. You're also required to complete the survey at the end of the program. Please note that the CLE credit cannot be given to those watching together on a single computer.

Tomorrow morning you will be sent out an email with a link to the archived recording of the webinar. The slides can be downloaded from the resource list at the widget at the bottom of your screen. Thank you all for attending today. And Darrel, the presentation is now turned over to you.

Dr. Suderman: Thank you. My presentation is entitled "Food Safety Risks Associated with CBD Oil Consumption." As many of you know, this is a very hot topic right now and one that's kind of been dragging along too because of the government regulations and their processes control. And will try to go through some of that today for you. I also encourage you to submit questions as we go along, we're gonna take a break in about the halfway point to look at some questions and also at the end of the program, so make sure you're jotting some of those questions down.

As a matter of introduction, over the past decade, there's been a growing interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabinoid oil, which is CBD. The FDA recognizes the potential opportunities that cannabis and cannabis-derived compounds may offer and acknowledges the significant interest in the possibilities but it's still not legal. And I think you'll kind of see that today the cat's kind of out of the bag, not only with CBD but with marijuana. I live in Denver, Colorado, so I'm very attuned to what's going on in the marijuana and the CBD world.

However, the FDA is aware some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act. And that may put the health and safety of consumers at risk. The agency is committed to protecting the public health while also taking steps to improve the efficacy of regulatory pathways for the lawful marketing and appropriate cannabis and cannabis-derived products. After all, it is primarily an adjusted compound. And it's very, very important to understand that versus cosmetics and we'll talk about cosmetics a little bit later. The fact that it goes into our bodies and we don't know that total chemistry that takes place to break down the chemistry during the digestive system and all, that's is probably the number one reason that the government gets involved in particularly in this type of product.

I've listed here, I have a couple of pages, just a presentation outline so you can follow and know the progression of events as we go through them. I'm gonna talk a little bit about hemp farming and harvesting and show you some pictures of hemp plant and some of the harvesting situations. So you get a little bit a better feel for the drug and how it's produced. And some of the benefit claims we'll talk about. And then we'll review the CBD manufacturing process. The FDA regulatory process which happens to be the GRAS guidance, so those of you that are familiar with GRAS approval, CBD is falling right in that path. Then the unregulated product safety and sales legality.

And I wanna talk a little bit about kind of a directional change that the government is making by including in the 2018 Farm Bill, basically the right to grow hemp. So we'll talk about that a little bit. I've tried to get an update on that, I'll share that with you. And schedule 1 and schedule 2 drugs and the right to try process, we'll talk about that a little bit. And then the cosmetic regulatory status, children regulatory status, pregnant and lactating mothers, pet food regulatory status. And then if I can launch the CNN film clip for about a minute is on your brain.

If you've never seen a hemp plant, here's kind of what it looks like. The upper left-hand corner shows a picture of a leaf configuration and it's very close to marijuana. And then in the upper right-hand slide, you can see the young plants of hemp growing in rows in the field and looking healthy and flesh. And then the lower left-hand picture is of a more fully-grown hemp. And then lower right-hand pictures shows a man taking the leaves in the other bark branches off and leaving the stock. We'll talk about that. But the stock goes through a crushing machine the plants, and then it's extracted with CO2 and I'll talk about that.

When it comes to harvesting hemp for CBD, I tried to put into perspective what, you know, some cost figures might be and profitability figure so you kind of know where the cash is, you know, generated. On this bit, one acre of hemp can yield...average is 700 pounds of grain and that's kind of the seed in the plants, which in turn can be pressed into about 22 gallons of oil, which would be the CBD oil and through 530 pounds of meal. The same maker will also produce an average of 5,300 pounds of straw which can be transformed into approximately 1,300 pounds of fiber. On average, hemp crops can yield anywhere between two-and-a-half to three ton of hemp fiber per acre, which means after cost farmers can make upwards of $480 or $500 per acre of profit. They can get several crops in one crop year too if the weather conditions are right and they get the right rainfall and everything.

What is CBD and CBD oil is what we've called different things early in our country's history, "snake oil." Each person can form their own opinions on that but it is a big unknown area right now. There are two main compounds found in the cannabis plant. Cannabinoid oil, also called CBD is a non-intoxicating chemical compound found in the cannabis or hemp plants. CBD will not make you high, more responsible for the high feeling associated with marijuana use is THC. The oil is in the end product of the extraction process which is usually a CO2 process. It is well documented that the oil's purity is directly related to process control. You can be sure product safety also varies with processes.

From a safety risk standpoint, there's about four areas I wanna highlight. One is variable purity basis process variations. So the keyword there is process. Then the cannabis is a plant in the cannabaceae family and contains more than 80 biologically active compounds. Most commonly known compounds are delta-9-tetrahydrocannabinol and cannabidiol, which is THC, and then cannabidiol which is the CBD. Marijuana is listed on schedule 1 of the CSA or Controlled Substances Act due to its high potential for abuse, which is attributed to a large part to the psychoactive effects of THC and the absence of current accepted medical use of the plants in the United States. So harvesting conditions are the next safety risks that can occur through the processing of cannabis and CBD.

The third area of safety risk is a variable purity basis dosage control and equipment variations. And here you see...I had a privilege of working with one company on developing some edibles with marijuana here in the Denver area. And you can either go with a little plastic pipette, so to speak, a syringe or an automatic dose application product that I have a pictured there with the red hoses on it. And then to the right, that is a functioning CO2 CBD processing plant. And you can see it's very sophisticated and costs can range probably over $100,000 just to put that kind of equipment in.

How is CBD manufactured? What is CO2 extraction? CO2 extraction is a process that uses pressurized carbon dioxide to pull the desired phytochemicals from the plant. In the world of cannabis, the process pulls all of the essential cannabinoids, terpene oils, and waxes out of the plant material. Here's the second type of extraction process and it's called supercritical CO2 and it's far more expensive to process with. It produces cannabis concentrates that are much safer, cleaner, less toxic and more cost-effective and produced en masse and more customized in terms of its cannabinoid content for the consumer. CO2 extraction is the cutting edge of the cannabis industry. However, a typical supercritical CO2 machine may cost way too much for most people to own. And for the small investor or the operator, you see you can get some kind of CO2 apparatus for about $5,000.

What are some of the benefit claims? CBD users and business owners claim CBD may be an anti-inflammatory, anti-anxiety, spasmodic and pain reliever. Though many of those claims remain largely unproven. According to medical researchers, there is significant research to support CBD for the treatment of epilepsy. And the CBD-based drug, Epidiolex, was approved by the USDA in the form of treatment. What's significant about this drug, so to speak, or this name of this drug, which is CBD is it's extremely pure. And it went through a very controlled purification extraction process. And so the government has approved this and it's something to keep in mind if you're working with clients, do a little bit more research on this. And the safety risk number four, I've mentioned three of them already, and that is a dosage variation that is mainly anecdotal or trial and error. And that puts a lot of guesswork into how effective the drug is when it's put into food products or different cosmetic applications.

What is the regulatory status and CBD in food and beverage products? You've likely have seen plenty of CBD products including sparkling water, candy, and other edibles on the market. And CBD cocktails additions are on the rise at restaurants too. There's been rumors that Coca-Cola is working on a wellness beverage with CBD and I have no doubt about that. The benefits that come from CBD-infused food and beverage depend upon the quality of the CBD and form CBD isolate versus whole plant.

"What is the Regulatory Status of CBD in Food and Beverage Products?" The author of this article, Bissex, explains that CBD works best when combined with other cannabinoids and terpenes found in the cannabis plant as they work synergistically. It's also interesting to note that CBD is better absorbed and the effects are longer-acting, which taken along with a fat source which probably indicates fat Cibo compound. Bissex says it should be consumed along with food containing some fat like nuts, trail mix, nut butter on crackers, yogurt, not fat-free, or guacamole in tortilla chips. Doses can vary from 2 milligrams to 100 milligrams. So it's important to work with a medical professional to decide what is right for you.

What is the right FDA regulatory role and the Drug Enforcement administration's role? The FDA is research, approval, regulation, and some enforcement. But the primary enforcement agency within our government is the DEA or the Drug Enforcement Administration. It is a federal agency responsible for enforcing and controlling substance laws and regulations in the U.S. And as such should be consulted with respect to any regulations and requirements they have regarding the import and export of products containing cannabis.

Is it illegal to sell products containing CBD? Well, general information about the import-export drug products regulated by the FDA can be found online here. The Drug Enforcement Administration is the federal agency responsible for enforcing controlled substance laws and regulations in the U.S. And as such should be consulted with respect to the regulations/requirements that may have regarding the import or export or products containing cannabis. Please see information about importing and exporting through this link. Regarding imports, if it appears that article is adulterated, misbranded in violation of section 505 of the FD&C Act are prohibited from introduction or delivery into interstate commerce. That means being able to move from one state to the other, very restrictive. Okay, I'd like to take this time to answer some questions. Rochelle, do you have any questions?

Rochelle: Thank you. If all the attendees could enter in the passcode for today in the Q&A section, which is safety, and any questions that you have. Our first question, what seems to be the biggest health opportunity for using CBD oil?

Dr. Suderman: From everything that I've read, it seems to be the control of pain and involuntary muscle action, quivering or things like that. That seems to be the two opportunity areas that get the most attention. And I can find more articles on that particular application.

Rochelle: Thank you, you can continue with the presentation.

Dr. Suderman: Okay. Let's talk a little bit about the cosmetic regulatory status. The cosmetic is defined in 201(i) as (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing and beautifying, promoting attractiveness, or altering appearance, and (2) articles intended for use as a component of any such articles with one exception, that is soap. If a product is intended to affect the structure or the function of the body, or to diagnose, cure, mitigate, treat, or prevent disease, it is a drug," in our government's eyes, or possibly both a cosmetic and a drug even if it affects the appearance.

The FDA can take action if it has information that an ingredient or cosmetic product is unsafe to consumers. Consumers can report the adverse events associated with cosmetic products via FDA's MedWatch and reporting system either online or by phone, or by contacting your nearest FDA district office consumer complaint coordinator. For more information, please see the FDA's web page on how to report a cosmetic related complaint."

Under the FDA FD&C Act, cosmetic products and ingredients are not subject to pre-market approval by FDA, except for most color additives. Certain cosmetic ingredients are also prohibited and restricted by regulation. But currently, that is not the case for cannabis and cannabis-derived ingredients. Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements. And no ingredients, including cannabis or cannabis-derived ingredients, can be used in a cosmetic if it causes a product to be adulterated or misbranded. In other words, adulterated and misbranded are pretty much the standard in the food industry too. A cosmetic generally is adulterated if it bears or contains any poisonous, or deleterious substance which may render dangerous to users under the conditions of use prescribed in labeling. And under such conditions of use that are customary, as usual of the FD&C Act 21.

Now let's look at the role of CBD in pet food industry. And I've heard more information and more work that's going on in Canada than in the U.S. But the FDA is aware that some cannabis product is being marketed as animal health products. We want to stress that the FDA is not approved cannabis for any use in animals. And FDA cautions pet owners against the use of such products and recommend that you talk with your veterinarian about the appropriate treatment options for your pet.

Now, I followed that recommendation in talking to my vet about my dog because he had hip dysplasia when he was young unfortunately, it's not inhibited as he's got older. But I talked to him and what I found from the veterinarian is that the veterinarian was ill-informed on CBD. He had heard about it, but he hadn't, you know, personally researched and learned as much as he can. Also, my daughter and her husband have a black Labrador dog and they bought some CBD here in Denver to take to their home in Illinois. And again, they purchased and they put it into the dog's food without really fully understanding the level of effectiveness. So it's kind of a hit or miss application for pet foods.

Now, there are some companies I think in Canada that are very specific with their levels, they have good manufacturing practices and probably lead the industry in that area. Signs that your pet may be suffering adverse effects from ingesting cannabis may include lethargy, depression, heavy drooling, vomiting, agitation, tremors, and convulsions. If you have concerns that your pet is suffering adverse effects from ingesting cannabis or another substance containing cannabis, consult your veterinary, local animal emergency hospital or Animal Poison Control Center immediately.

While the agency is aware of reports of pets consuming various products of cannabis, today the FDA has not directly received any reports of adverse events associated with animals given cannabis products. Another experience that I've had is not with the pets but just personally I've been working with a therapy for a back condition that I have. And they have a three-foot display of all kinds of CBD products and selling them. And again, I have no personal issue with using them, but at the same time, what is that right usage level, and that's the big question here.

When it comes to pregnant and lactating women, the FDA is aware that there are potential adverse effects with the use of cannabis products containing THC in pregnant and lactating women. Published scientific literature reports potential adverse effects of cannabis used in pregnant women, including fetal growth restriction, low birth rate, preterm birth, small-for-gestational-age, neonatal intensive care unit admission, and stillbirth. Based on published animal research, there are also concerns that the use of cannabis during pregnancy may negatively affect fetal brain development.

The American College of Obstetricians and Gynecologists recommends that women who are pregnant or contemplating pregnancy should be encouraged to discontinue cannabis. In addition, ACOG notes that there are insufficient data to evaluate the effects of cannabis use on breastfeeding. And pregnant and lactating women should talk with health care providers about the potential adverse effects of cannabis use. And again, you can talk to your provider but if they're not educated up to speed on some of the most current sciences, you're not getting probably the level of help that you want.

When it comes to children, the FDA has approved Epidiolex which contains a purified form of the drug substance CBD. In other words, it's the purest form, it's been approved, it went through the analytical testing and everything. I think it offers one of the best opportunities for people who feel that they absolutely need in CBD. And it's a treatment of seizures associated with Lennox-Gastaut syndrome or Dravet. This particular drug safety product is safe and effective for its intended use. Controlled FDA's drug approval processes passed the drug along with the intend to use.

Controlled critical trials testing the safety and efficacy of effectiveness where the FDA has concluded that the FDA's drug approval process is the most appropriate way to bring cannabis-derived treatments to patients because of the adequate and well-controlled clinical studies. Prescribers can also have confidence in the drugs. Uniform strength and consistent delivery, serious epilepsy syndrome. So this is truly an area of hope and opportunity, this Epidiolex, and I'll be following it as the years progress and advances in this chemical continue to move forward.

What should I do on the other hand if my child eats something containing cannabis or it could be a pet too? With the exception of products such as hemp seed ingredients discussed in question two which have been evaluated for safety, it is important to protect children from accidental ingestion of cannabis containing products. FDA recommends these products are kept out of the reach of children to reduce to risk.

What should I know before I make a purchase for myself or my pet? According to recent studies by researchers in the University of Pennsylvania, nearly 70% of the CBD products sold online are mislabeled, meaning some contain no CBD at all while others contain amounts beyond what's listed on this label. And again, this gets to the dosage control which we mentioned earlier. The study also found that one in five CBD products contain traces of THC. CBD products sold online or to customers without a medical marijuana card should not contain any THC. Bissex advises buying CBD products that are full-spectrum and from a company that provides ingredient lab testing to prove that what is claimed is actually in the product. Bottom line, make sure to read labels carefully before purchasing and speak with a dispensary pharmacist and store representative if you're unsure about the product.

I mentioned the Farm Bill of 2018 and I wanna give you as much of an update as I can on this. This allows pilot programs to study industrial hemp that was approved by both the U.S. Department of Agriculture and State Departments of Agriculture. This allowed small scale expansion of hemp and cultivation for limited purposes. The 2018 Farm Bill is more expansive, it also allows hemp cultivation for limited purposes. The 2018 programs were studying market interest in hemp-derived products. It explicitly allows hemp-derived products so long as the items are produced in a manner consistent with the law. And where we're seeing a lot of the hemp growing is in the Farm Bill areas in the southeastern part of the United States. And it's interesting and what I've found that most recently I had a neighbor who him and his family vacated their residence across street from where I live in Denver, and they went to Florida, bought a home and got involved in the hemp industry. And they were supposed to get all full legal authority to start working on hemp around September 1st. That date has passed and gone and I'm waiting to hear back from them on when they get the freedom to go ahead and start planting hemp and cultivating it in U.S soil.

First, as noted above, hemp cannot contain more than 0.3% THC per section 10113 of the Farm Bill. Any cannabis plant that contains more than 0.3% THC should be considered non-hemp cannabis or marijuana under federal law and would thus face no legal protection under the new legislation. So really it's an effort to get purity into the product and to help on the dosage control aspect of the product.

Second, there will be significant shared state-federal regulatory power over hemp cultivation and production. Under Section 10113 of the Farm Bill, State Department of Agriculture must consult with the state governor, the chief law enforcement officer to devise a plan that must be submitted to the secretary of ag of the USDA. The state's plan to license and regulate hemp can only commence once the secretary of USDA program approves the state's plan. So again, you get the federal-state power trumps the local state. So federal over local and we see that in a lot of other cases I have worked on. This system of shared regulatory program is very similar to options states had in other plans under the OSHA, both of which had federally run systems for states opting out of their own systems.

What are schedule 1 drugs? I mentioned that before schedule 1 drugs or substances or chemicals that are defined by the federal government as drugs, with no current acceptable medical use, and a high potential for abuse. And you see some of the main ones here in addition to marijuana, there's heroin, methaqualone, peyote these are some of the drugs that are considered to be section 1.

Difference between section 1 and 2 drugs are that level 2 drugs create a severe psychological and physical dependence. The biggest difference between a schedule 1 and schedule 2 drug is the latter often contain substances or drugs prescribed for medical use in the United States. You can see some of the level scheduled 2 drugs are cocaine, amphetamine, methadone, oxycodone, fentanyl. So these are some of the drugs and they're schedule 2.

Right to try process, I mentioned this earlier and I think it's one of the best go-forward options that we have as citizens of this country. And that's the right to try process because everything that I've researched and found, it...Federal government works slow and there doesn't seem to be any way necessarily of speeding them up. But if you can have a loved one or a cousin or whatever you might be in the family that is in a severe health situation and CBD might help them and save their life, the government has a path for that process to occur. And it's called the right to try process, information is available on the FDA website about it. RTT is designated to facilitate access to certain investigational drugs through direct interactions between patients, and physicians, and drug sponsors.

The FDA is not involved in these decisions. Sponsors developing drugs for life-threatening conditions are responsible for determining whether to make their products available to patients who qualify or access under the RTT. If you are interested in RTT, you should discuss the pathway with your licensed physician. Companies who develop drugs and biologics, also known as sponsors, can provide investigational drug under RTT and they are able to provide the drug biologic under the RTT Act and not be worried about the threat of a lawsuit or anything back then.

See if I can launch this. Doesn't look like I can. In summary, you know, I came up with the conclusion that it's still FDA's way or the highway. I hate to be negative, but that's the way it is. It's interesting though that...like I said earlier, the cat is out of the bag and people are using and finding applications and industry is improving their extraction capabilities from equipment standpoint. The drug approval process, which this would be, follows the original GRAS process, approval process. Right to try is an avenue that gives some hope.

The Farm Bill is slow in Florida was up against the September 1 deadline and Dorian Hurricane brought some slowness to it, some barriers. Effective CBD and THC on brain chemistry is not fully understood. And the fact that Epidiolex was approved by the FDA as a form of treatment and no other, so it's very restricted. There's some references that I used that you can follow. There's one that I have not read the book but it seemed to give an alternative view it's called "Tell Your Children The Truth About Marijuana Mental Illness and Violence," is a 2019 book by Anderson Berenson. So just something else to consider as you research this topic further. This might be it here.

Rochelle: Thanks, Dr. Suderman, we do have quite a few questions.

Dr. Suderman: You're welcome.

Rochelle: If all the attendees can enter in the passcode for today, which is safety, and any questions you may have. Our first question is what part of the plant is THC and what part is CBD?

Dr. Suderman: It's actually the entire plant. Hemp from where CBD is extracted from is a part of the same family that marijuana plant is. And so they both basically have the THC in the same location in the bud. So that's all I can say on that right now.

Rochelle: Next question, is there any other extraction process outside of the CO2 option?

Dr. Suderman: There are some, but the industry is kind of moving away from them. One is butane extraction, and I think there's a few others like that. But the industry is clearly moving away from that so they can get the purity and not have any derivative ingredients left in the product.

Rochelle: Next question, are you aware of any mass manufacturing processes for CBD that go beyond CO2?

Dr. Suderman: No, I don't. I'm not aware of that right at this moment.

Rochelle: Next question, where do you hemp seeds come from?

Dr. Suderman: They come from the hemp plant and the floral part of the plant. And as I mentioned earlier, when I had the slide that talked about the cost or the profitability of the plant, the seeds are in the flower or the bud so to speak so that's where you can find them. And the rest of the stock as I mentioned, I showed a couple pictures, that's where they extract the fiber to make clothing and other types of products with the fiber.

Rochelle: Next question, is CBD oil likely to show up on a drug test or cause someone to fail a drug test?

Dr. Suderman: That's a good question. I don't have an exact perspective on that. I have not heard it be an issue. I think the separation of definition really gets down to whether it's a schedule 1 or schedule 2 type drug or they really find THC in the blood. But I haven't talked to an employer or HR group to really know that for sure. I apologize for that.

Rochelle: Next question, what was the effect of CBD on your daughter's lab?

Dr. Suderman: Well, unfortunately, I think he's up against some age problems. And right now, at this moment, he hasn't eaten for about three days and drank water and they can't get any food into him. So he's had some other age complicating factors that have entered into the process here. So we're expecting an unpleasant phone call any moment.

Rochelle: Next question, I have heard that CBD creams can help things such as muscle aches and arthritis, is this true and how does it work topically?

Dr. Suderman: I'm not sure topically how it works. What I would assume and would be the best way from what I understand of CBD is that topical would be to mix it in with a cream and then rub the spot on your arm or your body that you want some relief for and apply it that way. What was the first part of the question? I think I forgot that.

Rochelle: That they heard that it can help muscle aches and arthritis.

Dr. Suderman: Yes, I've heard the same thing and in addition to that, also spasms. I'm particularly interested in it because my parents both have severe cases of Parkinson's disease and it's supposed to be effective in controlling spasms. And I've heard the pain issues. I've talked to people, friends and people that live in the neighborhood that have been involved indirectly or directly, and they seem to all agree that it does help. And, you know, it causes people to then begin questioning the government because you're holding up and we don't wanna wait 10 years before we have a process approval of a product. And so it's kind of a discouraging hope. And that's why I mentioned, in extreme cases, why the pure form and the right to try are good opportunities for people in that area too.

Rochelle: Next question, what is the difference between full-spectrum and isolate?

Dr. Suderman: Full-spectrum and what was the other comparison?

Rochelle: And isolate?

Dr. Suderman: I think the full-spectrum...you know, the hemp plant has somewhere around 70 different compounds in the plant. And I think marijuana is pretty much the same, there's not a little bit more. So those are all the different compounds that need to be removed so that you have a really pure form. And if you do a little Google search on compounds in hemp plant in the marijuana, you can get a listing of those plants in those compounds that you can read up and do a little more research on your own too.

Rochelle: Next question, why would you need to go through the RTT process if CBD is legal?

Dr. Suderman: Unfortunately, CBD is not officially legal right now. But if you wanted to go through a legal process, the right to try would be the only true option available where you wouldn't have to worry about, you know, breaking the law or knowing what the government can do. I mean you can buy CBD here in Denver at about every second street in the town I think. And you're starting to see it in exercise gyms and that kind of thing and different restaurants, they put a drop or two in for you in Coke or something like that. You know, you can do all those things, but no one knows for sure exactly what level is the right level and what you should be using and that'll hopefully come with time.

Rochelle: Next question, when will the FDA offer more guidance on this and safety?

Dr. Suderman: That's a very insightful and good question. I don't have the answer. I don't believe anyone else has the answer. I think some of these approval processes are years in the making and developing. Maybe if they work hard on one, they can get it done in two or three years. But that's the discouraging part about using this drug because, you know, you could talk to people and they say, "I use it, I smoke marijuana to relieve pain," and it's illegal. And it's illegal mainly for the usage and application standpoint, rather than what its competition is.

Rochelle: Next question, what is the GRAF process?

Dr. Suderman: GRAF? I have to apologize I have to look that up I'm not sure exactly what that is. Or would you be referring to GRAS? GRAS?

Rochelle: Probably GRAS, yes.

Dr. Suderman: GRAS project is what they call generally regarded as safe. And it's been more in the light or in dealing with different colors, artificial colors and natural colors, in food products such as red, blue, yellow, those types of colors. And basically, it looks at is it a product that is commonly used years ago such as 50 years ago or so? And what is the application? Has there been any side effects? It requires testing. So it's an approval/testing process that you can find it in the code federal regulations for food. And that's about all I can say right now, it's just a process that's used to approve the ingredients such as a natural color or something like that, that it hasn't had a track record of any negative, you know, reports or anything like that.

Rochelle: Next question, so the use of CBD in cosmetics is okay to use and safe to use?

Dr. Suderman: I don't think that's exactly true. The application...what you have to do is you have to demonstrate that it is safe and effective. In other words...if you remember I had a couple of comments in there about does it change the skin in any way? And that's what the government is looking for is, does it shrink the skin, or does it take wrinkles out, or whatever it does, that affects the skin directly, that has to be proven to be safe and effective in that area.

Rochelle: Next question, have you seen anyone turning hemp into a powder to get the CBD and safety?

Dr. Suderman: No, I have not seen it or not read anything on that. I'm sure it's being done, the fact that a listener brought it up, but I don't know anything more beyond that.

Michele: Next question, what are the safest ways to store CBD oil? What is the shelf life?

Dr. Suderman: I don't have the specific answers for that. But just speaking as a food science professional, maintaining it at refrigeration temperatures would be preferred over room temperature or any kind of warm holding cabinet just because the compounds, if they have any fat in them about that, it prevents lipid oxidation or fat oxidation. And that would be the thing that I would think about in considering consuming that product or storing it for a long period of time.

Regarding to the length of the shelf life, again, I would say you don't want it as long as you can do it but I would say at a refrigerator temperature standpoint it should hold up for at least six months. I know that one company I work for, we processed fats and you measure the shelf life of the fat by what they call an active oxygen method or AOM. And this particular company, Durkee Oils, [inaudible 00:53:52] and that kind of thing, it had a 400 AOM. There are oils out there with a 100 AOM. Beyond that, they drop off considerably.

Rochelle: Next question, do you know whether recent pressure from Senators McConnell and Schumer to get the FDA to issue guidance on CBD is going to be successful in the near term?

Dr. Suderman: You know, just speak from what I've heard, and I believe that it will be successful. It seems like they're both committed in opening up the doors for hemp production. So that's my understanding that it will eventually take place. And they, I believe, from what I've heard, have been a strong supporter of this Farm Bill 2018. There's probably gonna be some adjustment in the 2019 Farm Bill. It'll be interesting to watch to see what that is.

Rochelle: Next question, what do state regulations look like regarding CBD products, any requirements?

Dr. Suderman: To my understanding, even though it's illegal from a federal standpoint, from a state standpoint instance, an example would be the State of Colorado, there are no restrictions on that at this time.

Rochelle: Next question, has CBD been used for processing?

Dr. Suderman: You know, I don't have a specific case in mind, but I've heard that to be the case. You know, I run into the same situation other people, I thought, well, I'll put a couple drops in ice cream or something. But no one knows exactly what level turns the tide, you know, to a positive experience. And I think I, personally speaking, would like to use it if I knew exactly what was effective, you know, how pure is the product, how many drops of the liquid would I put into a food application, how often should it be, and is there a way to measure its effectiveness post-consumption? And that's just kind of my personal view on it, my opinion so to speak.

Rochelle: Next question, will poor quality CBD come up positive on a drug screen for THC?

Dr. Suderman: Oh, that I don't know. I have to look that up and research it, but unfortunately, I can't give you an exact answer on that at all.

Rochelle: Next question, will hemp cooking oil help with arthritis or should a person with arthritis use a different kind of hemp oil?

Dr. Suderman: CBD is the primary hemp oil so you're pretty much restricted to that. And as far as its application, in my opinion, what people need to do is just right now until some company or some government agency that proves the concentration level, it's just trial and error. And what I think is unfortunate is that leaving it to trial and error doesn't give you the help and the direction and the educational guidance on the chemistry and its effectiveness, that's unfortunate. But right now, the government is saying you can't use or sell it than what I mentioned earlier, this drug and right to try. That's all I can say right now from my knowledge and what research I've done on this subject.

Rochelle: Next question, what is the likelihood that the U.S. government will legalize marijuana on a federal level?

Dr. Suderman: Well, it's likely...I'll just give my personal opinion, I think they will. I think the cat is out of the bag. I get several marijuana magazines, both from the U.S. and Canada on a monthly basis. And I fully believe my personal opinion is that it's gonna be approved by the government. And the agencies are gonna have to scramble to do the testing and get everything, approval plan in process that is quick and easy and gives people answers quickly.

Rochelle: Next question, I've heard some concern about CBD linked to liver problems, any knowledge about this type of research?

Dr. Suderman: No, I don't. And in my research, I haven't found a university...there are some pretty prominent universities like University Hospital in Cleveland, Ohio, and others that have been working on this. But I can't give you any answer that's legitimate right now on that.

Rochelle: Next question, is there a decrease in CBD effectiveness when heated such as when you use it in culinary content?

Dr. Suderman: That I don't know. I would assume that when you heat it or put it into the secondary process on the skillet or saute, the fact that it's...I believe its oil-soluble helps keep that product in its effectiveness. But I haven't seen a research article. Again, this illustrates probably a good observation how culinary chefs and others like that are you using a product and experimenting with it. And as long as the government isn't shutting them down, probably that'll continue and they'll be at the forefront of development of products in that area.

Rochelle: And our last question, do you think that pharmaceutical firms discount CBD because they won't make money?

Dr. Suderman: No, I don't think so. I think there could be a lot of profit made on this product and you think of the foreign implications and the ability to ship products manufactured here in the U.S., as we are a leader in that industry, to countries around the world. I think it'd be a great opportunity for profitability. That's my personal take on it.

Rochelle: Thanks, Darrel. And just to let you know, all unanswered questions will go directly to Dr. Suderman for him to answer them as we don't have enough time to answer all the questions that were submitted. Please remember that if you are applying for CLE credit, you must have attended for the full 60 minutes of this presentation. You're also required to complete the survey at the end of the [inaudible 1:01:16].

I want to take this opportunity to thank everyone for attending and most especially Darrel Suderman for his time and effort in creating this presentation. If you would like to speak with Darrel or if you would like to speak with a TASA representative regarding expert witness for a case you are working on, please contact TASA at 1-800-523-2319. One of my colleagues will be following up with you regarding your feedback on today's presentation. Again, thank you all for attending. This concludes our program for today.

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