Dr. Sibyl Swift & Lance Blundell: cbdMD Re-Educates the FDA on Hemp | Episode #089

https://blog.priceplow.com/podcast/sibyl-swift-lance-blundell-cbdmd-089

On March 27, 2023 we hosted a tremendous conversation with Dr. Sibyl Swift and Lance Blundell of cbdMD, a premier hemp-based health solution company that sells CBD — and even THC — based supplements. In Lance’s words, they are a “hemp-extracted cannabinoid company”.

Dr. Sibyl Swift and Lance Blundell of cbdMD set the record straight on CBD and hemp-based products and help explain what the FDA is doing wrong about them.

Sibyl is cbdMD’s Chief Science Officer & VP of Regulatory Affairs, while Lance is the General Counsel at cbdMD. Together, they provide a powerhouse combination of science and regulatory affairs, and in the hemp-based industry, there’s plenty to discuss on that front.

After getting into their backgrounds, we discuss the ongoing issues between the FDA and CBD supplements, how cbdMD can legally sell THC products online, what CBD can actually do for consumers, and they problems a legitimate company like cbdMD faces in this wild world.

This one’s a good one, and it won’t be our last. As major updates regarding the FDA’s regulatory situation with CBD arise, and hemp-based research moves forward, we’ll be sure to have them back on.

Watch on YouTube below, or listen on your favorite podcast app in our audio feeds:

Podcast: Play in new window | Download (Duration: 1:23:02 — 85.6MB)

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Sybil Swift and Lance Blundell of cbdMD: Detailed Show Notes

• 0:00 – Introductions – Dr. Sibyl was at the FDA!

  As mentioned above, Dr. Sibyl Swift is cbdMD’s Chief Science Officer & VP Regulatory Affairs, while Lance is the General Counsel at cbdMD. Sibyl spent some time with the FDA in the Office of Dietary Supplements, so she has a very good understanding of what goes on behind the scenes there.

• 5:00 – cbdMD – Who they are and the goals for the company

  cbdMD was founded in 2016/2017, and was a product of a number of people in CBD, eCigs and dietary supplements coming together. They realized an opportunity for a certain hemp extraction cannabinoid. Despite CBD being in their name, they identify as a hemp extracted cannabinoid company. Once the Farm Bill (2018) passed, it opened up the availability of hemp plants for consumer use, which Lance explains falls under the cannabis plant which has many different chemovares – some have low THC and high CBD (which is what is typically thought of as hemp plants) and vice versa.

  The company goal was to bring high quality CBD to the dietary supplement market. They transitioned into a hemp-extracted supplement company with the addition of Dr. Sibyl Swift to the company, rather than selling only CBD. The company aims to focus on how cannabinoids can be combined with other botanical substances for functional purposes.

  Lance states that they are now the leading company in the space due to the high quality formulation of cannabinoids and the level of regulations and testing they conduct on their products, along with being the first company to achieve NSF Certification for their products.

• 9:45 – The CBD Market and what’s happening within this space

  cbdMD wants to be treated as a supplement company rather than a ‘CBD’ company as they aim to only claim what the facts are in what their products can do. The testing for hemp compared to supplements is a lot more in depth and harder to meet regulations.

• 11:50 – Compliance is the hardest complication with CBD & Hemp

  The issue with compliance is that each state has its own laws. Supplements have the federal standard to adhere to, however CBD has state compliance to follow in each state as well.

  As Dr Sibyl States, “As a CBD company, we were labeled in the dirty shirt pile. We were, however, the cleanest in the dirty shirt pile”. They both feel that there is no reason that the FDA can’t review the current status of CBD and Hemp. This brings up the recent news covered on PricePlow where the FDA asked for help from congress regarding CBD, claiming that they didn’t have the tools required to regulate it.

  cbdMD is still operating as a fully FDA-approved food company, so that when that changes they can carry on doing what they already have been for years.

• 16:30 – How should the FDA deal with CBD and Hemp companies like yourself?

  They want to be treated like any other supplement or food company as they are focusing on health and wellness, as opposed to treating serious illnesses like other companies may claim.

  They carried out a study that will be linked below, the study shows that their product can down regulate a receptor in the lungs known as the Ace-2 receptor. This study was done with only 100mg of the ingredient.

  Lance states “Oil does not make your car run, but oil makes your car run better.”

  They only aim to create things that help your body run better, they don’t claim to cure or fix anything within the body.

• 20:30 – Partnering with Whoop for a study

  cbdMD are going to be partnering with Whoop to run a study on the biomarkers of a group of individuals when taking the ingredient at 100mg a day. This way, it can’t be placebo, due to the fact that they are constantly measuring biomarkers on a daily basis.

• 22:00 – Sibyl talks about her time working for the FDA

  Sibyl explains how she doesn’t believe the office in general has much experience in being within the industry that it is operating in. They don’t understand how much reputable companies actually test their own products to make sure they are safe and compliant. Hemp hasn’t fallen out of the sky, it’s been around for years but because they have not come across it before, all the FDA’s tools to check something don’t work, they don’t understand how to deal with it.

  The question we need to ask ourselves is – “Are they going to prohibit anything new and exciting that comes through the door from innovation and that could really help people?”

  Sibyl states that if you are going to try and regulate the industry, at least try and have some transparency into what you are doing and why.

• 27:45 – What exactly have the FDA said about CBD

  Lance explains how the FDA has been very vague – they don’t know what to do with CBD as it doesn’t fit any of their toxicology models and there are a bunch of ways it can be used, even smoking it. The regulations change depending on the method of consumption and therefore they are uncertain on how to deal with CBD.

  The one CBD product they have approved was only tested on rat toxicology, which is not good enough to be approved for our dietary supplements, so why was this substance they claim to know nothing about approved?

• 33:20 – How does the FDA regulate CBD when it is a much bigger market than supplements

  The issue being that the CBD market would be much larger than the dietary supplement market and it already seems like they are struggling to audit enough products/companies in the supplement space, so how do they manage this larger market?

  Sybil mentions that the FDA was given a large budget to go and study CBD and also to figure out why the rat toxicity model does not work for it.

• 35:00 – Why is it legal for cbdMD to sell THC over the counter like they do?

  A hemp plant is categorized as a cannabis plant that contains less than 0.3% THC. If it is a cannabinoid that has been with the plant through the life cycle of the plant, that is now legal to sell according to the new law.

  Hemp can be used for many different things, it can be used to make plastic, fiberglass, clothes etc. The states themselves now regulate the CBD usage and products sold in the state due to the lack of FDA Regulation on CBD. This can either be a good or a bad thing.

  Long story short, if you have less than 0.3% THC, it’s acceptable per the 2018 farm bill. And this is the case with all of cbdMD’s Delta-9 THC products as well as their Full Spectrum CBD+THC products.

• 40:00 – CBD and Delta 8, turning CBD into Delta 8

  The psychoactive substance Delta 8 occurs naturally in hemp and CBD, however it’s in extremely small amounts which can’t be extracted. So a way of getting around that is to turn CBD into Delta 8. However according to food law you cannot turn one thing into another thing without very specific steps in how to do so being followed.

  Lance suggests that Delta 8 shouldn’t be a food, there needs to be strict quality standards in place for it. They can exist in the market, just not as a ‘food supplement’.

• 42:00 – The ratio of CBD to THC and how it feels when taken as a supplement

  With CBD, you have receptor competition, meaning that if you were to have a high CBD with medium to high THC in it, you will feel very little of the THC compared to if the amount of CBD was lower. cbdMD found that somewhere below 5mg of THC can present really good functionality results, whereas 10-15mg tends to give a lot more relaxation. The effects people feel from CBD are very different, some people can take a small 1mg dose and fall asleep, whereas others can take 10-15mg and just feel calm and relaxed.

  The difference between one person and another means that the dosage needed to cause an acute effect varies massively. You can have one person at 100lb and another person weighing 300lb, these will both need different dosages to feel the effects.

• 44:45 – The difference between cbdMD and other people in the space selling CBD

  The difference between cbdMD and many other stores/brands is that cbdMD focuses more on the nutritional value and health than just a ‘feeling’ or sensation CBD can give. If you go to your local gas station you can buy Delta 7, Delta 12, etc and that is all promoted for feeling, rather than the health aspect. Ben was shocked to hear that Delta 8 can be made from CBD and is even found in hemp at all.

  It is the same within the mushroom category, mushrooms have been used and consumed for years by humans, however now because some companies are trying to focus more on the experience a mushroom can give rather than the health benefits, it then causes the category to feel very adulterated.

• 49:45 – Bringing CBD into the sport and athlete market

  The CBD gummies are NSF Certified for Sport, meaning more athletes and professional teams will consider them for use to help with performance. They also make CBD Focus capsules which are non caffeinated and can give up to 6 hours of extra cognition and focus, which is very appealing to many people but specifically athletes.

  Ben states how he really enjoyed trying the focus product he was given to sample by cbdMD.

• 53:15 – EnXtra and how it works

  Next, we get into some nootropics. EnXtra is an ingredient by OmniActive, the studies were done with both caffeine and no caffeine or stimulants, EnXtra worked both times.

  CBD Focus Capsules by cbdMD includes EnXtra alongside a few other nootropic ingredients and hemp. The reason they opted for caffeine-free capsules was so it could be taken in an afternoon/evening time without interfering with sleep.

  One of Lance’s favorite combinations of ingredients is actually microdose THC alongside caffeine — he feels a great sense of focus but it is also calm and composed compared to feeling jittery and anxious.

• 58:30 – What claims can be made for CBD/THC etc?

  Lance explains that once legalities are met in terms of manufacturing and usage of hemp/CBD and the dosage they are used at, if you want to go on to make claims about what your product can do then studies need to be done to a reasonable level to showcase this.

  Food law states that you can make a claim on your product which is called a structure function claim. Creatine for example absorbs in muscles, it’s in red meat and it helps with oxygen transport which generates better muscle recovery.

  Due to the FDA’s suppression on CBD, we can’t make claims like we would be able to with any food supplement. Normally we would be able to suggest that CBD can reduce inflammation.

• 1:05:25 – Claims can’t be made due to the FDA’s stance on CBD

  Lance goes on in expressing his exasperation that in the UK, Europe and Australia their toxicity data from the studies they have done would be accepted but over in the states because of the FDA’s hands off approach they wont accept it.

  cbdMD have to use sentences like:

  • CBD is used for dealing with pain
  • CBD is used for helping with inflammation

  These are used rather than claiming things, but this in turn is a problem as it slows down the education of CBD and how it can really help.

• 1:09:20 – Does getting high have anything to do with the safety of the ingredient?

  Sibyl actually wrote the FDA’s guidance on caffeine, and with all things a ‘safe’ dosage limit is set. However at some point it comes down to a person’s free will: if they are willing to take the risk of ignoring the guidance and taking more than the recommended dosage then that is on them.

  cbdMD labels the product in a way that provides them with information for them to have a good customer experience, they can make the choice on what dosage to take, but here is the recommendation. There are more than enough warnings labeled on the product so the customer knows exactly what they are doing if they exceed the serving suggestion.

• 1:11:32 – What are the concerns for safety with people buying CBD?

  The main concern is the other companies in the market and where they are manufacturing and sourcing the CBD from. Some of them are not meeting regulatory requirements of manufacturing. They need to be going to a testing lab that is reliable too, anyone can get results from a non reliable testing company to make their product look safe.

• 1:13:28 – How can we help you here at PricePlow and in the Supplement industry in general?

  The main way that the supplement industry can help is through educating the consumers on the actual health benefits of CBD rather than using it for a ‘feeling’ or ‘experience’. Another way to look at it, is to buy our products here at cbdMD and to educate the customer on what they did for you yourself.

  By selling a product in your store, you are telling the customers that trust you, that you have checked the compliance and safety of the product before it’s sold in your store.

• 1:16:54 – Have you looked into endocannabinoids and things like Anandamide?

  Mike asks about anandamide, the blissful endocannabinoid generated within the human body with a structure that’s quite similar to CBD and THC.

  The main problem with anandamide is that it is very unstable, a lot of people claiming to have it, potentially do not actually have pure anandamide. However, cbdMD is very interested in using it and will continue to look into it for our products. With Anandamide being so unstable, it always needs to come in liquid form, however recently some companies have found a way to put it into capsules.

  Mike recently covered FastBliss by NNB Nutrition, you can read more about that in the anandamide article linked above.

• 1:19:30 – How do you see the future of CBD and Hemp?

  Once cannabis is legalized there are still going to be many problems with CBD and regulating it. The states themselves still need to control and regulate it, which they currently aren’t doing to the level it is needed.

  Overall we just need companies to take charge themselves with proving the safety of their products and the quality of manufacturing involved to ensure purity and safety.

Thank you to Dr. Sibyl and Lance for joining us!

How to follow Dr. Sybil, Lance, and cbdMD:

• Dr. Sibyl Swift on LinkedIn
• Lance Blundell on LinkedIn
• cbdMD on LinkedIn
• cbdMD on Instagram

You can also sign up for PricePlow’s cbdMD news alerts and we’ll contact you when new cbdMD content or product updates occur through our system!

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