A full spectrum CBD oil tinctures are produced from Colorado hemp ✔️ Produced using safe, solvent-free CO2 extraction ✔️ Fortified with our proprietary terpene blend ✔️ third-party lab tested… BioMDPlus CBD review, lab tests, & video. See if it's real. (CBD, THC, cannabinoids, price, value, and more.) Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Full Spectrum CBD Oil (Natural)
You’ve seen CBD in the news, and you probably have friends and family who use it daily. You’re curious about the benefits that CBD could potentially bring to your life, and you’re wondering where to begin. We suggest starting with BioMD+ Natural Hemp Oil. This hemp oil is a full-spectrum extract that preserves the plant’s natural terpenes and has a delicious botanical flavor.
In this industry, everything begins with trust. To earn your trust, we’ve created the best CBD oil on the market by scouring the country for the best organic farm, growing the best industrial hemp from the best seed stock and creating a pure plant extract that promotes full-body wellness with help from nature and a little touch of sound science.
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Full Spectrum CBD Oil
We believe that no aspect of a truly great product is insignificant – and the time needed to get every detail absolutely right is time well spent. BioMD+ Natural Hemp Extract is:
- A full-spectrum extract made from the highest-quality hemp plants available
- Grown in Colorado from non-GMO seed stock according to organic methods and without pesticides
- Compliant with all federal regulations and legal in all 50 states
- Extracted using safe carbon dioxide – not harsh, dangerous solvents
- Enhanced with natural plant terpenes to support a healthy, active lifestyle
- Blended with healthy coconut oil
- Free of added sweeteners, flavors, colors, alcohol and preservatives
- Cruelty free and vegan
- Tested frequently through an independent laboratory
What Is Full Spectrum CBD Oil?
Hemp oil extract comes from a strain of industrial hemp that’s rich in cannabinoids work synergistically with each other, but contains almost no THC and doesn’t produce the characteristic high of cannabis plants. Industrial hemp is legal to grow and use in all 50 states. In some states by law, industrial hemp must have less than 0.3 precent THC. CBD – its most plentiful cannabinoid – is the topic of some incredibly exciting medical research.
We don’t believe in cutting corners. For us, creating the world’s best CBD oil began with an exhaustive search for America’s best organic hemp farm. We found our partner farm in Colorado and worked with them to create a cannabinoid-rich CBD extract that preserves the complex and varied terpene profile that can only come from the best hemp seed stock.
After extracting our CBD oil using nothing but carbon dioxide as a solvent, we infuse the full spectrum CBD products with a proprietary blend of terpenes selected to support overall health and wellness. We control the entire farming and production process from seed to shelf.
Full Spectrum CBD Oil: Uses
The cannabinoids in our natural hemp extract interact with the body’s endocannabinoid system and can help to improve mood, reduce anxiety, promote restful sleep and more. We enhance our full spectrum CBD oil with a carefully selected terpene blend designed to provide the widest possible range of benefits.
How to Use bioMD+ Full Spectrum CBD Oil
CBD is a natural plant CBD products with virtually no known negative side effects. Start with a small dose . We suggest taking a single dose daily for several days. After gauging the effect of the CBD, increase to two or more daily doses if desired.
- Shake the bottle gently to distribute the CBD and terpenes evenly throughout the coconut oil.
- Place one dropper under the tongue, holding it there for 60 seconds before swallowing it.
- Store the bottle in a cool, dark cabinet.
How Do Terpenes Enhance bioMD+ Full Spectrum CBD Oil?
Our full-spectrum CBD oil has a wide range of potential benefits, and we’ve enhanced the CBD products further with a carefully selected blend of natural plant terpenes.
- Limonene gives our CBD extract a slightly citrusy flavor and can potentially benefit those experiencing stress and anxiety, poor mood, inflammation and chronic pain.
- Linalool – the scent of lavender – consistently ranks among the most relaxing plant extracts. In addition to promoting an improved mood, linalool may relieve worry and depression. It’s also thought to have neuroprotective effects.
- Humulene has the earthy aroma of hops and may help to reduce inflammation.
- Terpinolene has the relaxing scent of pine trees and flowers. It is thought to relax the body and combat oxidative stress.
Full Spectrum CBD Oil for Sale: How to Choose The Right One?
CBD oil has proven to be very effective against many symptoms that often come from a terminal disease. CBD oil is one of the many forms available on the market, but what makes CBD oil far better than any other form is its effectiveness. While other forms of CBD take time to affect the body, CBD oil will only take mere minutes to kick in. You will feel relaxed without any stress. That is why many people prefer CBD oil over other forms of cannabidiol CBD. One type is called full-spectrum CBD oil. In this article, you are going to learn everything about full-spectrum CBD oil.
Full-spectrum CBD oil is not something new; it’s been used as a medicine for thousands of years. Full-spectrum CBD oil is found in the Cannabis plant and hemp. Full spectrum CBD products must contain trace amounts of all primary and secondary cannabinoids. CBD is becoming more popular as some new information is being discovered about the CBD products. One of the reasons why it’s picking steam across the world is because of the anti-inflammatory, antioxidant properties it has. Scientists have high expectations of where the CBD will go in the future. Past research shows the product’s immense potential.
Full-Spectrum CBD Oil for Sale: Which One Should You Choose?
Through the investigation of hundreds of CBD tinctures available for sale, bioMD+ is the unanimously preferred product. Numbers of people have used the tincture and reported the best pick for the conditions. It’s third-party tested for potency and purity of contaminants. Authority-certified non-GMO hemp grown in the United States.
On the market, you will be able to find different types of CBD oil. One of them is CBD isolate – 99% pure CBD oil containing CBD molecule as known as isolated CBD. Since CBD products can contain trace amounts of THC, it’s still possible for it to show up on a drug test. CBD isolates have no identifiable amount of THC. By removing cannabinoids such as THC, passing a drug test may be easier. The second is known as broad-spectrum CBD oil. It contains different types of cannabinoids, terpenes, and essential oils. You won’t find a trace of THC in THC free products. Other components are preserved in the oil.
On top of the health benefits of the cannabinoids listed above, full spectrum CBD oil also contains various vitamins, with vitamins A, C, E, and B found in abundance in the product.
- Vitamin A is essential for growth and development and is important for the immune system. It also helps with vision and is a great way to ensure retina health
- Vitamin C is a powerful antioxidant and is a great way to keep your immune system healthy. It can also help control high blood pressure and may provide better memory health.
- Vitamin E is primarily used to regulate the amount of vitamin A found in the body and can also boost the immune system and your skin health. Research also shows that it can promote blood circulation and help prevent blood clots (especially useful for blood conditions).
- Vitamin B can help increase energy levels in the body as well as enhancing mood and improving memory. It also helps to boost skin condition and hair health while providing a stimulus to the immune system.
Full spectrum CBD oil contains over 20 amino acids. Amino acids are known for their brain and muscle health properties and can help with sleep problems, exercise performance (due to their recovery properties), hair problems, anxiety and other mood issues, and are even suspected to have antiaging properties.
Another compound found in full spectrum CBD oil are fatty acids, including Omega 3 and Omega 6. Fatty acids are great for cognitive and heart health and are known to help prevent cancer and maintain eye health.
We all know we need to consume dietary fiber to keep our digestive system healthy, but did you know that full spectrum CBD oil is a good source of nutrients for promoting stomach and bowel health? As full spectrum CBD oil is a whole plant product, it contains many of the fibre compounds required by our bodies to keep our digestive system ticking along nicely.
Finally, we get to full-spectrum, which is found in a cannabis plant that contains more than 100 compounds known as cannabinoids. We extract its CBD along with other naturally occurring compounds found in hemp to enhance absorption. In our products, you will find both THC and CBD, the main compounds of the plant. These two elements are recognized for their therapeutic effects. Other cannabinoids present in the extract are cannabinoid, cannabigerol, tetrahydrocannabivarin, and cannabichromene. These components of the full-spectrum oil stand out among the other CBD with THC products on the market. But there has to be another reason why it’s so popular amongst CBD users.
What is the “Entourage Effect?”
The entourage effect describes the combined outcome of consuming terpenes, cannabinoids, and other beneficial chemical compounds found in full spectrum CBD oil and hemp. Separately the compounds have various health and nutritional benefits, but together the effect is amplified to something greater than the sum of the individual parts.
A study in 1981 found that CBD products that use all the hemp plants like full spectrum CBD provide over 300% more beneficial activity than THC alone. Scientific research has determined that cannabinoids and terpenes are great at subduing THC’s negative effects whilst boosting its many benefits. All the news reports tell us that THC and CBD showed promising signs in treating neurological and cardiovascular diseases. On the market, you are going to find different variations of CBD oil filling the shelves. Each of them offers their unique spin and fancy name. This article is about full-spectrum CBD oil with THC in particular.
What Are the Health and Nutritional Benefits of Full Spectrum CBD Oil?
Early research into the benefits of full spectrum tincture suggests that it can aid in many different health areas, including inflammation of joints, pain and muscle tissues, and brain health. This is all down to the many different compounds found in the hemp plant, including cannabidiol CBD and other cannabinoids that work synergistically . Let’s have a look at a few in detail and discuss how they can benefit your health:
- Cannabichromene (also known as CBC): CBC is a great anti-inflammatory, works as an anti-depressant, is great as an anti-fungal treatment, and is known to have a variety of anti-cancer and tumor properties
- Cannabidivarin (also known as CBDV): CBDV is known to have anti-convulsion properties, can work as an anti-inflammatory, and has anti-nausea properties. Evidence also exists that it can work as a pain suppressant and help with mood disorders. This compound is one of the main reasons that full spectrum CBD oil and other whole-plant full spectrum hemp products are used to relieve the symptoms of HIV / AIDs, Crohn’s, and Multiple Sclerosis.
- Cannabigerol (also known as CBG): CBG also has anti-inflammatory properties, works as an anti-fungal treatment, and evidence suggests that it can prevent tumor growth and development. As such the CBG cannabinoid is often consumed to help with the symptoms of cancer, inflammation, glaucoma in the eyes, and various skin diseases.
- Cannabinol (also known as CBN): Research suggests that CBN has a sedative effect on those who consume it and provides anti-convulsant and anti-inflammatory properties.
While these compounds offer many benefits (as can be seen in the list above) their true potential is only realized when they work in unison and the “Entourage Effect” kicks in.
Why Is CBD Oil with THC so Preferable? Full Spectrum CBD Oil Demystified
Here are the reasons why full-spectrum CBD tincture is preferred compared to alternatives on the market.
- It has all the chemical compounds like THC, terpenes, cannabidiol CBD, and flavonoids. This extraction process can be used for a better effect.
- Full-spectrum oil has cannabidiol, which has been scientifically proven to work more efficiently in synergy with terpenes and other cannabinoids.
- Another reason why full-spectrum is preferable for most people is because of its smell and taste.
- CBD oil isn’t the same as hempseed oil.
Advantages of Full-Spectrum CBD Oil
Full-spectrum CBD products might help you deal with chronic pain and inflammation, which happens to be two of the best reasons to take CBD oil. If someone can’t get access to medical marijuana, they can switch to full-spectrum CBD to attack chronic diseases. The antioxidant properties of the CBD oil might help reduce inflammation. If you are suffering from an autoimmune illness, then taking a full-spectrum oil is one of the best choices for proper treatment.
Broad Spectrum CBD Oil Works With These Conditions
Full-spectrum CBD oil might help deal with the following chronic pain conditions that can arise from serious disease:
- Back pain
- Calming effect on the nervous system
- Neuropathic pain
- Sclerosis pain
- Back pain
Full-spectrum CBD oil has all of the ingredients you might try to address the conditions. Some of the other side effects, such as anxiety, stress, and nausea, can be treated with CBD. You should also pay attention to the amount of CBD oil that you consume per day, which may vary. If you are a newcomer, or after a few months of trying through trial and error, you should try normal doses, but eventually, you can increase the number each week.
If you don’t feel any effects from the CBD tincture with THC, you should increase the dosage a little. If you don’t feel any effects, contact your doctor immediately for advice on what kind of drug you should try next. Overall, though, CBD oil has been one of the most effective CBD products to enter the market in a long time. Many people take full-spectrum CBD oil as an alternative to pain medication, as the latter can be highly addictive. CBD, on the other hand, is less addictive and more effective. Balancing this combination has helped CBD with tetrahydrocannabinol THC gain a wider audience on the market.
What is the difference between CBD oil and full spectrum CBD oil?
CBD isolate – 99% pure CBD oil contains no THC (there are differences between broad-spectrum CBD and full-spectrum CBD). A full spectrum CBD, on the other hand, contains all the natural chemicals found in the whole plant, which include various other cannabinoids, essential oils, terpenes, cannabigerol CBG, cannabinol CBN, proteins fatty acids, chlorophyll, fiber, amino acids, high levels of vitamins A, C, E and flavonoids.
Final Thoughts on Full-Spectrum CBD Oil
Our high quality full spectrum CBD products Authority-certified non-GMO hemp grown in the United States have its own value and effectiveness compared to other versions of CBD oil without THC on the market. Based on customer reviews we know why people prefer full-spectrum CBD tincture instead of other alternatives. If you happen to be in a state where the laws are restrictive, then full-spectrum is the way to go since this variety doesn’t contain any THC. This makes it a perfect way to manage pain without getting addicted to painkillers. Please note that this article is Not Intended to Diagnose, Treat, Cure or Prevent Any Disease.
BioMD+ Full Spectrum CBD Review
We purchased this CBD product and tested it at independent testing facilities to measure levels of CBD, THC, and other cannabinoids and compare the results to the manufacturer’s claims. Here are the results. (Learn more about our review process.)
Our Lab Tests
From Lab A
From Lab B
* Products tested prior to 2020 were sent to only one independent testing facility.
The unadulterated test results on this page come directly from these certificates of analysis from two independent labs, which we pay directly. These are two independent lab tests of one product, at one point in time. We do not guarantee that all products or labs will produce the same results. Lab results may differ based on the different methodologies of testing used by each lab or inconsistencies in the product. Added ingredients may affect lab results. Volume of creams and edibles may change due to factors such as temperature, and this may impact lab results. Learn more about our review process.
From Lab A
From Lab B
Cannabinoid Breakdown by mL
From Lab A
Other Cannabinoids (mg / mL)
From Lab B
Other Cannabinoids (mg / mL)
BioMDplus claims to have 33 mg of CBD per 1 mL serving, as well as around 0.9 mg of THC, and it’s from hemp that’s rich in cannabinoids which work synergistically with each other. The labs found over 35 mg of CBD and no meaningful levels of any other cannabinoids.
See update below
*It’s common to see CBD doses at 5 mg, 15 mg, 25 mg, and 50 mg for consumer products. Researchers use much larger doses (25 mg to 1500 mg of CBD). CBD dosing is highly individualized.
BioMDPlus “full spectrum CBD oil” came in at 10.5 cents per milligram of CBD. The average full-spectrum extract costs 10 cents per milligram of CBD. However, this pretty much just CBD and the average cost of oils from CBD isolate is 7.5 cents per milligram. This product was also $115, making it an expensive entry point.
See update below
Details from the manufacturer
· Full-spectrum (conflicting information)
· THC: Yes (on the website), however, the bottle also states THC free
· Other cannabinoids: Yes
Instructions: take half a dropper twice daily.
About the product
BioMD+ makes conflicting claims. BioMd+ claims on their website that this product is a full spectrum CBD oil, which should include CBD, THC, and other cannabinoids. They specifically claim that it has 0.9 mg of THC per gram, which is a considerable amount. However, the bottle also states that this product contains “zero THC.”
Our independent lab tests suggest that this is not full spectrum as claimed and is from a CBD isolate. Lab A found trace amounts of THC, CBDV, and CBG that are extremely low and considered non-detectable by many labs, including lab B. It’s basically nothing but CBD.
The independent labs found that BioMD Plus contained 5% to 9% more CBD than suggested by their label. However, they also have conflicting THC claims.
See update below
This is the first and last BioMdPlus product I will review.
Update: BioMD+ reached out via Youtube and they believe they sent the wrong product. I received “isolate” instead of “full spectrum.” I tested it as “full spectrum” because I purchased “full spectrum”, the image on the purchase screen was identical to the bottle I received, and the packaging slip also stated “full spectrum.” According to the photos on their website, the products with THC and without THC appear identical. The similarity is likely why I received the wrong product. Here’s my update: it’s not good.
I paid for a full spectrum extract and didn’t get it. Does it matter what the cost is? It does. This was $115 for 1000 mg. I’ve tested actual full spectrum CBD with over 1800 mg for $30.
It tastes excellent for a full spectrum extract, and that might be because it’s not full spectrum. It’s flavored with terpenes and tastes like an orange creamsicle. Taste is not the issue with this product.
While this product passed with flying colors for CBD potency, it failed at all the other cannabinoids. I didn’t even need to send this one to the labs. The website claims “full spectrum” with 0.9 mg of THC per gram. However, the bottle also claims “isolate” and “THC Free.” My independent lab tests suggest that this product is just CBD with no meaningful levels of other cannabinoids.
The bottle is made of premium glass that is painted to protect CBD from sunlight, which causes deterioration of the CBD molecule. The label is also premium. The dropper is labeled, which is nice. Unfortunately, the label’s claims conflict with BioMDplus’ website.
There’s conflicting claims on the BioMDPlus website and the bottle of the product we reviewed. It’s sad when a CBD company tests poorly at the labs when they claim to “offer relief from pain, stress, anxiety and discomfort for those living with chronic conditions.”
BioMD Plus LLC MARCS-CMS 618460 — May 04, 2022
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.biomdplus.com in February 2022 and has determined that you take orders there for various human and animal products, which you represent as containing cannabidiol (CBD) or Delta-8 tetrahydrocannabinol (THC). We have also reviewed your social media websites at https://twitter.com/bioMDplus , https://www.facebook.com/bioMDplus/ and https://www.instagram.com/biomdplus/, which direct consumers to your website www.biomdplus.com to purchase your products. The claims on your website and social media accounts establish that your products, some of which are available in multiple varieties, “CBD Oil,” “CBD Capsules,” “Vegan CBD Gummies,” “CBD Pain Relief Cream,” “Delta 8 THC Gummies,” and “Delta 8 THC Vape Cartridge” (hereinafter referred to as “your CBD and Delta-8 THC products for humans”) are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).
In addition, your “Natural Pet CBD Oil” is an unapproved new animal drug that is unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and is adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).
FDA has also determined that certain food products that you market are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive.
As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find specific information about how FDA regulates cannabis-derived products at https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd .
Over the past several years, FDA has warned the public on various illegally marketed CBD-containing products. FDA has also observed a proliferation of products containing another cannabinoid, Delta-8 THC, and has recently expressed serious concerns about products containing Delta-8 THC that include: 1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk; 2) FDA has received adverse event reports involving Delta-8 THC containing products; 3) Delta-8 THC has psychoactive and intoxicating effects; 4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children. See https://www.fda.gov/consumers/consumer-updates/5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc . This letter is to inform you that your firm markets Delta-8 THC-containing products, and Delta-8 THC may pose a serious health risk to consumers.
Dietary Supplement Labeling
Information on your website at www.biomdplus.com indicates that you appear to market your CBD-containing “CBD Capsules” and “Vegan CBD Gummies” as dietary supplements. For example, the product webpages display a product label image with “hemp supplement” on them. However, your products cannot be dietary supplements because they do not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff). FDA has concluded, based on available evidence, that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.  There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence that has bearing on this issue.
Unapproved New Human Drugs
Based on a review of your website and social media accounts, your CBD and Delta-8 THC products for humans are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.
Examples of claims from your website www.biomdplus.com and social media accounts, https://twitter.com/bioMDplus , https://www.facebook.com/bioMDplus/ and https://www.instagram.com/biomdplus/, that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:
From your website www.biomdplus.com:
On your blog post titled, “Best CBD Oil for Stress & Depression: Can CBD Oil Help?”:
- “Many are turning to consume CBD oil for anxiety, depression, and bipolar disorder.”
- “The pre-clinical data support the possible use of CBD with Panic Disorder (PD), Obsessive-Compulsive Disorder (OCD), and Post Traumatic Stress Disorder (PTSD), and Bipolar Disorder.”
On your blog post titled, “CBD for Psychosis vs CBD Oil for Schizophrenia: Breaking News…”:
- “People are now taking CBD for anxiety, stress relief, proper pain medication, and to help fight addiction.”
- “High-level CBD can help manage symptoms of psychosis that come from schizophrenia.”
On your blog post titled, “CBD Oil Benefits”:
- “Relief for Chronic Pain . . . [t]hose who suffer from chronic pain from diseases such as fibromyalgia find relief in CBD. Taking CBD can relieve pain and even prevent the degeneration of the nervous system.”
- “IBD . . . [s]everal studies have suggested that one of the most important effects of CBD is that it may help patients with inflammatory bowel disease such as ulcerative colitis and Crohn’s disease.”
On your blog post titled, “CBD Oil for Sundowning, Dementia, Alzheimer’s Disease & Disorientation”:
- “The dementia-related conditions that can be helped by CBD Oil include Alzheimer’s disease, Vascular Dementia, Dementia with Lewy bodies (DLB), Parkinson’s disease, Frontotemporal dementia and Huntington’s disease.”
- “CBD could help remove dementia from brain cells.”
On your blog post titled, “Delta-8 THC: Discover This New Cannabinoid from Cannabis”:
- “[D]elta-8-THC was administered to eight children being treated for hematologic cancers. The children were 3 to 13 years old . . . [t]hey all experienced vomiting because of the chemo . . . they received delta-8-THC with their chemotherapy treatments, every single child stopped vomiting during and after their chemo sessions!”
- “[D]elta-8-THC has also been used to relieve pain, ease anxiety”
On your blog post titled, “How Long Does It Take For Results Using CBD Oil To Take Affect With OCD?”:
- “CBD oil is an effective natural treatment for OCD.”
On your blog post titled, “How To Take CBD Oil For Crohn’s Disease? Finding The Right Dosage”:
- “The study suggests that cbd oil or a derivative of it could be a useful treatment for Crohn’s.”
On your blog post titled, “Is CBD Oil Good For Idiopathic Pulmonary Fibrosis? The Ultimate Therapeutic Guide”:
- “[T]here are numerous studies that suggest CBD oil has the potential to treat a wide variety of health issues and could be effective in treating IPF [idiopathic pulmonary fibrosis].”
On your Delta 8 Gummies product webpage:
- “Another benefit that many people don’t know is that Cannabidiol can help with the growth and healing of damaged tissue, and it can also help reduce chronic pain and the likelihood of developing certain cancers, such as breast and prostate.”
- “The benefits of Delta 8 are the following . . . Reduce depression . . . Reduce anxiety and panic attacks . . .”
On your CBD Pain Relief Cream webpage:
- “bioMDplus Pain Cream in 500mg strength is a new formulated pain relief topical cream that made for use on sore muscle areas and areas where there is pain. bioMDplus Pain Cream infused with the Quality Full Spectrum CBD. bioMDplus CBD Cream provides effective, fast and long-lasting pain relief.”
- “Begin by rubbing small amounts of CBD cream to the affected area and wait for about an hour. You can increase the quantity depending on how fast it works. If the effects of the cream are slow to kick in, then its [sic] recommended to re-apply CBD cream after every 3-4 hours. . . . Using CBD cream is like using a moisturizing lotion, but making sure to apply the optimal dosage of CBD cream isn’t easy. Users have to determine the milligrams of CBD in the cream and decide whether it’s good enough for pain relief. CBD creams with low amounts of CBD will probably be less useful than those with higher concentrations. Begin by using small amounts of CBD cream before slowly increasing it until you find relief. Moreover, applying CBD cream on the body isn’t known to produce any significant side effects.”
- “CBD creams work when directly applied to the skin, which makes them an excellent alternative to traditional creams when it comes to pain relief. . . . For the most part, the effects of CBD cream can be felt 15-20 minutes and can keep working for as long as 6 hours or more.”
- “Applying CBD-infused creams is generally a straightforward process. Look for the areas of your body most affected by pain and discomfort, and apply small amounts of CBD cream around those areas for local treatment. . . . Elbows, knees, and joint . . . Bottoms of the feet and impact points . . . Face, particularly around the temples and the nose . . . Neck and shoulders”
From your social media websites:
On your Facebook Social Media page https://www.facebook.com/bioMDplus/:
- July 28, 2020 post – “Recent research has linked CBD with several benefits for the heart and circulatory system, including the ability to lower high blood pressure. High blood pressure is linked to higher risks of a number of health conditions, including stroke, heart attack, and metabolic syndrome.”
- April 14, 2020 post – “500mg: CBD & Menthol Pain Cream . . . bioMDplus 500mg CBD Pain Cream is a newly formulated pain relief topical cream made to soothe sore muscles and alleviate chronic joint pain. Derived from our signature potent hemp oil infused with peppermint oil, eucalyptus oil, menthol and our signature terpene blend, this cream allows for a unique and STRONG combination of natural ingredients and CBD to aid in POWERFUL relief. You can use our new topical pain cream to FIGHT back against sore muscles and achy joints!”
- April 7, 2020 post – “Just what does CBD do for the body and why are people so interested in this substance? . . . Pain relief from arthritis or inflammatory diseases . . . Treatment of insomnia . . . Lowering anxiety levels . . . May lower diabetes risk . . . Could lower levels of obesity”
On your Twitter Social Media Page https://twitter.com/bioMDplus :
- August 4, 2021 post – “62% of CBD users used it to treat health conditions. The most common uses were for pain, anxiety and depression.”
- July 25, 2021 post – “CBD Oil for Depression, Anxiety, and Bipolar disorder.”
On your Instagram Social Media Page https://www.instagram.com/biomdplus/:
- July 4, 2020 post – “75% of PTSD patients saw a reduction in PTSD symptoms, when they were using CBD products compared to when they were not.”
- November 5, 2019 post – “A recent study showed that CBD administration can prevent the death of the neurons and reduce brain damage in the event of a stroke. CBD also reduced stroke-related seizures.”
Based on the above labeling claims, your CBD and Delta-8 THC products for human use are drugs. We are not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that any of these products are generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended or suggested in their labeling. Thus, your CBD and Delta-8 THC products for human use are “new drugs” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here,  new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a), 331(d). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your CBD and Delta-8 THC products for humans. There is no basis under the FD&C Act under which these products would be legally marketed without an approved application. Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).
Misbranded Human Drugs
Your CBD and Delta-8 THC products for humans are also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. (See 21 CFR 201.5.) These products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Under 21 CFR 201.100(c)(2) and 201.115, FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your products are not exempt from the requirement that their labeling bear adequate directions for use, because no FDA-approved applications are in effect your products . 
The introduction or delivery for introduction into interstate commerce of misbranded drugs is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Even if your “CBD Pain Relief Cream” was considered a nonprescription drug, we note that a nonprescription drug product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient. To date, no CBD-containing drug has met applicable FDA requirements to be legally marketed for nonprescription use. Nonprescription drug products that include CBD as an active ingredient are not GRASE and are new drugs which require an approved application to be legally marketed. CBD is not an active ingredient in any OTC monograph under section 505G of the FD&C Act. Even if CBD could be considered an inactive ingredient in a nonprescription drug product, that product would still need an approved new drug application to be legally marketed, because the product would not meet the general requirements under section 505G of the FD&C Act under which certain nonprescription drug products may be marketed without an approved new drug application. In particular, such a product would not meet the general requirement with respect to the safety and suitability of inactive ingredients under 21 CFR 330.1(e).  , 
Adulterated Human Foods
According to your product labeling, your “Delta 8 THC Gummies” product is a food to which Delta-8 THC has been added.
You should be aware that, as defined in section 201(s) of the FD&C Act, 21 U.S.C. 321(s), the term “food additive” refers to any substance the intended use of which results in it becoming a component of any food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception. 
Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the FD&C Act, 21 U.S.C. 348(a), and causes the food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
There is no food additive regulation that authorizes the use of Delta-8 THC. We are not aware of any information to indicate that Delta-8 THC is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that Delta-8 THC is GRAS for use in conventional foods. FDA’s regulations in 21 CFR 170.30(a)-(c) describe the criteria for eligibility for classification of a food ingredient as GRAS. The use of a food substance may be GRAS based on either scientific procedures or, for a substance used in food before 1958, through experience based on common use in food (see 21 CFR 170.30).
We know of no basis for general recognition of safety for Delta-8 THC based either on scientific procedures or common use in food prior to January 1, 1958. Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of Delta-8 THC in food meets the criteria for GRAS status. Some of the available data raise serious concerns about potential harm from Delta-8 THC. Our review of published scientific literature identified potential for adverse effects on the central nervous and cardiopulmonary systems. In addition, studies in animals have suggested that gestational exposure to Delta-8 THC can interfere with neurodevelopment. Therefore, based on our review, the use of Delta-8 THC in your products does not satisfy the criteria for GRAS status under 21 CFR 170.30.
FDA is not aware of any other exception to the food additive definition that would apply to Delta-8 THC for use as an ingredient in a conventional food. Therefore, Delta-8 THC added to a conventional food is a food additive under section 201(s) of the FD&C Act and is subject to the provisions of section 409 of the FD&C Act. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Delta-8 THC is not approved for use in any conventional food. Food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Therefore, your “Delta 8 THC Gummies” are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act because they bear or contain an unsafe food additive. Introduction of these adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Unapproved New Animal Drugs
Based on our review of your website and social media websites, your “Natural Pet CBD Oil” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal. Further, as discussed below, this product is an unapproved new animal drug and marketing it violates the FD&C Act.
Examples of claims from your website https://biomdplus.com, and your social media websites https://www.facebook.com/bioMDplus/, https://www.instagram.com/biomdplus/ , and https://twitter.com/biomdplus, that provide evidence of the intended use of your “Natural Pet CBD Oil” as a drug include, but are not limited to, the following:
On your product page for “ Natural Pet CBD Oil”:
- “Whether you’re using CBD oil for pain relief or anxiety, the right full spectrum CBD oil for dogs dosage depends on a number of factors. . . .”
- “[L]inalool [an ingredient in your Natural Pet CBD Oil] may relieve . . . depression.”
- “Humulene [an ingredient in your Natural Pet CBD Oil] . . . may help to reduce inflammation.”
On your webpage blog titled, “How Effective Is CBD For Pets?”:
- “CBD tinctures are reported to help pets with seizures.”
- “Thanks to the natural anti-in f lammatory properties in CBD, it also makes for a great candidate in helping with anxiety, in fl ammation, and arthritis.”
- Under the heading “Top Uses CBD for Pets”:
- “Anxiety[:] One of the major bene fi ts reported with CBD is that it can help . . . alleviate their anxiety. Most pets will suffer from varying degrees of anxiety, especially dogs and cats.”
- “Pain . . . CBD can greatly help with [pain]. So any in fl ammatory pain that your pet may be suffering from may be greatly reduced with CBD. Since CBD has natural anti-in fl ammatory properties, it works especially well for in fl ammation-induced pain.”
- “Arthritis[:] Although there are yet to be more tests on the effectiveness of CBD against arthritis, there is a substantial reason and some tests that prove its ef fi cacy. Of course, the inherent anti-in fl ammatory properties of CBD do make it very valuable in providing substantial relief to arthritis. Moreover, research also supports these claims, ensuring that CBD can be a good substitute for regular arthritis medicine.”
- “Seizures[:] Seizures among pets can be a very serious concern, but research suggests that CBD can help in reducing certain types of seizures in dogs. . . . In dogs, research conducted on idiopathic epilepsy showed that CBD assisted in reducing the intensity of seizures. So if your dog suffers from the condition, CBD can prove to be useful in bringing relief.”
On your webpage blog titled, “Full Spectrum CBD Oil for Dogs”:
- “ Here are a few problems full-spectrum CBD oil can help treat:”
- “ Pain Including Joint Pain[:] It’s believed that CBD oil can reduce pain, especially neuropathic pain in dogs. It’s also said to be effective in reducing joint pain and arthritis, which is why it’s often recommended for older dogs.”
- “Inflammation[:] CBD oil is anti-in fl ammatory and can help reduce chronic in fl ammation in dogs due to genetics, parasites, metabolic diseases, food allergies, bacterial overgrowth, and environmental stress.”
- “ Anxiety[:] If your dog gets stressed or anxious then you may consider using CBD oil as it has been linked to less anxiety and stress.”
- “ Digestion Problems . . . Regular use of full-spectrum CBD oil for dogs can treat this problem as it’s said to eliminate digestive issues”
- “Pain Symptoms[:] There are reasons to believe that the best full-spectrum CBD oil for dogs can help alleviate symptoms of pains in dogs. . . . The use of CBD oil may not cure the disease but it can help reduce the pain and suffering.”
- “Seizures[:] Some experts are of the belief that regular use of full-spectrum CBD oil can reduce the risk of seizures in dogs. The AKC Canine Health Foundation is working with the Colorado State University to evaluate the use of full-spectrum CBD oil in treatment-resistant epileptic dogs. biomdplus offers the best full-spectrum CBD oil for dogs. Our product is meant to provide all the above-mentioned bene fi ts to dogs of all ages.”
On both your Facebook and Instagram social media websites at https://www.facebook.com/bioMDplus/ and https://www.instagram.com/biomdplus/ respectively:
- Facebook and Instagram July 23, 2020 postings with a photograph of a cat looking at your “Natural Pet CBD Oil” product:
- “Use bioMD+ CBD products made for cats to help with . . . pain”
- “For pets who . . . have swollen joints, or separation anxiety CBD has helped many!”
On your Twitter social media website at https://twitter.com/bioMDplus :
- October 13, 2020 posting of a graphic titled “CBD FOR PETS . . . What can CBD do for your pet?” (checklist at the bottom next to clipboard titled “CONDITIONS TREATED”):
- “ ? Allergies”
- “ ? Anxiety”
- “ ? Cancer Management”
- “ ? Inflamation [sic]”
- “ ? Glaucoma”
- “ ? Skin Irritation”
- “ ? Seizures and Epilepsy”
- “ ? Arthritis”
Your “Natural Pet CBD Oil” product is a “new animal drug” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because it is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.
To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. 360b, 360ccc, and 360ccc-1. This product is not approved or index listed by the FDA, and therefore this product is considered unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). Introduction of this adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to [email protected] .
Donald D. Ashley
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Division of Drug Compliance
Office of Surveillance & Compliance
Center for Veterinary Medicine
Food and Drug Administration
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 CBD is the active ingredient in the approved drug product Epidiolex. Furthermore, the existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome). FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under 21 CFR 312.2, unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.
 For example, under section 505G of the FD&C Act, 21 U.S.C. 355h, certain nonprescription drug products may be lawfully marketed without an approved application if applicable conditions are met, including conformity with an applicable OTC monograph. However, your products could not be lawfully marketed under section 505G, because based on your claims regarding these products, including on your website labeling, your products are marketed for uses not considered nonprescription indications. Further, even if certain of your products, such as your “CBD Pain Relief Cream” were marketed only for nonprescription indications, they would not meet the conditions under section 505G for lawful marketing without an approved application. For example, CBD — considered an active ingredient under 21 CFR 201.66(b)(2) due to its prominent featuring on your product labeling — is not an active ingredient in any OTC monograph under section 505G of the FD&C Act.
 Further, even if your products were marketed only for nonprescription indications, these products would be misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because they would be nonprescription drugs subject to section 505G of the FD&C Act that do not comply with the requirements for marketing under that section (see footnote 1) and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.
 21 CFR 330.1(e) requires in relevant part that “the product contains only suitable inactive ingredients which are safe in the amounts administered.” A suitable inactive ingredient generally provides a beneficial formulation function, such as a tablet binder or preservative, or improves product delivery (e.g., enhances absorption or controls release of the drug substance). CBD has no known functional role as an inactive ingredient in a finished drug product.
 Additionally, an inactive ingredient should not exert pharmacological effects and must be safe when used at the intended dosage. CBD has known pharmacological activity with demonstrated risks. For example, the labeling for Epidiolex (cannabidiol) prescription oral solution includes risks for the drug such as liver injury, interactions with other drugs or supplements, potential for male reproductive toxicity, somnolence, insomnia, diarrhea, decreased appetite, abdominal pain, upset stomach, changes in mood, irritability, and agitation. See https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210365s005s006s007lbl.pdf . It is unknown whether the levels of CBD used in your CBD products have pharmacological activity or pose any concern for safety events.
 Under section 201(s) of the FD&C Act (21 U.S.C. 321(s)), the following types of substances are excluded from the food additive definition: (1) pesticide chemical residues in or on a raw agricultural commodity or processed food, (2) pesticide chemicals, (3) color additives, (4) substances used in accordance with a “prior sanction” (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C Act, the Poultry Products Inspection Act, or the Meat Inspection Act), (5) new animal drugs, and (6) dietary ingredients in or intended for use in a dietary supplement.