The 2018 Farm Bill gave cannabis businesses around the country a legal path to market and sell hemp and hemp-derived products. Despite the groundbreaking law, several regulatory uncertainties remain. The FDA has been a source of many of those uncertainties, but recent action suggests that the agency plans to impose heavy burdens on companies selling CBD products that claim to provide health benefits. Recently, the FDA held a public hearing during which it signaled that health claims associated with cannabis-related products was a primary concern. Congress subsequently pressured the FDA to develop a regulatory framework for the cannabis industry and the agency announced that it was expediting its efforts to do so, promising an update on its progress by this fall.

FDAThen, on July 22, the agency issued a warning letter to Curaleaf regarding its claims that several of its products provide specific health benefits. The agency included a threat to seize Curaleaf’s products if the issues raised in the letter are not resolved. How the FDA ultimately regulates cannabis products going forward will have a significant impact on the industry as a whole. Indeed, the agency has significant powers over product manufacturers, including the ability to seize products through the U.S. Marshalls. This article will delve into the specifics on the FDA’s warning letter and address how manufacturers can limit the risks associated with making health-related claims.  

The FDA’s Warning: Beware of “Unsubstantiated” Health Claims

The FDA’s letter explained that it determined several of Curaleaf’s CBD products “are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA).” The letter goes on to say that one of Curaleaf’s pet CBD products “are unapproved new animal drugs that are unsafe.” Curaleaf has 15 days to respond to the agency’s letter. The agency cited the following health claims as problematic, among others.

  • “CBD has been demonstrated to have properties that counteract the growth of [and/or] spread of cancer.”
  • “CBD was effective in killing human breast cancer cells.”
  • “CBD has also been shown to be effective in treating Parkinson’s disease.”
  • “CBD has been linked to the effective treatment of Alzheimer’s disease ….”
  • “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
  • “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”
  • “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety … ADHD.”
  • “What are the benefits of CBD oil? …. Some of the most researched and well-supported hemp oil uses include …. Anxiety, depression, post-traumatic stress disorders, and even schizophrenia …. Chronic pain from fibromyalgia, slipped spinal discs . . . Eating disorders and addiction . . ..”
  • “[V]ets will prescribe puppy Xanax to pet owners which can help in certain instances but is not necessarily a desirable medication to give your dog continually. Whereas CBD oil is natural and offers similar results without the use of chemicals.”
  • “For dogs experiencing pain, spasms, anxiety, nausea or inflammation often associated with cancer treatments, CBD (aka cannabidiol) may be a source of much-needed relief.”

The letter explicitly warned, “Failure to correct the violations promptly may result in legal action, including product seizure and injunction.” The FDA has a history of seizing products it deems non-compliant with its regulations. Recently, the U.S. Marshals, at the direction of the FDA, seized 300,000 units of a cosmetic company’s product. The impact of such a seizure on a business’ profits and operations is staggering. FDA action also has a direct impact on publicly traded cannabis companies’ stock price. When news of the FDA’s Curaleaf letter circulated, Curaleaf shares plunged 8%.

Balancing Regulatory Risk and Business Objectives

While the FDA’s letter appears to create a new risk for the cannabis industry, the stock market’s reaction is arguably overblown. The fact that the FDA would question a product’s ability to kill cancer cells is not surprising. I am not familiar with Curaleaf’s research efforts and it is not my goal to pass judgment on their claims. Rather, my point is that manufacturers need to make sure legitimate scientific studies underpin all of their health claims, regardless of the industry. Manufacturers will never be able to avoid regulatory scrutiny or even litigation regarding their health claims entirely. Instead, cannabis companies should take steps to ensure that they can credibly respond to regulatory scrutiny or present strong defenses in potential litigation. Establishing a robust research department is a start. But manufacturers must develop institutional knowledge of the most cutting-edge research regarding their products.Developing in-depth institutional knowledge regarding the state-of-the-art scientific research on your product is a must. 

Manufacturers that market products primarily for their health benefits should consider working with clinical researchers to study their products. There should be written policies and guidelines, as well as employee training, for conducting these studies and dealing with researchers in order to protect the quality of the study. For purposes of mitigating regulatory and litigation risks, the perceived quality of these studies can be just as important as their actual quality. Regulators and plaintiff’s attorneys can easily misinterpret (sometimes intentionally) written communications between a manufacturer and researcher in ways that suggests a particular study was outcome-driven and not a legitimate scientific undertaking. Manufacturers should consult with attorneys experienced in defending product liability and mass tort litigation so that their labeling and research practices are based on historical examples of successful (and sometimes, unsuccessful) product manufacturers.

Key Takeaways

Manufacturing consumer products comes with substantial litigation and regulatory risks. There are several historical and current examples of product labels, health claims, and warnings leading to thousands of lawsuits filed simultaneously across the country against a single manufacturer. Fees associated with defending against even meritless claims can force a manufacturer into bankruptcy. The regulatory risks can also have devastating effects on the day-to-day business operations of any manufacturer. Eliminating these risks is impossible, but addressing them upfront before a product launch, regulatory crackdown, or lawsuit is considerably less expensive than dealing with costly litigation or government seizure of entire inventories. Developing in-depth institutional knowledge regarding the state-of-the-art scientific research on your product is a must. Also, consider working with a clinical researcher to support any claimed health benefits or even discover new health benefits associated with your product. Finally, consult a lawyer with experience in product liability and mass tort litigation to strengthen your policies and procedures regarding research, develop credible health claims, and craft strong warnings.

The post CBD Health Claims Spur FDA Warning & Product Seizure Threats appeared first on Cannabis Industry Journal.

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1. What is CBD? What is CBD Oil?

Cannabidiol (CBD) is a naturally occurring constituent of industrial hemp/cannabis. Its formula is C21H30O2 and it has a molecular mass of 314.4636. It is the most abundant non-psychoactive cannabinoid found in cannabis, and is being scientifically investigated for various reasons.

CBD oil is a cannabis oil (whether derived from marijuana or industrial hemp, as the word cannabis is the latin genus name for both) that has significant amounts of cannabidiol (CBD) contained within it. Our CBD products and extracts are derived from industrial hemp, so they could be considered CBD-rich hemp oil, hemp derived CBD oil, CBD-rich cannabis oil, or plainly “hemp extracts” since they typically contain much more than just CBD. Again, cannabis doesn’t mean marijuana, but is the genus name, and general umbrella term which all forms of marijuana and hemp fall under. The form of cannabis we use for our CBD and hemp extracts is industrial hemp; we do not sell marijuana.

2. If a hemp extract is 40% cannabinoids, what’s the other 60%? What’s in your hemp extracts besides the naturally occurring cannabinoids?

Our Kentucky hemp extracts contain over 80 different phyto-cannabinoids such as cannabidiol (CBD), CBC, CBG, CBN, etc.. In addition to the cannabinoids naturally present in our agricultural hemp extracts, there are also many other types of natural molecules and phyto-chemical compounds such as amino acids, carbohydrates, vitamins (including B1, B2, B6, D), fatty acids (including omega 3 & 6), trace minerals (including iron, zinc, calcium, magnesium, potassium), beta-carotene, chlorophyll, flavanoids, ketones, nitrogenous compounds, alkanes, glycosides, pigments, water, and terpenes. The most common terpenes in our hemp extracts are Myrcene, Beta-caryophyllene, Terpinolene, Linalool, alpha-Pinene, beta-Pinene, Nerolidol og Phytol, trans-alpha-Bergamotene, Limonene/ beta-Phellandrene (Co-elution), and alpha-Humulene.

3. What’s the difference between Hemp and Marijuana?

Scientifically, industrial Hemp and Marijuana are the same plant, with a genus and species name of Cannabis Sativa. They have a drastically different genetic profile though. Industrial Hemp is always a strain of Cannabis sativa, while marijuana can be Cannabis sativa, Cannabis indica, or Cannabis ruderalis. The major difference is how industrial hemp has been bred compared to a marijuana form of Cannabis sativa. organic hemp seedsTypically speaking, industrial hemp is very fibrous, with long strong stalks, and barely has any flowering buds, while a marijuana strain of Cannabis sativa will be smaller, bushier, and full of flowering buds. However, newer industrial hemp varieties in the USA are being bred to have more flowers and higher yields of cannabinoids and terpenes, such as our Kentucky hemp we’re now using!

99% of the time marijuana has a high amount of THC and only a very low amount of CBD. Hemp, on the other hand, naturally has a very high amount of CBD in most instances, and only a trace amount of THC. Fortunately, the cannabinoid profile of hemp is ideal for people looking for benefits from cannabis without the ‘high.’ Hemp is used for making herbal supplements, food, fiber, rope, paper, bricks, oil, natural plastic, and so much more, whereas marijuana is usually used just recreationally, spiritually, and medicinally. The term cannabis oil can refer to either a marijuana or hemp derived oil, since marijuana and hemp are two different forms of cannabis.

In the USA the legal definition of “industrial hemp,” per Section 7606 of the Agricultural Appropriations Act of 2014, is “INDUSTRIAL HEMP — The term ‘‘industrial hemp’’ means the plant Cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”

4. Are hemp derived cannabinoids such as CBD as good as CBD from marijuana?

The short answer is yes. CBD is CBD, whether from marijuana or hemp. Most marijuana has a very low non-psychoactive cannabinoid profile (like CBD, CBC, CBG), so most of the time hemp would be much more preferable for anything besides THC. Marijuana is usually very high in THC (gives people the high) but usually very low in other non-psychoactive cannabinoids.

Nowadays in the USA, many farmers are growing industrial hemp flowers that are just as beautiful, odor-producing, and terpene rich as the best marijuana strains, such as our partnered farmers in Kentucky.

5. Why don’t you source your Hemp and CBD from within Colorado?

colorado growing operationWe feel that the hemp program in Kentucky is more well suited for our company in regards to growing hemp, and that because it’s 100% compliant with Section 7606 of the 2014 Farm Bill (and the 2016 Agricultural Appropriations Act), procuring it from there is perfectly legal at the federal level. Kentucky’s ecology is perfect for hemp just as it is for tobacco. The growing season is longer than in Colorado, and the soil is richer, so the quality of the hemp and the yields are better.

6. What’s the percentage of cannabinoids and CBD in your product?

Our raw extracts have varying percentages of cannabinoid and cannabidiol (CBD) content, the range being 10%-99%. Each product has a unique formulation and uses varying ratios of our extract types. Our CBD Isolate is over 99% pure CBD.

7. What is the best method of use?

For our dietary supplements we can only recommend them for internal consumption. Our CBD isolate is for research purposes only. If you don’t like the flavor of the oil supplements, you can mix with something sweet like apple sauce or honey to cut through the flavor.

8. What’s the ideal serving size for me, and how often should I take it?

There is no easy answer to this. Our starting recommended serving size is 15 drops but we generally recommend experimenting to see what feels best to you. Some prefer 5 drops, some prefer over 50 drops per day.

9. What is the safety of your hemp extracts? Are there negative side effects?

Hemp is considered by many to be generally safe. We’ve never seen or heard of any significant or negative CBD Oil Extractside effects in our years in the industry. That said, we can’t rule them out. Please consult with your physician before using any dietary supplement including Hemp extract supplements.

10. Which of your CBD and hemp products should I get?

As a company who sells various dietary and food supplements, we can’t suggest any of our products for the prevention, treatment or cure of any disease or ailment.

When considering our different dietary hemp products, know that they all come in two strengths. Our Original Hemp blends (Classic Hemp Blend, Hemp Complete, Brainpower oil, & Signature Blend) all have 250+mg of cannabinoids per fluid ounce, and our concentrated blends have 1,500+mg per fluid ounce, six times the potency of our traditional oils. We’ve found that sometimes less is more, but nevertheless, some people like to take very large serving sizes of our hemp extracts.

The main difference between the four Original Blends is the additional herbal ingredients besides hemp. We suggest you research the separate components of each blend to determine which product may be most appealing to add to your dietary regimen. If you know it’s solely the hemp extract that you are looking for, with no additional ingredients, then Classic Hemp Blend or Classic Hemp 6x is what you’re looking for.

For dabbing and vaporizing or for research you can try our CBD Isolate.

THOSE WHO SUSPECT THEY MAY HAVE A DISEASE OR ARE SEEKING HELP FOR A DISEASE SHOULD CONSULT A QUALIFIED MEDICAL PROFESSIONAL.

11. Why do people use Hemp Extracts and CBD? What are the benefits and uses of CBD?

In accordance with federal regulations we cannot make health claims regarding our dietary supplement products. We can only recommend our products for general wellness.

12. Is a standard hemp seed oil the same as a high-CBD hemp extract?

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Hemp Oil For Dogs

Absolutely not. Standard hemp oil, which can be found very cheaply at a grocery store, is a much different product than our CO2 hemp extracts (not from seed). Standard hemp oil is produced by cold pressing the seeds, whereas our hemp extract is a supercritical CO2 extraction of the hemp plant itself, not the seeds. Hemp seed oil is considered to be a great nutritive food, but it doesn’t have the naturally occurring terpenes, cannabinoids and other components that our extracts do have.

13. Do I need to move to Colorado to get your Hemp Extracts and CBD? Where do you ship?

No. We actually source our hemp from Kentucky, as it’s legal to ship across state lines. Many people are under the impression that the only way to acquire hemp extracts and CBD for themselves or a loved one is to move to Colorado or another cannabis-friendly state. Many major news outlets are misinformed and are unfortunately spreading the idea that you can only get CBD oil in the states where medical marijuana has been legalized. This is simply not the case though. Because our extracts comes from hemp instead of marijuana, we can and do ship to all fifty states, and no medical marijuana card is needed. There are some exceptions, like with Indiana, Missouri and South Dakota we can’t sell our concentrated products due to state legislation.

We also ship to Japan, Australia, the EU, Switzerland, and Brazil. For all EU orders contact our exclusive distributor thereCannawell.

14. Is your Hemp Extract Oil similar to Rick Simpson Hemp Oil?

Not quite. Ours are from hemp and RSHO is usually using marijuana, a different form of cannabis than industrial hemp. Our industrial hemp extracts are more standardized and will usually have a much higher content of non-psychoactive cannabinoids like CBD than one produced through the Rick Simpson method. And oils produced through his method will usually have a much higher THC content, as it’s typically marijuana that is used for RSHO.†

Generally speaking, most marijuana producers and sellers (especially on the black market) don’t test for contaminants (metals, pesticides, bacteria, etc.). Rick Simpson Hemp Oil is actually more a method of extraction than it is a specific product. People use the Rick Simpson method with hundreds of different strains of marijuana, so the THC, CBD and other cannabinoid content of the final oil is always varying greatly, depending on the cannabis the consumers are acquiring. Usually what’s used for Rick Simpson oil is a strain with an inferior CBD content (and high THC), because that’s what the vast amount of marijuana is nowadays.

15. Where do you source your hemp and CBD from?

We have partners in Kentucky who grew a dedicated plot for us this year (2016) which is being used in our products now. mjna message boardWe also currently source from Europe but we’ll be changing that soon.

16. What kind of testing/analysis is performed on your products?

We have an industry leading quality control system, and we have third party laboratories analyze all of our hemp extracts and our final products for cannabinoid potency, heavy metals, bacterial and microbial life, mycotoxins (fungus), and pesticides.

17. What is CO2 extraction? What’s the difference between subcritical and supercritical CO2 extractions?

CO2 extraction is an extraction process that uses pressurized carbon dioxide to extract phyto-chemicals (such as CBD, CBG, or terpenes, flavonoids, etc.) from a plant. CO2 at certain temperatures and pressures acts like a solvent, without the dangers of actually being one. It is the most expensive extraction method, and is widely considered the most effective and safest plant extraction method in the world.

Many hemp and CBD companies boast about their supercritical CO2 extractions, but that’s actually only one (and perhaps an inferior) method of using a CO2 extraction machine. There are also subcritical CO2 extractions, and ‘mid-critical’, a general range between subcritical and supercritical. Subcritical (low temp, low pressure) CO2 extractions take more time and produce smaller yields than super-critical, but they retain the essential oils, terpenes, and other sensitive chemicals within the plant. Supercritical, on the other hand, is a high pressure and high temperature process that damages most terpenes and heat sensitive chemicals, but can extract much larger molecules such as lipids (omega 3 and 6), chlorophyll, and waxes. A truly full-spectrum CO2 extract includes first performing a subcritical extraction, separating the extracted oil, and then extracting the same plant material using supercritical pressure, and then homogenizing both oil extracts into one. In the essential oil industry, an extract made using this specific process is referred to as a CO2 Total.

18. What is the endocannabinoid system (ECS)?

“The endocannabinoid system (ECS) is a group of endogenous cannabinoid receptors located in the mammalian brain and throughout the central and peripheral nervous systems, consisting of neuromodulatory lipids and their receptors.” Wikipedia

There are two main types of receptors in the ECS, CB1 and CB2. CB1 receptors are primarily located in the central nervous system and brains of mammals, and CB2 are generally found in the peripheral nervous system. There are two main cannabinoids mammals produce- 2AG and Anandamide (named after the Sanskrit term “ananda” which translates to “peace”).

For hundreds of millions of years every vertebrate on Earth has been equipped with this ECS, a crucial system in the body, and it has been known about in the scientific and medical communities since the 1980’s. However, it’s still not taught about in most medical schools.

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