Cannabis CBD FDA Hearing

FDA Hearing Cannabis CBD
Drug Prevention Advocates Testified to FDA about Cannabis Dangers

It’s Best to Ignore This Health Trend

“The FDA must act quickly.” “Consumers need to be able to trust what they are buying.” “The cannabis market is the Wild Wild West.” These were common refrains from many of those who testified at the FDA Hearing on Cannabis and Cannabis Derived products on May 31, 2019. While there are many cannabis derived products now on the market in pot legal states, the speakers representing the industry seemed to concentrate on CBD, a product that is flooding the U.S. market at this time.

Much of the CBD on the market is mislabeled and misrepresented, according to a manufacturer of pharmaceutical ingredient materials.

Seen on a recent trip to the Eastern Shore of Maryland, a gas station, a health food store, and a Boardwalk t-shirt shop were all promoting CBD. A new Hemp store was replacing an ice cream and cookie store just one block off the Boardwalk. What is going on?

Transformation of a Cookies and Ice Cream Store into a Hemp Shop Selling CBD

In December of 2018, Congress passed the Farm Bill, which included lifting the ban on growing hemp in the U.S. This fairly recent development brings a glut on the market of the cannabinoid, CBD, which is being promoted as a supplement, apparently because CBD is considered an illegal drug by the FDA. It can’t be sold as a drug, so let’s sell it as an over-the-counter nutritional? Speakers during the hearing referred to CBD alternatively, as medicine, supplement and food additive. One speaker, from the Epilepsy Society, questioned how it could be all three.

Hemp and its derivative, cannabidiol (CBD) have not been granted GRAS status (generally recognized as safe), by the FDA. Many speakers yesterday asked that the FDA to evaluate hemp safety, to give consumers more confidence in the hemp products currently being aggressively marketed and sold. A number of watchdog groups testified that for hemp to enter the food supply it must go through the FDA New Dietary Ingredients (NDI) Notification Process. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that manufacturers and distributors who wish to market dietary supplements notify the Food and Drug Administration about these “new dietary ingredients”.

Last year, the FDA approved the first pharma drug made from CBD but restricted its proper application to two severe forms of epilepsy.

Yet, the Farm Bill just opened a floodgate of new hemp crops now seeking a market.

Are Americans Being Force Fed an Illegal Drug?

Alarmingly, hemp foods and hemp extracts are already being widely used already as food and in personal care products. A smoothie shop in Myrtle Beach infuses CBD into beverages. A chocolatier in Virginia adds hemp to candy bars. Grocery stores and beauty salons are selling hemp based shampoos and body lotions. Even coffee is being infused with CBD by one company. If CBD is a drug that can help conquer seizures, what is the potential harm of such casual, widespread use?

CBD for Sale at a Gas Station. Attendant Offers Drug Advice?

The FDA was described by a number of speakers as behind the curve of the industry which has “exploded outside of any regulatory framework”.

A North Carolina Agricultural official testified that in his state alone, there are 1000 growers cultivating 12000 acres of hemp. More is being grown in green houses. He was asked by the FDA panel where most of this hemp was going, what was the end use? He said that growers can make $30,000 an acre by selling their crop to the CBD makers, and only $700. per acre if it is being sold into the fiber sector. So most of it is expected to be sold to CBD processing companies.

A military veteran now a manufacturer of CBD oil claimed there will be a glut of hemp on the market and limited processing facilities. He estimated that 100,000 to 200,000 acres of hemp will be grown this year and that farmers may end up burning their fields.

Another likely scenario is that the excess hemp will find its way into animal feed. AFCO, which is the Association of Feed Control Officials came to the hearing to ask the FDA to  review hemp and possibly approve it as an ingredient in animal feed. Although she admitted CBD was a drug and needed to be considered separate from hemp meal or hemp seed oil, she said some farmers are interested in even feeding CBD to their animals. She said her Association is trying to stop horse and pet “hemp treats” already being sold.

Women Grow, an association of female cannabis farmers complained about poor quality products on the market. Their spokesperson asked for testing, clear and concise labeling and use of the drug in consult with a health professional.

CBD is Being Infused in Food. FDA Does Not Allow Highly Purified CBD in Food.

The Organic & Natural Health Association, which is a scientific group that develops standards for botanical products recommended that users not compare hemp extracts and CBD products to the pharmaceutical—they are not comparable. The ONHA registered their concerns about contamination and toxins, THC and heavy metals found in products currently in the market.

Contaminants Found in CBD Pose Health Risk

What contaminants are being found in American cannabis products? Mentioned during the hearing were pesticides, herbicides, microbials and mold, mycotoxins, heavy metals, and varying levels of THC.

A biological testing company, Tetra Bio Pharma found adverse effects and toxins in their testing of cannabis and CBD. The adverse events from smoked cannabis they reported were: nervous system disorders, euphoria, fatigue, dizziness, headache, substantial heart rate impact, somnolence, feeling abnormal. The adverse events found from CBD were: dizziness, constipation, decreased appetite, heart palpitation, anxiety, and nausea.

A woman suffering from a rare eye disease raised the issue of the increase in eye pressure from cannabinoids. She felt that blindness was also a potential risk that should be considered.

Consumers are getting no education on the potential risks of CBD, according to several of the presenters. A common refrain from both industry and public interest groups was that consumers of CBD need to be given information on potential side effects and contraindications. None of the cannabis industry presenters could speak to what was a safe dose or daily limit for the drug.

Academic researchers who testified mentioned the risk of liver toxicity and drug interactions. Scientists know, so far, that CBD use with the blood thinner Warfarin, the immunosuppressant Tacrolimus, and pain reliever Acetaminophen is ill advised. A dietary supplements researcher at the University of Arkansas said that CBD can exacerbate the risks of other drugs that can cause liver injury.

According to one researcher at Johns Hopkins, it is inappropriate to consider CBD as non-psychoactive. He claimed that mild cognitive impairment can occur with higher doses. He also said that the long term effects of CBD have not been studied. He also explained that no research has been done on the other components of hemp. He claimed that vaping produces stronger effects than smoking or oral methods of taking CBD.

The New York Times article on the FDA Cannabis hearing generated a lively discussion. Among the comments was this observation, “My wife and I have used topical creams with CBD and found them to be useless and expensive. There are much cheaper products already on store shelves like Arnica and Lidocaine at roughly 10% of the cost of CBD infused products.” Two other commenters on the article mentioned their discovery that CBD interacted negatively with their medications, the statin drug, Simvastatin and the antibiotic, Cefuroxime.

The CBD industry is currently generating around 1 billion dollars in revenue, and one expert testified that it may be $22 billion by 2022. Compare that to $2 billion a year in sales for non-prescription pain relievers, such as aspirin. Could it be that aggressive sales ambitions are the reason CBD is being marketed as more than just a pain reliever? If it can be infused in food, toiletries and animal feed, the market for the drug is virtually unlimited!

Consistency of the product was a big concern presented by University of Mississippi. Scientific researchers purchased 25 CBD products and had them analyzed for CBD content. The percentage of CBD in the products varied widely, from .3 % of the label claim to 2280% of the amount declared on the packaging label. Only one product (out of the 25) had 100% of the CBD content they claimed on the manufacturer’s label.

The representative of the College on Problems of Drug Dependence weighed in on the need for randomized placebo controlled trials. She explained that right now, public opinion and marketing are determining what consumers are using cannabis and cannabis derived products for. She also reported that few cannabis addicts achieve continued abstinence. Only 20% are successful at quitting the drug.

An expert that serves on advisory panels for the cannabis industry sounded the best caution. She asked, “has science based testing accurately evaluated the product and have risks been assessed?” She issued a strong warning to consumers, “Now more than ever, the public is gambling with its health. We are radically expanding the use of an untested product, a very frightening situation. Research needs to catch up.” She added, “Makers of CBD are susceptible to deception by laboratories. Also, laboratories known to be doing substandard testing are being chosen because of their lax standards.”

Click here for the YouTube of the entire hearing.

Kimberly Hartke blogs about health, wellness and homemaking.

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