FDA Cracks Down on CBD Oil

 

This is actually no surprise and actually long overdue.  Recent work has disclosed ample unexpected medical indicators for a range of known CBDs.   We are about to start the process of breeding out stronger vwersion of those products.  Perhaps it is time to do the scinece and discover valid dose levels as well.

Perhaps the FDA can really do its job this time around.   Inasmuch as the Trump administration is on to them and will certainly reform this whole agency in his second term.  

In the nonce, this also validates the rising claims been made regarding this newly acknowledged palette of health agents..

FDA Cracks Down on CBD Oil 

12-11-2019 • Mercola 

 https://articles.mercola.com/sites/articles/archive/2019/12/11/warning-letters-to-companies-marketing-cbd-products.aspx

 

Story at-a-glance

-While the widespread availability of CBD oil across the U.S. would make you believe it's legal everywhere, a recent consumer update from the Food and Drug Administration clarifies the issue, noting that CBD is not recognized as a nutritional supplement

-The FDA is now starting to crack down on CBD makers and sellers for illegal product claims. For the first time in nearly four years, warning letters have been issued to 15 companies for CBD products sold in violation of the Federal Food, Drug, and Cosmetic Act

-The only FDA-approved CBD product is a prescription drug for the treatment of two severe forms of epilepsy

-Whole hemp oil can be legally sold across the U.S., even if it contains naturally occurring CBD, but CBD isolates cannot be sold as a nutritional supplement, even if it's derived from legal hemp

-To stay within the legal framework, companies cannot advertise or list CBD on the label. Nor can they make any specific health or disease claims

The popularity of cannabidiol (CBD) — one of the nonpsychoactive components of cannabis and hemp — has exploded in recent years. As noted in a May 14, 2019, New York Times article:1,2

"… cannabidiol is everywhere. We are bombarded by a dizzying variety of CBD-infused products: beers, gummies, chocolates and marshmallows; lotions to rub on aching joints; oils to swallow; vaginal suppositories … CVS and Walgreens each recently announced plans to sell CBD products in certain states."

This mass emergence of CBD products came on the heels of the U.S. Food and Drug Administration's downgrading of CBD products from cannabis that contain no more than 0.1% tetrahydrocannabinols (THC, the psychoactive component of cannabis) from Schedule 1 to Schedule 5 at the end of 2018.3 Schedule 5 drugs are considered to have a lower potential for abuse than other controlled drugs.4

However, a vast majority of these CBD products are marketed illegally, as the FDA still does not recognize CBD as a nutritional supplement. Recent reports also warn that the FDA is now starting to crack down on CBD makers and sellers for illegal product claims.

As reported by Forbes5 November 25, 2019, for the first time in nearly four years, warning letters have been issued to 15 companies for CBD products sold in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA has also issued a general consumer update6 detailing various CBD safety concerns. Companies that received warning letters include:7

CBD Excluded From Dietary Supplement Definition

According to the FDA's consumer update, dated November 25, 2019, there's a lack of scientific information supporting the safety of CBD in food, stressing that "It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement."

In short, CBD is not legal for use in food, animal feed or supplements. The only FDA approved CBD product is a prescription drug for the treatment of two severe forms of epilepsy.8

In fact, the FDA's downgrading of CBD with minimal THC content to a Schedule 5 drug was in direct response to its approval of Epidiolex, which is approved for the treatment of Lennox-Gastaut syndrome and Dravet syndrome.

As mentioned, CBD can also be derived from hemp, which can now be grown and sold legally in the U.S. per the 2018 Farm Bill. In order to not fall within the definition of marijuana in the Controlled Substances Act, however, the hemp must (under the Farm Bill) contain less than 0.3% THC on a dry weight basis.⁹

With the legalization of hemp, hemp-derived CBD products grew fast and furious. However, it’s important to recognize that CBD isolates from hemp are still illegal as a dietary ingredient. By approving a CBD-only drug (Epidiolex), CBD cannot — per FDA rules — be sold as a supplement, even if it’s derived from legal hemp. 

So, to clarify, whole hemp oil can be legally sold across the U.S., even if it contains naturally occurring CBD, but CBD isolates cannot be sold as a nutritional supplement, even if it’s derived from legal hemp. 

What’s more, to stay within the legal framework, companies cannot advertise or list CBD on the label. Nor can they make any specific health or disease claims. As reported by Forbes, the 15 companies that received warning letters from the FDA:¹⁰

“… are using product webpages, online stores and social media to market CBD products in interstate commerce in ways that violate the FD&C Act, including marketing CBD products to treat diseases or for other therapeutic uses for humans and animals. Other violations include marketing CBD products as dietary supplements and adding CBD to human and animal foods.”

Considering the FDA’s strengthened position on CBD, it would be wise to leave any CBD products at home when traveling. In May 2019, a 69-year-old woman was arrested and spent 12 hours in jail after Disney World security found CBD oil in her purse.¹¹

The woman said she used it to alleviate arthritis pain. CBD is legal in her home state of North Carolina and is widely available in stores across Florida. The woman also had a doctor’s note for the CBD oil. While the drug charges against her were dropped, her case serves as a chilling warning to CBD-using travelers. 

Valuable Health Benefits Ignored

In the 1980s, a St. Louis University Medical School scientist named Allyn Howlett identified the cannabinoid receptor type 1 (CB1) in the human brain. We now know there are two types of cannabinoid receptors throughout the human body, CB1 and CB2. 

We also know the body produces endogenous cannabinoids that influence these receptors, and that this endocannabinoid system (ECS) plays an important role in human health, as it regulates homeostasis by orchestrating communication between your bodily systems, such as your respiratory, digestive, immune and cardiovascular systems. 

According to Project CBD, at least 50 conditions¹² are believed to be improved by CBD, including pain, seizures, muscle spasms, nausea associated with chemotherapy, digestive disorders, degenerative neurological disorders such as multiple sclerosis and Parkinson's disease, mood disorders, anxiety, PTSD and high blood pressure. 

Importantly, CBD has also been shown to provide valuable benefits for those struggling with opioid addiction. To learn more about the benefits of CBD, see “The Endocannabinoid System and the Important Role It Plays in Human Health.” 

FDA Overstates Risks 

According to New Hope,¹³ the FDA’s updated consumer guidance “’raises significant concerns’ among the hemp CBD industry because the FDA undersells its benefits and overstates the risks …” Loren Israelsen, president of the United Natural Products Alliance told New Hope:¹⁴

“This is a significant, concerted and highly orchestrated effort by FDA to put the brakes on the CBD market. The viewpoints and perspectives of the respective interests in this issue are becoming clearer as the anticipated struggle to determine the status of CBD and the other cannabinoids has begun …

The agency has yet to target companies that are not making claims, but it has expanded its concerns over common claims, such as stress, anxiety and pain.”

The U.S. Hemp Roundtable, which lobbies on behalf of the hemp industry, also expressed concern about the tone of the FDA’s consumer update document, stating the agency “severely overstates the health risks of hemp-derived CBD and … ignores much of the scientific evidence of CBD’s safety, in particular at dosage levels typically found in foods and dietary supplements.”¹⁵

Don’t Buy CBD Products on Amazon 

Despite its overly negative tone, the FDA does raise an important issue in its consumer update, namely that of quality control. There are plenty of bad actors out there, looking to make a quick buck, so it’s important to do your research before buying.

The worst place to source your CBD is from Amazon. As reported by the Organic & Natural Health Association¹⁶ on October 15, 2019, Amazon’s policy prohibits the sale of CBD products, yet, when you search for “CBD” in its search engine, thousands of products match that search term.

The reason for this is because Amazon allows vendors to tag their products with whatever search words they want — including terms that are prohibited per its own policy, apparently.  

Amazon also allows vendors to purchase advertising space for CBD products, again despite the fact that they don’t actually allow CBD products to be sold. To investigate this paradox, the Organic & Natural Health Association hired a third-party laboratory to test Amazon’s best-seller, New Age Premium Hemp Oil 1000 MG, for the presence of cannabinoids.  

In what appears to be a clear violation of Amazon’s policy, the product was found to contain approximately 1% CBD¹⁷ (7.7 milligrams of CBD per 30 drops). It does not list CBD on the label, however. 

As mentioned, companies are not allowed to list CBD content if they want to sell hemp oil legally, and this really puts consumers in a tough bind, as it’s impossible to know just how much CBD any given hemp oil might contain. In a statement, Karen Howard, CEO and executive director of Organic & Natural Health, said:¹⁸

“It’s really important for consumers to know that because Amazon doesn’t allow the sale of products with CBD, there are no reputable companies selling CBD on their site …

Amazon states it has banned the sale of CBD supplements on its site, but allows advertising and tagging of CBD instead, inviting an influx of products to consumers that the FDA has been warning about …

Essentially, the public is being defrauded twice. First, Amazon’s best-seller, New Age Premium Hemp Oil contains CBD even though its label does not list CBD. Second, those searching for CBD products are being misled into buying products containing zero CBD.”

The Case for Organic CBD

Also keep in mind that since CBD oil became a focus of popular holistic medicine almost overnight, effective quality control has not caught up yet and some products do not meet the claims made on the label.¹⁹ Until such a system is in place, it’s important you purchase your CBD products from a trusted source.

The need for more stringent quality control has already been demonstrated in studies²⁰ showing 26.19% of 84 CBD products tested contained less CBD than advertised, and 42.85% of them contained more. Only 30.95% were accurately labeled.

The FDA also rightly points out that heavy metal contaminants can be a concern. Indeed, heavy metal testing is particularly important component of quality control for hemp-based CBD products, as the plant is known to extract heavy metals from the soil. 

Hemp is actually used for bioremediation purposes²¹ to clean heavy metals out of soils, which is great if the hemp is used for rope, fuel and other nonmedical uses. When made into medicine, however, this soil-cleansing feature could pose significant problems. 

As a general rule, I recommend seeking out certified organic CBD products to ensure the least amount of contamination with pesticides and other harmful contaminants.