Legislative and FDA Approvals for CBD Products, An Overview

The Difference Between Pharmaceutical Grade and Food Grade CBD

With the passing of the 2014 Farm Bill, CBD derived from industrial hemp became legal in for a very narrow set of hemp cultivation activities. The legislation indicated that it is legal to grow hemp under a state pilot program or for academic research. It is also legal to cultivate under state law in which such institution of higher education or state department of agriculture is located and such research occurs.

Outside of these parameters, the Drug Enforcement Administration maintains that CBD is definitely still illegal and those who violate federal drug laws run the risk of arrest and prosecution. But the DEA has indicated that it is not going after individuals who have benefited from CBD oil – for example, a mother obtaining CBD to help her child who has epilepsy.

While CBD is not legal in all 50 states, it is widely available for purchase in a wide range of administration methods including:

• CBD isolate, or CBD crystals, is CBD in its purest form, generally around 98 to 99 percent. Crystals can be dabbed*, made into a tincture**, or as an edible by adding them to a high-fat food like butter or oil.

*Dabbing is defined as the consumption method associated with the flash vaporization of cannabis concentrates, once applied to a hot surface and inhaled.

**CBD tinctures are liquid extracts combining CBD-rich hemp oil and vegetable glycerin, ethanol, or other type of nutritious oil. 

• CBD topicals can take the form of shampoo, lotion, and soap.
• CBD extracts can also be made into a wax and dabbed.
• CBD edibles come in the form of gummies, chocolates and baked goods and are an easy way to ingest CBD without the need for inhalation.
• Pills and capsules are all unobtrusive ways to administer CBD.

Obtaining CBD Products
Those wanting to purchase CBD products can do so via online storefronts, or in some states, actual storefronts; however, in the absence of a regulatory system, consumers are reliant on company claims to ascertain any information about the complete make up and authenticity of the CBD product they are buying. Deciding which of the unregulated CBD brands to purchase can be problematic. While there are certainly CBD producers who source their hemp from cultivators that operate under the Farm Bill, it is unlikely that all of them were sourced from research hemp, due to its widespread distribution.

CBD derived from hemp that’s marketed to the general public is “sketchy at best” says Dan Linn, executive director of the Illinois chapter of the National Organization for the Reform of Marijuana Laws (NORML), a nonprofit group that opposes pot prohibition. “There is no testing or quality controls,” Linn says, “which are ultimately why I feel they are no different than snake-oil products.”

A 2016 study published in the Journal of Regulatory Science tested 23 products with “hemp oil and/or cannabinoid label claims” purchased on the Internet. Of these, 18 tested positive for the presence of at least one cannabinoid compound. But three contained less than 0.01 percent of a cannabinoid, and four products labeled as CBD “were found not to contain any CBD,” according to the study.

CBD and Food
In July of 2018, the California Department of Public Health’s Food and Drug Branch issued a revised FAQ on CBD in food products. They have determined that CBD sourced from industrial hemp cannot be added to food, including drinks for either humans or pets.

“Until the FDA rules that industrial hemp-derived CBD oil and CBD products can be used as a food or California makes a determination that they are safe to use for human and animal consumption, CBD products are not an approved food, food ingredient, food additive or dietary supplement,” the state agency concluded.

What’s the FDA Have To Do With It?
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, tobacco products, dietary supplements, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, and veterinary foods, feeds and other products.

FDA & CBD Food Additives
The FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the make up and the health benefits of foods. Although FDA does not have premarket approval of food products, it has the authority to approve certain ingredients before they are used in foods. Those include food additives, such as substances added intentionally to food, and color additives.

Companies that want to add new food additives such as CBD to food need to provide the FDA with information proving that the additives are safe. FDA experts review the results of appropriate tests done by companies to ensure that the food additive complies with regulations and is safe for consumption.

CBD Food Grade & Other Products
The FDA has taken recent actions against several companies distributing unapproved CBD products. These products have been marketed in a variety of formulations, such as teas, capsules, oil drops, syrups, and topical lotions and creams. These companies have claimed that various CBD products could be used to treat or cure serious diseases such as cancer with no scientific evidence to support such claims. Marketing of CBD-containing products with unproven medical claims is illegal.

The FDA is especially sensitive to products, which are marketed for serious, or life threatening diseases, where the illegal promotion of an unproven compound could discourage a patient from seeking other therapies that have proven benefits. This is the line that crosses into medical treatment and utilizing a product as a drug, which comes hand-in-hand with a different, more stringent set of regulation, protocols, clinical trials, and research requirements to receive FDA approvals.

FDA & Pharmaceutical Grade CBD
In order to obtain FDA approval for a new drug, such as a CBD pharmaceutical grade drug, there are rigorous requirements that are in place. The most substantial requirements apply to new molecular entities: drugs that are not based on existing medications.

Before a high-quality drug can be developed, evaluated, and eventually approved by the FDA; it’s critical that the necessary work is done to identify drugs of potential medical benefit and conduct extensive, in-depth scientific research through stringent and well-controlled clinical trials. This is true for all drugs, including ones derived from plant materials, like hemp.

This research process – from early development through preclinical and clinical research – gives researchers a comprehensive understanding of a new drug. That includes an understanding of whether the new product is safe and effective for treating a particular medical condition, what the proper dosage is and for what populations it is safe and effective, how the new compound could interact with other drugs, or whether the new drug has side effects or other safety concerns.

This work also helps product developers, researchers, and doctors identify the appropriate dosage needed to achieve the desired therapeutic effect while minimizing toxicity and risk. When the research and clinical trials are complete, the scientific evidence generated by these studies forms the basis of the FDA’s evaluation of benefit versus risk. This careful, scientific and evidence-based assessment by the FDA enables health care providers to be able to ensure they are prescribing a quality product that delivers a consistent, uniform dose of an effective medication that is able to deliver predictable treatment results in patients. This is especially important when considering treatment for serious medical conditions that will be utilized in the clinical care of patients who may have any number of health vulnerabilities.

How the New Farm Bill Will Affect CBD Products
With Congress on the verge of approving the new 2018 Farm Bill, which includes legislation to legalize hemp, it is predicted that hemp-derived CBD sales will expand to more than $450 million by 2020.

How this new legislation will affect state and local laws? How will food grade CBD be regulated? What will the changes be for the pharmaceutical grade CBD industry? The answers to all of these questions have yet to be completely defined. What is known is that for many in the hemp-derived CBD industry, their work has just begun. Whether they are seeking to introduce a new CBD edible into the market or are pushing forward with their CBD cancer research and clinical trials, ahead of them lies months of paperwork, research, and financial expenditure with the hope for many cures and supplemental treatments for some of today’s most prevalent medical ailments.

About Diverse Biotech, Inc.
Diverse Biotech Inc. is an innovative, clinical-stage biopharmaceutical research company, committed to discovering and developing novel therapeutics from its proprietary cannabinoid product platform.

For more information on Diverse Biotech or its Cannabinoid (CBD) clinical trials, use in the treatment of specific types of malignancies related to glioblastoma, myeloma, gastrointestinal, and breast cancer, when administered in conjunction with Standard of Care, please contact Diverse Biotech by phone at 407-776-9217 or visit the company’s headquarters at 805 S. Kirkman Rd, Suite 202, Orlando, Florida 32811.