We Need FDA Regulation For CBD Today, Not Tomorrow
If you haven’t tried hemp CBD yet, you probably know somebody who has—this popular compound seems to be all over the place. Unfortunately, so do regulations about producing, labeling, and selling it, and that’s a problem. Consumers, CBD companies, retailers and others are begging for more FDA involvement in the Hemp CBD industry.
CBD Is Everywhere
With the passage of the 2018 Farm Bill, Hemp was removed from the federal controlled substances list. Following this change in status, Hemp-derived CBD has become a booming industry. According to a 2019 report by the Brightfield Group, there are currently more than a thousand different CBD brands out there. Within these brands, there is an enormous variety of CBD items including tinctures, vape oils, capsules, beauty products, foods, beverages, and even pet foods. That’s already a lot, but experts believe that the CBD industry may just be getting started. In the Brightfield report, researchers estimate that by the end of 2019 the CBD market will reach $5 billion, a 706% increase compared to 2018. By 2023, the market is projected to reach a massive $23.7 billion.
Is Anyone Regulating this Market?
So, what’s being done to regulate all these new companies and products, and as a consumer how can you be confident that the Hemp CBD product you’re purchasing is legal, safe or effective? Unfortunately, a lot of the existing guidelines are unclear, and knowing what you’re getting can be difficult. Rules about CBD differ by state, and federal law is also confusing.
Federally, CBD regulation is the domain of the U.S. Food and Drug Administration (FDA). This agency is responsible for protecting public health by ensuring food and drug safety. However, FDA action to regulate CBD hasn’t been nearly as fast-moving as the growth of the Hemp CBD industry. On its website, the FDA has a page titled, “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD,” where it states, “Other than one prescription drug product to treat rare, severe forms of epilepsy, the FDA has not approved any other CBD products.” In relation to when there might be additional regulation, it says, “There are many unanswered questions about the science, safety, and quality of products containing CBD. The Agency is working on answering these questions through ongoing efforts including feedback from a recent FDA hearing and information and data gathering through a public docket.”
However, while the FDA is still in the information-gathering process, the public is already buying. More and more CBD products are becoming available, and a large number of people are using them. In 2019, Consumer Reports surveyed more than 4,000 Americans and found that more than a quarter have tried CBD in the last 24 months. One in seven said they use CBD every day.
Guidance Is Desperately Needed
In order to protect everyone involved in this rapidly growing industry, consumers, CBD companies, retailers and others are asking for more FDA guidance on Hemp CBD. For example, in July 2019 the Food Marketing Institute (FMI)—which represents thousands of companies in the food retail industry—submitted a letter to the FDA. In that letter, the organization stresses that the number of foods, beverages, and supplements with CBD in them keeps growing. As a result of this proliferation, and the absence of clear FDA guidelines, it says, “Consumers currently face a variety of risks, from unsubstantiated health and benefit claims to a lack of standardization in product labeling and packaging, to products that may not contain the ingredients it purports to contain.” FMI argues, “In short, the market is far too large to remain unregulated, and the current lack of FDA regulation is creating significant confusion in the marketplace.”
U.S. Senator for New York, Charles E. “Chuck” Schumer, has also been vocal about the need for additional FDA guidance, urging the agency to set guidelines on producing, labeling and marketing products that have CBD in them. In a recent press statement, he said, “CBD is brimming with potential to be a billion-dollar industry across New York State, bringing along countless jobs and truly meaningful economic development with it. But before that can happen, farmers, growers, producers, consumers, and vendors need to know exactly what the rules of the road are and right now they’ve got no idea.”
Disturbing Test Results
Fears about risk are not unfounded. There have been a number of different analyses done on CBD products, which have revealed that it’s true that you can’t always trust what you read on the label. The most common problems are inaccurate labeling regarding CBD content and the presence of other chemicals or contaminants that could be harmful to users. The FDA itself has tested a number of CBD products and reports, “Many were found to not contain the levels of CBD they claimed to contain.” Further, states the agency, “We have also heard reports of CBD potentially containing contaminants (e.g., pesticides, heavy metals).”
Other researchers have found similar problems. For instance, in a study that was published in 2017, researchers analyzed 84 different CBD products sold online and found that many had inaccurate labeling. Some had more CBD than claimed (about 43 percent), and others had less (about 26 percent). Only about 31 percent actually had the amount of CBD stated on the label. 18 of the samples also contained THC (which was not disclosed on the label). The researchers note, “The THC content observed may be sufficient to produce intoxication or impairment, especially among children.”
In another study, researchers analyzed 9 CBD e-liquids from one manufacturer. “The website where these e-liquids were purchased stated that these products were ‘100% natural CBD extracts’ and provided no indication that these products contained any other active substances,” they state. However, the researchers detected some other alarming compounds in the e-liquids. They report that 4 of the products contained something called 5F-ADB, which can have psychoactive effects, and one contained DXM, which is an ingredient in many cough and cold medicines. DXM can cause agitation, sedation, or even hallucinations. They conclude, “The inclusion of these drugs in e-liquids can lead to dangerous consequences; particularly when the users are unaware, and the products are used for therapeutic reasons.”
Some People Are Stepping Up
Fortunately, you can find CBD products that aren’t contaminated with things like pesticides or DXM and do contain the amount of CBD printed on the label. That’s because, in the absence of clear guidelines, some of the people in the CBD industry have taken it upon themselves to create and follow their own guidelines to ensure the quality and safety of hemp CBD products. For example, more than thirty companies have been certified by the U.S. Hemp Authority Certification Program, a program established in 2018 and funded by the U.S. Hemp Roundtable. To be certified through this voluntary program, participants must meet rigorous self-regulatory standards and pass a third-party audit. U.S. Hemp Authority president Marielle Weintraub explains, “In the interim of FDA action, we feel the US Hemp Authority guidelines and certification program hold companies to the highest industry standards while giving consumers an easy way to identify products they can trust.”
CV Sciences, which makes PlusCBD™ Oil, is a U.S. Hemp Authority Certified Company. A market leader among U.S. CBD companies, CV Sciences is committed to transparency and consumer safety. Dr. Duffy Mackay, N.D., senior vice president of Scientific and Regulatory Affairs for CV Sciences explains why. He insists, “The success and sustainability of the Hemp CBD industry is dependent on establishing consumer trust. It’s important that hemp CBD brands demonstrate that their products are safe and manufactured to meet quality standards that are expected by consumers.” As part of its efforts to create that trust, CV Sciences was the first Hemp company to invest in the scientific research necessary to receive something called a self-affirmed Generally Recognized as Safe (GRAS) status. GRAS status is generally a U.S. Food and Drug Administration (FDA) designation which requires that experts review the testing and research to determine that a product is safe. However, companies can invest prior to FDA designation to determine themselves if a product should be considered GRAS. This is what CV Sciences did.
We Need the FDA
Ultimately though, many of those within the hemp CBD industry stress that additional FDA guidance and clarification is desperately needed. The U.S. Hemp Roundtable is one organization that is pushing to make that happen. Jonathan Miller, General Counsel for the U.S. Hemp Roundtable, insists, “We believe that there is an urgent need for an efficient regulatory framework for CBD.” He explains, “The FDA’s public guidance on CBD . . . has cast a cloud on commerce in the Hemp CBD space, discouraging some financial institutions from engaging with the industry and encouraging some local and state officials to issue their own negative guidance. That’s why it is so critical that the FDA lift this cloud by developing a clear regulatory structure for the safe sale of hemp CBD products.”
As stated on the FDA website, two of the agency’s primary goals are to protect and advance public health. With so many Americans now using hemp CBD, it’s evident that this substance definitely has the potential to impact public health. That’s why we need more FDA involvement in hemp CBD regulation, and we need it yesterday.
