When the FDA held a public hearing on CBD a number of people testified about the benefits, dangers, and confusion associated with the quickly expanding market. One of these presenters was Jackie Bowan, Executive Director of The Clean Label Project. Jackie testified about the inconsistencies in CBD labels, the lack of clear quality guidelines, and the dangers unregulated supplements pose to consumers. Recently, we spoke with Jackie about her work and the state of the CBD market.
Clean Label Project is a national non-profit with the mission to bring truth and transparency to food and consumer product labeling. We believe that sometimes what’s NOT on a label is what matters most. Food safety attention and regulation has largely been focused on short term acute exposure to food-borne microbiological pathogens like salmonella, E. coli, and listeria. The long-term threat of cancers and reproductive disorders linked to industrial and environmental contaminant exposure (like heavy metals, pesticide residues, and plasticizers) have largely gone unnoticed, untested, and therefore unregulated in food and consumer products, until now.
Through data, science, and benchmarking, Clean Label Project uses retail sampling and analytical chemistry testing to reveal levels of contaminants in America’s best-selling foods and consumer products. We believe that the power of transparency and consumer awareness can change the status quo.
Together, we are changing the definition of food and consumer product safety in America.
I grew up in the midwestern United States to a modest upbringing. Growing up on the shores of Lake Michigan, my love for nature was fostered at an early age. At the age of fifteen, I became a vegetarian and 25 years later I’ve still never looked back. It was this commitment to the environment that led me to pursue my undergraduate degree in Environmental Biology from Michigan State University. After finishing my undergraduate degree, 9/11 happened and it was difficult for recent graduates to get a job. I took a position at a hagwan (English Institute) in Seoul, South Korea teaching conversational English for a year for the adventure and to weather the job market storm. When my contract was up, I returned home to Michigan and took a position in the chemistry lab at NSF International, a World Health Organization partnering centre for food safety and water quality. I was at NSF for 15 years, working in a variety of technical and leadership capacities including standards development, food safety, label claims substantiation around certified organic, Non-GMO Project, gluten-free, and others. During this time, I also completed my two master’s degrees in Public Health and Quality Engineering.
What brought me to Clean Label Project is the fact that I have professionally served as a catalyst for the increase in consumer product label claims and certification logos. However, at the same time that you see this proliferation of ”markers of quality” on product packaging, you see an increase in consumer, media, and academia interest and concern of pollution from mining, fracking, industrial agriculture and food production, and the resulting industrial and environmental contaminants in our food and consumer product supply chain. Yet, so much of the food and consumer product safety regulatory focus and framework in the US is based on short term adverse health effects from microbiological contaminants like E. coli, salmonella, and listeria. What about long-term adverse health effects associated with chronic exposure to heavy metals, pesticide residues and plasticizers in our food supply with known links to cancer and infertility? My mission, and Clean Label Project’s mission, is to change the definition of food and consumer product safety with a long-term view on environmental and public health.
We tested CBD because it is a high growth consumer product category with premium pricing, FDA had previously identified CBD potency & purity issues, and there has been a plethora of recent media reports on both CBD’s risks and benefits. My overall observation is that Clean Label Project’s findings and conclusions are consistent with other studies: this category has systemic quality control issues. I would boil that observation into these three categories:
Be a conscious-consumer! Do your homework! Marketing departments do an effective job at selling comfort and security so ask more questions of the brands. Ask them what they test for and down to what sensitivity. Sometimes the best way to do this is to vocalize your concerns of quality, purity, and label accuracy to retailers. This way, retailers can tighten their supplier specifications and demand that brands that they carry meet tighter requirements. In other words, in the absence of strict regulatory oversight, retailers can play a key role in setting stricter requirements based on consumer expectations.
The issue of industrial and environmental contaminants is not unique to the CBD industry. To me, the new & different concern with CBD as opposed to other consumer products comes down to the potency inconsistency. As mentioned before, for some products, either the blatant absence of CBD or the CBD content varying widely from the values listed on the label is what’s most troubling, most egregious, and most avoidable.
The FDA’s remit is for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply. Having a CBD product that is both safe and consistent with what is represented on the packaging should not be a novel concept.
According to the Center for Disease Control, each year roughly 3,000 people die of food-borne microbiological pathogens. However, this year about 10% of women (6.1 million) in the US ages 15-44 will have difficulty getting or staying pregnant. This year, an estimated 1.8 million new cases of cancer will be diagnosed in the US and 610,000 will die from this disease.
When someone has exposure to a food-borne pathogen, the body’s response is rather immediate through vomiting or diarrhea within hours or a few days. Conversely, you don’t immediately see the formation of cancer cells that can come from heavy metal and pesticide exposure. You don’t immediately see endocrine disruption that can come from plasticizer exposure.
Things like leaded gasoline were considered safe, until studies showed the disastrous effect lead had on childhood health and neurological development and it was phased out by the EPA in the 1970s. Prior to the 1900s, lung cancer was considered a rare disease. In the 1940s and 1950s, cigarettes were heavily marketed to doctors and women. Cigarette smoking was even encouraged for pregnant women to calm their nerves and control weight gain. This is until studies started showing the cause and effect relationship between lung cancer and smoking, and low birth weight and birth defects and smoking. We know that heavy metals are linked to cancer, if we know that pesticides (including glyphosate) are linked to cancers like non-Hodgkin’s lymphoma, and if we know that plasticizers like BPA, BPS, and phthalates are linked to endocrine disruption and infertility, so why wouldn’t we want to minimize our exposure?
Twenty years from now, we will look back and be greatly disturbed about what we allowed within our food and consumer product supply. Especially what we allowed within the food and products marketed to vulnerable populations like children, the sick, and the elderly.
Right now, the CBD industry is attempting to self-regulate in the absence of federal regulation. The FDA needs to establish minimum standards. If the private sector, industry, states, non-profits, retailers, and other associations want to set complementary standards around sustainability, purity, and labeling, that is important as well. Ultimately, the market will determine what attributes are valued and expected by consumers. We must first start with a level playing field and those minimum expectations need to be established by the FDA.
I think you are going to begin seeing more states lean into the testing and standards setting process as well. Here in Colorado, I am especially excited by the strategic and progressive Colorado Hemp Advancement Management Plan (CHAMP) program. Colorado became a national leader in industrial hemp cultivation and production when it launched one of the first successful pilot hemp programs in the US five years ago. The recent passage of 2018 Agricultural Improvement Act, commonly called the Farm Bill, requires each state department of agriculture to submit a state management plan to the USDA, outlining how various aspects of hemp cultivation and processing will be managed within their jurisdiction. The 2018 Farm Bill provides Colorado a unique opportunity to establish a comprehensive blueprint for how the state will not only manage but also advance this emerging industry by examining the entire supply chain from cultivation, to testing, to marketing, and the steps in between. In keeping with the Colorado Department of Agriculture’s core mission to continuously strengthen and advance Colorado agriculture, a key objective of the CHAMP initiative will be to define a well-structure and defined supply chain for hemp in order to establish a strong market for the state’s farming communities.
In the absence of federal regulation, in the absence of defined terms and labeling, and in the absence of validated test methods, you are correct, the laboratory testing industry is also developing and maturing. However, great strides have been made by AOAC International to establish voluntary consensus standards around cannabis potency testing. In the interim, I think organizations like Remedy Review are doing a great job of reviewing and providing commentary on some of the latest CBD scientific studies. I hope Clean Label Project also adds value to consumers by providing a different way to think about product quality, safety, and marketing.
That’s an interesting question. Across all foods and consumer packaged goods, what I see is that brands that are vertically integrated, on average, have higher product purity and quality. CBD is not an exception. When it comes to food and consumer packaged goods, 80% of brands use co-manufacturers (a third-party to manufacturer the foods or in this case the CBD for them). Some brands that use co-manufacturers have little to no involvement in the ingredient sourcing and this shows in the finished product quality. Vertically integrated companies that are involved in most or all aspects of production like planting, harvesting, and processing of the hemp can have some of the best products out there. So, I wouldn’t discount small brands. However, some large brands also own their own farms. Overall, across all food and consumer packaged goods, a brand that is actively involved in ingredient quality and sourcing is going to have a higher quality product than one that subcontracts that quality assurance and quality control to a third party.
As a public health professional, I have heard amazing stories about the benefits of CBD. Hearing of CBD’s potential for families and communities ravaged by the opioid epidemic, I can’t help but to be optimistic. So absolutely, I would not hesitate to purchase CBD for myself or members of my family if suffering from conditions that CBD can help ameliorate. However, based on my study and testing, this industry is still in its infancy and is experiencing growing pains. FDA has some work to do, but I am confident that with new large retailers gaining interest in the category, they too will help bring some much-needed quality assurance, consistency, and clarity to this industry.