Despite the U.S. Food and Drug Administration’s position that hemp-derived cannabidiol (CBD) cannot be sold legally in food or dietary supplements because it was studied as an Investigational New Drug first, the genie is out of the bottle with consumers gravitating to cannabis (in all its forms).

The U.S. Agriculture Improvement Act of 2018 (the Farm Bill) delisted hemp from the Controlled Substances Act, effectively legalizing cultivation of hemp as long as it contains no more than 0.3% delta-9-tetrahydrocannabinol (THC) on a dry weight basis. As a result, the market has been flooded with products containing CBD.

Now, industry stakeholders have been focused on ensuring products that are in commerce conform to the standards and guardrails that govern and steer the legal dietary supplements market. At the same time, with more consumers evaluating products and scrutinizing brands, the work of ensuring product integrity is essential.

Foundations for Integrity
The American Herbal Products Association (AHPA) has been raising awareness within the hemp industry about the need to comply with regulations, noted Jane Wilson, director of program development at AHPA, such as current Good Manufacturing Practices (cGMPs) for hemp CBD products being marketed as supplements and foods.

“Regardless of FDA’s position on the status of these products, the industry can demonstrate its commitment to quality by complying with all federal and state laws that are intended to safeguard consumers,” said Wilson. “AHPA issued a guidance policy in 2019 recommending that hemp CBD product marketers comply with such federal regulations.”

According to Wilson, AHPA’s perspective is that hemp is another botanical, like echinacea or turmeric, “and the same laws that ensure product integrity for other botanicals should also apply to hemp products.”

Companies that follow cGMPs can have confidence in product integrity “by developing rigorous supplier qualification programs and long term relationships with producers, setting appropriate specifications, and selecting fit for purpose methods for evaluating ingredients and products, and establishing a comprehensive quality control system,” Wilson said.

Elan Sudberg, CEO, Alkemist Labs, said his company’s initial strategy for cannabis was to support its clients as the category entered the dietary supplements market. “We have helped all of them start the vetting process of the ingredient and vendors and then ongoing lot to lot testing. Because our clientele have high standards and well-thought-out procurement procedures, we only see top quality materials.”

Sudberg noted Alkemist also serves local hemp farms. Occasionally, samples may test above the 0.3% THC threshold, he said. “Occasional ‘hot’ samples are generally due to growing conditions.”

He also advised companies to “source thoughtfully, formulate carefully, test thoroughly, and be transparent about everything, including your testing lab and the results they give you.”

The bio-hemp industry continues to evolve with persistence, noted Michael Sandoval, president and chief operations officer, Santé Laboratories. “As regulations trickle down, there will be several finished product manufacturers and brands that will experience unfamiliar concerns with product, process, and marketing compliance.”

“A systematic approach to compliance testing and product development based on sound science and quality risk management will be foundational for existing businesses,” Sandoval continued. “This not only applies to THC compliance testing, but also process/product understanding and control; therefore, working with commercial contract research organizations and laboratories with this understanding will be important.”

Additionally, Sandoval noted, “to ensure raw materials and finished products are produced with quality, safety, and efficacy as promised by the label, traditional contaminant testing like residual solvents, heavy metals, microbial, pesticides, and cannabinoids will be the bare minimum. Over time, raw materials and finished products lose strength and purity. This is a fact. For example, to ensure materials, products, and components are stable for months or years, shelf-stability testing will be a necessary part of the product development lifecycle.”

Generally, Sandoval noted the current CBD market struggles with label compliance, as shown by numerous FDA and consumer product and safety studies. “CBD is not stable in all aqueous and non-aqueous oil delivery systems, and it’s not stable in the presence of known dietary ingredients that the market suddenly embraced to achieve known health claims,” he said. “Whether CBD degrades rapidly or steady over time, issues with compliance will be observed.” A lack of understanding in manufacturing processes and controls can also lead to quality issues and failure to meet label claims, he added.

Tips & Trends
Companies having products tested should first look at the qualifications of the laboratory doing the testing, Wilson advised. “How long have they been testing botanical products, do they have accreditation to do the required analyses, etc.? Companies should also consider the purpose of the testing. Is it for routine QA/QC purposes or is the testing for compliance purposes that may require certain laboratory qualifications or registrations? Another consideration is whether the analytical methods used by the laboratory are fit for purpose for the type of material being tested. A crude CBD extract may need to be tested differently than CBD that has been infused into a food product or other complex matrix.”

Though the regulatory landscape continues to evolve, from a testing standpoint, Sudberg said CBD isn’t much different than other plant-derived products. “You gotta start with identity and make sure you have the right plant, in any form possible. You gotta make sure the ingredient meets specification for phytochemicals. You gotta make sure it doesn’t contain pesticides, heavy metals, or residual solvents above established limits.”

Additionally, he continued, “You have to be transparent about what you’ve done to ensure identity, potency, and purity. We’ve developed a version of our CofA (Certificate of Analysis) that consumers can understand, which should be shared openly. All of this assumes, of course, that you’re working with a highly proficient lab that is DEA registered and USDA listed.”

Ultimately, all the same factors that go into ensuring product quality and integrity for other herbal products are applicable to hemp CBD products, according to Wilson. “Brands should establish relationships with ingredient suppliers that share a commitment to quality. Making the investment in understanding and implementing the regulatory requirements for their product category goes a long way towards achieving consistent product quality and exhibits a commitment to providing products in which consumers can have confidence.”   

Sudberg also suggested companies carefully vet everyone involved in product development and manufacturing, from suppliers to processers to labs. “While we wait for the U.S. to decide how this class of goods is going to be regulated, don’t do the least you can get away with; go above and beyond. This not only establishes you in good stead with regulatory agencies and helps the industry reach legitimacy, it means you’re producing good products that will earn customer loyalty.”

Sandoval recommended companies establish functional relationships and partner with experts in chemistry, manufacturing, and controls that are commonly found at traditional or specialty contract research organizations to facilitate innovation and product development. “The product development process should not be discounted and should embrace elements of quality by design for successful market launch,” he said.

It’s important to partner with a mature, cGMP compliant, FDA registered contract manufacturer with well-defined and scalable processes, Sandoval noted. “Set specifications for your raw materials and final products, working with suppliers that can provide traceability and compliance testing results. Inevitably, shelf stability will fall on the final product manufacturer and should be substantiated from an accredited, professional laboratory.” 

In terms of formulation trends, Wilson noted increased use of hemp CBD as a component of multi-ingredient supplement formulations, in addition to its marketing as a standalone product. “It continues to grow as an ingredient in topical cosmetic and personal care products as well, given the regulatory status of CBD use in that product category is clearer than for supplements and foods.”

At the end of the day, Sandoval said consumers want high quality products from authentic brands that deliver on their promises. “Without science-driven product development and regulatory compliance, brands and manufacturers will continue to place the industry we love at risk and at the sacrifice of the health and safety of the consumers we serve. We must all be held accountable.”

Brands and manufacturers will need to differentiate in order to thrive, he added. “To do that, they will need access to innovative, safe, and scalable ingredient formulation technology to meet regulatory requirements and consumer preferences.”

Looking Ahead
The future of the CBD market in the U.S. will eventually be framed by regulation, in some form.

AHPA sees companies being proactive in trying to influence both regulatory and legislative pathways for the use of hemp CBD in supplements and foods, said Wilson. “Our members provide excellent feedback to AHPA that forms the basis of our public comments and legislative proposals. Many in the industry are actively advocating for the passage of the recently introduced HR 8179 Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020. We anticipate companies and hemp industry groups will be very active in providing public comments on the FDA draft CBD enforcement guidance that has been developed and is under review by the White House when it is released.”

Sudberg encouraged companies to join AHPA, which has the experience and resources “to make sure this herbal product is ultimately regulated in a way that makes sense.”

As the haze around the future of CBD eventually lifts, companies that planned accordingly will have an advantage, according to Sandoval. “Brands with vision and aspiration for longevity will make the most impact and therefore win. Ready or not, regulation by FDA is quickly approaching.”