The Agriculture Improvement Act of 2018, better known as the Farm Bill, was enacted in December 2018. This version of the Farm Bill, which Congress reauthorizes about every 5 years, effectively freed hemp from Schedule I status under the Controlled Substances Act as long as it contains little to no detectable THC (no more than 0.3%).

However, as the next Farm Bill comes up for reauthorization this year, federal regulation and guidance has remained hazy, raining disappointment on a market that was bursting with potential.

In January, after years of review, FDA announced that instead of providing a dietary supplement pathway for hemp-derived cannabinoids like CBD, the agency would instead seek a custom-developed regulatory framework.

“This news was a major letdown for a market that desperately needs regulatory clarity to ensure consumer safety and responsible production and distribution of cannabinoid products,” said Nicole Brown, chief innovation officer for Open Book Extracts, Roxboro, NC, an ingredient manufacturer and product development partner focused on cannabinoid-enabled health and wellness.

“A tried-and-true dietary supplement framework would protect existing consumers and attract new ones by establishing much-needed manufacturing standards, product requirements, and labeling guidelines, as well as preventing the proliferation of untested and potentially impairing products,” Brown added.

However, confronting the reality of the marketplace, Brown said “OBX is grateful for like-minded companies who together are shaping a responsible, custom framework the FDA seeks. And, in the meantime, we’re doing our part to raise the bar for our consumers to ensure safety, education, and awareness.”

At OBX, Brown is responsible for channeling and leveraging data-driven consumer insights while driving awareness and thought leadership by overseeing strategic marketing efforts and partnerships.

She offered perspective on regulation, cannabinoid innovation, R&D, and more in the interview that follows.

NW: What impact do you expect new cosmetic regulations will have on the market for topical CBD products?

Brown: As more and more countries and states are legalizing the use of CBD and other cannabinoids, it can be expected that demand for CBD cosmetics will continue to grow. Keeping THC levels below regionally specified levels will remain a key element of market approval for CBD skin care products.

Additionally, care must be taken to define the CBD source, the plant species, the part of the plant, extraction and processing methods to meet local requirements. The variation in local requirements creates some barriers to international marketing efforts, but CBD oil with very low or non-detectable levels of THC sourced from other than the flowering parts of the hemp plant meets most global requirements.

As with all cosmetic products, any therapeutic claims must be supported by scientific evidence. The products must also be manufactured in accordance with accepted quality standards for cosmetics. All these factors may add considerable cost to CBD products, but market trends show that consumers often accept paying a premium for CBD skin care products.

NW: Let’s talk about other cannabinoids. What do you currently offer? Where are you investigating?

Brown: OBX offers one of the broadest portfolios of minor and rare cannabinoids, including CBG, CBN, CBC, THCV, CBDV, CBDA, CBGA, and CBT, alongside innovative products such as water-soluble and emulsion technologies.

OBX is dedicated to bringing scientific rigor and research-backed innovation to the cannabinoid product category. In support of this objective, OBX has internal teams committed to the pursuit of scientific excellence.

• Ingredients & New Technologies: Led by David Temelkoff and supported by several PhD scientists, the Ingredients R&D team is focused on the development and commercialization of novel cannabinoid ingredients and enhancement technologies.

• Formulation & Finished Goods: Led by Andrea Baillo and supported by a team of chemists and food scientists, the Formulation and Finished Goods R&D team is focused on the development and commercialization of research-backed finished products, combining effective formulations with new and existing product form factors to create next-generation cannabinoid products.

Both teams leverage the internal OBX Quality team to ensure all ingredients and finished products comply with defined standards for quality and safety, as well as OBX research platforms to validate their scientific efforts, including internal consumer insights and external pre-clinical and clinical studies.

OBX serves most of today’s leading CBD brands and is a trusted on-ramp for nutraceutical and CPG companies seeking research-backed products and a trustworthy supply chain. The company’s certifications include NSF GMP for CFR parts 111 and 117, ISO 9001, USDA Organic, and Kosher. 

Manufacturing capabilities span gummies, tinctures, softgels, and capsules, to beverages, tablets, aerosol sprays, and single-serve Easysnap sachets. While most CBD manufacturers provide basic products, the OBX approach is to work collaboratively with each client to develop sophisticated, innovative formulations delivered in unique and delicious product formats.

OBX products feature cannabinoids, often in combination with clinically studied complementary co-actives such as functional mushrooms, vitamins, and nootropics to address a range of specific need states, including: sleep, pain, anxiety, mood enhancement and relaxation, energy and focus, recovery, relief, immunity, and everyday wellness.

The company is dedicated to supporting its clients and the industry as a whole with a universe of cannabinoid-enabled products that are effective, evidence-based, and of the highest quality. With research at the heart and foundation of OBX product offerings, the company is able to provide the holistic knowledge needed to unlock the potential of the plant to support better quality of life outcomes.

NW: Can you tell us about your research strategy? What can we expect from OBX this year and beyond?

Brown: Since 2019, the OBX business has been deeply rooted in science. It leads pioneering research around the world, in fields related to quality of life, health, wellbeing and supply chain resilience. Key projects that the business has delivered include three clinical studies with Radicle Science, the largest randomized, controlled clinical studies on minor cannabinoids on quality of life outcomes, including pain, sleep, and focus; safety and toxicology studies on CBN, CBC, THCV, CBDV; a clinical study on THCV to address acne, in partnership with Dr. Zoe Dralos and Dr. Jeffrey Dover; and university research programs with Case Western Reserve University School of Medicine (mechanistic effects of cannabinoids on brain cell functions), Harvard University (Alzheimer’s, dementia, bipolar disorder, and depression), FAMU (cancer), and UC Boulder (depression/PTSD).

At OBX, we’re fundamentally dedicated to supporting our clients and the industry with a universe of cannabinoid-enabled products that are effective, evidence-based, and of the highest quality. With research as our focus and foundation, we can better understand the potential of cannabinoids as an ingredient and, in particular, their ability to support better quality of life outcomes.