This week we talk to Duffy MacKay, ND Senior Vice President, Scientific & Regulatory Affairs CV Sciences, Makers of PlusCBD
Dr. MacKay has over 20 years of experience in nutrition research, dietary supplements, health sciences and regulatory affairs after spending a decade at the Council for Responsible Nutrition (CRN), where he served as Senior Vice President of Scientific and Regulatory Affairs.
MacKay’s responsibilities at CRN included providing scientific expertise in nutrition, pharmacology, pharmacognosy, toxicology, for evaluating proposed government and industry actions; building effective rapport with scientific communities; establishing working relationships with regulators through engagement on dietary supplement and functional food regulatory matters; and educating regulators, legislators, and Attorney Generals regarding industry self-regulatory and compliance initiatives.
Duffy thankyou for your valuable time and taking time to speak with Cannabis Law Report
First up, for our readers who might not be aware, what is AB 45. w
Who has drawn up the legislation and what are its basic aims?
AB 45 is key California legislation, passed in early September 2021, that makes a clear legal path for the retail sale of hemp- derived CBD dietary supplements, foods, and cosmetics in the state of California. Rep. Cecilia Aguiar-Curry sponsored the bill, which was strongly supported by the efforts of the U.S. Hemp Roundtable, California Hemp Council, and other California stakeholders.
The new law sets manufacturing, testing, and labeling standards for products that include CBD as an ingredient. With clear regulations for everyone involved in the CBD product lifecycle, California consumers will no longer face uncertainty about quality or safety when looking for CBD products at mainstream retail stores.
We see CV Sciences is a U.S. Hemp Roundtable member and keen to see the bill passed…why?
CV Sciences is headquartered in San Diego, CA. As pioneers in the CBD industry and manufacturers of hemp-derived CBD products under our flagship PlusCBD brand, we are committed to ensuring safe, high quality CBD products are accessible to informed consumers.
Due to FDA inaction, regulations are well behind consumer demand. At present, major retailers like Kroger and Sprouts only carry topical CBD products.
With the passage of AB 45, California retailers that have been reluctant to carry ingestible CBD products are expected to open-up their shelves to ingestible CBD, increasing consumer access and product availability.
We would love to dig into some of the details of the provisions with you.
Allowing hemp to be used in F&B and supplements.
What are the provisions for labelling and packaging?
The labeling and packaging regulations defer heavily to federal or existing state guidelines for foods and dietary supplements.
This reflects efforts to reduce burden and improve consumer communication by harmonizing labeling and packaging requirements.
Unfortunately, there are some label requirements that are unique to California and will further complicated the patchwork of state regulations that CBD companies must attempt to comply with.
Will these products be sold just in CA or out of state, too?
The California requirements are in line with most other state requirements, so products made for California can cross many state lines smoothly.
There are some states outside of California with their own unique requirements, like product registration, leaving CBD marketers to navigate states on a case-by case basis.
This underscores the importance of federal regulation of hemp-derived CBD products.
Are we talking just about processed and factory produced products, or also food in terms of the restaurant trade and say supermarket in-house products?
The law is structured for products made under specific Good Manufacturing Practices and labeled with a nutrition or Supplements Facts panel.
The manufacturing and testing requirements are too burdensome for a restaurant or smoothie shop.
Same question about cosmetics. Do they have to be processed and factory produced, or can they be made in- house or by hand?
The manufacturing and testing requirements for cosmetics are more attainable than for foods and supplements and can be achieved by small companies.