The Umbrella of Botanical Products Regulations

DESCRIPTION: From teas, tinctures, capsules, and salves, botanical products manufacturers face a daunting and unique regulatory landscape in the US. In this discussion, I’ll break down the federal regulations governing each type of product and provide clarification on how FDA views these products and their current thinking on requirements for testing, manufacturing, and labeling.

SPEAKER BIO:After graduating from college with a bachelor’s degree in mathematics, Anne began a long career in medical device and pharmaceutical manufacturing when she accepted a position in Engineering at Abbott Critical Care in Salt Lake City. Throughout the next 25 years, she wore many hats at various companies, starting with manufacturing engineering technician and filtering through quality engineer, quality auditor, validation engineer, quality manager, and eventually consultant. Speaking “GMP” became second nature. She left that world behind as an obsession with herbal medicine began 10 years ago and became consumed with learning, making products, wildcrafting, and growing plant allies. As a member of the American Herbalists Guild, she co-founded the Herbal Research chapter for individuals to share studies and scientific observations pertaining to plant medicine. With the skyrocketing interest in alternative therapies, and FDA’s increased scrutiny over the production and marketing of products, she recognized a need to assist small herbal product companies navigate 21 CFR 111, cGMP requirements for Dietary Supplements, and she launched cOMPliants, LLC to provide this service remotely from her farm in Bay City, WI where she shares 60 acres with horses, dogs, cats, chickens, and many, many plants.