On April 1, 2020, Claudia Lewis was featured on Natural Products Insider’s podcast Hemp Collective to discuss the regulatory requirements and manufacturing practices required for producing the highest-quality hemp CBD products. The podcast explores the Food and Drug Administration’s (FDA) current priorities, the nuances of understanding customers, and what manufacturers can do to ensure they deliver on their brand's quality promise.
“The FDA does expect full compliance with the manufacturing regulations under part 11, which apply to dietary supplements, and they are expecting that there be quality safeguards in place,” said Lewis. “The focus there is making sure the products actually contain the ingredients as declared on the label.”
“Even before the Farm Bill passed in 2018, the FDA was testing and identifying products that didn’t have the amount of CBD as declared on the label. I’m also very aware that the plaintiff’s attorneys have been looking at this and know that the FDA has found some products to be under potent in that regard,” Lewis added. “I would encourage every CBD distributor to ensure that there are strict controls when they’re talking about manufacturing the product and whatever is included on the label.”