CBD product makers should be mindful of FDA guidelines, says Kline

Late last month the FDA convened a hearing on cannabis. Over 100 speakers gave presentations and well over 1000 people attended the hearing (in-person and remotely). And the Administration is still—through July 2—accepting comments to “inform FDA as we consider the important policy options related to the regulation of products containing cannabis or cannabis-derived compounds,” ​according to opening remarks given by Norman Sharpless, acting commissioner of food and drugs at the US Food and Drug Administration. (To comment, click here​.)

Agency oversight ​

In his opening remarks, Sharpless set the context, stating that “Cannabis contains more than 80 biologically active chemical compounds, including the two best known compounds, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD),” ​and explaining that “If one of these compounds, or the plant itself, is added to a food or cosmetic, marketed as a drug, or otherwise added to an FDA-regulated product in interstate commerce, then it falls within FDA’s jurisdiction. As I said,” ​he emphasized, “this is nothing new for FDA.” He went on however to acknowledge that recent changes in both State and Federal laws, have made “FDA’s authorities…more relevant.”​​

And he pointed out how the medical applications of cannabis complicate matters for beauty and supplement makers. “Some compounds found in cannabis – specifically, CBD and THC – have been studied and even approved as drugs. It’s important to note that the Federal Food, Drug & Cosmetic Act prohibits adding drugs to human or animal food in interstate commerce,” ​says Sharpless, adding that “That includes both substances that have been approved as drugs, as well as compounds for which substantial clinical investigations have been instituted. Similarly, the law excludes these products from the statutory definition of a dietary supplement.”​

Current and future guidelines​

Research and consulting firm Kline paid particular attention to the comments that manufacturers made at last month’s FDA hearing and issued a media release highlighting 3 takeaways from the day’s conversation:

1.FDA is empowered to enforce and ensure that CBD manufacturers are compliant with current good manufacturing practices (cGMP). ​

2.FDA should ensure safe concentrations and daily intake levels of CBD and specifically THC. ​

3.FDA guidelines in place should be used for packaging and labeling (for food, dietary supplements, and cosmetics).​

As the frim sees it, currently consumers are compelled to take responsibility for quality and correctness of any CDB products they buy. “Oversight on consumer-use CBD products is required because there are many producers operating with various levels of standards. Labeling, dosing, and contents of products need to have some minimum requirements quickly in order to protect American consumers,”​ believes Laura Mahecha, Kline's healthcare industry manager.   

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Deanna Utroske, CosmeticsDesign.com Editor, covers beauty business news in the Americas region and publishes the weekly Indie Beauty Profile column, showcasing the inspiring work of entrepreneurs and innovative brands.