Cannabis Labeling Legal Issues
Cannabis labeling legal issues are the subject of today’s video. By the end of this video you’ll have some basic familiarity with the way FDA lawyers approach labeling issues for dietary supplements as well as for cannabis products.
In other videos, we’ve looked at how FDA regulates cannabis products, including CBD oil products, and at some of the legal and regulatory issues that cannabis companies face, where nuanced legal counsel by experienced healthcare and FDA attorneys can make a huge difference.
I’m Michael H Cohen, founding attorney of Cohen Healthcare Law Group. Since 1999, we’ve made a difference in the lives of healthcare entrepreneurs in cutting-edge areas of law, from complementary medicine to biotech to medical marijuana and cannabis.
We’ve talked before about how a request for “label review” often involves several different components: (1) technical review of the label itself for compliance with very detailed federal regulations; (2) legal review of the claims, to ensure that that product is making claims that are allowed by federal law, and not prohibited “disease,” or “drug” or “therapeutic” claims; (3) an overview of FDA and FTC requirements of “substantiation,” to reduce the risk that claims could be considered false or misleading.
Our focus today is on technical label review. Here are some sample items we identified in a recent technical label review for a cannabis product.
As this was a review of the label itself, we did not review safety or ingredients or whether FDA would take issue with any of the ingredients generally being included within the product, nor did we assess claim substantiation.
First, we recommended that the client place their product within the federal exemptions for hemp, which suited this particular product.
Second, we made recommendations about increasing serving size, to comply with some very technical requirements about the Supplement Facts panel; recommendations about servings per container; recommendations about things like where to put bold font and where not, where to put Amount per Serving and % Daily Value; and about making declarations re total calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium.
We also recommended including certain things that the technical regulations require to be placed in footnotes, revising some of the names of ingredients for compliance, deciding whether to list amino acids individually or declaring a propriety blend, listing ingredients in descending order or predominance by weight, appropriately describing preservatives, revising the net quantity of contents and statement of identity, having the right type size, and including the right disclaimer.
As I said, technical label review is … very technical. But it’s important, and we do this for our cannabis and dietary supplement and cosmetics clients, as long as they realize that technical label review and a technical markup of the proposed label are part of the process, and that the claims review is also very important.
Thanks for watching. Here’s to the success of your medical spa or other healthcare venture, we look forward to speaking with you soon.
I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable.
Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes.