Hoban writes,
All Nine Innings: A Word On the FDA’s Warning to Curaleaf
This is the first inning for the hemp industry. If you want to participate, wouldn’t you rather play the whole game rather than fizzle out in the third inning?
In recent days, the FDA has issued a notification letter addressed to Cualeaf, unleashing a panic that’s had the phones here at HLG ringing off the hook. This doesn’t represent a shift in the FDA’s treatment of CBD, but follows a fundamental rule for CBD companies we’ve seen a handful of times before: stop making claims.
Here’s where the horsehide meets the wood: a supplement can make a ‘structure-function’ claim, but it can’t claim to treat or cure a human health condition. The FDA reviewed Curaleaf’s website and found products being misrepresented as drugs – from claiming to treat chronic pain to breast cancer. That’s an FDA violation whether you’re selling echinacea, melatonin or CBD; and if it’s on the website, it may as well be listed on the product itself, in the opinion of the Federal Trade Commission. By now, this should be foundational to CBD companies. If a CBD product hasn’t gone through the drug approval process it will never be able to make these kinds of claims.
Take into account the timing of the FDA’s letter. Curaleaf was recently chosen by CVS to be one of the first to fill their shelves with CBD-containing products. While the FDA has committed to expediting the rulemaking process, retailers like CVS are looking at states like Colorado that have health and safety measures provided for these products.
But the question remains: how are major retailers deciding which products to offer on the shelf? That best answer may from an attorney. That’s likely not your first instinct, but in this industry lawyers are not just lawyers; they also possess institutional knowledge of the industry. As such they’re a necessary resource to counsel retailers on which companies and products are playing by the rules – and which aren’t.
Should we be treating hemp-derived extracts differently from other nutraceutical products? The natural product industry was built by risk-takers who helped create the regulatory frameworks, along with the FDA. If you don’t want to fizzle out in the third inning, follow the rules that apply now.
