Four new letters sent by the US Food and Drug Administration (FDA) in the month of April mark a bit of a change in approach. Two of them were fairly standard warnings about health claim marketing potentially in violation of the Food Drug & Cosmetics (FD&C) Act. But the other two represented something different.
For one, they came from a new FDA subdivision. Typically, warnings come out of the FDA’s Center for Drug Evaluation and Research (CDER) or the separate Office of Human and Animal Food Operations (Part of the Office of Regulatory Affairs). But the most recent came from the Office of Pharmaceutical Quality Operations (still part of the overall Office of Regulatory Affairs but operating as a separate subdivision).
This potentially indicates an increased scope of oversight and interest in CBD products from the FDA, encompassing more arms of the administration. It may also increase the lack of regulatory clarity for the time being, with CBD companies suddenly having to deal with the enforcement of a host of new regulations from a different area with which they were previously unfamiliar.
It also marks a change in enforcement topic with the Division of Pharmaceutical Quality Operations (unsurprisingly given the name) concerning itself with whether CBD companies claiming good manufacturing practice (GMP) certification had facilities up to scratch. The letters follow a number of inspections – all taking place before the lockdown – and were highly critical of instances reported at two sites.
This serves as a timely warning to other CBD companies with GMP certification. Inspections were almost certainly stopped during the pandemic but are likely starting to resume. Companies should be aware of any inconsistencies and be taking steps to fix them already.
Beyond that, for the wider market that may not be claiming GMP certification for its manufacturing facilities, the two letters still serve as a further stark warning about common CBD marketing practices. The FDA, in its two letters, took a dim view of the use of other active ingredients to make limited qualified health claims for products containing CBD while listing CBD as an inactive ingredient.
The FDA found both the idea of other ingredient health claims on a CBD product and CBD being listed as an inactive ingredient to be problematic. It said prominent use of CBD and associated symbols in marketing, packaging and supporting documentation like websites made it blatantly clear that these were meant to be health claims for CBD, no matter what ingredient the company claimed was actually allowing the product to make the claim.
Furthermore, even if that was not the case, the FDA said CBD could not be listed as an inactive ingredient as it served no function that an inactive ingredient would normally fulfil (such as to improve binding in a pill) and was thus, in the FDA’s opinion, an obvious workaround to avoid current prohibitions on CBD product marketing.
This is potentially serious news for an industry where the use of alternative ingredients – like melatonin, vitamin C, methol and camphor – to make so-called combo-health claims for products also containing CBD is an increasingly common trend.
Companies should be aware of the FDA’s opinion on this and adjust any marketing activities accordingly.
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