By Tim McCarthy
No joke…on April Fool’s Day, Johnson & Johnson, an enormous, well-funded and established major pharmaceutical company, had to announce a “setback” in its efforts to stay on schedule with its Covid-19 vaccine production. Not so minor, the setback was 15 million doses ruined. Unfortunately for J&J, the issues didn’t stem from their direct production activities but rather from a key link in its supply chain that “failed quality control tests”. The news quickly grabbed the headlines of CNBC, NPR, USA Today, CBS News, The New York Times, and many others and highlights the fact that every single link in your supply chain is critical.
Sellers of hemp/CBD products should ask themselves: if a well-established brand like J&J with a heavily regulated framework can land in this situation, how vulnerable am I? In a crowded and emerging market, can you afford to rebound and overcome the negative headlines that can come from a weak - or worse, negligent - link in your supply chain?
In a rush to market, too many hemp/CBD manufacturers think mostly about the ‘potency’ numbers on the package and not enough about what goes into the functional reliability behind those numbers. Unfortunately, the mindset for many at this point, due to lack of regulation, historically limited supply, and unpredictable demand, is to focus on procuring the cheapest, most readily available supply without applying as much scrutiny towards partner selection as the average consumer might hope. For hemp and CBD products to become widely accepted, Current Good Manufacturing Practice (CGMP) standards must be required from all parts of your supply chain. Consumers want it, and regulatory agencies will soon demand it.
Brand expansion comes from trust and confidence, which takes time, money, and creative energy to build. How terrible would it be to watch all of that hard work get tarnished and market gains vanish due to an unlucky choice in a supplier? This is why you should pay careful attention to each component of your supply chain.
By now, you probably know that the FDA acts quickly to address CBD marketing containing unsubstantiated medical and drug claims. In two recent actions on CBD companies dated March 22, 2021, the FDA added a new twist of regulation to its warning letters. Besides addressing medical claims, the recent letters also addressed the failure to comply with Current Good Manufacturing processes. So, ready or not, CGMP standards have just been added to the hemp/CBD industry supply chains, even without separate CBD declared regulatory guidelines.
The time to fully vet suppliers is here. When evaluating, keep the following in mind:
Purity
Full-panel tests for impurities to assure safety from contaminants
Process
CGMP standards with written standard operating procedures that show time documented records
Tracking standards to show sources, batch separations, and proper training
Tracing standards to determine what recalls should be required
Potency
What’s printed on the label is truly in the product, and your supplier should sell by the active ingredient
“CBD 2.0” has just begun, and broader acceptance is coming, but the days to think you can operate “under the radar” without documentable ingredient quality and process is coming to an end.
Safety of the consumer within hemp/CBD products is now on par with unsubstantiated medical claims in an FDA and FTC regulatory framework. Your readiness to meet this, grow, and protect all of your hard work starts with a reliable supply chain.