“The number one question that people ask us is how do we know what to look for and how do we know what we’re buying?” BBB CEO Robert Di Marco told FoodNavigator-USA.
“Things have definitely got better, but some of that is because people [selling extracts] have learned the lingo, so they say all the right things like ‘GMP compliant’ or show you a certificate of analysis (CoA) that looks good.
“But if you are new to the industry you should never just trust a CoA; you should always get the product tested by another lab – and ask around to find out which labs to trust – before signing up.
“We just had a large national chain come to us for private label manufacturing and they had a pretty well-known brand they wanted to be sure was ‘zero-THC’ and we third party tested it, and it was way off so that if you had consumed it, you’d test positive [in a drugs test].”
70% of the raw material that comes in through this building from outside supply channels fails our quality controls
Other issues that come up repeatedly are discrepancies between stated and actual CBD levels, and unacceptable levels of pesticides, heavy metals, volatiles or mold, claimed Di Marco.
“In the beginning [before BBB set up its own growing operation] we had to go to Europe to import materials because the biomass we were being sent [from hemp farms in North America] was failing our quality controls. Even now, about 70% of the raw material that comes in through this building from outside supply channels fails our quality controls.”
The Biova Hemp seal
All hemp products and extract formulations manufactured by BBB Labs now feature the Biova Hemp seal, which BBB Labs customers can also feature on white-label or private-label products. The seal reassures buyers that the extracts:
- Are derived from organically grown hemp from BBB Labs’ farms in Colorado;
- Have passed rigorous testing for plant cannabinoid and terpene content, and to ensure there are no pesticides, heavy metals, or other contaminants present;
- Come with cannabinoid profiles and Certificates of Analysis (COA) from reputable third-party laboratories;
- Are produced in accordance with strict Good Manufacturing Practice (GMP) standards in BBB Labs’ facilities.
The regulatory pathway for CBD
The FDA - which maintains that CBD is illegal in foods, beverages and supplements, but is focusing enforcement action on companies making “egregious” claims – is considering “legislative options that might lead to more efficient and appropriate pathways than might be available under current law” for CBD products.
However, Todd Harrison, an attorney at Venable who has been trying to help clients navigate the CBD minefield, told FoodNavigator-USA: “FDA has numerous options already available if someone in the industry would actually file something with FDA to show that CBD at a low dose does not pose a safety concern nor would it act as a pharmaceutical, but nobody in this industry is willing to do it the right way.
“I believe if someone would file with FDA that a non standardized hemp extract that contains CBD and other cannabinoids was safe, FDA will permit its marketing… but someone has to step up [CV Sciences recently announced the self-determined GRAS status of its hemp-derived CBD gold extract but has not said whether it plans to submit this to the FDA, while other companies say they are working on GRAS determinations for hemp extracts].”
National Organization for the Reform of Marijuana Laws: This retail market is far too large to remain unregulated, and this lack of regulation is leading to a variety of problems. There exists significant confusion within the marketplace, as well as among state regulators and law enforcement, with regard to whether these products are legal or illegal.
We are aware of numerous instances where local law enforcement has seized CBD products from shelves, only to refuse to file criminal charges later. In other instances, regulators have called for removing certain CBD products from retailers because of ongoing questions regarding their legal status. In some cases, consumers have been arrested for possessing these products, despite the good faith belief that they were legal.”
Amyris: Any action that FDA takes with regard to the use of CBD in food or dietary supplements should include CBD produced through all types of technologies.
Biotechnology Innovation Organization: We are concerned that a lack of enforcement against unsupported medical claims by dietary supplement manufacturers will reduce incentives to study and invest in more targeted drug products in this similar ingredient category This could rob patients of the potential for new treatments that may evolve from intensive and thorough research, and instead increasingly subject them to relying on unsubstantiated claims being marketed by non-compliant dietary supplement products.
Shaman Botanicals: We recommend that the FDA allow food products containing less than 10mg per serving and establish a total daily CBD intake from all sources of 60 mg, requiring that higher doses of CBD be managed by a physician.
Allay Consulting: Many CBD companies do not understand that in order to use an ingredient in a consumable it has to be food grade and produced in a food grade licensed facility. Several recalls have taken place due to this issue for example when a manufacturer is using aromatic essential oils as a flavoring and not a food grade oil… I have personally found dangerously high levels of Myclobutanil, Arsenic, Mercury, and Imidacloprid in CBD oil that was sold to my clients.