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Will established certification companies and laboratories now starting to offer services for this market boost quality control in the industry and help everyone better navigate this hazy space?
The CBD market as it stands today is often described as a “Wild West.” With FDA withholding any guidance on CBD short of saying that CBD isn’t allowed in foods and supplements, the market has churned out a large number of CBD companies, big and small, launching products whose quality can run the gamut from good to questionable. There is a great need for quality control in the mushrooming CBD and hemp products market that has so far outpaced regulatory oversight, and thus numerous certification programs have sprung up to offer a way for responsible companies to differentiate themselves.
The U.S. Hemp Authority is one program that began stamping its seal on certified hemp products early in 2019. This summer, contract research organization Nutrasource (Canada) recruited U.S. testing laboratory Alkemist Labs (Garden Grove, CA) to be the official testing lab for its new International Cannabinoid Analysis Program (ICAP), a third-party certification program that tests THC content in ingredients and finished products. And this fall, one the most established certification companies of them all, NSF International (Ann Arbor, MI), announced plans to add CBD and hemp testing, auditing, and certification services to its offerings.
Will established certification companies and laboratories now starting to offer services for this market boost quality control in the industry and help everyone better navigate this hazy space? We spoke to several companies at October’s SupplySide West trade show about the possibilities.
David Trosin, NSF International's newly annointed general manager of health sciences, said NSF ultimately decided to begin offering hemp testing and certification services because of the great need it saw in the marketplace.
“We’re a really conservative organization, so we went into this with a great deal of thought and board approval,” he said at SupplySide West. “Our mission is to protect and improve public health, and we saw a tremendous need. We would go to events and survey the landscape of this whole market, where you have everything from the most sophisticated companies with Wall Street investment to companies who frankly have no idea of quality standards. And that of course leads to this massive variety of product quality as well. And so to go back in the spirit of our mission, we felt that we couldn’t sit on the sideline, that we had to get involved as a thought leader and work with industry to make sure that good product, good processes, were being put in place to protect the consumers and also to protect the industry…We need to make sure that they’re following the highest standards possible and giving them the tools to do so.”
Eventually, NSF will offer testing and certification services for both hemp ingredients and finished products. Currently, NSF is only actively operating the testing arm of its hemp program, including testing to ensure that ingredients and products are within the 0.3%-or-below threshold for tetrahydrocannabinol (THC) content required for legal hemp by the 2018 U.S. Farm Bill, which states that hemp products may not contain more than 0.3% THC by dry weight.
As Nutritional Outlook has reported, NSF is waiting to open up its certification services until it is able to establish what it believes is a safe usage level for hemp extracts. Trosin said NSF hopes to have that safety work, and subsequent review by its health advisory board, completed very soon.
NSF is also only offering testing and certification services for broad-spectrum hemp extracts, and not CBD isolates, which Trosin said are “still considered a drug, so we can’t certify it as a dietary supplement. Once FDA comes out with a stance on that and says it’s an acceptable dietary ingredient, we’ll revisit, but we can’t get out ahead of that.” He said NSF is limiting its scope to products containing no more than 70% CBD content, “because otherwise it starts to flirt with isolate.”
While testing for THC content is well within NSF’s analytical wheelhouse, certification is not so simple, Trosin said. “The certification side is much more complex because you have to look and make sure there’s a safe upper limit, because it’s not just about certifying that the content is there; it’s that it’s there at a safe level. So when we certify a product, we’re first verifying the cGMP"-current good manufacturing practices-"atmosphere in which it was produced, so before product can be submitted for certification, it has to be produced in an NSF cGMP–registered facility. And then it comes in for testing and the label is reviewed. It goes for a complete lineup of contaminant testing, including heavy metals and microbes, aflatoxins, in this case pesticides, and then we do identification testing.”
“We’re currently doing test-only work on the products because that’s different than certification," he continued. "So when we test, it’s just a yes/no. It’s a test report.”
Is it difficult to test hemp products for THC content? The testing labs we spoke to said that it is not much different than testing for any of the other constituents that analytical labs are asked to check for.
“It’s just one more plant,” said Alkemist Labs’ CEO Elan Sudberg at SupplySide West. “We test almost 2000 of them, and it’s just one more. I know it’s an exciting category and it’s gotten a lot of attention, but to me, it’s just one more plant and one more analyte.” (Alkemist actually tests to a stricter limit than U.S. regulations, instead testing to the 0.2%-or-less THC threshold set by the European Union’s agricultural cannabis policies.)
Testing finished products is more complicated, he said. “Finished products test differently than ingredients, so if [we’re testing] a bunch of complicated gummies, it might be slower.”
He elaborated: “It can be done. It just takes more development. It takes more time to essentially test a method on it and test for robustness and repeatability.”
Trosin said that THC testing is also not new to NSF. For instance, NSF already tests products for THC content (or lack of THC) as part of its longtime NSF Certified for Sport program, which ensures that products used by athletes are devoid of banned substances.
“We’ve been doing this type of testing for a long time,” Trosin said. “This is just another ingredient. It takes some different considerations than other ingredients-but then there are a number of things, like protein, that take special consideration. So we are very good, and our expertise runs very deep in terms of developing the methods, and we’ve been testing for THC for a long time. It’s part of our other programs.”
Sudberg said Alkemist Labs decided to get into this market specifically at this time for good reason. “Our strategy was to wait for our industry, the customers we already have, to start incorporating these ingredients, and then they’ll come to us, their lab that they’ve always used, rather than go out hunting,” he said. “I was hoping to work with companies that are established and that have good products, so those are the ones that are coming to us and saying, ‘We’re ready to launch our hemp product.’”
Finding a good testing lab is more challenging than some companies realize, Trosin said. “One of the things we’ve seen in the marketplace is a lot of new labs popping up, and there are certainly some really legitimate labs out there. But as we see a lot of new service providers pop up, what we’re hearing from our customers is, ‘I sent three samples of the same product to a lab and got three different results. Three completely different results.' So, especially in a situation like this, faster and cheaper is not always the best approach. It may be a little better to go deeper, with greater expertise, and make sure you’re getting something other than just a piece of paper. And think about the people who aren’t sending out duplicate samples. They’re just getting a Certificate of Analysis back and saying, ‘It must be good.’ So, we would look at that and say, ‘Wouldn’t it be better to send one or two samples to a highly qualified lab than having to feel like you have to send multiple samples to other labs?’”
Sudberg also sees quality in the lab space vary, and not just regarding hemp but other ingredients as well. “It’s the same thing with caffeine and green tea,” he said. “You send it to three different labs, they use three different methods, and you get three different results. All the good labs in the industry will tell you that.” He said that testing to the 0.2% THC threshold, rather than 0.3%, also helps safeguard against variations between labs or tests.
NSF Not Certifying for Sport
Trosin said that although NSF does regularly test sports products as part of its NSF Certified for Sport, it will not be certifying any hemp products through this program. This is namely because NSF’s sports partners for which it acts as an exclusive certification body, from Major League Baseball to the National Football League, “have yet to make CBD or broad-spectrum hemp eligible for use by their athletes, so we can’t get ahead of that. And we can’t let the athletes think that there’s a product that’s approved for their use unless their leagues say that we, as a policy, approve use of broad-spectrum hemp.” Most sports leagues adhere to the World Anti-Doping Agency (WADA) guidelines, he added, and “WADA has yet to approve the use, or the complete use of, this type of product.”
“In terms of [NSF Certified for Sport] certification,” Trosin said, “it’s not eligible for that program until a lot of things change. So we’re not even addressing that.”
Cleaning Up the Market
It's clear that the CBD and hemp market is in dire need of clarity in order for manufacturers-and retailers-to determine who the responsible players are. At this year’s SupplySide West show, more reputable suppliers begun rolling out CBD and hemp offerings for the first time, enabling companies to find these ingredients from some of their trusted suppliers.
But in large part, Sudberg said, “It’s still a huge mess. There are still a ton of companies in the market selling a ton of stuff with a ton of quality varieties, and a ton of different labs doing a ton of different methods and producing a ton of different results. So it is confusing.”
He said Alkemist Labs has begun testing samples under the ICAP program. Surprisingly, he said, while Alkemist has received requests to test CBD and hemp ingredients even prior to ICAP’s formation, noting that it’s probably “the number-one HPLC test we run these days," the lab hasn’t received a “flood” of demand yet specifically from ICAP.
“We thought there would be a flood of it. I think people in that industry are still confused about what they need to do, should do, and who to do it with. So no one is quick to move on this,” he said. Nevertheless, he said, “there’s definitely a flood coming.”
We spoke to several of the ingredient supply companies introducing hemp ingredients at SupplySide West. They agreed that these certification programs could help distinguish good players from bad.
“Yes, I think it will help,” said Randy Kreienbrink, vice president of marketing for BI Nutraceuticals (Rancho Dominguez, CA), which introduced full-spectrum hemp offerings for the first time at SupplySide West. “And it’s names that people will recognize and that they’ll get behind.”
CV Sciences (San Diego, CA) is also a fan of more trusted and respected certification companies getting into the CBD and hemp game. The company was one of the first certified by the U.S. Hemp Authority. “We want to keep getting more and more of these organizations to basically sign off on what we’re doing,” said Jesse Karagianes, vice president of sales for CV Sciences, at SupplySide West.
Certification, as it always does, will help level the playing field, said NSF’s Trosin: “Our job is to level the playing field from a quality standpoint. That’s where we’re hoping to be able to help the industry really inform the consumer. That if they’re looking at a product, they can look at it and say, ‘I can trust this product; this other one I don’t know about.’”
While he acknowledged that the cost of NSF certification might be “prohibitive” to some smaller companies, “that’s the nature of a start-up business, that cost is important.”
“But,” he continued, “the law is the law. It’s not differentiated by number of employees or the revenue. The law is the law, whether you have one employee or 1000 employees. So, I think that’s going to be important because of the smaller companies needing that guidance, needing that differentiation. The larger companies will get there, and they’ll get there with greater ease. They’re very sophisticated. And they won’t have a problem.”
More certifications will hopefully prevent irresponsible players in the hemp and CBD market from sullying the industry as a whole down the line. “[H]opefully it helps the industry in general look at this and say we all have to raise the bar because if with this new line coming in, we’re just going to have more spotlight on us, and let’s face it, outside of industry press, we don’t have the mainstream press necessarily looking to write a lot of positive stories about the industry. And so if we can all utilize this opportunity to raise the bar, I think we’ll all benefit,” said Trosin.