Only two of the 24 CBD products from eight companies cited in Warning Letters from the FDA on Feb. 4 passed the agency’s test for having the amount of CBD in the product that matched the amount claimed on product labels.
To be fair, 11 of the products made no declaration on the label as to the amount of CBD to be found inside the bottle. Still, eight of the remaining 13 products failed outright, and three others failed but were close. That makes 11 out of 13 products that failed. (Test results can be found here.)
To meet label claim, a product must contain at least the amount claimed on the label. The close failures were ones that were very close but contained less than the amount claimed on the label.
For example, Michigan Herbal Remedies’ US Hemp Wholesale 25 percent CBD Hemp Oil Supplement Gold Label claimed to contain 250mg/g CBD, but the FDA test showed it contained only 244mg/g – fail. Another of its products, Endoca Hemp Oil, claimed 150mg/g and came in at 159mg/g – pass.
But others were not even close. Some of these things failed by an order of magnitude – 100 times less than claimed.
“According to the FDA lab results, some of these products contain much less CBD than claimed on the label,” said Holly Johnson, Ph.D., laboratory director at Alkemist Labs, a contract testing company based in Southern California. “Ensuring proper dosage in cannabis products with oral administration routes is a manufacturing and testing challenge, but most of these warning letters also concern marketing claims that are not allowed by DSHEA.”
How can you save the children?
This is a pretty big issue, especially considering that the most celebrated use of CBD is for seizure conditions. The Denver Post has reported on hundreds of families from around the country who have moved to Colorado to access CBD when it first came to light that CBD could ameliorate seizure symptom in their disabled children.
“There’s a concerning aspect to it,” said Alice Mead, vice president of U.S. professional relations for GW Pharmaceuticals, the company FDA says has supremacy over CBD supplements because the U.K.-based pharma company filed for an Investigational New Drug in 2005. If a drug is on the market before a supplement, by law a supplement can never come into the market, making CBD illegal as a supplement because it came on the market after 2005, according to the FDA's reckoning. “FDA sent the first warning letters out in February 2015, and half had no CBD. You have a vulnerable patient population and a lot have no CBD,” said Mead.
And that gets back to the other issue with supplements today—that they are not meeting the bar set for Good Manufacturing Practices (GMPs) because companies are not properly testing either incoming ingredients or finished products. In the last year records were released, fiscal year 2014, the FDA noted about 19 percent of all companies that failed GMPs did so because of inadequate testing to ensure the supplement contained everything inside the bottle that is listed on the label.
The FDA does not conduct tests on all products that are subject to Warning Letters, though the agency does do so when testing for the presence of illegal pharmaceutical analogs in products.
The Council for Responsible Nutrition has compiled a database of FDA Warning Letters to manufacturers and marketers of supplements. In 2015, FDA issued 83 Warning Letters, of which 53 were for the problem of making drug claims, which is what every CBD marketer cited by FDA this month was cited for. Interestingly, while the number of Warning Letters is trending upward, from 61 in 2013 to 69 in 2014 to 83 in 2015, the number of follow-up letters for significant violations of the GMP regulations have dropped, from 43 in 2013 to 37 in 2014 to 24 in 2015. Steve Mister, president of CRN, called this “one bright trend.”
The trend suggests that while the larger supplements industry is perhaps getting better at fixing GMP problems, that message has not quite trickled down to the nascent CBD world.
But some people say that the eight companies cited represent scofflaws and not the responsible core of the CBD market.
"The companies that received the letters were outside the mainstream," said Eric Steenstra, president of Vote Hemp and also executive director of the Hemp Industries Association. "I think the companies that got involved with the warning letters were outliers."
Sarah Syed, director of marketing at CV Sciences (formerly Cannavest), noted that CV Sciences’ CBD product—a top seller nationwide—did not receive a Warning Letter. And that’s because products make no health claims, are strictly standardized so there would be no failed tests and, perhaps most importantly, are not even marketed as cannabis.
“As a company,” Syed said, “we are positioning ourselves outside of the marijuana discussion because we are in the business of hemp. It is possible the ‘establishment’ may not be able to wrap their head around the benefits of cannabis considering the abundance of confusion that remains around the cannabis plant, the overwhelming stigma that we have been faced with for the better part of the last century.”