Delta-8 THC marketer faces ‘conundrum’ after receiving FDA letter
The recipient of a warning letter goes ‘on record’ to discuss his business, his planned response to FDA and the U.S. markets for CBD and delta-8 THC.
The chief science officer of a company that received an FDA warning letter targeting the sale of products containing delta-8 THC and CBD said he respects the agency’s “opinions” and will “make appropriate changes” to comply with its “desires and demands.”’
“I plan on making every single change that’s requested in that letter,” Mark Hubbard of M Six Labs Inc. said in an interview. “I think that these are all gray areas that need to be defined as black or white.”
On the other hand, Hubbard acknowledged he faces a quandary after his company received a letter from FDA that identified improper marketing claims and other issues related to delta-8 THC and CBD, two substances from cannabis that are intertwined since delta-8 THC is typically made from hemp-based CBD through a process of chemical synthesis.
“We have a conundrum on how … we function as a business without being able to market our business,” Hubbard told Natural Products Insider. “This is a big problem. Now, I’m being handicapped versus everybody else.”
In a May 4 letter to M Six Labs CEO Terry Maxwell, FDA concluded M Six Labs’ claims on its website—such as “Fighting Cancer . . . Δ8 may also have cancer-fighting properties”—established its CBD and delta-8 THC products are unapproved new drugs. The products also are "misbranded" because they fail to include adequate directions for use as a drug, according to FDA.
“I can go to a handful of sites out there—dozens and dozens that make exactly similar claims,” remarked Hubbard, who’s also a minority owner of M Six Labs. “I could go on social media and find this non-stop.”
In the warning letter to M Six Labs, FDA stated adding CBD to food is a “prohibited act” given the compound was studied as a drug, and CBD and delta-8 THC products are “adulterated” since they contain an “unsafe food additive.” The company also was advised CBD cannot be lawfully marketed as a dietary supplement, a position long held by FDA.
Along with M Six Labs, FDA delivered warning letters to ATLRx Inc., BioMD Plus LLC, Delta 8 Hemp and Kingdom Harvest LLC. None of the companies responded to emails from Natural Products Insider seeking comment.
Hubbard said the marketing claims have been on his website for years, and FDA had raised no issues until now.
“These are gray-area statements,” he said. “We want to communicate a message, but we have to be strategic about how we communicate that.”
Minor panic, major implications
He acknowledged his business partners have expressed trepidation over the FDA letter, but added, “It’s not a cease-and-desist letter… [There are] many worse things that can come from the FDA. This is just a clarification that, ‘Hey, your words are not right.’”
Hubbard shared customers have called “in a panic saying that they’re fearful that the quality of product that we provide for them that has changed the quality of their life is something that may not be available to them.”
Hubbard juxtaposed an industry that has been years in development with FDA’s statements regarding CBD products for human consumption.
“Can we consume this product, yes or no?” he asked. “If not, man, there’s a lot of people that are going to be financially hurt all over this whole entire country that have invested their life savings, their time and effort into developing products that are consumed.”
“This is a problem for the FDA,” Hubbard continued. “It’s a bad situation for the entire industry and ultimately for farmers because they’re at the bottom of the food chain trying to make money off of this.”
He added, “My cousin married a dairy farmer 40 years ago, and he makes less money now than he did in the ‘80s milking cows. That’s a bigger problem than saying we’re making gray-area suggestions of what CBD or cannabinoids can do for the human.”
Hubbard expressed hope that federal regulators would turn their agenda to regulating “delta-8 as a product that people want to consume—no different than the 132 other different cannabinoids—and not control them and limit access.”
In the absence of a federal regulatory framework, states across the U.S. have taken myriad approaches to regulating cannabinoids, work that continues to this day. M Six Labs is based in Wisconsin, where a legislative service agency in July 2021 issued a two-page brief on delta-8 THC, asserting its legality “under the controlled substances laws remains an open question.”
“Naturally occurring delta-8 THC extracted from hemp is likely not controlled by federal or state law,” the Wisconsin Legislative Council concluded. “However, if the conversion of delta-8 THC from hemp-derived CBD renders the substance ‘synthetically’ derived or ‘chemically synthesized,’ then it constitutes a Schedule I substance under federal and state law. Until regulators or lawmakers provide further clarity, the legality of delta-8 THC appears to depend significantly on the nature and characterization of the process used for its production.”
During an interview a few days after FDA announced its warning letters, Hubbard said he wields “some political influence” in Wisconsin and had scheduled meetings with a few state senators to discuss delta-8 THC. He did not identify them. He said he also requested a meeting with the office of Wisconsin Attorney General Josh Kaul.
‘Nobody’s shoving a gummy bear up their butt’
Hubbard was a bit perplexed that, in addition to delta-8 THC, FDA discussed CBD in its warning letters. Commenting on the number of companies selling CBD products in the U.S., he said, “I could list thousands.”
The practice of adding CBD to food, he noted, is widespread.
“I know over 300 companies in Washington state that sell CBD products in food under the recreational [marijuana] system,” he said. “Why are [FDA officials] stretching their muscle to only one small segment when there’s Colorado, Chicago or Illinois, Washington state, California, Oregon. Those are just five that regularly sell CBD products.”
He added, “You’re going to single out five companies out of thousands in the United States that market this as food. Nobody’s shoving a gummy bear up their butt.”
Asked whether he planned to stop marketing CBD in food, Hubbard said, “We’ll change it to an intent-of-use product. We will not market it as a food… If you believe it does something for you, you can use it for that.”
M Six Labs also plans to remove “dietary supplement” language from products it’s selling, according to Hubbard.
“Now, is it going to become nutritional information?” he stated. “Don’t know. ‘Nutritional’ means something that could be consumed. I think that’s the directed language that is complicating the situation.”
In the warning letters to M Six Labs and others, FDA concluded:
Delta-8 THC features “intoxicating” and “psychoactive” effects.
Delta-8 THC products haven’t been assessed or approved by FDA for safety.
And delta-8 products may be marketed in ways that endanger public health.