Delta-8 THC marketer faces ‘conundrum’ after receiving FDA letter

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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.

“Has it been evaluated? No,” Hubbard conceded. “It has not been evaluated as a drug to do anything, but it doesn’t mean that it’s unsafe.”

‘Vanilla' packaging, no marketing to kids 

FDA raised additional concerns about labeling and packaging of delta-8 products that may appeal to kids, and the agency said it has received adverse event reports involving products containing delta-8 THC. Some of these adverse events have led to hospitalizations or treatments at emergency rooms, FDA said.

M Six Labs has received no reports of adverse events linked to its products, according to Hubbard.

“I’ve never heard of any of these claims, and we’ve been selling products for over two years,” he said. “I regularly go to trade shows and communicate online with people. They communicate back with me their effects and what happens with them.”

Hubbard said he is aware of companies in the recreational marijuana market that incorporated delta-8 THC in cannabis products without letting consumers know.

“Most likely, somebody got something that was over 0.3% delta-9 THC and that created the intoxication,” Hubbard said. “That created the negative effect.”

He said M Six Labs tests the batches of its products, and none of them exceed 0.3% delta-9 THC—the threshold specified in the federal 2018 Farm Bill, which legalized hemp across the nation.

“There’s no products that are sold by M Six Labs that exceed 0.3% delta-9 because of the potential for somebody to get something that they’re not anticipating,” Hubbard said.

Commenting on his testing and documentation practices, Hubbard noted “family members consume these products, and I want them to get what they’re anticipating for something that is going to change the quality of their life.”

Hubbard described the packaging of his products as “very vanilla, and he said M Six Labs requires age verification for its shipments.

“We clearly state on our products and on our label that nobody under 21 is supposed to have this or consume this product,” he said. “This is something that we take very seriously to not market to kids.”

Asked how his contacts have reacted to the FDA warning letter, he responded, “Certain partners and investors are way more conservative, and this is something that keeps them up at night—something from the FDA.”

Hubbard, on the other hand, viewed the letter as “just a course of being in the cannabis and marijuana industry.”

“This is nothing new to me,” he said.

 

 

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