Breaking Down the FDA Announcement

Breaking Down the FDA Announcement

Hey New Brew family,

You may have seen the headlines about the FDA taking action on '7-OH' and kratom. With so much media coverage, we wanted to share a clear, simple update. As part of our commitment to being a trusted source of information on the plants in New Brew, we're here to help break things down.

The Core Update

On Tuesday, July 29th, the FDA announced its intent to recommend that all products containing concentrated levels of the kratom alkaloid 7-hydroxymitragynine (“7-OH”) be scheduled under the Controlled Substances Act.

While 7-OH is naturally found in kratom, it typically makes up less than 2% of the plant’s 40+ alkaloids. For reference, New Brew contains just 0.08% 7-OH—well within naturally occurring levels.

Why Is This Happening?

In recent years, some companies began isolating 7-OH in its pure form and selling it in highly potent products like tablets and gummies—often branded as “kratom.” But it’s critically important to understand that these products are not kratom. They’re lab-manipulated derivatives with entirely different safety profiles and potential for misuse.

This Isn’t a Kratom Ban

Kratom products, as broadly defined by the FDA, will not be impacted by this latest action. That’s good news for us. The FDA has specifically communicated that it is distinguishing between products with natural or “trace” amounts of 7-OH and those that have been intentionally manipulated to contain higher levels. New Brew is not one of those.

What Kind of Kratom Is in New Brew?

We use broad-spectrum kratom extract that maintains the plant's natural balance and alkaloid composition. As mentioned, New Brew contains 0.08% 7-OH by volume—right in line with what you'd find in nature.

While the FDA hasn't set exact thresholds for 7-OH levels, everything indicated so far suggests those thresholds will be far higher than anything found in a New Brew. All signs point to the majority of leaf kratom and broad-spectrum extract products remaining unaffected.

Our Take

While prohibition usually isn't the ideal long-term solution, something had to be done about the flood of hyper-potent 7-OH products hitting the market—products entering the space with no guardrails and little consumer awareness. We believe this action from the federal government will help protect access to traditional kratom products for informed adults who choose to use them.

While the existential threat to natural kratom may have been reduced, we still believe its long-term availability will depend on a federal framework of common-sense laws that protect responsible companies and consumers alike.

Bottom Line

This news doesn't affect us, our retailers, or how we make our products. We see it as a step toward smarter regulation—one that draws a clear line between the kratom plant and synthetic knockoffs.

As always, thanks for being part of our community.

With love,

New Brew Team

 

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