AHPA POLICY WARNS AGAINST LABELING 7-HYDROXYMITRAGYNINE AS KRATOM

Following a flurry of state-level actions targeting a specific alkaloid found in kratom, the American Herbal Products Association (AHPA) has issued guidance warning consumers about the risks associated with products falsely labeled as kratom. 

A lot has been made of 7-hydroxymitragynine (7-OH) and how it fits into the landscape of kratom products. Some states have set strict limits on the percentage of 7-OH that can be included in a product legally labeled as a “kratom product.” Others have left the market unregulated, set age limits or targeted kratom altogether due to a lack of guidance on the topic of 7-OH. 

As advocates continue to push for legislation against 7-OH, the AHPA’s guidance will be a welcome addition to the evidence against those particular products. 

Starting with the basics: 7-OH is an oxidation product of the naturally occurring elements in the kratom plant, meaning it’s an alkaloid that develops as the plant leaves dry out. Although it can be found in dried kratom leaves, the naturally occurring quantities of 7-OH in pure kratom leaves are far below the levels in kratom products that have been ‘enhanced’ with 7-OH. 

Scientists Sound Alarm

That’s why a group of researchers sounded the alarm in testimony in front of Congress in 2024. Dr. Christopher McCurdy testified specifically about 7-OH and its chemical profile after combining with a coalition of other researchers to publish a formal warning against 7-OH in June of 2024.

Both times, McCurdy’s message carried the same warning. 

“Such products should not be scientifically considered or commercially categorized as kratom or as a kratom product,” the statement read. “Companies making claims that such products are “kratom products” should not be considered to be making credible or factual claims.” 

When testifying in front of Congress, McCurdy showed the concentration of various alkaloids and compounds found in natural kratom products versus those that had been ‘enhanced’ by 7-OH. In addition to elevated levels of 7-OH found in the product, and the smaller concentration of kratom’s primary alkaloid, McCurdy pointed out that there were unknown alkaloids and compounds found in these “adulterated” products. 

With what researchers have learned about 7-OH, McCurdy and his group of researchers made it clear: Not only are these products NOT kratom, they cannot be classified as a supplement due to high amounts of compounds that are “isolated, purified, or semi-synthetically generated form(s)” of 7-OH. 

The statement concluded: “Instead, any such product is subject to the US Food and Drug Administration (FDA) process for drug approval as established in the Food, Drugs, and Cosmetic Act.”

That alarm was heard by a handful of states across the country. 

South Dakota became the 14th state to ratify some form of kratom protection with a law passed earlier this year that specifically targets 7-OH products. The threat of 7-OH was also behind the changes made to a proposed law in Missouri. As lawmakers have learned more about these ‘enhanced’ kratom products, the push to ban all kratom products has given way to a more focused approach. 

And that’s where the AHPA’s new guidance comes into play. 

The Value of ‘New Guidance’

As local governments across the country have debated kratom, 7-OH and other natural products, one recurring theme comes up in the discussions: A lack of available information and guidance. 

While the scientists have been sounding the alarm for years, the AHPA’s position on 7-OH gives kratom an ally beyond the companies and advocacy groups that have formed to support natural kratom. Whereas some lawmakers have been hesitant to support kratom regulations proposed by those who work in the industry, the AHPA’s press release provides third-party backing for what kratom advocates have been saying for years. 

“This policy also strongly discourages labeling or marketing such products as ‘kratom.’ AHPA has since 1999 held a trade requirement on the disclosure of added constituents,” said the press release. 

For example, a proposed law to ban synthetic alkaloids in Mississippi failed to advance due to confusion over allowable concentrations of 7-OH. At the hearing for the bill, the sponsor of the proposed law was unable to paint a clear enough picture of the problem presented by 7-OH to gather enough support to ratify the law. 

The updated AHPA policy sets a clear definition of “synthesized alkaloids” and provides the necessary information required for politicians to set clear definitions of what constitutes a natural kratom product. 

“AHPA strongly discourages the labeling or marketing as “kratom” of any product intended for consumption by any route that consists of or contains synthesized 7-OH or other synthesized kratom alkaloids,” said the new policy. 

Advocates also welcome the AHPA’s updated policy, particularly in light of recent developments from the FDA regarding the scheduling of 7-OH and actions against those making false claims. 

In the last month, the FDA has sent a batch of warning letters to 7-OH producers about false claims and misleading medical information, and held a press conference announcing plans to schedule 7-OH products. More importantly, the FDA said it is not targeting pure leaf kratom, leaving an exception for products that contain trace amounts of 7-OH, instead opting to target products with artificial levels of the potent alkaloid. 

“The boom of 7-OH products has been terrible for the perception of kratom,” said Super Speciosa founder Ken Loricchio. “The general population is not going to be interested enough in the subject to take the time to differentiate and understand the two products - and they are two completely different products.”

But now, with agencies such as the AHPA and the FDA making the key differentiation between kratom and 7-OH, Loricchio said the picture is clearing up about the future of kratom–and the future is natural kratom products.  

“7-OH is not kratom full stop…The positive is that we heard from the FDA this week, and for the first time, we have a commissioner who is publicly acknowledging that "kratom" products have a range of safety profiles depending on whether or not they contain the leaf's natural alkaloid profile, or if they contain synthetic alkaloids like 7-OH.”