Kratom & 7-OH Update

This past June, the US Food and Drug Administration (FDA) issued warning letters to seven companies for illegally distributing products containing 7-OH, including tablets, gummies, drink mixes and shots. In late July, FDA announced it would begin taking steps to restrict the sale of 7-OH products.

FDA published recommendations in July about the potential risks associated with 7-OH products with the aim to educate the public about the health concerns of 7-OH and the distinctions between 7 -OH and kratom.

FDA and DEA have been scrutinizing kratom products for well over a decade. There have been attempts to have kratom classified under Schedule I of the Controlled Substances Act (CSA). However, even though bills have been introduced in Congress, none have passed, and kratom remains federally "legal." In addition, seven states and a handful of municipalities have banned the sale of kratom. For example, some local governments in California have already taken action, with the cities of San Diego, Newport Beach and Oceanside banning the sale of kratom.

With regards to 7-OH, FDA recommended in July that the substance be made federally illegal via a Schedule I classification under the Controlled Substances Act, though the natural kratom products would remain available. At some point in the near future, we may see another push in Congress to declare kratom and/or 7-OH declared illegal.

At the state level, Florida passed emergency regulations and at present is the only state to specifically ban 7-OH products.

California lawmakers have proposed a similar remedy (AB-1088) that would ban most concentrated 7-OH products. The bill would prohibit the sale of kratom products and 7-OH products to those under 21 years of age and would require the packaging of kratom products and 7-OH products to be child resistant. The sale and manufacture of a kratom product or 7-OH product that is attractive to children would also be prohibited. AB 1088 referred to the Senate Health Committee on June 11, 2025. However, the bill has not passed.

On October 24, 2025, the California Department of Public Health (CDPH) issued a press release advising consumers that food and dietary supplements containing kratom or 7-OH are illegal to sell or manufacture in California. Further, CDPH advised consumers to "avoid using 7-OH and kratom-related products." CDPH also indicated it will continue its enforcement activity in the coming months to remove kratom and 7-OH products from the market in California and urged anyone locating kratom and 7-OH to contact CDPH.

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