Optimized Plant Mediated Solutions, O.P.M.S., Kratom industry leader since 2010, applauds the U.S. Food and Drug Administration’s actions against dangerous products containing synthetically concentrated 7-hydroxymitragynine (7-OH). As part of those actions the Agency recommended the scheduling of certain 7-OH products under the Controlled Substances Act (CSA).

FDA also released letters to heath care professionals and consumers to educate them on the risks of these dangerous products masquerading as kratom. These documents highlight differences between natural kratom products and concentrated 7-OH products, saying “7-OH products are designed to look like everyday treats like gummies, candies, and ice cream” and “enhanced or spiked kratom products may appear to be natural leaf, but actually contain as much as 500% more 7-OH than would be expected naturally.”

This follows a series of warning letters issued to companies illegally marketing products containing 7-OH products and was careful to clarify that its efforts were not related to kratom products with naturally occurring trace amounts of 7-OH. The Agency reassured Americans that they are not focused on scheduling or taking action against natural kratom leaf products.

We applaud this enforcement action as a critical step for consumer protection. We encourage regulatory agencies and state officials to take aggressive action to remove these products from the market and safeguard the American public. We also encourage distributors to stop selling these products immediately.

O.P.M.S. kratom products are and have always been free of harmful, synthetic alkaloids like 7-OH. Our strict manufacturing processes ensure that all O.P.M.S. products contain only natural kratom alkaloids and comply with alkaloid content and purity regulations. We will continue to support scientific, legislative, and regulatory efforts to ensure Americans have access to safe, efficacious kratom products.

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