Legal / Regulatory

The latest news, analysis and updates on Legal / Regulatory

Herbsens Botanicals – Warning Letter

This warning letter addresses regulatory violations identified at Herbsens Botanicals during an FDA inspection. The inspection revealed significant issues regarding the labeling and marketing practices of

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NDI 1264 FDA

The FDA requires manufacturers or distributors of dietary ingredients introduced after October 15, 1994, to submit an NDIN at least 75 days prior to marketing the

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NDI 881 FDA

The document is an NDI application letter related to a kratom product called Atomic K. Below you will also find the response from the FDA, indicating

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Kratom Exchange – Warning Letter

On June 30, 2022, the U.S. Food and Drug Administration (FDA) issued a warning letter to the Kratom Exchange, addressing significant concerns regarding the marketing practices

Klarity Kratom – Warning Letter

On June 30, 2022, the U.S. Food and Drug Administration (FDA) issued a warning letter to Klarity Kratom, a manufacturer of kratom products, highlighting significant regulatory

Herbsens Botanicals – Warning Letter

This warning letter addresses regulatory violations identified at Herbsens Botanicals during an FDA inspection. The inspection revealed significant issues regarding the labeling and marketing practices of

Front Range Kratom – Warning Letter

On May 18, 2018, the U.S. Food and Drug Administration (FDA) issued a warning letter to Front Range Kratom regarding the sale and distribution of kratom

Chillin Mix Kratom – Warning Letter

On September 4, 2018, the U.S. Food and Drug Administration (FDA) issued a warning letter to Chillin Mix Kratom, addressing significant safety concerns associated with the

NDI 1264 FDA

The FDA requires manufacturers or distributors of dietary ingredients introduced after October 15, 1994, to submit an NDIN at least 75 days prior to marketing the

NDI 881 FDA

The document is an NDI application letter related to a kratom product called Atomic K. Below you will also find the response from the FDA, indicating

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