- Delta-8 Tetrahydrocannabinol (Delta-8 THC) is an isomer of Delta-9 THC, the intoxicating component of certain cannabis plants. It is naturally occurring at very low levels in hemp and can be
FDA ENFORCEMENT
FDA Issues Warning Letters to 7 Dietary Supplement Companies for Drug Claims
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- On November 17, 2022, FDA posted warning letters to 7 companies for selling different dietary supplements with claims that caused the products to be “drugs” in violation of the Federal
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New Draft Guidance on FDA Enforcement Discretion for Past-Due NDI Notifications
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- The Dietary Supplement Health and Education Act of 1994 (DSHEA) requires manufacturers and distributors who wish to market a dietary supplement containing a new dietary ingredient (NDI) that has not
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FDA Issues Company-Wide Warning Letter Re Pet Food
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- FDA issued a corporate-wide warning letter to Midwestern Pet Foods, Inc. (Midwestern) on August 9, 2021. The letter states that inspections of the company’s pet food manufacturing plants revealed violations
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FDA Continues Enforcement Action Against Kratom
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- FDA has warned consumers for years against using products containing Mitragyna speciosa, a plant from Southeast Asia that is commonly known as kratom, or its psychoactive compounds, mitragynine and
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Blue Bell Fined Record $17.25 Million in Post-Conviction Criminal Penalties for Listeria Outbreak
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- As previously reported on this blog, a multi-state listeriosis outbreak in 2015 linked to Blue Bell Creameries LP’s ice cream products contaminated with Listeria monocytogenes led to recalls, state
FDA Issues Final Compliance Policy Guide on the Use of The Seafood List to Determine Acceptable Seafood Names
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- The U.S. Food and Drug Administration (FDA) has issued a final Compliance Policy Guide (CPG), Sec. 540.750, on the “Use of The Seafood List to Determine Acceptable Seafood Names
FDA and FTC Issue Warning Letters to Companies Marketing and Selling Products Deemed Fraudulent for the Treatment or Prevention of COVID-19
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- On May 26, 2020, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued joint warning letters to four companies for the marketing and sale of products
Federal Court Enters Temporary Restraining Order Against Xephyr LLC (dba N-Ergetics) to Prevent the Sale and Distribution of Colloidal Silver Products for Treatment of COVID-19
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- On May 14, 2020, the Hon. Ronald A. White, a federal judge in the United States District Court for the Eastern District of Oklahoma, issued a Temporary Restraining Order (“TRO”)
Blue Bell Pleads Guilty to Distributing Adulterated Ice Cream and Former President Faces Charges of Criminal Conspiracy to Conceal Listeria Contamination
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- A multi-state listeriosis outbreak linked to consumption of Blue Bell Creameries’ ice cream products in 2015 lead to state regulatory enforcement actions (discussed here) and multiple civil lawsuits. As