DIETARY SUPPLEMENTS

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FDA to Strengthen Dietary Supplements Regulation

Posted on February 12, 2019

On February 11, FDA Commissioner Scott Gottlieb, M.D. announced a new plan for modernizing and strengthening dietary supplement regulation and oversight. In making the announcement, Dr. Gottlieb pointed out

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In Light of 2018 Farm Bill, FDA Issues Statement on Use of CBD in Food; Completes Evaluation of 3 Hemp-Related GRASNs

Posted on January 2, 2019

The Agriculture Improvement Act (also known as “the 2018 Farm Bill”) was signed into law on December 20, 2018. Among other things, the law changes certain federal authorities relating to

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Contrary to Popular Reports, Farm Bill Will Not Affect FDA Status of CBD

Posted on December 13, 2018

Media outlets are reporting that a Farm Bill provision removing industrial hemp (Cannabis sativa L.) from Schedule I of the Controlled Substances Act will change the FDA status

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FDA Finds High Levels of Heavy Metals in Kratom Products

Posted on November 30, 2018

In a press announcement released on November 27, 2018, FDA Commissioner Scott Gottlieb revealed that FDA scientists found “disturbingly” high levels of heavy metals in kratom products. Kratom, also known

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FDA Action Against Dietary Supplements Containing Tianeptine Signals Renewed Focus on Protecting Consumers from Dietary Supplements with Unauthorized Drug Claims

Posted on November 26, 2018

The Dietary Supplement Health and Education Act of 1993 (DSHEA) was intended to provide a framework for FDA to regulate dietary supplements. DSHEA established a new category

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FDA Announces Continued Kratom Safety Concerns and Issues Warning Letters to Kratom Marketers

Posted on September 12, 2018

In a press announcement released on September 11, 2018, FDA Commissioner Scott Gottlieb, M.D., emphasized the Agency’s continuing concerns about kratom products. Our readers may remember our previous posts about

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FDA Renews Cautions Against Consumption of Kratom Following Conclusion of Salmonella Investigation

Posted on July 5, 2018

Kratom is a botanical substance that grows naturally in Southeast Asia. FDA classifies kratom as an opioid, noting that it is addictive and has been linked to severe health consequences

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FDA Warns Companies Illegally Marketing Dietary Supplements as Sunscreen

Posted on May 23, 2018

On May 22, 2018, FDA sent warning letters to companies illegally marketing dietary supplements that make unproven drug claims about sun protection without meeting FDA’s standards for safety and effectiveness.

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FDA Targets Highly Concentrated Caffeine in Dietary Supplements

Posted on April 17, 2018

As previously reported on this blog in 2015, FDA warned that it intended to “aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.” The Agency

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FDA Issues First Ever Mandatory Recall Order for Kratom Products

Posted on April 4, 2018

On April 2, 2018, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for

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