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New Draft Guidance on FDA Enforcement Discretion for Past-Due NDI Notifications

Posted on May 23, 2022

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 Warning Letters to 11 Supplement Companies

Posted on May 11, 2022

On May 9, the FDA posted warning letters to 11 companies for selling adulterated dietary supplements that either contained new dietary ingredients (NDIs) for which the FDA had not received

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FDA Confirms N-acetyl-L-cysteine (NAC) is Excluded From the Dietary Supplement Definition and Leaves Open Potential Rulemaking to Allow the use of NAC in Dietary Supplements

Posted on April 4, 2022

We previously reported on FDA’s November 24, 2021 tentative response denying requests in two citizens petitions (June 1, 2021 Council for Responsible Nutrition (CRN) petition and August 18, 2021 Natural

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FDA Publishes List of Priority Guidance Documents

Posted on February 2, 2022

On January 31, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released a list of draft and final guidance topics

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FDA Seeks Information on N-acetyl-L-cysteine (NAC)

Posted on November 29, 2021

N-acetyl-L-cysteine (NAC) is widely available as a dietary supplement and is also used to treat acetaminophen (Tylenol) poisoning and other conditions, such as lung collapse. In July 2020, the U.S.

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FDA Releases List of Draft & Final Guidance Topics

Posted on June 30, 2021

On June 29, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released a list of draft and final guidance topics

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New Supplemented Foods Framework in Canada

Posted on June 28, 2021

Proposed New Regulatory Framework for Supplemented Foods in Canada

Prepackaged foods marketed in Canada as providing specific physiological or health effects, based on containing one or more added supplemental ingredients,

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FDA Warns Companies over Unapproved Fertility Claims

Posted on May 27, 2021

On May 26, FDA published a constituent update informing the public that it has issued warning letters to five companies for marketing dietary supplements that claim to cure, treat, mitigate,

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FDA Continues Enforcement Action Against Kratom

Posted on May 24, 2021

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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FDA Sends Warning Letters to Companies Illegally Selling Hangover Supplements

Posted on July 30, 2020

In a July 29, 2020 news release, the U.S. Food and Drug Administration (FDA) announced that it had issued warning letters to seven companies for illegally selling unapproved products

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