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The Daily Intake

Legal and Regulatory updates for the food and supplement industry

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FDA Letter States that β-Nicotinamide Mononucleotide is Not Lawful Dietary Supplement

Posted on December 13, 2022
  • This past summer Inner Mongolia Kingdomway Pharmaceutical Limited (“Kingdom”) submitted a new dietary ingredient (NDI) notification to FDA for β-Nicotinamide Mononucleotide (NMN), a compound that has been touted for its
… Continue Reading FDA Letter States that β-Nicotinamide Mononucleotide is Not Lawful Dietary Supplement

New Draft Guidance on FDA Enforcement Discretion for Past-Due NDI Notifications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

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Continue Reading New Draft Guidance on FDA Enforcement Discretion for Past-Due NDI Notifications

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

…
Continue Reading FDA Issues Warning Letters to 11 Supplement Companies

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Recent Updates

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  • Texas Court Blocks Enforcement of Texas Warning Label Requirement

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Keller and Heckman, founded in 1962, has a broad practice in the areas of regulatory law, public policy, and litigation, serving both domestic and international clients. Our firm is a pioneer in the use of interdisciplinary approaches to problem-solving. Since 1971, we have had an in-house scientific staff that works closely with the firm’s attorneys on matters of technical complexity. Many of our attorneys also have government experience and expertise in multiple areas of the law.

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