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The Daily Intake

Legal and Regulatory updates for the food and supplement industry

GUIDANCE

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FDA Draft Guidance: Scaling Back Sodium

Posted on June 2, 2016

FDA issues draft guidance to encourage food industry to reduce sodium added to food.

  • According to FDA, average sodium intake in the U.S. is too high at approximately 3,400 mg/day. 

…
Continue Reading FDA Draft Guidance: Scaling Back Sodium

FDA Final Guidance on “Evaporated Cane Juice”

Posted on May 25, 2016

FDA releases final guidance regarding use of the term “evaporated cane juice” on food labeling.

  • As previously covered on this blog, food companies have been grappling for years with

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Continue Reading FDA Final Guidance on “Evaporated Cane Juice”

FSMA Guidance: Qualified Facility Q&A

Posted on May 16, 2016

FDA issues draft guidance regarding “qualified facilities” under FSMA HARPC framework.

  • In September 2015, FDA issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions of

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Continue Reading FSMA Guidance: Qualified Facility Q&A

Medical Food FAQs

Posted on May 12, 2016

FDA issues final guidance related to medical foods.

  • Medical foods are a special sub-category of foods that are “formulated to be consumed or administered enterally under the supervision of a

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Continue Reading Medical Food FAQs

Pets and Vets: Therapeutic Vet Diet CPG Finalized

Posted on May 3, 2016

FDA finalizes enforcement policy with respect to therapeutic veterinary diets.

  • As a general matter, companies may not make therapeutic or “drug” claims in connection with the marketing of food or

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Continue Reading Pets and Vets: Therapeutic Vet Diet CPG Finalized

Final Menu Labeling Guidance Issued

Posted on May 2, 2016

FDA issues final menu labeling guidance.

  • As previously covered on this blog, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug,

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Continue Reading Final Menu Labeling Guidance Issued

Infant Formula Guidance Issued

Posted on April 18, 2016

FDA issues guidance on production of exempt infant formula.

  • In 2014 — 17 years after the initial proposed rule was issued — FDA finalized its rulemaking related to the manufacture

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Continue Reading Infant Formula Guidance Issued

Risk Reduction: Arsenic Limit for Infant Rice Cereal

Posted on April 4, 2016

FDA proposes limit for inorganic arsenic in infant rice cereal.

  • Arsenic is a naturally-occurring element that can be found in water, soil, and air.  Long-term exposures to one type of

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Continue Reading Risk Reduction: Arsenic Limit for Infant Rice Cereal

Acrylamide Guide

Posted on March 11, 2016

FDA issues final guidance on reduction of acrylamide in certain foods.

  • Acrylamide is a chemical that forms during high-temperature cooking of certain foods, e.g., in the preparation of French fries,

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Continue Reading Acrylamide Guide

Supplement SOI Snafu Solved

Posted on March 8, 2016

FDA updates dietary supplement labeling guidance to confirm “dietary supplement” as appropriate SOI.

  • In April 2005, FDA issued a guidance document entitled, “A Dietary Supplement Labeling Guide.”  The guidance covers

…
Continue Reading Supplement SOI Snafu Solved

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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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